Medication Errors and Patient Safety in Mental Health CME/CE · 2019. 6. 27. · Medication Errors...

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Medication Errors and Patient Safety in Mental Health CME/CE Complete author affiliations and disclosures are at the end of this activity. Release Date: September 26, 2007; Valid for credit through September 26, 2009 Target Audience This activity is intended for primary care and mental health clinicians who care for patients with psychiatric and substance abuse disorders. Goal The goal of this activity is to demonstrate critical system and practice areas contributing to medical errors in diagnosing or treating psychiatric or substance abuse disorders. Learning Objectives Upon completion of this activity, participants will be able to: 1. Summarize the historical background of efforts to reduce medical errors n psychiatry 2. Describe major classes of healthcare safety problems, such as missed diagnoses of mood and anxiety disorders, insufficient treatment, preventable adverse events, and errors of commission 3. Discuss errors in the use of seclusion and restraint and analyze efforts to reduce them 4. Review the factors that contribute to medical errors in high risk clinical populations, such as persons with comorbid diagnoses, children who may have ADHD, and recipients of electroconvulsive therapy 5. Analyze both systemic factors that affect patient safety and recommendations to address them Credits Available Physicians - maximum of 1.5 AMA PRA Category 1 Credit(s)™ for physicians; Nurses - 1.5 nursing contact hours (None of these credits is in the area of pharmacology) All other healthcare professionals completing continuing education credit for this activity will be issued a certificate of participation. Physicians should only claim credit commensurate with the extent of their participation in the activity. Accreditation Statements

Transcript of Medication Errors and Patient Safety in Mental Health CME/CE · 2019. 6. 27. · Medication Errors...

Page 1: Medication Errors and Patient Safety in Mental Health CME/CE · 2019. 6. 27. · Medication Errors and Patient Safety in Mental Health CME/CE Complete author affiliations and disclosures

Medication Errors and Patient Safety in Mental Health CMECE

Complete author affiliations and disclosures are at the end of this activity

Release Date September 26 2007 Valid for credit through September 26 2009

Target Audience

This activity is intended for primary care and mental health clinicians who care for patients with psychiatric and substance abuse disorders

Goal

The goal of this activity is to demonstrate critical system and practice areas contributing to medical errors in diagnosing or treating psychiatric or substance abuse disorders

Learning Objectives

Upon completion of this activity participants will be able to

1 Summarize the historical background of efforts to reduce medical errors n psychiatry 2 Describe major classes of healthcare safety problems such as missed diagnoses of

mood and anxiety disorders insufficient treatment preventable adverse events and errors of commission

3 Discuss errors in the use of seclusion and restraint and analyze efforts to reduce them 4 Review the factors that contribute to medical errors in high risk clinical populations such

as persons with comorbid diagnoses children who may have ADHD and recipients of electroconvulsive therapy

5 Analyze both systemic factors that affect patient safety and recommendations to address them

Credits Available

Physicians - maximum of 15 AMA PRA Category 1 Credit(s)trade for physicians Nurses - 15 nursing contact hours (None of these credits is in the area of pharmacology)

All other healthcare professionals completing continuing education credit for this activity will be issued a certificate of participation

Physicians should only claim credit commensurate with the extent of their participation in the activity

Accreditation Statements

For Physicians

Medscape LLC is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians

Medscape LLC designates this educational activity for a maximum of 15 AMA PRA Category 1 Credit(s)trade Physicians should only claim credit commensurate with the extent of their participation in the activity

For questions regarding the content of this activity contact the accredited provider for this CMECE activity CMEmedscapenet For technical assistance contact CMEwebmdnet

For Nurses

This Activity is sponsored by Medscape Continuing Education Provider Unit Medscape is an approved provider of continuing nursing education by the New York State Nurses Association an accredited approver by the American Nurses Credentialing Centers Commission on Accreditation

Awarded 15 contact hour(s) of continuing nursing education for RNs and APNs none of these credits is in the area of pharmacology Provider Number 6FDKKC-PRV-05

For questions regarding the content of this activity contact the accredited provider for this CMECE activity CMEmedscapenet For technical assistance contact CMEwebmdnet

Instructions for Participation and Credit

There are no fees for participating in or receiving credit for this online educational activity For information on applicability and acceptance of continuing education credit for this activity please consult your professional licensing board This activity is designed to be completed within the time designated on the title page physicians should claim only those credits that reflect the time actually spent in the activity To successfully earn credit participants must complete the activity online during the valid credit period that is noted on the title page Follow these steps to earn CMECE credit

1 Read the target audience learning objectives and author disclosures 2 Study the educational content online or printed out 3 Online choose the best answer to each test question To receive a certificate you must

receive a passing score as designated at the top of the test Medscape encourages you to complete the Activity Evaluation to provide feedback for future programming

You may now view or print the certificate from your CMECE Tracker You may print the certificate but you cannot alter it Credits will be tallied in your CMECE Tracker and archived for 6 years at any point within this time period you can print out the tally as well as the certificates by accessing Edit Your Profile at the top of your Medscape homepage The credit that you receive is based on your user profile

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Copyright copy 2007 Medscape

Contents of This CMECE Activity

o Medication Errors and Patient Safety in Mental HealthBenjamin C Grasso MD Miles

F Shore MD Cathryn M Clary MD MBA Benjamin Eng MD MA Kevin Ann Huckshorn RN MSN CAP ICADC Joseph J Parks MD Kenneth Minkoff MD Stanley J Evans MD FASAM PA Terry J Golash MD

Medication Errors and Patient Safety in Mental Health

Introduction

In To Err Is Human[1] and Crossing the Quality Chasm[2] the Institute of Medicine (IOM) shed light on high rates of medical errors and unintended harm to recipients of care Subsequent efforts in the Quality Chasm series have elucidated components of a safer healthcare system[3-8] However the series has largely focused on medical and surgical care In this article we address quality and safety concerns for another group of persons that are perhaps more vulnerable to unintended harm and less likely to advocate for themselves -- recipients of mental health and substance abuse treatment

The charge from the Institute of Medicines Committee on Crossing the Quality Chasm -- Adaptation to Mental Health and Addictive Disorders has been to produce a clear picture of the incidence and nature of errors and preventable adverse events in the treatment of mental illnesses and substance use disorders

Background

The number of persons receiving inpatient or outpatient treatment for mental illness and substance abuse disorders is substantial The Centers for Disease Control and Preventions

(CDC)s 2000 National Hospital Discharge Survey reported more than 2 million discharges for care recipients with an International Classification of Disease Clinical Modification (ICD-CM) Mental Disorder[9] Their 2001 National Ambulatory Medical Care Survey reported[10]

26 million visits with symptoms referable to psychologicalmental disorders

25 million visits with symptoms referable to the nervous system (excluding sense organs) and

51 million visits with symptoms referable to general symptoms

It is likely that a significant percentage of individuals in the 2 latter categories of visits have mental illness

Despite the staggering numbers few reports have been published on medical errors in mental health and substance abuse or related methodological issues[11-14] Some prominent psychiatric journals have yet to include medical errors or adverse drug events as keyword options for submitted manuscripts In addition terms more recently invoked in patient safety research such as near risks and preventable adverse events are largely unknown in mental health and substance abuse A MEDLINE search performed June 2004 using medication errors and psychiatry as search terms yielded 37 citations A similar search using medication errors and substance abuse yielded 69 citations and medication errors cross-referenced with addiction yielded 1 citation In contrast a search of medication errors in general yielded 4892 citations most of which were in anesthesiology and medicine

History

The study of unintended harm caused by medical errors began in the field of anesthesiology 20 years ago[15] At that time anesthesia death rates were roughly 1 in 10000 and there was a precipitous rise in medical liability premiums An anesthesia research foundation was formed numerous research and performance improvement initiatives were undertaken and death rates have since dropped to approximately 1 in 200000

In the early 1990s Classen and colleagues as well as Brennan and associates in the Harvard Medical Practice Study made forays into internal medicine patient safety research[16-18] Once the Institute of Medicine released To Err Is Human in 2000 the often-cited medical error mortality rate of 44000 to 98000 per year began to increasingly appear in the lay press[1] In 2000 the Centers for Disease Control reported that approximately 100000 persons die annually from hospital-acquired infection which heightened concerns over patient safety[19]

Crossing the Quality Chasm released by the Institute of Medicine in 2001 marked the beginning of the Quality Chasm Series focusing on remedies needed to transform the US healthcare system[1-8] The series chronicled the substantial progress made identifying and quantifying unintended harm incurred by medical and surgical patients and in developing the architecture of a patient safety regimen The time has come to apply this experience and frame of reference to the inpatient and outpatient care of mental heath and substance abuse patients

As a specialty psychiatry has started to adopt elements of the patient safety movement The American Psychiatric Association (APA) convened its first Task Force on Patient Safety in 2002[20] Four areas were presented as priorities (1) change in clinical culture to focus on patient safety (2) adverse medication events (3) use of seclusion and restraint and (4) suicides in inpatient and residential settings

Additional recommendations included local and regional educational efforts through APA district branches and inclusion of patient safety initiatives in medical school and residency programs Its recommendations were approved by the Board of Trustees November 24 2002 and by the Assembly Executive Committee January 24 2003 leading to the inception of the APA Committee on Patient Safety[20]

Some potential harms to mental healthcare recipients have been studied extensively including

Adverse drug reactions such as

o Tardive dyskinesia

o Neuroleptic malignant syndrome

o Obesity and insulin resistance and

o Serotonin syndrome

Harm resulting from seclusion and restraint

The incidence and etiology of suicide and

Inappropriate psychiatrist-patient contact

However errors have not been systematically examined and the contemporary patient safety paradigm and terminology have not been widely incorporated into the lexicon research and daily clinical practice of mental health and substance use treatment[1112]

Terminology

According to the Institute of Medicines nomenclature a medical error is any mistake made in diagnosis or treatment[8] One category of medical errors is medication errors defined as mistakes made in prescribing transcribing dispensing or administering medication Mistaken diagnoses and errors in treatment are examples of errors of commission missed diagnoses and needed treatments not given are errors of omission A mistake that has not caused harm is a near miss When harm is caused by a mistake it is termed a preventable adverse event Adverse drug events that cause harm but have not resulted from an error and could not have been prevented (for example a drug rash when a medication is correctly prescribed to a patient without a history of allergic reaction) are adverse drug reactions

Applying this nomenclature mental health and substance abuse clinicians and researchers have had some success studying medical errors that cause preventable adverse events including errors of commission and omission Examples of errors of commission include the physical and psychological harm caused by excessive seclusion and restraint and by medication errors An example of an error of omission causing preventable adverse events is the under-diagnosis and treatment of depression and subsequent morbidity and mortality

There are only a few studies of medication errors causing near misses and of errors in psychotherapy (including insufficient coordination of care between non-psychiatric prescribers and counselors and psychotherapists) causing near misses

This paper summarizes research on medical errors in mental health and substance abuse and recommends future initiatives Additional areas of potential harm not usually characterized as errors are also considered from a patient safety perspective including

Memory loss from electroconvulsive therapy and

Inappropriate clinician-patient contact

Medication Errors Recap

Medication errors in mental health settings have been reviewed by Grasso and colleagues for IOM[11] and for Medscape[12] and are summarized here Adverse drug events (ADEs) were defined as any patient harm caused by administration of a medication and were categorized as either adverse drug reactions (ADRs) or medication errors The World Health Organization (WHO) definition of an adverse drug reaction was used -- namely a complication caused by a drug when used in the usual manner and dosage[21] Medication errors were defined in accordance with the recommendations of The National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional patient or consumer[22] Such events may be related to professional practice or healthcare products procedures and systems including

Prescribing

Order communication

Product labeling packaging and nomenclature

Compounding

Dispensing

Distribution

Administration

Education

Monitoring and

Use

Methodologically this review involved an extensive literature review English-language studies involving ADEs and medication errors in psychiatry were identified by reviewing the following keywords in MEDLINE from 1966 to 2002 all cross-referenced with the term psychiatry

Medication error

Adverse drug event and

Adverse drug reaction

Studies were included if they contained original data on medication errors or adverse drug events in mental healthcare

Incidence studies of ADEs had been conducted almost exclusively in general medical settings and had primarily examined ADRs not medication errors Only 2 medication error incidence studies in mental health settings were found One was a 1984 epidemiologic study of state psychiatric hospitals which reported that 75 of randomly selected patients experienced ADRs[23] medication errors were not examined

In the only study examining the incidence of medication errors in a mental health setting Grasso and colleagues retrospectively studied 31 state psychiatric inpatients over 2 months of care[1314] Nine errors were self-reported using the usual incident reporting process whereas an independent multidisciplinary review team found 2194 errors for the same 31 patients and episode of care

19 of errors were rated as having a low risk of harm

23 as having a moderate risk and

58 as having a high risk

The absence of studies of medication errors understood as near misses is highlighted This is a significant category of errors which can occur during prescribing transcribing dispensing and administering medications and has the potential to cause significant harm Indeed near misses may sometimes be termed as such because the study did not include assessment of patients and an attempt at drawing causal connections between the observed medical errors and the patients clinical course

The literature review noted above yielded

No reports on medication errors in outpatient mental health settings

No medication error incidence studies in settings where psychologists have prescriptive authority and

No studies on the incidence and characteristics of medication errors in substance abuse settings including medical detoxification for alcohol sedative hypnotic or opiate withdrawal

One important concern rarely addressed in published studies is the exclusive reliance upon self-reporting in psychiatric and medical-surgical hospitals[1112] Only 3 studies were found that compared self-reporting with an independent teams detection and reporting of errors (a methodological factor affecting the validity of reported error rates) In these studies independent review teams detected error rates that ranged from 88 to 1000 times higher than self-reported error rates and that were determined to be more valid that self-reported rates[13141624]

Medication Error Summary

Medication errors in mental health treatment settings have not been adequately studied The potential for errors of omission and commission in mental health however causing either near misses or preventable adverse events is high for each of the following reasons

Volume of outpatient visits

Number of psychiatric medication prescriptions written

Absence of evidence of a contemporary understanding of medication errors and their consequences in both inpatient and outpatient mental health treatment settings

High prevalence of co-occurring substance abuse disorders that complicate diagnosis and treatment and

Greater vulnerability of individuals with mental illness

In addition the validity of reported error rates is limited by self-reporting -- the error reporting method currently used in almost all hospitals

Errors in Diagnosis

Missed Diagnoses and Insufficient Treatment of Mood and Anxiety Disorders in Ambulatory Medical Settings

Introduction to missed diagnosis Over half of patients with a psychiatric problem receive treatment solely from a primary care physician rather than a mental health specialist[25] Of all patients seen in primary care from 15 to 25 have a mood or anxiety disorder[26-29] Because mood and anxiety disorders are common in ambulatory medical settings but providers in these setting are usually non-psychiatric clinicians treatment rendered in this setting may be prone to medical errors

Errors of omission The primary errors of omission in ambulatory medical settings where non-mental health clinicians are the only providers interacting with patients are missed diagnoses and failure to implement a needed treatment

Missed diagnoses Although the reliability of psychiatric diagnoses when made by trained diagnosticians using structured interviews is a good approach for most disorders errors are made even under conditions considered ideal or nearly ideal[30] In primary care medical practice the following factors are likely to increase diagnostic errors of omission

Time constraints

Competing demands

Minimal training in mental health diagnosis and treatment and

Lack of use of a systematic diagnostic interview

The overall missed diagnosis error rate for the detection of any mood or anxiety disorder by primary care physicians compared with a psychiatric interview has been reported to range from 25[26] to almost 67[31] Primary care physicians correctly diagnose only 35 to 57 of the cases of major depressive disorder (MDD) that are identified with a psychiatric interview[32-36] A multinational investigation found that[37]

27 of false-negative cases (that is primary care physician missing the diagnosis of MDD) were due to complete disagreement with a standardized interview diagnosis

397 were due to the primary care physician recognizing some symptoms of depression but underestimating the severity of the condition and therefore not giving the diagnosis and

33 were diagnosed with another condition

Correct identification of MDD by primary care physicians is associated with[38]

Greater familiarity with the patient and

Presence of suggestive clinical cues (eg a history of depression or the presence of vegetative symptoms)

Anxiety disorders also frequently go undetected[313940] In 1 study about 10 of primary care patients with an anxiety disorder were identified by their physician[41] Approximately 70 of the time that a primary care physician identifies an anxiety problem they diagnose an anxiety state unspecified rather than a specific anxiety disorder[42] In 1 study in Israel only 2 of patients with posttraumatic stress disorder (PTSD) were diagnosed correctly by the primary care physician[43] This underdiagnosis may be a result of inadequate education about anxiety disorders for example only 57 of primary care doctors in a study conducted in Germany considered generalized anxiety disorder to be an independent disorder[44]

Insufficient treatment Treatment is absent when mood and anxiety disorders are missed Insufficient treatment may occur even when anxiety and mood disorders are diagnosed correctly Only about half of patients diagnosed in primary care settings with mood or anxiety disorders receive medication treatment[4546] Psychotherapy referrals were not examined in these studies so it remains unclear whether the patients who did not receive medication treatment were offered psychological treatment

Even when a psychiatrist provided a consultation and advised antidepressant treatment only 53 of appropriate primary care patients received antidepressant medication over the next year[47] The National Ambulatory Medical Care Survey database from 1985 to 1998 documented that treatment for anxiety is offered in 60 of visits to primary care physicians compared with over 95 of visits for anxiety to a psychiatrists[42] A recent naturalistic study of anxiety disordered patients in primary care found that 47 were receiving treatment from either the primary care physician or a specialty mental health clinician[48] A study of patients with panic disorder in primary care settings revealed that only 64 were found to be receiving either medication or psychotherapy[49]

Preventable adverse events Missed diagnoses and insufficient treatment of mood and anxiety disorders in medical settings may cause serious preventable adverse events For MDD preventable adverse events include impairment in physical and mental functioning that is comparable to that found with common medical disorders such as hypertension and diabetes[5051] Depression exacerbates the outcomes of chronic medical illnesses[52] and is associated with higher rehospitalization rates[53] and higher mortality rates[5455] following a myocardial infarction

MDD is also associated with a substantial risk of suicide which is increased when treatment is insufficient[56-58] The economic burden in the United States due to MDD has been estimated at about $83 billion as of 2000[59] Of these costs about three-fourths represent indirect costs (vs the direct cost of providing treatment) particularly reduced productivity and absenteeism in the workplace The World Health Organization has ranked MDD as second only to ischemic heart disease in magnitude of disease burden in countries with established market economies[60]

The functional and economic burden of MDD has been an area of focus for payers and employers Less recognized however is the substantial impairment in social and occupational functioning and in physical health documented in mental health treatment settings for individuals with specific anxiety disorders such as

PTSD[6162]

Panic disorder[6364]

Generalized anxiety disorder[65] and

Social anxiety disorder[6667]

Impairment from anxiety disorders is also apparent in those who present to a primary care physician[496869] Generalized anxiety disorder produces impairment in health-related functioning that is equivalent to or significantly greater than patients with diabetes and recent myocardial infarction

Primary care patients with anxiety disorder are high utilizers of general medical services resulting in increased overall healthcare costs compared with primary care patients who have subthreshold disorders or no anxiety disorder[70] The economic burden of anxiety disorders in the United States has been estimated to be $423 billion in 1990 primarily due to increased use of non-psychiatric medical services[71]

However missed diagnoses do not necessarily lead to preventable adverse events Some studies have suggested that patients with unrecognized MDD in the primary care setting are less severely depressed and less functionally impaired[323770] and therefore at less risk for

Loss of employment

Impaired social functioning

Exacerbation of co-occurring medical disorders and

Suicide

When recognized and unrecognized patients with MDD are tracked over time clinical improvement has often been comparable[3770] although greater short-term improvement for recognized cases has also been reported for MDD[34] and anxiety disorders[72]

Errors of commission mistaken diagnoses As described previously for MDD about one-third of the diagnostic errors in primary care are mistaken diagnoses[37] Mistaken diagnoses range from anxiety disorders to alcoholsubstance abuse to psychoticdissociative disorders Conversely when an anxiety disorder is present a mistaken diagnosis of depression is sometimes given[39] The high level of comorbidity between anxiety and mood disorders is likely to contribute substantially to such diagnostic errors[73]

Primary care physicians also occasionally diagnose a mood or anxiety disorder when it is not present (false positive) Among non-depressed patients a false positive rate of 12 in primary care was reported in 1 study[38] and 14 in another[37] About 25 of these MDD false-positives in the Tiemens study actually had an anxiety disorder 20 were the result of overestimation of severity of depression by the primary care physician and 55 were true false positives In the Klinkman study a history of depression was apparent in over half of the false-positive cases

suggesting that physicians might have been unduly influenced by a history of depression rather than the clinical evidence for depression at the time of examination

The implications of these misdiagnoses require more study Because the treatments for most mood and anxiety disorders are similar and because even subsyndromal disorders cause significant distress and functional disability it is possible that imprecision in diagnosis may still result in the use of appropriate medication treatment Of course treatment of an individual without a disorder even subsyndromal causes unneeded exposure to medication errors

Recommendations to diminish misdiagnoses in primary care Since primary care clinicians will most likely continue to be the point of entry and often the sole provider of mental health treatment for patients suffering from mood and anxiety disorders improvements in diagnosis and appropriate treatment of these disorders in primary care should be an important priority Better education of primary care providers about the symptoms and management of depression and anxiety are essential Programs designed to increase primary care clinicians recognition of depression and other psychiatric disorders have not yet proved to improve treatment outcome[7475] However studies that have added training in depression management in addition to education on better recognition of its presence have yielded better outcomes[76]

The feasibility and sustainability of programs focusing on better education of primary care clinicians has not been established Because of the time constraints of standard primary care practice fast efficient methods of screening such as the Primary Care Evaluation of Mental Disorders (PRIME-MD) for anxiety depression and other psychiatric disorders are recommended[77] The Patient Health Questionnaire a 9-item subset of the PRIME-MD is a more concise screen for depression if time constraints preclude use of the full PRIME-MD questionnaire The routine use of such simple methods for screening and ongoing monitoring might provide a sustainable way of reducing diagnostic errors in ambulatory medical settings

A final recommendation is for managed care and insurance companies as well as health systems and provider networks to consider the implementation of incentives for better detection and treatment of mood and anxiety disorders Pilot pay for performance programs such as Bridges to Excellence[78] or the Integrated Healthcare Association initiative in California[79] have focused on physical conditions such as diabetes or asthma Quality measures do exist for the medication treatment and follow up of diagnosed depression such as performance standard and report card measures[80] Adding incentives for better detection and treatment to the use of quality measures is a recommended first step

Errors in the Use of Seclusion and Restraint

In October 1998 The Hartford Courant reported on the death of Andrew McClain an 11-year-old boy who died while restrained and secluded in a psychiatric hospital in Connecticut[81] Thus began the Courants 5-part series based on a 50-state survey that confirmed 142 deaths related to the use of seclusion and restraint in mental health settings over the past decade[82-85] The series cautioned that most deaths related to seclusion and restraints are unreported and that the actual number of annual deaths was possibly much higher

The national response to the Courant exposeacute was far reaching Congress commissioned the US General Accounting Office (USGAO) to report on the use of seclusion and restraint The USGAO responded by releasing a report in 1999 entitled Improper Restraint or Seclusion Places People at Risk[82] The USGAO report confirmed the majority of the Courants allegations including the following

Improper use of seclusion and restraint are dangerous

There is inadequate monitoring and reporting of its use and of resulting harm (or preventable adverse events) to patients

Serious injuries or death can occur and are underreported

Licensing and accreditation of seclusion and restraint standards are inconsistent and insufficient and

Successful strategies for preventing seclusion and restraint as well as reducing the risk of injury when use occurs are not widely used

Seclusion and restraint are commonly used practices intended to prevent adults and children with mental health and substance abuse diagnoses from harming themselves or others in inpatient or residential treatment environments Unfortunately access to incidence data collected by The National Association of State Mental Health Program Directors (NASMHPD) is controlled (and forbidden) by participating hospitals There are no published data interpreted as accurately reflecting the true incidence of seclusion and restraint use

The use of these interventions is intended to be severely restricted to individual situations in which an emergency safety need is identified but as use is generally ordered by staff and based on subjective criteria the use of these emergency interventions has a wide range [86] Restraint is defined in a variety of ways but the term generally refers to a manual method or mechanical device material or equipment attached or adjacent to the patients body that he or she cannot easily remove and that restricts the patients freedom or normal access to ones body[87] Seclusion refers to the involuntary confinement of a person in a room where they are physically prevented from leaving[88] Recent literature reviews of seclusion and restraint reflect the absence of[8990]

Substantiated prevention strategies

Indications for use

Application methods

Monitoring

Post-event activities and

Absence of evidence of its effectiveness in preventing harm

The Centers for Medicare and Medicaid Services (CMS) -- formerly known as the Healthcare Financing Administration (HCFA) the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and state licensing agencies have attempted to regulate the use of seclusion and restraint through licensing and accreditation standards[879192] However the Courant series the USGAO report and others have documented alarming rates of patient harm including death despite the application of such standards[818286] While efforts are underway to resolve these issues the appropriate and safe use of seclusion and restraint is far from assured[8693]

In recent years advocates consumers professional associations provider organizations and the legal field have increasingly recommended a reduction in the use of seclusion and restraint or even its elimination[83-86 94] These recommendations resonate with Recommendation no 1 in the IOMs Crossing the Quality Chasm that states All healthcare organizations professional groups

and private and public health purchasers should adopt as their explicit purpose to continually reduce the burden of illness injury and disability and to improve the health and functioning of the people of the United States[2] Using the IOMs medical error nomenclature reports about seclusion and restraint reflect high rates of medical errors mostly errors of commission perhaps errors of omission causing either near misses or preventable adverse events in routine clinical practice

Safety in healthcare practices is defined as keeping the patient free from accidental injury[2] Although not all errors cause injury accidental injury can be due to error either by the failure of a planned action to be completed as intended or use of the wrong plan to achieve an aim The improper use of seclusion and restraint is not safe and causes serious and preventable adverse injuries including death[8182] The media continues to report adverse events as well[9596] For example in 2000 3 deaths were reported just in Texas including that of 2 boys one 9 and the other 11 years old and a 16-year-old girl In South Carolina in 2003 a 9-year-old boy died after he kicked a staff member in the leg and ran down the hall which resulted in a take down and the boys asphyxiation In Arizona a 32-year-old woman died in restraints for behavior that was later judged as not meeting the threshold of imminent danger[96]

Reducing and Improving Seclusion and Restraint Events Recent Performance Improvement Initiatives

Several initiatives focused on seclusion and restraint reduction (embedded in public health prevention continuous quality improvement principles supporting recovery from mental illness and trauma-informed care) have been developed by the American Psychiatric Nurses Association the APA the National Association for Private Health Systems the American Hospital Association the National Alliance on Mental Illness (NAMI) and the Childrens Welfare League of America[2083859798] These initiatives are intended to complement other essential elements such as adequate numbers of well-trained staff and the use of proven psychological and medication treatments

The public health constructs of primary secondary and tertiary prevention create a logical framework and redirect the focus from safer use of seclusion and restraint to interventions that prevent its use[86] The model of recovery espoused by the Surgeon Generals Mental Health report necessitates[99]

System-wide transformation by adopting goals of full recovery in a life outside the hospital

Emphasis on instilling hope

Availability of multiple treatment options and

Development of partnerships with those who seek services

The use of controlling or coercive interventions is counterintuitive in this model and is to be avoided except perhaps as the last alternative in preventing death or significant harm to self or others caused by treatable manifestations of mental illness[94100] A growing understanding of the neurologic biologic psychological and social effects of trauma and its high prevalence in the populations that seek mental health services is informing approaches to assessment diagnosis stabilization and treatment of individuals with mental illness including the use of seclusion and restraint as a means of preventing injury to self or others[101-108]

Data should be analyzed for characteristics of facility usage by

Unit

Shift

Day and

Staff member involved

With rare exception data on individuals should be used confidentially to identify individual staff training needs not for disciplinary actions[88109] The facility needs to highlight data on seclusion and restraint use by graphing and posting this data on all units so that it is clearly visible for staff and consumers of service Facility-generated data on seclusion and restraint used in a non-punitive way provides for healthy competition among treatment units and elevates the general oversight and knowledge of use and outcomes for everyone involved[88109110] It allows and encourages administration to identify successful staff and treatment units so that successful improvements can be shared

A comprehensive national health information infrastructure could be a useful tool in reducing seclusion and restraint events[2111] The National Association of State Mental Health Program Directors Research Institute Inc (NRI) performance improvement system has developed a set of technology standards applications systems and values that include a number of recommendations for reducing seclusion and restraint events and making their occurrence less error prone[112]

Reduction of the use of seclusion and restraint must start with clear leadership and a specific plan that articulates a mission and philosophy about seclusion and restraint reduction and defines the roles and responsibilities of all facility staff[109] One core component is use of an executive on-call function and the daily review of the use of seclusion and restraint by executive leadership[88110]

Creating a treatment environment that prevents seclusion and restraint is based on the principles of recovery and the characteristics of trauma-informed systems of care[88109] Staff education needs to

Include the experiences of consumers and staff

Address the common myths associated with use

Introduce the rationale and characteristics of trauma-informed care

Educate on the neurobiological and psychological effects of trauma and

Describe a prevention-based approach to reduction

Seclusion and Restraint Summary

The use of seclusion and restraint is associated with substantial harm to recipients of care including death Medical errors precede many seclusion and restraint events which in turn cause further errors and substantial harm to both recipients and providers of care Several local and national initiatives are underway to improve the safety of seclusion and restraint events and to decrease its use The results of their successful application can be seen in facilities in[88 109]

Pennsylvania

New York

Massachusetts

Maine

Florida

New Jersey and

South Dakota

Further study of causal antecedent events and of harm resulting from seclusion and restraint events is recommended using the patient safety paradigm and nomenclature

High-Risk Clinical Populations Lacking Adequate Patient Safety Research

Introduction to High-Risk Clinical Populations

There are no empirical data to quantify characterize or confirm medical errors in certain populations with mental illness andor substance abuse where multiple risk factors for error also exist A brief discussion of these populations and their risks for errors is provided below It is hoped that heightened focus on these high-risk populations will be an impetus for medical error research

Persons with Co-occurring Mental Illness and Substance Abuse

Individuals with co-occurring psychiatric and substance disorders have not been studied for medical errors yet they are perhaps at greater risk for harm because of the nature and number of their co-occurring disorders Several studies have reported the common occurrence of comorbidity among persons with a recognized diagnosis of either mental illness or substance abuse For example in 1990 Regier[74] found a lifetime prevalence of substance abuse among 62 of persons with bipolar disorder In 1996 Kessler and colleagues[113] reported a lifetime prevalence of 599 of psychiatric illness among persons with substance abuse disorders while 31 had a concurrent psychiatric disorder

Persons with co-occurring disorders are high utilizers of medical resources and therefore more exposed to systems issues that may predispose to unintended harm In 1995 an estimated 26 million (27) of the 965 million emergency department (ED) visits were related to alcohol abuse alone[114]

In a study by Dickey and associates[115] using data from the Massachusetts Division of Medical Assistance and death records from the Department of Public Health individuals with co-occurring psychiatric and substance use disorders had the highest risk of medical morbidity for 5 of the studied medical disorders Medicaid beneficiaries with dual diagnoses are 6 to 8 times more likely to die of injury primarily poisoning than their counterparts treated for medical conditions only[116117]

It is well-substantiated that persons with psychiatric and substance abuse disorders have higher rates of suicide attempts and death by suicide[118-123] In 2001[124]

20308 deaths were caused by homicide

30622 deaths by suicide and

101537 deaths were caused by accidents

Given the frequency with which substance abuse by itself has been implicated in these 3 causes of death the scope of morbidity and mortality related to co-occurring disorders is staggering

The effects of substance abuse disorders in adults also affected the mortality rates of children during 1985 to 1996 -- 8482 (24) of the 35547 children aged younger than 15 years died in alcohol-related motor vehicle crashes[125]

A subset of those with co-occurring disorders have substance dependence PTSD and chronic pain The presence of chronic pain and the complexities surrounding treatment of individuals with PTSD increase the risk for unintended harm and of a poor fit between clinical needs and the design of current healthcare systems Despite the added risk factors there is little science to direct clinicians A Medline search using substance abuse PTSD and chronic pain as search terms in June 2004 yielded 10 citations There were no incidence studies and no published treatment guidelines

Conclusion regarding co-occurring disorders Individuals with co-occurring disorders are frequently encountered and at risk for multiple diagnostic and treatment errors including

Missed mental health substance abuse and medical diagnoses and

Insufficient or excessive medication treatment of either their substance abuse or psychiatric disorder

Compared with the general population these individuals are at higher risk for

Suicide attempt

Death by suicide and

Death at a younger age by medical illness

There is a paucity of published studies on medical errors among individuals with co-occurring disorders despite several risk factors for unintended harm and high rates of morbidity and mortality

Attention Deficit-Hyperactivity Disorder in Children Excessive or Insufficient Diagnosis and Treatment

Inattentiveness distractibility impulsivity and hyperactivity were recognized as elements of minimal brain dysfunction (now termed attention deficit hyperactivity disorder [ADHD]) and treated with stimulants especially methylphenidate beginning in the late 1960s[101126127] Over the past 3 decades the rate of drug treatment for behavior problems has increased exponentially culminating in the prescription of ADHD drug treatment for at least 5-6 million American children annually[128]

Children diagnosed with ADHD have been the focus of thousands of research studies over the last 40 years yet the diagnosis and treatment of ADHD remain controversial among some within medicine and the general public[129130] Recent prevalence data from the 1998 National Institutes

of Health (NIH) consensus review[131] and reported by Jensen[132] suggest a prevalence of approximately 5 affecting 3 million school-aged children[133134]

ADHD is associated with[135-137]

Increased risk of accidents

Family and social dysfunction

Poor academic achievement

Substance abuse and

Antisocial behavior

Recent treatment data based on the number of methylphenidate prescriptions show an estimated 5-6 million American children receive ADHD-related drug treatment annually[128] Aggregate national methylphenidate use has increased 100-fold from 1960 until 2000 Globally nearly 90 of the worlds stimulant medication supply is consumed by the US population[138139]

Substantial state-to-state and community-to-community variability in methylphenidate use raises concerns about potential pockets of over- and under-diagnosis and over- and under-prescribing Drug Enforcement Association data on stimulant use reflect a 6-fold per capita variation in methylphenidate prescribing between some states[140] and a 20-fold prescribing variation between some communities[130141]

LeFever and colleagues argue that while the data are inconclusive if communities such as Salt Lake City Utah are used as a benchmark of acceptable diagnosis and treatment then children in 36 states may be subject to over-diagnosis and over-treatment Conversely Jensen argues that ADHD is under-diagnosed and under-treated based on national aggregate data allowing for pockets of over-diagnosis and treatment in some geographic areas[142] Given that in 1995 there were approximately 2 million pediatric visits in which ADHD was the focus of treatment and 6 million stimulant prescriptions were written[132] 1 conclusion is that 3 million children with ADHD received an average of 2 prescriptions and 1 outpatient visit during that year suggesting insufficient treatment In another study cited by Jensen the Multimodal Treatment Study of Children with ADHD two thirds of ADHD children from reportedly highly motivated families obtained medication treatments and for an average duration of only 8-14 months[142143]

Despite the number of studies done the strength of conclusions that can be drawn is contingent upon the adequacy of reported data Studies to date are variously limited by data sources sampling accuracy and interpretation[130]

When considered in aggregate national ADHD prevalence rates and numbers of prescriptions written do not suggest excessive diagnosis and treatment However prevalence rates and stimulant use can vary as much as 30-fold when comparing different communities A prevalence rate of 33 among white elementary-aged boys in southeastern Virginia significantly challenges credibility[130] Such variability makes it essential that prevalence rates and stimulant use estimates be linked to sufficient demographics such as

Geography

Age

Race and

Gender

ADHD prevalence rates and stimulant use appear to be

Excessive in some communities

Plausible in other communities and

Perhaps insufficient in yet other communities

Additional epidemiologic studies reporting prevalence rates with specific demographics rather than in aggregate and broader use of practice guidelines promulgated by the American Academy of Pediatrics (AAP) and others that advocate multimodal treatment rather than solely prescribing stimulants or other medications[130144] will help provide evidence of the extent of errors in the diagnosis and treatment of children with ADHD

Electroconvulsive Therapy

Electroconvulsive therapy (ECT) remains a controversial treatment in psychiatry As stated in the 1985 NIH Consensus Statement The nature of the treatment itself its history of abuse unfavorable media presentations compelling testimony of former patients special attention by the legal system uneven distribution of ECT use among practitioners and facilities and uneven access by patients all contribute to the controversial context in which the consensus panel has approached its task[145]

Epidemiologic data reported by Thompson and colleagues in 1994 found that[146]

58667 patients received ECT in 1975

31514 in 1980

36558 in 1986

71 of the patients who received ECT were women and

Individuals older than 65 years of age had the highest rates per number of inpatients

The rate of ECT use has been highly variable For example in 1995 Herman and associates[147] reported that among 202 metropolitan statistical areas annual ECT use varied from 04 to 812 patients per 10000 population

The most common adverse effect from ECT is memory loss In a recent review of patients perspectives as well as clinicians studies Rose and associates[148] concluded that 29 to 55 of ECT treatment recipients experienced persistent memory loss Recent empirical studies of ECT and memory loss continue to find persistent memory loss with bilateral ECT producing more profound memory deficits than right unilateral ECT[149]

In a review of deaths caused by ECT Abrams reported that ECT is 10 times safer than childbirth that approximately 6 times as many deaths annually in the US are caused by lightning as by ECTand that the death rate reported for ECT is an order of magnitude smaller than the spontaneous death rate in the general population[150]

Corroboration of a low ECT death rate has arisen from 1993 legislation in Texas mandating reporting of all ECT-related deaths[151] As a result the risk of death from ECT in Texas has been systematically tracked and reviewed More than 8000 patients received 49048 ECT treatments between 1993 and 1998 However only 1 death could be linked to the associated anesthesia An additional 4 deaths could plausibly have been associated with the anesthesia yielding a mortality rate between 2 and 10 per 100000 and the causes of death most likely were not the ECT stimulus or seizure

Emotional harm and erosion of faith in the medical profession that undermines accepting other needed treatments can come to recipients of care for whom the experience of ECT is frightening

ECT conclusion ECT is effective for severe major affective illness and is associated with a low mortality rate Persistent memory loss is a consistent finding despite attempts to optimize ECT administration and must be expected at an incidence of approximately 25 to 50 by those contemplating and those providing ECT treatment

Despite its relative safety ECT continues to cause alarm in the general public Even within medicine it is described as dangerous and unethical by some[152] Such fears can cause emotional harm among ECT recipients This may be especially true for older women (who comprise the majority of ECT subjects) some of whom may be accustomed to deferring to healthcare providers when consenting to treatment despite insufficient understanding of benefits and risks

Recommendations include

Emphasis on pre-treatment education

Collaborative relationship with ECT recipients

Increased transparency regarding the substantial risk of persistent memory loss when seeking informed consent and

Continued research on its safety

Systems Issues Related to Patient Safety

Outpatient Care

Risk of unintended harm may be increased by the segregated care settings in which psychiatric and substance abuse services are often delivered including solo practitioner offices and free-standing psychiatric and substance abuse treatment facilities[153154] and by insufficient communication and coordination of care between prescribers and psychotherapists[155-157] Despite the recognition of these potential contributing factors there are no existing reports of the association between systems issues and medical errors

Olfson[158] reported that in 1987 there were 84 million outpatient visits with mental health practitioners including

Psychiatrists

Psychologists

Social workers and

Licensed counselors

Kessler[154] reported in 1999 that an estimated 133 of a representative sample of Americans reported used outpatient services for mental health problems in the previous 12 months Clearly there are high numbers of individuals at risk for errors in outpatient mental health and substance abuse treatment

Ethics and Malpractice Risk Management Boundary Violations

A survey of recently published reviews and commentaries on patient safety reveals that for mental health and substance abuse issues such discussion takes place mainly within the context of ethics and malpractice risk management[159-162] Ethics statements from both the APA[162] and the American Psychological Association[163] support the duty to report and protect patients from deviations from the standards of care This approach uses the individual practitioners frame of reference and relies on voluntary reporting from professionals who have been trained to consider confidentiality a critical component of their work Harm caused by clinician boundary violations are understood as issues of professional misconduct not as errors resulting from system failure and that minimize the individual clinicians responsibility and advise against punitive action [164-167]

With the advent of therapeutic exchanges through email and other means of communication additional boundary violations are possible The Internet now has at least 110 million users including 70 million using it for health-related information[168] A recent survey indicated 40 to 50 of physicians use the Internet (or are preparing to use it) for clinical care[169]

There is a risk of errors of omission or commission arising from lack of coordination of care between clinicians Differences in therapeutic orientation and nomenclature used by the following specialists can compound systems issues that increase the risk of medical errors [158]

Social workers

Psychiatric nurse specialists

Psychologists

Licensed counselors and

Psychiatrists

Confidentiality is critical in providing effective treatment within the secure and private setting of the therapists office and in protecting the patient from unauthorized disclosures of sensitive information and potential abuse from a third party[170] However confidentiality can also inhibit disclosure of near misses impasses in treatment (for example when treatment is not working) and preventable adverse events due to avoidance of sharing important clinical information with other professionals and with appropriate family members and other supportive resources[171172]

The solo practice model commonly used by mental health clinicians can also inhibit the adoption of best practices and the development of policies and procedures to reduce risk because all such practice management activities are left to the individual clinician whose focus is more likely to be exclusively clinical

Summary About Systems Issues and Patient Safety

Systems for reliably reporting outpatient psychotherapy medical errors particularly among the large numbers of solo practitioners do not exist The prevailing paradigm for reducing harm arises from risk reduction in order to diminish medical liability exposure Studies that shed light on potential medical errors have arisen from risk management claims medical liability lawsuits and reports of death by suicide not from research intended to examine patient safety per se

Error reporting systems applicable to outpatient mental health settings including incentives for their use need to be developed Professional risk management programs primarily used to diminish medical liability exposure from the following could also be used to promulgate the relevance and value of the patient safety paradigm

Boundary violations

Suicide and

Treatment errors

Most particularly thought needs to be given to developing systems of error prevention applicable to the solo practitioner

Recommendations

Recommendation no 1

Widespread adoption of the IOM patient safety paradigm and nomenclature in mental health and substance abuse treatment settings is recommended

Advantages of its use include

Consistency with the nomenclature used by other medical specialties

Increased leverage in advocating for needed services and resources when the absence of essential treatments are quantified as errors of omission causing near misses or preventable adverse events

Increased likelihood that medication errors in mental health and substance abuse will be researched and a determination made whether such errors are causing preventable adverse events and

Increased awareness among mental health and substance abuse clinicians that patient harm can come from a broader array of errors in diagnosis and treatment than has been studied to date

Widespread adoption will require systematic educational efforts for trainees and current practitioners in mental health and substance abuse including systematic introduction to the IOMs existence mission and safety and quality efforts such as the Quality Chasm Series (Many mental health and substance abuse clinicians and administrators seem unaware of the IOM at all)

Recommendation no 2

Further studies of medical error in mental health and substance disorders are needed

Some areas of potential harm in this field remain largely unexamined For example we found only 2 studies of medication errors in mental health settings and none in substance abuse detoxification and stabilization settings despite multiple risk factors for errors and preventable adverse events The impact of variable education -- in pharmacology physiology and general medicine -- on the safety of prescribing practices has not been studied nor has the clinical consequences of formulary restrictions on clinical outcome and potential patient harm The current acceptance of self-reported hospital error rates must be challenged through a process of independently validating self-reported errors

Recommendation no 3

Integration of mental health and substance abuse services is recommended

High rates of co-occurrence and associated higher rates of morbidity and mortality among those with mental health and substance abuse disorders requires integration of mental health and substance abuse treatment paradigms This has not occurred to date

Recommendation no 4

The IOMs 10 rules for change in healthcare should be adopted

The 10 IOM rules for change in healthcare are as follows[173]

1 Care based on continuous healing relationships

2 Customization based on patient needs and values

3 The patient as the source of control

4 Shared knowledge and the free-flow of information

5 Evidence-based decision-making

6 Safety as a system property

7 The need for transparency

8 Anticipation of needs

9 Continuous decrease in waste

10 Cooperation among clinicians

As an example of adoption of these rules seclusion and restraint remain high risk treatments yet current reporting systems do not permit transparency regarding the rate and types of injuries incurred including mortality rates Such transparency requires a non-punitive work culture yet there is little evidence to suggest its adoption in high-risk environments such as state psychiatric hospitals or inpatient detoxification and stabilization substance abuse treatment settings

Recommendation no 5

Reporting systems in outpatient mental health and substance abuse treatment settings must be adopted

Reliance upon unsubstantiated self-reporting of medication errors in inpatient mental health and substance abuse settings remains a significant flaw when attempting accurate assessment of near misses and preventable adverse events and must be changed A key necessity is anonymous yet authenticated medication error reporting for all staff using available web-based error reporting systems Such systems are cost-savers and make reported error data immediately and continuously available Web-based reporting systems providing anonymity with authentication could be used for further seclusion and restraint data collection and as a means of establishing an outpatient error reporting system of safety and quality data by recipients and providers of outpatient treatment

Recommendation no 6

Resources should be allocated to study and develop practical interventions to improve patient safety

Much current research in mental health and substance abuse and resource appropriation is focused on efficacy of pharmacotherapy and psychotherapy and on establishing neurobiologic evidence to support causal theories of known clinical disorders At a policy level we recommend more consideration be given to funding practical interventions predicted to immediately improve patient safety

References

[ CLOSE WINDOW ]

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Authors and Disclosures

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Author

Benjamin C Grasso MD

Staff Psychiatrist VA Clinic Saco Maine Disclosure Benjamin C Grasso MD has disclosed no relevant financial relationships

Cathryn M Clary MD MBA

Vice President US External Medical Affairs Pfizer Inc New York NY Disclosure Cathryn M Clary MD MBA has disclosed that she is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Benjamin Eng MD MA

Senior Medical Director Group Leader Pfizer Inc New York NY Disclosure Benjamin Eng MD MA has disclosed that he is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Stanley J Evans MD FASAM PA

Assistant Professor of Clinical Medicine St Matthews University Windham Maine

Medical Director Renaissance Institute of Palm Beach Boca Raton Florida Disclosure Stanley J Evans MD has disclosed no relevant financial relationships

Terry J Golash MD

Clinical Instructor Psychiatry Columbia University New York NY Assistant Attending St Lukersquos Roosevelt Hospital Center New York NY Disclosure Terry J Golash MD has disclosed no relevant financial relationships

Kevin Ann Huckshorn RN MSN CAP ICADC

Director Office of Technical Assistance National Association of State mental Health Program Directors Inc Alexandria Virginia Disclosure Kevin Ann Huckshorn RN MSN CAP ICADC has disclosed no relevant financial relationships

Kenneth Minkoff MD

Clinical Assistant Professor Department of Psychiatry Cambridge Hospital Harvard University Acton Massachusetts Consultant ZiaLogic Acton Massachusetts Disclosure Kenneth Minkoff MD has disclosed no relevant financial relationships

Joseph J Parks MD

Assistant Associate Professor Department of Psychiatry University of Missouri Columbia Missouri Disclosure Joseph J Parks MD has disclosed that he has received grants for educational activities from Letters amp Science and Physician Postgraduate Press Dr Parks has also disclosed that he has served as a consultant to the National Association of State Mental Health Program Directors and Bristol-Myers Squibb Dr Parks has also disclosed that he has received funds for services provided to the state of Missouri from Eli Lilly and Abbott

Miles F Shore MD

Bullard Distinguished Professor of Psychiatry Harvard Medical School Needham Massachusetts Junior Consultant Harvard Medical International Boston Massachusetts Disclosure Miles F Shore MD has disclosed no relevant financial relationships

Editor

Jacqueline A Hart MD

Freelance Clinical Editor Medscape LLC New York New York Disclosure Jacqueline A Hart MD has disclosed no relevant financial relationships

Elizabeth Saenger PhD

Editorial Director Medscape LLC New York NY Disclosure Elizabeth Saenger PhD has disclosed no relevant financial relationships

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Contents of This CMECE Activity

o Medication Errors and Patient Safety in Mental HealthBenjamin C Grasso MD Miles

F Shore MD Cathryn M Clary MD MBA Benjamin Eng MD MA Kevin Ann Huckshorn RN MSN CAP ICADC Joseph J Parks MD Kenneth Minkoff MD Stanley J Evans MD FASAM PA Terry J Golash MD

Medication Errors and Patient Safety in Mental Health

Introduction

In To Err Is Human[1] and Crossing the Quality Chasm[2] the Institute of Medicine (IOM) shed light on high rates of medical errors and unintended harm to recipients of care Subsequent efforts in the Quality Chasm series have elucidated components of a safer healthcare system[3-8] However the series has largely focused on medical and surgical care In this article we address quality and safety concerns for another group of persons that are perhaps more vulnerable to unintended harm and less likely to advocate for themselves -- recipients of mental health and substance abuse treatment

The charge from the Institute of Medicines Committee on Crossing the Quality Chasm -- Adaptation to Mental Health and Addictive Disorders has been to produce a clear picture of the incidence and nature of errors and preventable adverse events in the treatment of mental illnesses and substance use disorders

Background

The number of persons receiving inpatient or outpatient treatment for mental illness and substance abuse disorders is substantial The Centers for Disease Control and Preventions

(CDC)s 2000 National Hospital Discharge Survey reported more than 2 million discharges for care recipients with an International Classification of Disease Clinical Modification (ICD-CM) Mental Disorder[9] Their 2001 National Ambulatory Medical Care Survey reported[10]

26 million visits with symptoms referable to psychologicalmental disorders

25 million visits with symptoms referable to the nervous system (excluding sense organs) and

51 million visits with symptoms referable to general symptoms

It is likely that a significant percentage of individuals in the 2 latter categories of visits have mental illness

Despite the staggering numbers few reports have been published on medical errors in mental health and substance abuse or related methodological issues[11-14] Some prominent psychiatric journals have yet to include medical errors or adverse drug events as keyword options for submitted manuscripts In addition terms more recently invoked in patient safety research such as near risks and preventable adverse events are largely unknown in mental health and substance abuse A MEDLINE search performed June 2004 using medication errors and psychiatry as search terms yielded 37 citations A similar search using medication errors and substance abuse yielded 69 citations and medication errors cross-referenced with addiction yielded 1 citation In contrast a search of medication errors in general yielded 4892 citations most of which were in anesthesiology and medicine

History

The study of unintended harm caused by medical errors began in the field of anesthesiology 20 years ago[15] At that time anesthesia death rates were roughly 1 in 10000 and there was a precipitous rise in medical liability premiums An anesthesia research foundation was formed numerous research and performance improvement initiatives were undertaken and death rates have since dropped to approximately 1 in 200000

In the early 1990s Classen and colleagues as well as Brennan and associates in the Harvard Medical Practice Study made forays into internal medicine patient safety research[16-18] Once the Institute of Medicine released To Err Is Human in 2000 the often-cited medical error mortality rate of 44000 to 98000 per year began to increasingly appear in the lay press[1] In 2000 the Centers for Disease Control reported that approximately 100000 persons die annually from hospital-acquired infection which heightened concerns over patient safety[19]

Crossing the Quality Chasm released by the Institute of Medicine in 2001 marked the beginning of the Quality Chasm Series focusing on remedies needed to transform the US healthcare system[1-8] The series chronicled the substantial progress made identifying and quantifying unintended harm incurred by medical and surgical patients and in developing the architecture of a patient safety regimen The time has come to apply this experience and frame of reference to the inpatient and outpatient care of mental heath and substance abuse patients

As a specialty psychiatry has started to adopt elements of the patient safety movement The American Psychiatric Association (APA) convened its first Task Force on Patient Safety in 2002[20] Four areas were presented as priorities (1) change in clinical culture to focus on patient safety (2) adverse medication events (3) use of seclusion and restraint and (4) suicides in inpatient and residential settings

Additional recommendations included local and regional educational efforts through APA district branches and inclusion of patient safety initiatives in medical school and residency programs Its recommendations were approved by the Board of Trustees November 24 2002 and by the Assembly Executive Committee January 24 2003 leading to the inception of the APA Committee on Patient Safety[20]

Some potential harms to mental healthcare recipients have been studied extensively including

Adverse drug reactions such as

o Tardive dyskinesia

o Neuroleptic malignant syndrome

o Obesity and insulin resistance and

o Serotonin syndrome

Harm resulting from seclusion and restraint

The incidence and etiology of suicide and

Inappropriate psychiatrist-patient contact

However errors have not been systematically examined and the contemporary patient safety paradigm and terminology have not been widely incorporated into the lexicon research and daily clinical practice of mental health and substance use treatment[1112]

Terminology

According to the Institute of Medicines nomenclature a medical error is any mistake made in diagnosis or treatment[8] One category of medical errors is medication errors defined as mistakes made in prescribing transcribing dispensing or administering medication Mistaken diagnoses and errors in treatment are examples of errors of commission missed diagnoses and needed treatments not given are errors of omission A mistake that has not caused harm is a near miss When harm is caused by a mistake it is termed a preventable adverse event Adverse drug events that cause harm but have not resulted from an error and could not have been prevented (for example a drug rash when a medication is correctly prescribed to a patient without a history of allergic reaction) are adverse drug reactions

Applying this nomenclature mental health and substance abuse clinicians and researchers have had some success studying medical errors that cause preventable adverse events including errors of commission and omission Examples of errors of commission include the physical and psychological harm caused by excessive seclusion and restraint and by medication errors An example of an error of omission causing preventable adverse events is the under-diagnosis and treatment of depression and subsequent morbidity and mortality

There are only a few studies of medication errors causing near misses and of errors in psychotherapy (including insufficient coordination of care between non-psychiatric prescribers and counselors and psychotherapists) causing near misses

This paper summarizes research on medical errors in mental health and substance abuse and recommends future initiatives Additional areas of potential harm not usually characterized as errors are also considered from a patient safety perspective including

Memory loss from electroconvulsive therapy and

Inappropriate clinician-patient contact

Medication Errors Recap

Medication errors in mental health settings have been reviewed by Grasso and colleagues for IOM[11] and for Medscape[12] and are summarized here Adverse drug events (ADEs) were defined as any patient harm caused by administration of a medication and were categorized as either adverse drug reactions (ADRs) or medication errors The World Health Organization (WHO) definition of an adverse drug reaction was used -- namely a complication caused by a drug when used in the usual manner and dosage[21] Medication errors were defined in accordance with the recommendations of The National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional patient or consumer[22] Such events may be related to professional practice or healthcare products procedures and systems including

Prescribing

Order communication

Product labeling packaging and nomenclature

Compounding

Dispensing

Distribution

Administration

Education

Monitoring and

Use

Methodologically this review involved an extensive literature review English-language studies involving ADEs and medication errors in psychiatry were identified by reviewing the following keywords in MEDLINE from 1966 to 2002 all cross-referenced with the term psychiatry

Medication error

Adverse drug event and

Adverse drug reaction

Studies were included if they contained original data on medication errors or adverse drug events in mental healthcare

Incidence studies of ADEs had been conducted almost exclusively in general medical settings and had primarily examined ADRs not medication errors Only 2 medication error incidence studies in mental health settings were found One was a 1984 epidemiologic study of state psychiatric hospitals which reported that 75 of randomly selected patients experienced ADRs[23] medication errors were not examined

In the only study examining the incidence of medication errors in a mental health setting Grasso and colleagues retrospectively studied 31 state psychiatric inpatients over 2 months of care[1314] Nine errors were self-reported using the usual incident reporting process whereas an independent multidisciplinary review team found 2194 errors for the same 31 patients and episode of care

19 of errors were rated as having a low risk of harm

23 as having a moderate risk and

58 as having a high risk

The absence of studies of medication errors understood as near misses is highlighted This is a significant category of errors which can occur during prescribing transcribing dispensing and administering medications and has the potential to cause significant harm Indeed near misses may sometimes be termed as such because the study did not include assessment of patients and an attempt at drawing causal connections between the observed medical errors and the patients clinical course

The literature review noted above yielded

No reports on medication errors in outpatient mental health settings

No medication error incidence studies in settings where psychologists have prescriptive authority and

No studies on the incidence and characteristics of medication errors in substance abuse settings including medical detoxification for alcohol sedative hypnotic or opiate withdrawal

One important concern rarely addressed in published studies is the exclusive reliance upon self-reporting in psychiatric and medical-surgical hospitals[1112] Only 3 studies were found that compared self-reporting with an independent teams detection and reporting of errors (a methodological factor affecting the validity of reported error rates) In these studies independent review teams detected error rates that ranged from 88 to 1000 times higher than self-reported error rates and that were determined to be more valid that self-reported rates[13141624]

Medication Error Summary

Medication errors in mental health treatment settings have not been adequately studied The potential for errors of omission and commission in mental health however causing either near misses or preventable adverse events is high for each of the following reasons

Volume of outpatient visits

Number of psychiatric medication prescriptions written

Absence of evidence of a contemporary understanding of medication errors and their consequences in both inpatient and outpatient mental health treatment settings

High prevalence of co-occurring substance abuse disorders that complicate diagnosis and treatment and

Greater vulnerability of individuals with mental illness

In addition the validity of reported error rates is limited by self-reporting -- the error reporting method currently used in almost all hospitals

Errors in Diagnosis

Missed Diagnoses and Insufficient Treatment of Mood and Anxiety Disorders in Ambulatory Medical Settings

Introduction to missed diagnosis Over half of patients with a psychiatric problem receive treatment solely from a primary care physician rather than a mental health specialist[25] Of all patients seen in primary care from 15 to 25 have a mood or anxiety disorder[26-29] Because mood and anxiety disorders are common in ambulatory medical settings but providers in these setting are usually non-psychiatric clinicians treatment rendered in this setting may be prone to medical errors

Errors of omission The primary errors of omission in ambulatory medical settings where non-mental health clinicians are the only providers interacting with patients are missed diagnoses and failure to implement a needed treatment

Missed diagnoses Although the reliability of psychiatric diagnoses when made by trained diagnosticians using structured interviews is a good approach for most disorders errors are made even under conditions considered ideal or nearly ideal[30] In primary care medical practice the following factors are likely to increase diagnostic errors of omission

Time constraints

Competing demands

Minimal training in mental health diagnosis and treatment and

Lack of use of a systematic diagnostic interview

The overall missed diagnosis error rate for the detection of any mood or anxiety disorder by primary care physicians compared with a psychiatric interview has been reported to range from 25[26] to almost 67[31] Primary care physicians correctly diagnose only 35 to 57 of the cases of major depressive disorder (MDD) that are identified with a psychiatric interview[32-36] A multinational investigation found that[37]

27 of false-negative cases (that is primary care physician missing the diagnosis of MDD) were due to complete disagreement with a standardized interview diagnosis

397 were due to the primary care physician recognizing some symptoms of depression but underestimating the severity of the condition and therefore not giving the diagnosis and

33 were diagnosed with another condition

Correct identification of MDD by primary care physicians is associated with[38]

Greater familiarity with the patient and

Presence of suggestive clinical cues (eg a history of depression or the presence of vegetative symptoms)

Anxiety disorders also frequently go undetected[313940] In 1 study about 10 of primary care patients with an anxiety disorder were identified by their physician[41] Approximately 70 of the time that a primary care physician identifies an anxiety problem they diagnose an anxiety state unspecified rather than a specific anxiety disorder[42] In 1 study in Israel only 2 of patients with posttraumatic stress disorder (PTSD) were diagnosed correctly by the primary care physician[43] This underdiagnosis may be a result of inadequate education about anxiety disorders for example only 57 of primary care doctors in a study conducted in Germany considered generalized anxiety disorder to be an independent disorder[44]

Insufficient treatment Treatment is absent when mood and anxiety disorders are missed Insufficient treatment may occur even when anxiety and mood disorders are diagnosed correctly Only about half of patients diagnosed in primary care settings with mood or anxiety disorders receive medication treatment[4546] Psychotherapy referrals were not examined in these studies so it remains unclear whether the patients who did not receive medication treatment were offered psychological treatment

Even when a psychiatrist provided a consultation and advised antidepressant treatment only 53 of appropriate primary care patients received antidepressant medication over the next year[47] The National Ambulatory Medical Care Survey database from 1985 to 1998 documented that treatment for anxiety is offered in 60 of visits to primary care physicians compared with over 95 of visits for anxiety to a psychiatrists[42] A recent naturalistic study of anxiety disordered patients in primary care found that 47 were receiving treatment from either the primary care physician or a specialty mental health clinician[48] A study of patients with panic disorder in primary care settings revealed that only 64 were found to be receiving either medication or psychotherapy[49]

Preventable adverse events Missed diagnoses and insufficient treatment of mood and anxiety disorders in medical settings may cause serious preventable adverse events For MDD preventable adverse events include impairment in physical and mental functioning that is comparable to that found with common medical disorders such as hypertension and diabetes[5051] Depression exacerbates the outcomes of chronic medical illnesses[52] and is associated with higher rehospitalization rates[53] and higher mortality rates[5455] following a myocardial infarction

MDD is also associated with a substantial risk of suicide which is increased when treatment is insufficient[56-58] The economic burden in the United States due to MDD has been estimated at about $83 billion as of 2000[59] Of these costs about three-fourths represent indirect costs (vs the direct cost of providing treatment) particularly reduced productivity and absenteeism in the workplace The World Health Organization has ranked MDD as second only to ischemic heart disease in magnitude of disease burden in countries with established market economies[60]

The functional and economic burden of MDD has been an area of focus for payers and employers Less recognized however is the substantial impairment in social and occupational functioning and in physical health documented in mental health treatment settings for individuals with specific anxiety disorders such as

PTSD[6162]

Panic disorder[6364]

Generalized anxiety disorder[65] and

Social anxiety disorder[6667]

Impairment from anxiety disorders is also apparent in those who present to a primary care physician[496869] Generalized anxiety disorder produces impairment in health-related functioning that is equivalent to or significantly greater than patients with diabetes and recent myocardial infarction

Primary care patients with anxiety disorder are high utilizers of general medical services resulting in increased overall healthcare costs compared with primary care patients who have subthreshold disorders or no anxiety disorder[70] The economic burden of anxiety disorders in the United States has been estimated to be $423 billion in 1990 primarily due to increased use of non-psychiatric medical services[71]

However missed diagnoses do not necessarily lead to preventable adverse events Some studies have suggested that patients with unrecognized MDD in the primary care setting are less severely depressed and less functionally impaired[323770] and therefore at less risk for

Loss of employment

Impaired social functioning

Exacerbation of co-occurring medical disorders and

Suicide

When recognized and unrecognized patients with MDD are tracked over time clinical improvement has often been comparable[3770] although greater short-term improvement for recognized cases has also been reported for MDD[34] and anxiety disorders[72]

Errors of commission mistaken diagnoses As described previously for MDD about one-third of the diagnostic errors in primary care are mistaken diagnoses[37] Mistaken diagnoses range from anxiety disorders to alcoholsubstance abuse to psychoticdissociative disorders Conversely when an anxiety disorder is present a mistaken diagnosis of depression is sometimes given[39] The high level of comorbidity between anxiety and mood disorders is likely to contribute substantially to such diagnostic errors[73]

Primary care physicians also occasionally diagnose a mood or anxiety disorder when it is not present (false positive) Among non-depressed patients a false positive rate of 12 in primary care was reported in 1 study[38] and 14 in another[37] About 25 of these MDD false-positives in the Tiemens study actually had an anxiety disorder 20 were the result of overestimation of severity of depression by the primary care physician and 55 were true false positives In the Klinkman study a history of depression was apparent in over half of the false-positive cases

suggesting that physicians might have been unduly influenced by a history of depression rather than the clinical evidence for depression at the time of examination

The implications of these misdiagnoses require more study Because the treatments for most mood and anxiety disorders are similar and because even subsyndromal disorders cause significant distress and functional disability it is possible that imprecision in diagnosis may still result in the use of appropriate medication treatment Of course treatment of an individual without a disorder even subsyndromal causes unneeded exposure to medication errors

Recommendations to diminish misdiagnoses in primary care Since primary care clinicians will most likely continue to be the point of entry and often the sole provider of mental health treatment for patients suffering from mood and anxiety disorders improvements in diagnosis and appropriate treatment of these disorders in primary care should be an important priority Better education of primary care providers about the symptoms and management of depression and anxiety are essential Programs designed to increase primary care clinicians recognition of depression and other psychiatric disorders have not yet proved to improve treatment outcome[7475] However studies that have added training in depression management in addition to education on better recognition of its presence have yielded better outcomes[76]

The feasibility and sustainability of programs focusing on better education of primary care clinicians has not been established Because of the time constraints of standard primary care practice fast efficient methods of screening such as the Primary Care Evaluation of Mental Disorders (PRIME-MD) for anxiety depression and other psychiatric disorders are recommended[77] The Patient Health Questionnaire a 9-item subset of the PRIME-MD is a more concise screen for depression if time constraints preclude use of the full PRIME-MD questionnaire The routine use of such simple methods for screening and ongoing monitoring might provide a sustainable way of reducing diagnostic errors in ambulatory medical settings

A final recommendation is for managed care and insurance companies as well as health systems and provider networks to consider the implementation of incentives for better detection and treatment of mood and anxiety disorders Pilot pay for performance programs such as Bridges to Excellence[78] or the Integrated Healthcare Association initiative in California[79] have focused on physical conditions such as diabetes or asthma Quality measures do exist for the medication treatment and follow up of diagnosed depression such as performance standard and report card measures[80] Adding incentives for better detection and treatment to the use of quality measures is a recommended first step

Errors in the Use of Seclusion and Restraint

In October 1998 The Hartford Courant reported on the death of Andrew McClain an 11-year-old boy who died while restrained and secluded in a psychiatric hospital in Connecticut[81] Thus began the Courants 5-part series based on a 50-state survey that confirmed 142 deaths related to the use of seclusion and restraint in mental health settings over the past decade[82-85] The series cautioned that most deaths related to seclusion and restraints are unreported and that the actual number of annual deaths was possibly much higher

The national response to the Courant exposeacute was far reaching Congress commissioned the US General Accounting Office (USGAO) to report on the use of seclusion and restraint The USGAO responded by releasing a report in 1999 entitled Improper Restraint or Seclusion Places People at Risk[82] The USGAO report confirmed the majority of the Courants allegations including the following

Improper use of seclusion and restraint are dangerous

There is inadequate monitoring and reporting of its use and of resulting harm (or preventable adverse events) to patients

Serious injuries or death can occur and are underreported

Licensing and accreditation of seclusion and restraint standards are inconsistent and insufficient and

Successful strategies for preventing seclusion and restraint as well as reducing the risk of injury when use occurs are not widely used

Seclusion and restraint are commonly used practices intended to prevent adults and children with mental health and substance abuse diagnoses from harming themselves or others in inpatient or residential treatment environments Unfortunately access to incidence data collected by The National Association of State Mental Health Program Directors (NASMHPD) is controlled (and forbidden) by participating hospitals There are no published data interpreted as accurately reflecting the true incidence of seclusion and restraint use

The use of these interventions is intended to be severely restricted to individual situations in which an emergency safety need is identified but as use is generally ordered by staff and based on subjective criteria the use of these emergency interventions has a wide range [86] Restraint is defined in a variety of ways but the term generally refers to a manual method or mechanical device material or equipment attached or adjacent to the patients body that he or she cannot easily remove and that restricts the patients freedom or normal access to ones body[87] Seclusion refers to the involuntary confinement of a person in a room where they are physically prevented from leaving[88] Recent literature reviews of seclusion and restraint reflect the absence of[8990]

Substantiated prevention strategies

Indications for use

Application methods

Monitoring

Post-event activities and

Absence of evidence of its effectiveness in preventing harm

The Centers for Medicare and Medicaid Services (CMS) -- formerly known as the Healthcare Financing Administration (HCFA) the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and state licensing agencies have attempted to regulate the use of seclusion and restraint through licensing and accreditation standards[879192] However the Courant series the USGAO report and others have documented alarming rates of patient harm including death despite the application of such standards[818286] While efforts are underway to resolve these issues the appropriate and safe use of seclusion and restraint is far from assured[8693]

In recent years advocates consumers professional associations provider organizations and the legal field have increasingly recommended a reduction in the use of seclusion and restraint or even its elimination[83-86 94] These recommendations resonate with Recommendation no 1 in the IOMs Crossing the Quality Chasm that states All healthcare organizations professional groups

and private and public health purchasers should adopt as their explicit purpose to continually reduce the burden of illness injury and disability and to improve the health and functioning of the people of the United States[2] Using the IOMs medical error nomenclature reports about seclusion and restraint reflect high rates of medical errors mostly errors of commission perhaps errors of omission causing either near misses or preventable adverse events in routine clinical practice

Safety in healthcare practices is defined as keeping the patient free from accidental injury[2] Although not all errors cause injury accidental injury can be due to error either by the failure of a planned action to be completed as intended or use of the wrong plan to achieve an aim The improper use of seclusion and restraint is not safe and causes serious and preventable adverse injuries including death[8182] The media continues to report adverse events as well[9596] For example in 2000 3 deaths were reported just in Texas including that of 2 boys one 9 and the other 11 years old and a 16-year-old girl In South Carolina in 2003 a 9-year-old boy died after he kicked a staff member in the leg and ran down the hall which resulted in a take down and the boys asphyxiation In Arizona a 32-year-old woman died in restraints for behavior that was later judged as not meeting the threshold of imminent danger[96]

Reducing and Improving Seclusion and Restraint Events Recent Performance Improvement Initiatives

Several initiatives focused on seclusion and restraint reduction (embedded in public health prevention continuous quality improvement principles supporting recovery from mental illness and trauma-informed care) have been developed by the American Psychiatric Nurses Association the APA the National Association for Private Health Systems the American Hospital Association the National Alliance on Mental Illness (NAMI) and the Childrens Welfare League of America[2083859798] These initiatives are intended to complement other essential elements such as adequate numbers of well-trained staff and the use of proven psychological and medication treatments

The public health constructs of primary secondary and tertiary prevention create a logical framework and redirect the focus from safer use of seclusion and restraint to interventions that prevent its use[86] The model of recovery espoused by the Surgeon Generals Mental Health report necessitates[99]

System-wide transformation by adopting goals of full recovery in a life outside the hospital

Emphasis on instilling hope

Availability of multiple treatment options and

Development of partnerships with those who seek services

The use of controlling or coercive interventions is counterintuitive in this model and is to be avoided except perhaps as the last alternative in preventing death or significant harm to self or others caused by treatable manifestations of mental illness[94100] A growing understanding of the neurologic biologic psychological and social effects of trauma and its high prevalence in the populations that seek mental health services is informing approaches to assessment diagnosis stabilization and treatment of individuals with mental illness including the use of seclusion and restraint as a means of preventing injury to self or others[101-108]

Data should be analyzed for characteristics of facility usage by

Unit

Shift

Day and

Staff member involved

With rare exception data on individuals should be used confidentially to identify individual staff training needs not for disciplinary actions[88109] The facility needs to highlight data on seclusion and restraint use by graphing and posting this data on all units so that it is clearly visible for staff and consumers of service Facility-generated data on seclusion and restraint used in a non-punitive way provides for healthy competition among treatment units and elevates the general oversight and knowledge of use and outcomes for everyone involved[88109110] It allows and encourages administration to identify successful staff and treatment units so that successful improvements can be shared

A comprehensive national health information infrastructure could be a useful tool in reducing seclusion and restraint events[2111] The National Association of State Mental Health Program Directors Research Institute Inc (NRI) performance improvement system has developed a set of technology standards applications systems and values that include a number of recommendations for reducing seclusion and restraint events and making their occurrence less error prone[112]

Reduction of the use of seclusion and restraint must start with clear leadership and a specific plan that articulates a mission and philosophy about seclusion and restraint reduction and defines the roles and responsibilities of all facility staff[109] One core component is use of an executive on-call function and the daily review of the use of seclusion and restraint by executive leadership[88110]

Creating a treatment environment that prevents seclusion and restraint is based on the principles of recovery and the characteristics of trauma-informed systems of care[88109] Staff education needs to

Include the experiences of consumers and staff

Address the common myths associated with use

Introduce the rationale and characteristics of trauma-informed care

Educate on the neurobiological and psychological effects of trauma and

Describe a prevention-based approach to reduction

Seclusion and Restraint Summary

The use of seclusion and restraint is associated with substantial harm to recipients of care including death Medical errors precede many seclusion and restraint events which in turn cause further errors and substantial harm to both recipients and providers of care Several local and national initiatives are underway to improve the safety of seclusion and restraint events and to decrease its use The results of their successful application can be seen in facilities in[88 109]

Pennsylvania

New York

Massachusetts

Maine

Florida

New Jersey and

South Dakota

Further study of causal antecedent events and of harm resulting from seclusion and restraint events is recommended using the patient safety paradigm and nomenclature

High-Risk Clinical Populations Lacking Adequate Patient Safety Research

Introduction to High-Risk Clinical Populations

There are no empirical data to quantify characterize or confirm medical errors in certain populations with mental illness andor substance abuse where multiple risk factors for error also exist A brief discussion of these populations and their risks for errors is provided below It is hoped that heightened focus on these high-risk populations will be an impetus for medical error research

Persons with Co-occurring Mental Illness and Substance Abuse

Individuals with co-occurring psychiatric and substance disorders have not been studied for medical errors yet they are perhaps at greater risk for harm because of the nature and number of their co-occurring disorders Several studies have reported the common occurrence of comorbidity among persons with a recognized diagnosis of either mental illness or substance abuse For example in 1990 Regier[74] found a lifetime prevalence of substance abuse among 62 of persons with bipolar disorder In 1996 Kessler and colleagues[113] reported a lifetime prevalence of 599 of psychiatric illness among persons with substance abuse disorders while 31 had a concurrent psychiatric disorder

Persons with co-occurring disorders are high utilizers of medical resources and therefore more exposed to systems issues that may predispose to unintended harm In 1995 an estimated 26 million (27) of the 965 million emergency department (ED) visits were related to alcohol abuse alone[114]

In a study by Dickey and associates[115] using data from the Massachusetts Division of Medical Assistance and death records from the Department of Public Health individuals with co-occurring psychiatric and substance use disorders had the highest risk of medical morbidity for 5 of the studied medical disorders Medicaid beneficiaries with dual diagnoses are 6 to 8 times more likely to die of injury primarily poisoning than their counterparts treated for medical conditions only[116117]

It is well-substantiated that persons with psychiatric and substance abuse disorders have higher rates of suicide attempts and death by suicide[118-123] In 2001[124]

20308 deaths were caused by homicide

30622 deaths by suicide and

101537 deaths were caused by accidents

Given the frequency with which substance abuse by itself has been implicated in these 3 causes of death the scope of morbidity and mortality related to co-occurring disorders is staggering

The effects of substance abuse disorders in adults also affected the mortality rates of children during 1985 to 1996 -- 8482 (24) of the 35547 children aged younger than 15 years died in alcohol-related motor vehicle crashes[125]

A subset of those with co-occurring disorders have substance dependence PTSD and chronic pain The presence of chronic pain and the complexities surrounding treatment of individuals with PTSD increase the risk for unintended harm and of a poor fit between clinical needs and the design of current healthcare systems Despite the added risk factors there is little science to direct clinicians A Medline search using substance abuse PTSD and chronic pain as search terms in June 2004 yielded 10 citations There were no incidence studies and no published treatment guidelines

Conclusion regarding co-occurring disorders Individuals with co-occurring disorders are frequently encountered and at risk for multiple diagnostic and treatment errors including

Missed mental health substance abuse and medical diagnoses and

Insufficient or excessive medication treatment of either their substance abuse or psychiatric disorder

Compared with the general population these individuals are at higher risk for

Suicide attempt

Death by suicide and

Death at a younger age by medical illness

There is a paucity of published studies on medical errors among individuals with co-occurring disorders despite several risk factors for unintended harm and high rates of morbidity and mortality

Attention Deficit-Hyperactivity Disorder in Children Excessive or Insufficient Diagnosis and Treatment

Inattentiveness distractibility impulsivity and hyperactivity were recognized as elements of minimal brain dysfunction (now termed attention deficit hyperactivity disorder [ADHD]) and treated with stimulants especially methylphenidate beginning in the late 1960s[101126127] Over the past 3 decades the rate of drug treatment for behavior problems has increased exponentially culminating in the prescription of ADHD drug treatment for at least 5-6 million American children annually[128]

Children diagnosed with ADHD have been the focus of thousands of research studies over the last 40 years yet the diagnosis and treatment of ADHD remain controversial among some within medicine and the general public[129130] Recent prevalence data from the 1998 National Institutes

of Health (NIH) consensus review[131] and reported by Jensen[132] suggest a prevalence of approximately 5 affecting 3 million school-aged children[133134]

ADHD is associated with[135-137]

Increased risk of accidents

Family and social dysfunction

Poor academic achievement

Substance abuse and

Antisocial behavior

Recent treatment data based on the number of methylphenidate prescriptions show an estimated 5-6 million American children receive ADHD-related drug treatment annually[128] Aggregate national methylphenidate use has increased 100-fold from 1960 until 2000 Globally nearly 90 of the worlds stimulant medication supply is consumed by the US population[138139]

Substantial state-to-state and community-to-community variability in methylphenidate use raises concerns about potential pockets of over- and under-diagnosis and over- and under-prescribing Drug Enforcement Association data on stimulant use reflect a 6-fold per capita variation in methylphenidate prescribing between some states[140] and a 20-fold prescribing variation between some communities[130141]

LeFever and colleagues argue that while the data are inconclusive if communities such as Salt Lake City Utah are used as a benchmark of acceptable diagnosis and treatment then children in 36 states may be subject to over-diagnosis and over-treatment Conversely Jensen argues that ADHD is under-diagnosed and under-treated based on national aggregate data allowing for pockets of over-diagnosis and treatment in some geographic areas[142] Given that in 1995 there were approximately 2 million pediatric visits in which ADHD was the focus of treatment and 6 million stimulant prescriptions were written[132] 1 conclusion is that 3 million children with ADHD received an average of 2 prescriptions and 1 outpatient visit during that year suggesting insufficient treatment In another study cited by Jensen the Multimodal Treatment Study of Children with ADHD two thirds of ADHD children from reportedly highly motivated families obtained medication treatments and for an average duration of only 8-14 months[142143]

Despite the number of studies done the strength of conclusions that can be drawn is contingent upon the adequacy of reported data Studies to date are variously limited by data sources sampling accuracy and interpretation[130]

When considered in aggregate national ADHD prevalence rates and numbers of prescriptions written do not suggest excessive diagnosis and treatment However prevalence rates and stimulant use can vary as much as 30-fold when comparing different communities A prevalence rate of 33 among white elementary-aged boys in southeastern Virginia significantly challenges credibility[130] Such variability makes it essential that prevalence rates and stimulant use estimates be linked to sufficient demographics such as

Geography

Age

Race and

Gender

ADHD prevalence rates and stimulant use appear to be

Excessive in some communities

Plausible in other communities and

Perhaps insufficient in yet other communities

Additional epidemiologic studies reporting prevalence rates with specific demographics rather than in aggregate and broader use of practice guidelines promulgated by the American Academy of Pediatrics (AAP) and others that advocate multimodal treatment rather than solely prescribing stimulants or other medications[130144] will help provide evidence of the extent of errors in the diagnosis and treatment of children with ADHD

Electroconvulsive Therapy

Electroconvulsive therapy (ECT) remains a controversial treatment in psychiatry As stated in the 1985 NIH Consensus Statement The nature of the treatment itself its history of abuse unfavorable media presentations compelling testimony of former patients special attention by the legal system uneven distribution of ECT use among practitioners and facilities and uneven access by patients all contribute to the controversial context in which the consensus panel has approached its task[145]

Epidemiologic data reported by Thompson and colleagues in 1994 found that[146]

58667 patients received ECT in 1975

31514 in 1980

36558 in 1986

71 of the patients who received ECT were women and

Individuals older than 65 years of age had the highest rates per number of inpatients

The rate of ECT use has been highly variable For example in 1995 Herman and associates[147] reported that among 202 metropolitan statistical areas annual ECT use varied from 04 to 812 patients per 10000 population

The most common adverse effect from ECT is memory loss In a recent review of patients perspectives as well as clinicians studies Rose and associates[148] concluded that 29 to 55 of ECT treatment recipients experienced persistent memory loss Recent empirical studies of ECT and memory loss continue to find persistent memory loss with bilateral ECT producing more profound memory deficits than right unilateral ECT[149]

In a review of deaths caused by ECT Abrams reported that ECT is 10 times safer than childbirth that approximately 6 times as many deaths annually in the US are caused by lightning as by ECTand that the death rate reported for ECT is an order of magnitude smaller than the spontaneous death rate in the general population[150]

Corroboration of a low ECT death rate has arisen from 1993 legislation in Texas mandating reporting of all ECT-related deaths[151] As a result the risk of death from ECT in Texas has been systematically tracked and reviewed More than 8000 patients received 49048 ECT treatments between 1993 and 1998 However only 1 death could be linked to the associated anesthesia An additional 4 deaths could plausibly have been associated with the anesthesia yielding a mortality rate between 2 and 10 per 100000 and the causes of death most likely were not the ECT stimulus or seizure

Emotional harm and erosion of faith in the medical profession that undermines accepting other needed treatments can come to recipients of care for whom the experience of ECT is frightening

ECT conclusion ECT is effective for severe major affective illness and is associated with a low mortality rate Persistent memory loss is a consistent finding despite attempts to optimize ECT administration and must be expected at an incidence of approximately 25 to 50 by those contemplating and those providing ECT treatment

Despite its relative safety ECT continues to cause alarm in the general public Even within medicine it is described as dangerous and unethical by some[152] Such fears can cause emotional harm among ECT recipients This may be especially true for older women (who comprise the majority of ECT subjects) some of whom may be accustomed to deferring to healthcare providers when consenting to treatment despite insufficient understanding of benefits and risks

Recommendations include

Emphasis on pre-treatment education

Collaborative relationship with ECT recipients

Increased transparency regarding the substantial risk of persistent memory loss when seeking informed consent and

Continued research on its safety

Systems Issues Related to Patient Safety

Outpatient Care

Risk of unintended harm may be increased by the segregated care settings in which psychiatric and substance abuse services are often delivered including solo practitioner offices and free-standing psychiatric and substance abuse treatment facilities[153154] and by insufficient communication and coordination of care between prescribers and psychotherapists[155-157] Despite the recognition of these potential contributing factors there are no existing reports of the association between systems issues and medical errors

Olfson[158] reported that in 1987 there were 84 million outpatient visits with mental health practitioners including

Psychiatrists

Psychologists

Social workers and

Licensed counselors

Kessler[154] reported in 1999 that an estimated 133 of a representative sample of Americans reported used outpatient services for mental health problems in the previous 12 months Clearly there are high numbers of individuals at risk for errors in outpatient mental health and substance abuse treatment

Ethics and Malpractice Risk Management Boundary Violations

A survey of recently published reviews and commentaries on patient safety reveals that for mental health and substance abuse issues such discussion takes place mainly within the context of ethics and malpractice risk management[159-162] Ethics statements from both the APA[162] and the American Psychological Association[163] support the duty to report and protect patients from deviations from the standards of care This approach uses the individual practitioners frame of reference and relies on voluntary reporting from professionals who have been trained to consider confidentiality a critical component of their work Harm caused by clinician boundary violations are understood as issues of professional misconduct not as errors resulting from system failure and that minimize the individual clinicians responsibility and advise against punitive action [164-167]

With the advent of therapeutic exchanges through email and other means of communication additional boundary violations are possible The Internet now has at least 110 million users including 70 million using it for health-related information[168] A recent survey indicated 40 to 50 of physicians use the Internet (or are preparing to use it) for clinical care[169]

There is a risk of errors of omission or commission arising from lack of coordination of care between clinicians Differences in therapeutic orientation and nomenclature used by the following specialists can compound systems issues that increase the risk of medical errors [158]

Social workers

Psychiatric nurse specialists

Psychologists

Licensed counselors and

Psychiatrists

Confidentiality is critical in providing effective treatment within the secure and private setting of the therapists office and in protecting the patient from unauthorized disclosures of sensitive information and potential abuse from a third party[170] However confidentiality can also inhibit disclosure of near misses impasses in treatment (for example when treatment is not working) and preventable adverse events due to avoidance of sharing important clinical information with other professionals and with appropriate family members and other supportive resources[171172]

The solo practice model commonly used by mental health clinicians can also inhibit the adoption of best practices and the development of policies and procedures to reduce risk because all such practice management activities are left to the individual clinician whose focus is more likely to be exclusively clinical

Summary About Systems Issues and Patient Safety

Systems for reliably reporting outpatient psychotherapy medical errors particularly among the large numbers of solo practitioners do not exist The prevailing paradigm for reducing harm arises from risk reduction in order to diminish medical liability exposure Studies that shed light on potential medical errors have arisen from risk management claims medical liability lawsuits and reports of death by suicide not from research intended to examine patient safety per se

Error reporting systems applicable to outpatient mental health settings including incentives for their use need to be developed Professional risk management programs primarily used to diminish medical liability exposure from the following could also be used to promulgate the relevance and value of the patient safety paradigm

Boundary violations

Suicide and

Treatment errors

Most particularly thought needs to be given to developing systems of error prevention applicable to the solo practitioner

Recommendations

Recommendation no 1

Widespread adoption of the IOM patient safety paradigm and nomenclature in mental health and substance abuse treatment settings is recommended

Advantages of its use include

Consistency with the nomenclature used by other medical specialties

Increased leverage in advocating for needed services and resources when the absence of essential treatments are quantified as errors of omission causing near misses or preventable adverse events

Increased likelihood that medication errors in mental health and substance abuse will be researched and a determination made whether such errors are causing preventable adverse events and

Increased awareness among mental health and substance abuse clinicians that patient harm can come from a broader array of errors in diagnosis and treatment than has been studied to date

Widespread adoption will require systematic educational efforts for trainees and current practitioners in mental health and substance abuse including systematic introduction to the IOMs existence mission and safety and quality efforts such as the Quality Chasm Series (Many mental health and substance abuse clinicians and administrators seem unaware of the IOM at all)

Recommendation no 2

Further studies of medical error in mental health and substance disorders are needed

Some areas of potential harm in this field remain largely unexamined For example we found only 2 studies of medication errors in mental health settings and none in substance abuse detoxification and stabilization settings despite multiple risk factors for errors and preventable adverse events The impact of variable education -- in pharmacology physiology and general medicine -- on the safety of prescribing practices has not been studied nor has the clinical consequences of formulary restrictions on clinical outcome and potential patient harm The current acceptance of self-reported hospital error rates must be challenged through a process of independently validating self-reported errors

Recommendation no 3

Integration of mental health and substance abuse services is recommended

High rates of co-occurrence and associated higher rates of morbidity and mortality among those with mental health and substance abuse disorders requires integration of mental health and substance abuse treatment paradigms This has not occurred to date

Recommendation no 4

The IOMs 10 rules for change in healthcare should be adopted

The 10 IOM rules for change in healthcare are as follows[173]

1 Care based on continuous healing relationships

2 Customization based on patient needs and values

3 The patient as the source of control

4 Shared knowledge and the free-flow of information

5 Evidence-based decision-making

6 Safety as a system property

7 The need for transparency

8 Anticipation of needs

9 Continuous decrease in waste

10 Cooperation among clinicians

As an example of adoption of these rules seclusion and restraint remain high risk treatments yet current reporting systems do not permit transparency regarding the rate and types of injuries incurred including mortality rates Such transparency requires a non-punitive work culture yet there is little evidence to suggest its adoption in high-risk environments such as state psychiatric hospitals or inpatient detoxification and stabilization substance abuse treatment settings

Recommendation no 5

Reporting systems in outpatient mental health and substance abuse treatment settings must be adopted

Reliance upon unsubstantiated self-reporting of medication errors in inpatient mental health and substance abuse settings remains a significant flaw when attempting accurate assessment of near misses and preventable adverse events and must be changed A key necessity is anonymous yet authenticated medication error reporting for all staff using available web-based error reporting systems Such systems are cost-savers and make reported error data immediately and continuously available Web-based reporting systems providing anonymity with authentication could be used for further seclusion and restraint data collection and as a means of establishing an outpatient error reporting system of safety and quality data by recipients and providers of outpatient treatment

Recommendation no 6

Resources should be allocated to study and develop practical interventions to improve patient safety

Much current research in mental health and substance abuse and resource appropriation is focused on efficacy of pharmacotherapy and psychotherapy and on establishing neurobiologic evidence to support causal theories of known clinical disorders At a policy level we recommend more consideration be given to funding practical interventions predicted to immediately improve patient safety

References

[ CLOSE WINDOW ]

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Authors and Disclosures

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Medscape LLC encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration at first mention and where appropriate in the content

Author

Benjamin C Grasso MD

Staff Psychiatrist VA Clinic Saco Maine Disclosure Benjamin C Grasso MD has disclosed no relevant financial relationships

Cathryn M Clary MD MBA

Vice President US External Medical Affairs Pfizer Inc New York NY Disclosure Cathryn M Clary MD MBA has disclosed that she is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Benjamin Eng MD MA

Senior Medical Director Group Leader Pfizer Inc New York NY Disclosure Benjamin Eng MD MA has disclosed that he is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Stanley J Evans MD FASAM PA

Assistant Professor of Clinical Medicine St Matthews University Windham Maine

Medical Director Renaissance Institute of Palm Beach Boca Raton Florida Disclosure Stanley J Evans MD has disclosed no relevant financial relationships

Terry J Golash MD

Clinical Instructor Psychiatry Columbia University New York NY Assistant Attending St Lukersquos Roosevelt Hospital Center New York NY Disclosure Terry J Golash MD has disclosed no relevant financial relationships

Kevin Ann Huckshorn RN MSN CAP ICADC

Director Office of Technical Assistance National Association of State mental Health Program Directors Inc Alexandria Virginia Disclosure Kevin Ann Huckshorn RN MSN CAP ICADC has disclosed no relevant financial relationships

Kenneth Minkoff MD

Clinical Assistant Professor Department of Psychiatry Cambridge Hospital Harvard University Acton Massachusetts Consultant ZiaLogic Acton Massachusetts Disclosure Kenneth Minkoff MD has disclosed no relevant financial relationships

Joseph J Parks MD

Assistant Associate Professor Department of Psychiatry University of Missouri Columbia Missouri Disclosure Joseph J Parks MD has disclosed that he has received grants for educational activities from Letters amp Science and Physician Postgraduate Press Dr Parks has also disclosed that he has served as a consultant to the National Association of State Mental Health Program Directors and Bristol-Myers Squibb Dr Parks has also disclosed that he has received funds for services provided to the state of Missouri from Eli Lilly and Abbott

Miles F Shore MD

Bullard Distinguished Professor of Psychiatry Harvard Medical School Needham Massachusetts Junior Consultant Harvard Medical International Boston Massachusetts Disclosure Miles F Shore MD has disclosed no relevant financial relationships

Editor

Jacqueline A Hart MD

Freelance Clinical Editor Medscape LLC New York New York Disclosure Jacqueline A Hart MD has disclosed no relevant financial relationships

Elizabeth Saenger PhD

Editorial Director Medscape LLC New York NY Disclosure Elizabeth Saenger PhD has disclosed no relevant financial relationships

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Contents of This CMECE Activity

o Medication Errors and Patient Safety in Mental HealthBenjamin C Grasso MD Miles

F Shore MD Cathryn M Clary MD MBA Benjamin Eng MD MA Kevin Ann Huckshorn RN MSN CAP ICADC Joseph J Parks MD Kenneth Minkoff MD Stanley J Evans MD FASAM PA Terry J Golash MD

Medication Errors and Patient Safety in Mental Health

Introduction

In To Err Is Human[1] and Crossing the Quality Chasm[2] the Institute of Medicine (IOM) shed light on high rates of medical errors and unintended harm to recipients of care Subsequent efforts in the Quality Chasm series have elucidated components of a safer healthcare system[3-8] However the series has largely focused on medical and surgical care In this article we address quality and safety concerns for another group of persons that are perhaps more vulnerable to unintended harm and less likely to advocate for themselves -- recipients of mental health and substance abuse treatment

The charge from the Institute of Medicines Committee on Crossing the Quality Chasm -- Adaptation to Mental Health and Addictive Disorders has been to produce a clear picture of the incidence and nature of errors and preventable adverse events in the treatment of mental illnesses and substance use disorders

Background

The number of persons receiving inpatient or outpatient treatment for mental illness and substance abuse disorders is substantial The Centers for Disease Control and Preventions

(CDC)s 2000 National Hospital Discharge Survey reported more than 2 million discharges for care recipients with an International Classification of Disease Clinical Modification (ICD-CM) Mental Disorder[9] Their 2001 National Ambulatory Medical Care Survey reported[10]

26 million visits with symptoms referable to psychologicalmental disorders

25 million visits with symptoms referable to the nervous system (excluding sense organs) and

51 million visits with symptoms referable to general symptoms

It is likely that a significant percentage of individuals in the 2 latter categories of visits have mental illness

Despite the staggering numbers few reports have been published on medical errors in mental health and substance abuse or related methodological issues[11-14] Some prominent psychiatric journals have yet to include medical errors or adverse drug events as keyword options for submitted manuscripts In addition terms more recently invoked in patient safety research such as near risks and preventable adverse events are largely unknown in mental health and substance abuse A MEDLINE search performed June 2004 using medication errors and psychiatry as search terms yielded 37 citations A similar search using medication errors and substance abuse yielded 69 citations and medication errors cross-referenced with addiction yielded 1 citation In contrast a search of medication errors in general yielded 4892 citations most of which were in anesthesiology and medicine

History

The study of unintended harm caused by medical errors began in the field of anesthesiology 20 years ago[15] At that time anesthesia death rates were roughly 1 in 10000 and there was a precipitous rise in medical liability premiums An anesthesia research foundation was formed numerous research and performance improvement initiatives were undertaken and death rates have since dropped to approximately 1 in 200000

In the early 1990s Classen and colleagues as well as Brennan and associates in the Harvard Medical Practice Study made forays into internal medicine patient safety research[16-18] Once the Institute of Medicine released To Err Is Human in 2000 the often-cited medical error mortality rate of 44000 to 98000 per year began to increasingly appear in the lay press[1] In 2000 the Centers for Disease Control reported that approximately 100000 persons die annually from hospital-acquired infection which heightened concerns over patient safety[19]

Crossing the Quality Chasm released by the Institute of Medicine in 2001 marked the beginning of the Quality Chasm Series focusing on remedies needed to transform the US healthcare system[1-8] The series chronicled the substantial progress made identifying and quantifying unintended harm incurred by medical and surgical patients and in developing the architecture of a patient safety regimen The time has come to apply this experience and frame of reference to the inpatient and outpatient care of mental heath and substance abuse patients

As a specialty psychiatry has started to adopt elements of the patient safety movement The American Psychiatric Association (APA) convened its first Task Force on Patient Safety in 2002[20] Four areas were presented as priorities (1) change in clinical culture to focus on patient safety (2) adverse medication events (3) use of seclusion and restraint and (4) suicides in inpatient and residential settings

Additional recommendations included local and regional educational efforts through APA district branches and inclusion of patient safety initiatives in medical school and residency programs Its recommendations were approved by the Board of Trustees November 24 2002 and by the Assembly Executive Committee January 24 2003 leading to the inception of the APA Committee on Patient Safety[20]

Some potential harms to mental healthcare recipients have been studied extensively including

Adverse drug reactions such as

o Tardive dyskinesia

o Neuroleptic malignant syndrome

o Obesity and insulin resistance and

o Serotonin syndrome

Harm resulting from seclusion and restraint

The incidence and etiology of suicide and

Inappropriate psychiatrist-patient contact

However errors have not been systematically examined and the contemporary patient safety paradigm and terminology have not been widely incorporated into the lexicon research and daily clinical practice of mental health and substance use treatment[1112]

Terminology

According to the Institute of Medicines nomenclature a medical error is any mistake made in diagnosis or treatment[8] One category of medical errors is medication errors defined as mistakes made in prescribing transcribing dispensing or administering medication Mistaken diagnoses and errors in treatment are examples of errors of commission missed diagnoses and needed treatments not given are errors of omission A mistake that has not caused harm is a near miss When harm is caused by a mistake it is termed a preventable adverse event Adverse drug events that cause harm but have not resulted from an error and could not have been prevented (for example a drug rash when a medication is correctly prescribed to a patient without a history of allergic reaction) are adverse drug reactions

Applying this nomenclature mental health and substance abuse clinicians and researchers have had some success studying medical errors that cause preventable adverse events including errors of commission and omission Examples of errors of commission include the physical and psychological harm caused by excessive seclusion and restraint and by medication errors An example of an error of omission causing preventable adverse events is the under-diagnosis and treatment of depression and subsequent morbidity and mortality

There are only a few studies of medication errors causing near misses and of errors in psychotherapy (including insufficient coordination of care between non-psychiatric prescribers and counselors and psychotherapists) causing near misses

This paper summarizes research on medical errors in mental health and substance abuse and recommends future initiatives Additional areas of potential harm not usually characterized as errors are also considered from a patient safety perspective including

Memory loss from electroconvulsive therapy and

Inappropriate clinician-patient contact

Medication Errors Recap

Medication errors in mental health settings have been reviewed by Grasso and colleagues for IOM[11] and for Medscape[12] and are summarized here Adverse drug events (ADEs) were defined as any patient harm caused by administration of a medication and were categorized as either adverse drug reactions (ADRs) or medication errors The World Health Organization (WHO) definition of an adverse drug reaction was used -- namely a complication caused by a drug when used in the usual manner and dosage[21] Medication errors were defined in accordance with the recommendations of The National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional patient or consumer[22] Such events may be related to professional practice or healthcare products procedures and systems including

Prescribing

Order communication

Product labeling packaging and nomenclature

Compounding

Dispensing

Distribution

Administration

Education

Monitoring and

Use

Methodologically this review involved an extensive literature review English-language studies involving ADEs and medication errors in psychiatry were identified by reviewing the following keywords in MEDLINE from 1966 to 2002 all cross-referenced with the term psychiatry

Medication error

Adverse drug event and

Adverse drug reaction

Studies were included if they contained original data on medication errors or adverse drug events in mental healthcare

Incidence studies of ADEs had been conducted almost exclusively in general medical settings and had primarily examined ADRs not medication errors Only 2 medication error incidence studies in mental health settings were found One was a 1984 epidemiologic study of state psychiatric hospitals which reported that 75 of randomly selected patients experienced ADRs[23] medication errors were not examined

In the only study examining the incidence of medication errors in a mental health setting Grasso and colleagues retrospectively studied 31 state psychiatric inpatients over 2 months of care[1314] Nine errors were self-reported using the usual incident reporting process whereas an independent multidisciplinary review team found 2194 errors for the same 31 patients and episode of care

19 of errors were rated as having a low risk of harm

23 as having a moderate risk and

58 as having a high risk

The absence of studies of medication errors understood as near misses is highlighted This is a significant category of errors which can occur during prescribing transcribing dispensing and administering medications and has the potential to cause significant harm Indeed near misses may sometimes be termed as such because the study did not include assessment of patients and an attempt at drawing causal connections between the observed medical errors and the patients clinical course

The literature review noted above yielded

No reports on medication errors in outpatient mental health settings

No medication error incidence studies in settings where psychologists have prescriptive authority and

No studies on the incidence and characteristics of medication errors in substance abuse settings including medical detoxification for alcohol sedative hypnotic or opiate withdrawal

One important concern rarely addressed in published studies is the exclusive reliance upon self-reporting in psychiatric and medical-surgical hospitals[1112] Only 3 studies were found that compared self-reporting with an independent teams detection and reporting of errors (a methodological factor affecting the validity of reported error rates) In these studies independent review teams detected error rates that ranged from 88 to 1000 times higher than self-reported error rates and that were determined to be more valid that self-reported rates[13141624]

Medication Error Summary

Medication errors in mental health treatment settings have not been adequately studied The potential for errors of omission and commission in mental health however causing either near misses or preventable adverse events is high for each of the following reasons

Volume of outpatient visits

Number of psychiatric medication prescriptions written

Absence of evidence of a contemporary understanding of medication errors and their consequences in both inpatient and outpatient mental health treatment settings

High prevalence of co-occurring substance abuse disorders that complicate diagnosis and treatment and

Greater vulnerability of individuals with mental illness

In addition the validity of reported error rates is limited by self-reporting -- the error reporting method currently used in almost all hospitals

Errors in Diagnosis

Missed Diagnoses and Insufficient Treatment of Mood and Anxiety Disorders in Ambulatory Medical Settings

Introduction to missed diagnosis Over half of patients with a psychiatric problem receive treatment solely from a primary care physician rather than a mental health specialist[25] Of all patients seen in primary care from 15 to 25 have a mood or anxiety disorder[26-29] Because mood and anxiety disorders are common in ambulatory medical settings but providers in these setting are usually non-psychiatric clinicians treatment rendered in this setting may be prone to medical errors

Errors of omission The primary errors of omission in ambulatory medical settings where non-mental health clinicians are the only providers interacting with patients are missed diagnoses and failure to implement a needed treatment

Missed diagnoses Although the reliability of psychiatric diagnoses when made by trained diagnosticians using structured interviews is a good approach for most disorders errors are made even under conditions considered ideal or nearly ideal[30] In primary care medical practice the following factors are likely to increase diagnostic errors of omission

Time constraints

Competing demands

Minimal training in mental health diagnosis and treatment and

Lack of use of a systematic diagnostic interview

The overall missed diagnosis error rate for the detection of any mood or anxiety disorder by primary care physicians compared with a psychiatric interview has been reported to range from 25[26] to almost 67[31] Primary care physicians correctly diagnose only 35 to 57 of the cases of major depressive disorder (MDD) that are identified with a psychiatric interview[32-36] A multinational investigation found that[37]

27 of false-negative cases (that is primary care physician missing the diagnosis of MDD) were due to complete disagreement with a standardized interview diagnosis

397 were due to the primary care physician recognizing some symptoms of depression but underestimating the severity of the condition and therefore not giving the diagnosis and

33 were diagnosed with another condition

Correct identification of MDD by primary care physicians is associated with[38]

Greater familiarity with the patient and

Presence of suggestive clinical cues (eg a history of depression or the presence of vegetative symptoms)

Anxiety disorders also frequently go undetected[313940] In 1 study about 10 of primary care patients with an anxiety disorder were identified by their physician[41] Approximately 70 of the time that a primary care physician identifies an anxiety problem they diagnose an anxiety state unspecified rather than a specific anxiety disorder[42] In 1 study in Israel only 2 of patients with posttraumatic stress disorder (PTSD) were diagnosed correctly by the primary care physician[43] This underdiagnosis may be a result of inadequate education about anxiety disorders for example only 57 of primary care doctors in a study conducted in Germany considered generalized anxiety disorder to be an independent disorder[44]

Insufficient treatment Treatment is absent when mood and anxiety disorders are missed Insufficient treatment may occur even when anxiety and mood disorders are diagnosed correctly Only about half of patients diagnosed in primary care settings with mood or anxiety disorders receive medication treatment[4546] Psychotherapy referrals were not examined in these studies so it remains unclear whether the patients who did not receive medication treatment were offered psychological treatment

Even when a psychiatrist provided a consultation and advised antidepressant treatment only 53 of appropriate primary care patients received antidepressant medication over the next year[47] The National Ambulatory Medical Care Survey database from 1985 to 1998 documented that treatment for anxiety is offered in 60 of visits to primary care physicians compared with over 95 of visits for anxiety to a psychiatrists[42] A recent naturalistic study of anxiety disordered patients in primary care found that 47 were receiving treatment from either the primary care physician or a specialty mental health clinician[48] A study of patients with panic disorder in primary care settings revealed that only 64 were found to be receiving either medication or psychotherapy[49]

Preventable adverse events Missed diagnoses and insufficient treatment of mood and anxiety disorders in medical settings may cause serious preventable adverse events For MDD preventable adverse events include impairment in physical and mental functioning that is comparable to that found with common medical disorders such as hypertension and diabetes[5051] Depression exacerbates the outcomes of chronic medical illnesses[52] and is associated with higher rehospitalization rates[53] and higher mortality rates[5455] following a myocardial infarction

MDD is also associated with a substantial risk of suicide which is increased when treatment is insufficient[56-58] The economic burden in the United States due to MDD has been estimated at about $83 billion as of 2000[59] Of these costs about three-fourths represent indirect costs (vs the direct cost of providing treatment) particularly reduced productivity and absenteeism in the workplace The World Health Organization has ranked MDD as second only to ischemic heart disease in magnitude of disease burden in countries with established market economies[60]

The functional and economic burden of MDD has been an area of focus for payers and employers Less recognized however is the substantial impairment in social and occupational functioning and in physical health documented in mental health treatment settings for individuals with specific anxiety disorders such as

PTSD[6162]

Panic disorder[6364]

Generalized anxiety disorder[65] and

Social anxiety disorder[6667]

Impairment from anxiety disorders is also apparent in those who present to a primary care physician[496869] Generalized anxiety disorder produces impairment in health-related functioning that is equivalent to or significantly greater than patients with diabetes and recent myocardial infarction

Primary care patients with anxiety disorder are high utilizers of general medical services resulting in increased overall healthcare costs compared with primary care patients who have subthreshold disorders or no anxiety disorder[70] The economic burden of anxiety disorders in the United States has been estimated to be $423 billion in 1990 primarily due to increased use of non-psychiatric medical services[71]

However missed diagnoses do not necessarily lead to preventable adverse events Some studies have suggested that patients with unrecognized MDD in the primary care setting are less severely depressed and less functionally impaired[323770] and therefore at less risk for

Loss of employment

Impaired social functioning

Exacerbation of co-occurring medical disorders and

Suicide

When recognized and unrecognized patients with MDD are tracked over time clinical improvement has often been comparable[3770] although greater short-term improvement for recognized cases has also been reported for MDD[34] and anxiety disorders[72]

Errors of commission mistaken diagnoses As described previously for MDD about one-third of the diagnostic errors in primary care are mistaken diagnoses[37] Mistaken diagnoses range from anxiety disorders to alcoholsubstance abuse to psychoticdissociative disorders Conversely when an anxiety disorder is present a mistaken diagnosis of depression is sometimes given[39] The high level of comorbidity between anxiety and mood disorders is likely to contribute substantially to such diagnostic errors[73]

Primary care physicians also occasionally diagnose a mood or anxiety disorder when it is not present (false positive) Among non-depressed patients a false positive rate of 12 in primary care was reported in 1 study[38] and 14 in another[37] About 25 of these MDD false-positives in the Tiemens study actually had an anxiety disorder 20 were the result of overestimation of severity of depression by the primary care physician and 55 were true false positives In the Klinkman study a history of depression was apparent in over half of the false-positive cases

suggesting that physicians might have been unduly influenced by a history of depression rather than the clinical evidence for depression at the time of examination

The implications of these misdiagnoses require more study Because the treatments for most mood and anxiety disorders are similar and because even subsyndromal disorders cause significant distress and functional disability it is possible that imprecision in diagnosis may still result in the use of appropriate medication treatment Of course treatment of an individual without a disorder even subsyndromal causes unneeded exposure to medication errors

Recommendations to diminish misdiagnoses in primary care Since primary care clinicians will most likely continue to be the point of entry and often the sole provider of mental health treatment for patients suffering from mood and anxiety disorders improvements in diagnosis and appropriate treatment of these disorders in primary care should be an important priority Better education of primary care providers about the symptoms and management of depression and anxiety are essential Programs designed to increase primary care clinicians recognition of depression and other psychiatric disorders have not yet proved to improve treatment outcome[7475] However studies that have added training in depression management in addition to education on better recognition of its presence have yielded better outcomes[76]

The feasibility and sustainability of programs focusing on better education of primary care clinicians has not been established Because of the time constraints of standard primary care practice fast efficient methods of screening such as the Primary Care Evaluation of Mental Disorders (PRIME-MD) for anxiety depression and other psychiatric disorders are recommended[77] The Patient Health Questionnaire a 9-item subset of the PRIME-MD is a more concise screen for depression if time constraints preclude use of the full PRIME-MD questionnaire The routine use of such simple methods for screening and ongoing monitoring might provide a sustainable way of reducing diagnostic errors in ambulatory medical settings

A final recommendation is for managed care and insurance companies as well as health systems and provider networks to consider the implementation of incentives for better detection and treatment of mood and anxiety disorders Pilot pay for performance programs such as Bridges to Excellence[78] or the Integrated Healthcare Association initiative in California[79] have focused on physical conditions such as diabetes or asthma Quality measures do exist for the medication treatment and follow up of diagnosed depression such as performance standard and report card measures[80] Adding incentives for better detection and treatment to the use of quality measures is a recommended first step

Errors in the Use of Seclusion and Restraint

In October 1998 The Hartford Courant reported on the death of Andrew McClain an 11-year-old boy who died while restrained and secluded in a psychiatric hospital in Connecticut[81] Thus began the Courants 5-part series based on a 50-state survey that confirmed 142 deaths related to the use of seclusion and restraint in mental health settings over the past decade[82-85] The series cautioned that most deaths related to seclusion and restraints are unreported and that the actual number of annual deaths was possibly much higher

The national response to the Courant exposeacute was far reaching Congress commissioned the US General Accounting Office (USGAO) to report on the use of seclusion and restraint The USGAO responded by releasing a report in 1999 entitled Improper Restraint or Seclusion Places People at Risk[82] The USGAO report confirmed the majority of the Courants allegations including the following

Improper use of seclusion and restraint are dangerous

There is inadequate monitoring and reporting of its use and of resulting harm (or preventable adverse events) to patients

Serious injuries or death can occur and are underreported

Licensing and accreditation of seclusion and restraint standards are inconsistent and insufficient and

Successful strategies for preventing seclusion and restraint as well as reducing the risk of injury when use occurs are not widely used

Seclusion and restraint are commonly used practices intended to prevent adults and children with mental health and substance abuse diagnoses from harming themselves or others in inpatient or residential treatment environments Unfortunately access to incidence data collected by The National Association of State Mental Health Program Directors (NASMHPD) is controlled (and forbidden) by participating hospitals There are no published data interpreted as accurately reflecting the true incidence of seclusion and restraint use

The use of these interventions is intended to be severely restricted to individual situations in which an emergency safety need is identified but as use is generally ordered by staff and based on subjective criteria the use of these emergency interventions has a wide range [86] Restraint is defined in a variety of ways but the term generally refers to a manual method or mechanical device material or equipment attached or adjacent to the patients body that he or she cannot easily remove and that restricts the patients freedom or normal access to ones body[87] Seclusion refers to the involuntary confinement of a person in a room where they are physically prevented from leaving[88] Recent literature reviews of seclusion and restraint reflect the absence of[8990]

Substantiated prevention strategies

Indications for use

Application methods

Monitoring

Post-event activities and

Absence of evidence of its effectiveness in preventing harm

The Centers for Medicare and Medicaid Services (CMS) -- formerly known as the Healthcare Financing Administration (HCFA) the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and state licensing agencies have attempted to regulate the use of seclusion and restraint through licensing and accreditation standards[879192] However the Courant series the USGAO report and others have documented alarming rates of patient harm including death despite the application of such standards[818286] While efforts are underway to resolve these issues the appropriate and safe use of seclusion and restraint is far from assured[8693]

In recent years advocates consumers professional associations provider organizations and the legal field have increasingly recommended a reduction in the use of seclusion and restraint or even its elimination[83-86 94] These recommendations resonate with Recommendation no 1 in the IOMs Crossing the Quality Chasm that states All healthcare organizations professional groups

and private and public health purchasers should adopt as their explicit purpose to continually reduce the burden of illness injury and disability and to improve the health and functioning of the people of the United States[2] Using the IOMs medical error nomenclature reports about seclusion and restraint reflect high rates of medical errors mostly errors of commission perhaps errors of omission causing either near misses or preventable adverse events in routine clinical practice

Safety in healthcare practices is defined as keeping the patient free from accidental injury[2] Although not all errors cause injury accidental injury can be due to error either by the failure of a planned action to be completed as intended or use of the wrong plan to achieve an aim The improper use of seclusion and restraint is not safe and causes serious and preventable adverse injuries including death[8182] The media continues to report adverse events as well[9596] For example in 2000 3 deaths were reported just in Texas including that of 2 boys one 9 and the other 11 years old and a 16-year-old girl In South Carolina in 2003 a 9-year-old boy died after he kicked a staff member in the leg and ran down the hall which resulted in a take down and the boys asphyxiation In Arizona a 32-year-old woman died in restraints for behavior that was later judged as not meeting the threshold of imminent danger[96]

Reducing and Improving Seclusion and Restraint Events Recent Performance Improvement Initiatives

Several initiatives focused on seclusion and restraint reduction (embedded in public health prevention continuous quality improvement principles supporting recovery from mental illness and trauma-informed care) have been developed by the American Psychiatric Nurses Association the APA the National Association for Private Health Systems the American Hospital Association the National Alliance on Mental Illness (NAMI) and the Childrens Welfare League of America[2083859798] These initiatives are intended to complement other essential elements such as adequate numbers of well-trained staff and the use of proven psychological and medication treatments

The public health constructs of primary secondary and tertiary prevention create a logical framework and redirect the focus from safer use of seclusion and restraint to interventions that prevent its use[86] The model of recovery espoused by the Surgeon Generals Mental Health report necessitates[99]

System-wide transformation by adopting goals of full recovery in a life outside the hospital

Emphasis on instilling hope

Availability of multiple treatment options and

Development of partnerships with those who seek services

The use of controlling or coercive interventions is counterintuitive in this model and is to be avoided except perhaps as the last alternative in preventing death or significant harm to self or others caused by treatable manifestations of mental illness[94100] A growing understanding of the neurologic biologic psychological and social effects of trauma and its high prevalence in the populations that seek mental health services is informing approaches to assessment diagnosis stabilization and treatment of individuals with mental illness including the use of seclusion and restraint as a means of preventing injury to self or others[101-108]

Data should be analyzed for characteristics of facility usage by

Unit

Shift

Day and

Staff member involved

With rare exception data on individuals should be used confidentially to identify individual staff training needs not for disciplinary actions[88109] The facility needs to highlight data on seclusion and restraint use by graphing and posting this data on all units so that it is clearly visible for staff and consumers of service Facility-generated data on seclusion and restraint used in a non-punitive way provides for healthy competition among treatment units and elevates the general oversight and knowledge of use and outcomes for everyone involved[88109110] It allows and encourages administration to identify successful staff and treatment units so that successful improvements can be shared

A comprehensive national health information infrastructure could be a useful tool in reducing seclusion and restraint events[2111] The National Association of State Mental Health Program Directors Research Institute Inc (NRI) performance improvement system has developed a set of technology standards applications systems and values that include a number of recommendations for reducing seclusion and restraint events and making their occurrence less error prone[112]

Reduction of the use of seclusion and restraint must start with clear leadership and a specific plan that articulates a mission and philosophy about seclusion and restraint reduction and defines the roles and responsibilities of all facility staff[109] One core component is use of an executive on-call function and the daily review of the use of seclusion and restraint by executive leadership[88110]

Creating a treatment environment that prevents seclusion and restraint is based on the principles of recovery and the characteristics of trauma-informed systems of care[88109] Staff education needs to

Include the experiences of consumers and staff

Address the common myths associated with use

Introduce the rationale and characteristics of trauma-informed care

Educate on the neurobiological and psychological effects of trauma and

Describe a prevention-based approach to reduction

Seclusion and Restraint Summary

The use of seclusion and restraint is associated with substantial harm to recipients of care including death Medical errors precede many seclusion and restraint events which in turn cause further errors and substantial harm to both recipients and providers of care Several local and national initiatives are underway to improve the safety of seclusion and restraint events and to decrease its use The results of their successful application can be seen in facilities in[88 109]

Pennsylvania

New York

Massachusetts

Maine

Florida

New Jersey and

South Dakota

Further study of causal antecedent events and of harm resulting from seclusion and restraint events is recommended using the patient safety paradigm and nomenclature

High-Risk Clinical Populations Lacking Adequate Patient Safety Research

Introduction to High-Risk Clinical Populations

There are no empirical data to quantify characterize or confirm medical errors in certain populations with mental illness andor substance abuse where multiple risk factors for error also exist A brief discussion of these populations and their risks for errors is provided below It is hoped that heightened focus on these high-risk populations will be an impetus for medical error research

Persons with Co-occurring Mental Illness and Substance Abuse

Individuals with co-occurring psychiatric and substance disorders have not been studied for medical errors yet they are perhaps at greater risk for harm because of the nature and number of their co-occurring disorders Several studies have reported the common occurrence of comorbidity among persons with a recognized diagnosis of either mental illness or substance abuse For example in 1990 Regier[74] found a lifetime prevalence of substance abuse among 62 of persons with bipolar disorder In 1996 Kessler and colleagues[113] reported a lifetime prevalence of 599 of psychiatric illness among persons with substance abuse disorders while 31 had a concurrent psychiatric disorder

Persons with co-occurring disorders are high utilizers of medical resources and therefore more exposed to systems issues that may predispose to unintended harm In 1995 an estimated 26 million (27) of the 965 million emergency department (ED) visits were related to alcohol abuse alone[114]

In a study by Dickey and associates[115] using data from the Massachusetts Division of Medical Assistance and death records from the Department of Public Health individuals with co-occurring psychiatric and substance use disorders had the highest risk of medical morbidity for 5 of the studied medical disorders Medicaid beneficiaries with dual diagnoses are 6 to 8 times more likely to die of injury primarily poisoning than their counterparts treated for medical conditions only[116117]

It is well-substantiated that persons with psychiatric and substance abuse disorders have higher rates of suicide attempts and death by suicide[118-123] In 2001[124]

20308 deaths were caused by homicide

30622 deaths by suicide and

101537 deaths were caused by accidents

Given the frequency with which substance abuse by itself has been implicated in these 3 causes of death the scope of morbidity and mortality related to co-occurring disorders is staggering

The effects of substance abuse disorders in adults also affected the mortality rates of children during 1985 to 1996 -- 8482 (24) of the 35547 children aged younger than 15 years died in alcohol-related motor vehicle crashes[125]

A subset of those with co-occurring disorders have substance dependence PTSD and chronic pain The presence of chronic pain and the complexities surrounding treatment of individuals with PTSD increase the risk for unintended harm and of a poor fit between clinical needs and the design of current healthcare systems Despite the added risk factors there is little science to direct clinicians A Medline search using substance abuse PTSD and chronic pain as search terms in June 2004 yielded 10 citations There were no incidence studies and no published treatment guidelines

Conclusion regarding co-occurring disorders Individuals with co-occurring disorders are frequently encountered and at risk for multiple diagnostic and treatment errors including

Missed mental health substance abuse and medical diagnoses and

Insufficient or excessive medication treatment of either their substance abuse or psychiatric disorder

Compared with the general population these individuals are at higher risk for

Suicide attempt

Death by suicide and

Death at a younger age by medical illness

There is a paucity of published studies on medical errors among individuals with co-occurring disorders despite several risk factors for unintended harm and high rates of morbidity and mortality

Attention Deficit-Hyperactivity Disorder in Children Excessive or Insufficient Diagnosis and Treatment

Inattentiveness distractibility impulsivity and hyperactivity were recognized as elements of minimal brain dysfunction (now termed attention deficit hyperactivity disorder [ADHD]) and treated with stimulants especially methylphenidate beginning in the late 1960s[101126127] Over the past 3 decades the rate of drug treatment for behavior problems has increased exponentially culminating in the prescription of ADHD drug treatment for at least 5-6 million American children annually[128]

Children diagnosed with ADHD have been the focus of thousands of research studies over the last 40 years yet the diagnosis and treatment of ADHD remain controversial among some within medicine and the general public[129130] Recent prevalence data from the 1998 National Institutes

of Health (NIH) consensus review[131] and reported by Jensen[132] suggest a prevalence of approximately 5 affecting 3 million school-aged children[133134]

ADHD is associated with[135-137]

Increased risk of accidents

Family and social dysfunction

Poor academic achievement

Substance abuse and

Antisocial behavior

Recent treatment data based on the number of methylphenidate prescriptions show an estimated 5-6 million American children receive ADHD-related drug treatment annually[128] Aggregate national methylphenidate use has increased 100-fold from 1960 until 2000 Globally nearly 90 of the worlds stimulant medication supply is consumed by the US population[138139]

Substantial state-to-state and community-to-community variability in methylphenidate use raises concerns about potential pockets of over- and under-diagnosis and over- and under-prescribing Drug Enforcement Association data on stimulant use reflect a 6-fold per capita variation in methylphenidate prescribing between some states[140] and a 20-fold prescribing variation between some communities[130141]

LeFever and colleagues argue that while the data are inconclusive if communities such as Salt Lake City Utah are used as a benchmark of acceptable diagnosis and treatment then children in 36 states may be subject to over-diagnosis and over-treatment Conversely Jensen argues that ADHD is under-diagnosed and under-treated based on national aggregate data allowing for pockets of over-diagnosis and treatment in some geographic areas[142] Given that in 1995 there were approximately 2 million pediatric visits in which ADHD was the focus of treatment and 6 million stimulant prescriptions were written[132] 1 conclusion is that 3 million children with ADHD received an average of 2 prescriptions and 1 outpatient visit during that year suggesting insufficient treatment In another study cited by Jensen the Multimodal Treatment Study of Children with ADHD two thirds of ADHD children from reportedly highly motivated families obtained medication treatments and for an average duration of only 8-14 months[142143]

Despite the number of studies done the strength of conclusions that can be drawn is contingent upon the adequacy of reported data Studies to date are variously limited by data sources sampling accuracy and interpretation[130]

When considered in aggregate national ADHD prevalence rates and numbers of prescriptions written do not suggest excessive diagnosis and treatment However prevalence rates and stimulant use can vary as much as 30-fold when comparing different communities A prevalence rate of 33 among white elementary-aged boys in southeastern Virginia significantly challenges credibility[130] Such variability makes it essential that prevalence rates and stimulant use estimates be linked to sufficient demographics such as

Geography

Age

Race and

Gender

ADHD prevalence rates and stimulant use appear to be

Excessive in some communities

Plausible in other communities and

Perhaps insufficient in yet other communities

Additional epidemiologic studies reporting prevalence rates with specific demographics rather than in aggregate and broader use of practice guidelines promulgated by the American Academy of Pediatrics (AAP) and others that advocate multimodal treatment rather than solely prescribing stimulants or other medications[130144] will help provide evidence of the extent of errors in the diagnosis and treatment of children with ADHD

Electroconvulsive Therapy

Electroconvulsive therapy (ECT) remains a controversial treatment in psychiatry As stated in the 1985 NIH Consensus Statement The nature of the treatment itself its history of abuse unfavorable media presentations compelling testimony of former patients special attention by the legal system uneven distribution of ECT use among practitioners and facilities and uneven access by patients all contribute to the controversial context in which the consensus panel has approached its task[145]

Epidemiologic data reported by Thompson and colleagues in 1994 found that[146]

58667 patients received ECT in 1975

31514 in 1980

36558 in 1986

71 of the patients who received ECT were women and

Individuals older than 65 years of age had the highest rates per number of inpatients

The rate of ECT use has been highly variable For example in 1995 Herman and associates[147] reported that among 202 metropolitan statistical areas annual ECT use varied from 04 to 812 patients per 10000 population

The most common adverse effect from ECT is memory loss In a recent review of patients perspectives as well as clinicians studies Rose and associates[148] concluded that 29 to 55 of ECT treatment recipients experienced persistent memory loss Recent empirical studies of ECT and memory loss continue to find persistent memory loss with bilateral ECT producing more profound memory deficits than right unilateral ECT[149]

In a review of deaths caused by ECT Abrams reported that ECT is 10 times safer than childbirth that approximately 6 times as many deaths annually in the US are caused by lightning as by ECTand that the death rate reported for ECT is an order of magnitude smaller than the spontaneous death rate in the general population[150]

Corroboration of a low ECT death rate has arisen from 1993 legislation in Texas mandating reporting of all ECT-related deaths[151] As a result the risk of death from ECT in Texas has been systematically tracked and reviewed More than 8000 patients received 49048 ECT treatments between 1993 and 1998 However only 1 death could be linked to the associated anesthesia An additional 4 deaths could plausibly have been associated with the anesthesia yielding a mortality rate between 2 and 10 per 100000 and the causes of death most likely were not the ECT stimulus or seizure

Emotional harm and erosion of faith in the medical profession that undermines accepting other needed treatments can come to recipients of care for whom the experience of ECT is frightening

ECT conclusion ECT is effective for severe major affective illness and is associated with a low mortality rate Persistent memory loss is a consistent finding despite attempts to optimize ECT administration and must be expected at an incidence of approximately 25 to 50 by those contemplating and those providing ECT treatment

Despite its relative safety ECT continues to cause alarm in the general public Even within medicine it is described as dangerous and unethical by some[152] Such fears can cause emotional harm among ECT recipients This may be especially true for older women (who comprise the majority of ECT subjects) some of whom may be accustomed to deferring to healthcare providers when consenting to treatment despite insufficient understanding of benefits and risks

Recommendations include

Emphasis on pre-treatment education

Collaborative relationship with ECT recipients

Increased transparency regarding the substantial risk of persistent memory loss when seeking informed consent and

Continued research on its safety

Systems Issues Related to Patient Safety

Outpatient Care

Risk of unintended harm may be increased by the segregated care settings in which psychiatric and substance abuse services are often delivered including solo practitioner offices and free-standing psychiatric and substance abuse treatment facilities[153154] and by insufficient communication and coordination of care between prescribers and psychotherapists[155-157] Despite the recognition of these potential contributing factors there are no existing reports of the association between systems issues and medical errors

Olfson[158] reported that in 1987 there were 84 million outpatient visits with mental health practitioners including

Psychiatrists

Psychologists

Social workers and

Licensed counselors

Kessler[154] reported in 1999 that an estimated 133 of a representative sample of Americans reported used outpatient services for mental health problems in the previous 12 months Clearly there are high numbers of individuals at risk for errors in outpatient mental health and substance abuse treatment

Ethics and Malpractice Risk Management Boundary Violations

A survey of recently published reviews and commentaries on patient safety reveals that for mental health and substance abuse issues such discussion takes place mainly within the context of ethics and malpractice risk management[159-162] Ethics statements from both the APA[162] and the American Psychological Association[163] support the duty to report and protect patients from deviations from the standards of care This approach uses the individual practitioners frame of reference and relies on voluntary reporting from professionals who have been trained to consider confidentiality a critical component of their work Harm caused by clinician boundary violations are understood as issues of professional misconduct not as errors resulting from system failure and that minimize the individual clinicians responsibility and advise against punitive action [164-167]

With the advent of therapeutic exchanges through email and other means of communication additional boundary violations are possible The Internet now has at least 110 million users including 70 million using it for health-related information[168] A recent survey indicated 40 to 50 of physicians use the Internet (or are preparing to use it) for clinical care[169]

There is a risk of errors of omission or commission arising from lack of coordination of care between clinicians Differences in therapeutic orientation and nomenclature used by the following specialists can compound systems issues that increase the risk of medical errors [158]

Social workers

Psychiatric nurse specialists

Psychologists

Licensed counselors and

Psychiatrists

Confidentiality is critical in providing effective treatment within the secure and private setting of the therapists office and in protecting the patient from unauthorized disclosures of sensitive information and potential abuse from a third party[170] However confidentiality can also inhibit disclosure of near misses impasses in treatment (for example when treatment is not working) and preventable adverse events due to avoidance of sharing important clinical information with other professionals and with appropriate family members and other supportive resources[171172]

The solo practice model commonly used by mental health clinicians can also inhibit the adoption of best practices and the development of policies and procedures to reduce risk because all such practice management activities are left to the individual clinician whose focus is more likely to be exclusively clinical

Summary About Systems Issues and Patient Safety

Systems for reliably reporting outpatient psychotherapy medical errors particularly among the large numbers of solo practitioners do not exist The prevailing paradigm for reducing harm arises from risk reduction in order to diminish medical liability exposure Studies that shed light on potential medical errors have arisen from risk management claims medical liability lawsuits and reports of death by suicide not from research intended to examine patient safety per se

Error reporting systems applicable to outpatient mental health settings including incentives for their use need to be developed Professional risk management programs primarily used to diminish medical liability exposure from the following could also be used to promulgate the relevance and value of the patient safety paradigm

Boundary violations

Suicide and

Treatment errors

Most particularly thought needs to be given to developing systems of error prevention applicable to the solo practitioner

Recommendations

Recommendation no 1

Widespread adoption of the IOM patient safety paradigm and nomenclature in mental health and substance abuse treatment settings is recommended

Advantages of its use include

Consistency with the nomenclature used by other medical specialties

Increased leverage in advocating for needed services and resources when the absence of essential treatments are quantified as errors of omission causing near misses or preventable adverse events

Increased likelihood that medication errors in mental health and substance abuse will be researched and a determination made whether such errors are causing preventable adverse events and

Increased awareness among mental health and substance abuse clinicians that patient harm can come from a broader array of errors in diagnosis and treatment than has been studied to date

Widespread adoption will require systematic educational efforts for trainees and current practitioners in mental health and substance abuse including systematic introduction to the IOMs existence mission and safety and quality efforts such as the Quality Chasm Series (Many mental health and substance abuse clinicians and administrators seem unaware of the IOM at all)

Recommendation no 2

Further studies of medical error in mental health and substance disorders are needed

Some areas of potential harm in this field remain largely unexamined For example we found only 2 studies of medication errors in mental health settings and none in substance abuse detoxification and stabilization settings despite multiple risk factors for errors and preventable adverse events The impact of variable education -- in pharmacology physiology and general medicine -- on the safety of prescribing practices has not been studied nor has the clinical consequences of formulary restrictions on clinical outcome and potential patient harm The current acceptance of self-reported hospital error rates must be challenged through a process of independently validating self-reported errors

Recommendation no 3

Integration of mental health and substance abuse services is recommended

High rates of co-occurrence and associated higher rates of morbidity and mortality among those with mental health and substance abuse disorders requires integration of mental health and substance abuse treatment paradigms This has not occurred to date

Recommendation no 4

The IOMs 10 rules for change in healthcare should be adopted

The 10 IOM rules for change in healthcare are as follows[173]

1 Care based on continuous healing relationships

2 Customization based on patient needs and values

3 The patient as the source of control

4 Shared knowledge and the free-flow of information

5 Evidence-based decision-making

6 Safety as a system property

7 The need for transparency

8 Anticipation of needs

9 Continuous decrease in waste

10 Cooperation among clinicians

As an example of adoption of these rules seclusion and restraint remain high risk treatments yet current reporting systems do not permit transparency regarding the rate and types of injuries incurred including mortality rates Such transparency requires a non-punitive work culture yet there is little evidence to suggest its adoption in high-risk environments such as state psychiatric hospitals or inpatient detoxification and stabilization substance abuse treatment settings

Recommendation no 5

Reporting systems in outpatient mental health and substance abuse treatment settings must be adopted

Reliance upon unsubstantiated self-reporting of medication errors in inpatient mental health and substance abuse settings remains a significant flaw when attempting accurate assessment of near misses and preventable adverse events and must be changed A key necessity is anonymous yet authenticated medication error reporting for all staff using available web-based error reporting systems Such systems are cost-savers and make reported error data immediately and continuously available Web-based reporting systems providing anonymity with authentication could be used for further seclusion and restraint data collection and as a means of establishing an outpatient error reporting system of safety and quality data by recipients and providers of outpatient treatment

Recommendation no 6

Resources should be allocated to study and develop practical interventions to improve patient safety

Much current research in mental health and substance abuse and resource appropriation is focused on efficacy of pharmacotherapy and psychotherapy and on establishing neurobiologic evidence to support causal theories of known clinical disorders At a policy level we recommend more consideration be given to funding practical interventions predicted to immediately improve patient safety

References

[ CLOSE WINDOW ]

References

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4 Institute of Medicine Leadership by Example Coordinating Government Roles in Improving Healthcare Quality Washington DC The National Academies Press 2002

5 Institute of Medicine Key Capabilities of an Electronic Health Record System Letter Report Washington DC The National Academies Press 2003

6 Institute of Medicine Priority Areas for National Action Transforming Healthcare Quality Washington DC The National Academies Press 2003

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Medscape LLC encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration at first mention and where appropriate in the content

Author

Benjamin C Grasso MD

Staff Psychiatrist VA Clinic Saco Maine Disclosure Benjamin C Grasso MD has disclosed no relevant financial relationships

Cathryn M Clary MD MBA

Vice President US External Medical Affairs Pfizer Inc New York NY Disclosure Cathryn M Clary MD MBA has disclosed that she is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Benjamin Eng MD MA

Senior Medical Director Group Leader Pfizer Inc New York NY Disclosure Benjamin Eng MD MA has disclosed that he is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Stanley J Evans MD FASAM PA

Assistant Professor of Clinical Medicine St Matthews University Windham Maine

Medical Director Renaissance Institute of Palm Beach Boca Raton Florida Disclosure Stanley J Evans MD has disclosed no relevant financial relationships

Terry J Golash MD

Clinical Instructor Psychiatry Columbia University New York NY Assistant Attending St Lukersquos Roosevelt Hospital Center New York NY Disclosure Terry J Golash MD has disclosed no relevant financial relationships

Kevin Ann Huckshorn RN MSN CAP ICADC

Director Office of Technical Assistance National Association of State mental Health Program Directors Inc Alexandria Virginia Disclosure Kevin Ann Huckshorn RN MSN CAP ICADC has disclosed no relevant financial relationships

Kenneth Minkoff MD

Clinical Assistant Professor Department of Psychiatry Cambridge Hospital Harvard University Acton Massachusetts Consultant ZiaLogic Acton Massachusetts Disclosure Kenneth Minkoff MD has disclosed no relevant financial relationships

Joseph J Parks MD

Assistant Associate Professor Department of Psychiatry University of Missouri Columbia Missouri Disclosure Joseph J Parks MD has disclosed that he has received grants for educational activities from Letters amp Science and Physician Postgraduate Press Dr Parks has also disclosed that he has served as a consultant to the National Association of State Mental Health Program Directors and Bristol-Myers Squibb Dr Parks has also disclosed that he has received funds for services provided to the state of Missouri from Eli Lilly and Abbott

Miles F Shore MD

Bullard Distinguished Professor of Psychiatry Harvard Medical School Needham Massachusetts Junior Consultant Harvard Medical International Boston Massachusetts Disclosure Miles F Shore MD has disclosed no relevant financial relationships

Editor

Jacqueline A Hart MD

Freelance Clinical Editor Medscape LLC New York New York Disclosure Jacqueline A Hart MD has disclosed no relevant financial relationships

Elizabeth Saenger PhD

Editorial Director Medscape LLC New York NY Disclosure Elizabeth Saenger PhD has disclosed no relevant financial relationships

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Page 4: Medication Errors and Patient Safety in Mental Health CME/CE · 2019. 6. 27. · Medication Errors and Patient Safety in Mental Health CME/CE Complete author affiliations and disclosures

(CDC)s 2000 National Hospital Discharge Survey reported more than 2 million discharges for care recipients with an International Classification of Disease Clinical Modification (ICD-CM) Mental Disorder[9] Their 2001 National Ambulatory Medical Care Survey reported[10]

26 million visits with symptoms referable to psychologicalmental disorders

25 million visits with symptoms referable to the nervous system (excluding sense organs) and

51 million visits with symptoms referable to general symptoms

It is likely that a significant percentage of individuals in the 2 latter categories of visits have mental illness

Despite the staggering numbers few reports have been published on medical errors in mental health and substance abuse or related methodological issues[11-14] Some prominent psychiatric journals have yet to include medical errors or adverse drug events as keyword options for submitted manuscripts In addition terms more recently invoked in patient safety research such as near risks and preventable adverse events are largely unknown in mental health and substance abuse A MEDLINE search performed June 2004 using medication errors and psychiatry as search terms yielded 37 citations A similar search using medication errors and substance abuse yielded 69 citations and medication errors cross-referenced with addiction yielded 1 citation In contrast a search of medication errors in general yielded 4892 citations most of which were in anesthesiology and medicine

History

The study of unintended harm caused by medical errors began in the field of anesthesiology 20 years ago[15] At that time anesthesia death rates were roughly 1 in 10000 and there was a precipitous rise in medical liability premiums An anesthesia research foundation was formed numerous research and performance improvement initiatives were undertaken and death rates have since dropped to approximately 1 in 200000

In the early 1990s Classen and colleagues as well as Brennan and associates in the Harvard Medical Practice Study made forays into internal medicine patient safety research[16-18] Once the Institute of Medicine released To Err Is Human in 2000 the often-cited medical error mortality rate of 44000 to 98000 per year began to increasingly appear in the lay press[1] In 2000 the Centers for Disease Control reported that approximately 100000 persons die annually from hospital-acquired infection which heightened concerns over patient safety[19]

Crossing the Quality Chasm released by the Institute of Medicine in 2001 marked the beginning of the Quality Chasm Series focusing on remedies needed to transform the US healthcare system[1-8] The series chronicled the substantial progress made identifying and quantifying unintended harm incurred by medical and surgical patients and in developing the architecture of a patient safety regimen The time has come to apply this experience and frame of reference to the inpatient and outpatient care of mental heath and substance abuse patients

As a specialty psychiatry has started to adopt elements of the patient safety movement The American Psychiatric Association (APA) convened its first Task Force on Patient Safety in 2002[20] Four areas were presented as priorities (1) change in clinical culture to focus on patient safety (2) adverse medication events (3) use of seclusion and restraint and (4) suicides in inpatient and residential settings

Additional recommendations included local and regional educational efforts through APA district branches and inclusion of patient safety initiatives in medical school and residency programs Its recommendations were approved by the Board of Trustees November 24 2002 and by the Assembly Executive Committee January 24 2003 leading to the inception of the APA Committee on Patient Safety[20]

Some potential harms to mental healthcare recipients have been studied extensively including

Adverse drug reactions such as

o Tardive dyskinesia

o Neuroleptic malignant syndrome

o Obesity and insulin resistance and

o Serotonin syndrome

Harm resulting from seclusion and restraint

The incidence and etiology of suicide and

Inappropriate psychiatrist-patient contact

However errors have not been systematically examined and the contemporary patient safety paradigm and terminology have not been widely incorporated into the lexicon research and daily clinical practice of mental health and substance use treatment[1112]

Terminology

According to the Institute of Medicines nomenclature a medical error is any mistake made in diagnosis or treatment[8] One category of medical errors is medication errors defined as mistakes made in prescribing transcribing dispensing or administering medication Mistaken diagnoses and errors in treatment are examples of errors of commission missed diagnoses and needed treatments not given are errors of omission A mistake that has not caused harm is a near miss When harm is caused by a mistake it is termed a preventable adverse event Adverse drug events that cause harm but have not resulted from an error and could not have been prevented (for example a drug rash when a medication is correctly prescribed to a patient without a history of allergic reaction) are adverse drug reactions

Applying this nomenclature mental health and substance abuse clinicians and researchers have had some success studying medical errors that cause preventable adverse events including errors of commission and omission Examples of errors of commission include the physical and psychological harm caused by excessive seclusion and restraint and by medication errors An example of an error of omission causing preventable adverse events is the under-diagnosis and treatment of depression and subsequent morbidity and mortality

There are only a few studies of medication errors causing near misses and of errors in psychotherapy (including insufficient coordination of care between non-psychiatric prescribers and counselors and psychotherapists) causing near misses

This paper summarizes research on medical errors in mental health and substance abuse and recommends future initiatives Additional areas of potential harm not usually characterized as errors are also considered from a patient safety perspective including

Memory loss from electroconvulsive therapy and

Inappropriate clinician-patient contact

Medication Errors Recap

Medication errors in mental health settings have been reviewed by Grasso and colleagues for IOM[11] and for Medscape[12] and are summarized here Adverse drug events (ADEs) were defined as any patient harm caused by administration of a medication and were categorized as either adverse drug reactions (ADRs) or medication errors The World Health Organization (WHO) definition of an adverse drug reaction was used -- namely a complication caused by a drug when used in the usual manner and dosage[21] Medication errors were defined in accordance with the recommendations of The National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional patient or consumer[22] Such events may be related to professional practice or healthcare products procedures and systems including

Prescribing

Order communication

Product labeling packaging and nomenclature

Compounding

Dispensing

Distribution

Administration

Education

Monitoring and

Use

Methodologically this review involved an extensive literature review English-language studies involving ADEs and medication errors in psychiatry were identified by reviewing the following keywords in MEDLINE from 1966 to 2002 all cross-referenced with the term psychiatry

Medication error

Adverse drug event and

Adverse drug reaction

Studies were included if they contained original data on medication errors or adverse drug events in mental healthcare

Incidence studies of ADEs had been conducted almost exclusively in general medical settings and had primarily examined ADRs not medication errors Only 2 medication error incidence studies in mental health settings were found One was a 1984 epidemiologic study of state psychiatric hospitals which reported that 75 of randomly selected patients experienced ADRs[23] medication errors were not examined

In the only study examining the incidence of medication errors in a mental health setting Grasso and colleagues retrospectively studied 31 state psychiatric inpatients over 2 months of care[1314] Nine errors were self-reported using the usual incident reporting process whereas an independent multidisciplinary review team found 2194 errors for the same 31 patients and episode of care

19 of errors were rated as having a low risk of harm

23 as having a moderate risk and

58 as having a high risk

The absence of studies of medication errors understood as near misses is highlighted This is a significant category of errors which can occur during prescribing transcribing dispensing and administering medications and has the potential to cause significant harm Indeed near misses may sometimes be termed as such because the study did not include assessment of patients and an attempt at drawing causal connections between the observed medical errors and the patients clinical course

The literature review noted above yielded

No reports on medication errors in outpatient mental health settings

No medication error incidence studies in settings where psychologists have prescriptive authority and

No studies on the incidence and characteristics of medication errors in substance abuse settings including medical detoxification for alcohol sedative hypnotic or opiate withdrawal

One important concern rarely addressed in published studies is the exclusive reliance upon self-reporting in psychiatric and medical-surgical hospitals[1112] Only 3 studies were found that compared self-reporting with an independent teams detection and reporting of errors (a methodological factor affecting the validity of reported error rates) In these studies independent review teams detected error rates that ranged from 88 to 1000 times higher than self-reported error rates and that were determined to be more valid that self-reported rates[13141624]

Medication Error Summary

Medication errors in mental health treatment settings have not been adequately studied The potential for errors of omission and commission in mental health however causing either near misses or preventable adverse events is high for each of the following reasons

Volume of outpatient visits

Number of psychiatric medication prescriptions written

Absence of evidence of a contemporary understanding of medication errors and their consequences in both inpatient and outpatient mental health treatment settings

High prevalence of co-occurring substance abuse disorders that complicate diagnosis and treatment and

Greater vulnerability of individuals with mental illness

In addition the validity of reported error rates is limited by self-reporting -- the error reporting method currently used in almost all hospitals

Errors in Diagnosis

Missed Diagnoses and Insufficient Treatment of Mood and Anxiety Disorders in Ambulatory Medical Settings

Introduction to missed diagnosis Over half of patients with a psychiatric problem receive treatment solely from a primary care physician rather than a mental health specialist[25] Of all patients seen in primary care from 15 to 25 have a mood or anxiety disorder[26-29] Because mood and anxiety disorders are common in ambulatory medical settings but providers in these setting are usually non-psychiatric clinicians treatment rendered in this setting may be prone to medical errors

Errors of omission The primary errors of omission in ambulatory medical settings where non-mental health clinicians are the only providers interacting with patients are missed diagnoses and failure to implement a needed treatment

Missed diagnoses Although the reliability of psychiatric diagnoses when made by trained diagnosticians using structured interviews is a good approach for most disorders errors are made even under conditions considered ideal or nearly ideal[30] In primary care medical practice the following factors are likely to increase diagnostic errors of omission

Time constraints

Competing demands

Minimal training in mental health diagnosis and treatment and

Lack of use of a systematic diagnostic interview

The overall missed diagnosis error rate for the detection of any mood or anxiety disorder by primary care physicians compared with a psychiatric interview has been reported to range from 25[26] to almost 67[31] Primary care physicians correctly diagnose only 35 to 57 of the cases of major depressive disorder (MDD) that are identified with a psychiatric interview[32-36] A multinational investigation found that[37]

27 of false-negative cases (that is primary care physician missing the diagnosis of MDD) were due to complete disagreement with a standardized interview diagnosis

397 were due to the primary care physician recognizing some symptoms of depression but underestimating the severity of the condition and therefore not giving the diagnosis and

33 were diagnosed with another condition

Correct identification of MDD by primary care physicians is associated with[38]

Greater familiarity with the patient and

Presence of suggestive clinical cues (eg a history of depression or the presence of vegetative symptoms)

Anxiety disorders also frequently go undetected[313940] In 1 study about 10 of primary care patients with an anxiety disorder were identified by their physician[41] Approximately 70 of the time that a primary care physician identifies an anxiety problem they diagnose an anxiety state unspecified rather than a specific anxiety disorder[42] In 1 study in Israel only 2 of patients with posttraumatic stress disorder (PTSD) were diagnosed correctly by the primary care physician[43] This underdiagnosis may be a result of inadequate education about anxiety disorders for example only 57 of primary care doctors in a study conducted in Germany considered generalized anxiety disorder to be an independent disorder[44]

Insufficient treatment Treatment is absent when mood and anxiety disorders are missed Insufficient treatment may occur even when anxiety and mood disorders are diagnosed correctly Only about half of patients diagnosed in primary care settings with mood or anxiety disorders receive medication treatment[4546] Psychotherapy referrals were not examined in these studies so it remains unclear whether the patients who did not receive medication treatment were offered psychological treatment

Even when a psychiatrist provided a consultation and advised antidepressant treatment only 53 of appropriate primary care patients received antidepressant medication over the next year[47] The National Ambulatory Medical Care Survey database from 1985 to 1998 documented that treatment for anxiety is offered in 60 of visits to primary care physicians compared with over 95 of visits for anxiety to a psychiatrists[42] A recent naturalistic study of anxiety disordered patients in primary care found that 47 were receiving treatment from either the primary care physician or a specialty mental health clinician[48] A study of patients with panic disorder in primary care settings revealed that only 64 were found to be receiving either medication or psychotherapy[49]

Preventable adverse events Missed diagnoses and insufficient treatment of mood and anxiety disorders in medical settings may cause serious preventable adverse events For MDD preventable adverse events include impairment in physical and mental functioning that is comparable to that found with common medical disorders such as hypertension and diabetes[5051] Depression exacerbates the outcomes of chronic medical illnesses[52] and is associated with higher rehospitalization rates[53] and higher mortality rates[5455] following a myocardial infarction

MDD is also associated with a substantial risk of suicide which is increased when treatment is insufficient[56-58] The economic burden in the United States due to MDD has been estimated at about $83 billion as of 2000[59] Of these costs about three-fourths represent indirect costs (vs the direct cost of providing treatment) particularly reduced productivity and absenteeism in the workplace The World Health Organization has ranked MDD as second only to ischemic heart disease in magnitude of disease burden in countries with established market economies[60]

The functional and economic burden of MDD has been an area of focus for payers and employers Less recognized however is the substantial impairment in social and occupational functioning and in physical health documented in mental health treatment settings for individuals with specific anxiety disorders such as

PTSD[6162]

Panic disorder[6364]

Generalized anxiety disorder[65] and

Social anxiety disorder[6667]

Impairment from anxiety disorders is also apparent in those who present to a primary care physician[496869] Generalized anxiety disorder produces impairment in health-related functioning that is equivalent to or significantly greater than patients with diabetes and recent myocardial infarction

Primary care patients with anxiety disorder are high utilizers of general medical services resulting in increased overall healthcare costs compared with primary care patients who have subthreshold disorders or no anxiety disorder[70] The economic burden of anxiety disorders in the United States has been estimated to be $423 billion in 1990 primarily due to increased use of non-psychiatric medical services[71]

However missed diagnoses do not necessarily lead to preventable adverse events Some studies have suggested that patients with unrecognized MDD in the primary care setting are less severely depressed and less functionally impaired[323770] and therefore at less risk for

Loss of employment

Impaired social functioning

Exacerbation of co-occurring medical disorders and

Suicide

When recognized and unrecognized patients with MDD are tracked over time clinical improvement has often been comparable[3770] although greater short-term improvement for recognized cases has also been reported for MDD[34] and anxiety disorders[72]

Errors of commission mistaken diagnoses As described previously for MDD about one-third of the diagnostic errors in primary care are mistaken diagnoses[37] Mistaken diagnoses range from anxiety disorders to alcoholsubstance abuse to psychoticdissociative disorders Conversely when an anxiety disorder is present a mistaken diagnosis of depression is sometimes given[39] The high level of comorbidity between anxiety and mood disorders is likely to contribute substantially to such diagnostic errors[73]

Primary care physicians also occasionally diagnose a mood or anxiety disorder when it is not present (false positive) Among non-depressed patients a false positive rate of 12 in primary care was reported in 1 study[38] and 14 in another[37] About 25 of these MDD false-positives in the Tiemens study actually had an anxiety disorder 20 were the result of overestimation of severity of depression by the primary care physician and 55 were true false positives In the Klinkman study a history of depression was apparent in over half of the false-positive cases

suggesting that physicians might have been unduly influenced by a history of depression rather than the clinical evidence for depression at the time of examination

The implications of these misdiagnoses require more study Because the treatments for most mood and anxiety disorders are similar and because even subsyndromal disorders cause significant distress and functional disability it is possible that imprecision in diagnosis may still result in the use of appropriate medication treatment Of course treatment of an individual without a disorder even subsyndromal causes unneeded exposure to medication errors

Recommendations to diminish misdiagnoses in primary care Since primary care clinicians will most likely continue to be the point of entry and often the sole provider of mental health treatment for patients suffering from mood and anxiety disorders improvements in diagnosis and appropriate treatment of these disorders in primary care should be an important priority Better education of primary care providers about the symptoms and management of depression and anxiety are essential Programs designed to increase primary care clinicians recognition of depression and other psychiatric disorders have not yet proved to improve treatment outcome[7475] However studies that have added training in depression management in addition to education on better recognition of its presence have yielded better outcomes[76]

The feasibility and sustainability of programs focusing on better education of primary care clinicians has not been established Because of the time constraints of standard primary care practice fast efficient methods of screening such as the Primary Care Evaluation of Mental Disorders (PRIME-MD) for anxiety depression and other psychiatric disorders are recommended[77] The Patient Health Questionnaire a 9-item subset of the PRIME-MD is a more concise screen for depression if time constraints preclude use of the full PRIME-MD questionnaire The routine use of such simple methods for screening and ongoing monitoring might provide a sustainable way of reducing diagnostic errors in ambulatory medical settings

A final recommendation is for managed care and insurance companies as well as health systems and provider networks to consider the implementation of incentives for better detection and treatment of mood and anxiety disorders Pilot pay for performance programs such as Bridges to Excellence[78] or the Integrated Healthcare Association initiative in California[79] have focused on physical conditions such as diabetes or asthma Quality measures do exist for the medication treatment and follow up of diagnosed depression such as performance standard and report card measures[80] Adding incentives for better detection and treatment to the use of quality measures is a recommended first step

Errors in the Use of Seclusion and Restraint

In October 1998 The Hartford Courant reported on the death of Andrew McClain an 11-year-old boy who died while restrained and secluded in a psychiatric hospital in Connecticut[81] Thus began the Courants 5-part series based on a 50-state survey that confirmed 142 deaths related to the use of seclusion and restraint in mental health settings over the past decade[82-85] The series cautioned that most deaths related to seclusion and restraints are unreported and that the actual number of annual deaths was possibly much higher

The national response to the Courant exposeacute was far reaching Congress commissioned the US General Accounting Office (USGAO) to report on the use of seclusion and restraint The USGAO responded by releasing a report in 1999 entitled Improper Restraint or Seclusion Places People at Risk[82] The USGAO report confirmed the majority of the Courants allegations including the following

Improper use of seclusion and restraint are dangerous

There is inadequate monitoring and reporting of its use and of resulting harm (or preventable adverse events) to patients

Serious injuries or death can occur and are underreported

Licensing and accreditation of seclusion and restraint standards are inconsistent and insufficient and

Successful strategies for preventing seclusion and restraint as well as reducing the risk of injury when use occurs are not widely used

Seclusion and restraint are commonly used practices intended to prevent adults and children with mental health and substance abuse diagnoses from harming themselves or others in inpatient or residential treatment environments Unfortunately access to incidence data collected by The National Association of State Mental Health Program Directors (NASMHPD) is controlled (and forbidden) by participating hospitals There are no published data interpreted as accurately reflecting the true incidence of seclusion and restraint use

The use of these interventions is intended to be severely restricted to individual situations in which an emergency safety need is identified but as use is generally ordered by staff and based on subjective criteria the use of these emergency interventions has a wide range [86] Restraint is defined in a variety of ways but the term generally refers to a manual method or mechanical device material or equipment attached or adjacent to the patients body that he or she cannot easily remove and that restricts the patients freedom or normal access to ones body[87] Seclusion refers to the involuntary confinement of a person in a room where they are physically prevented from leaving[88] Recent literature reviews of seclusion and restraint reflect the absence of[8990]

Substantiated prevention strategies

Indications for use

Application methods

Monitoring

Post-event activities and

Absence of evidence of its effectiveness in preventing harm

The Centers for Medicare and Medicaid Services (CMS) -- formerly known as the Healthcare Financing Administration (HCFA) the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and state licensing agencies have attempted to regulate the use of seclusion and restraint through licensing and accreditation standards[879192] However the Courant series the USGAO report and others have documented alarming rates of patient harm including death despite the application of such standards[818286] While efforts are underway to resolve these issues the appropriate and safe use of seclusion and restraint is far from assured[8693]

In recent years advocates consumers professional associations provider organizations and the legal field have increasingly recommended a reduction in the use of seclusion and restraint or even its elimination[83-86 94] These recommendations resonate with Recommendation no 1 in the IOMs Crossing the Quality Chasm that states All healthcare organizations professional groups

and private and public health purchasers should adopt as their explicit purpose to continually reduce the burden of illness injury and disability and to improve the health and functioning of the people of the United States[2] Using the IOMs medical error nomenclature reports about seclusion and restraint reflect high rates of medical errors mostly errors of commission perhaps errors of omission causing either near misses or preventable adverse events in routine clinical practice

Safety in healthcare practices is defined as keeping the patient free from accidental injury[2] Although not all errors cause injury accidental injury can be due to error either by the failure of a planned action to be completed as intended or use of the wrong plan to achieve an aim The improper use of seclusion and restraint is not safe and causes serious and preventable adverse injuries including death[8182] The media continues to report adverse events as well[9596] For example in 2000 3 deaths were reported just in Texas including that of 2 boys one 9 and the other 11 years old and a 16-year-old girl In South Carolina in 2003 a 9-year-old boy died after he kicked a staff member in the leg and ran down the hall which resulted in a take down and the boys asphyxiation In Arizona a 32-year-old woman died in restraints for behavior that was later judged as not meeting the threshold of imminent danger[96]

Reducing and Improving Seclusion and Restraint Events Recent Performance Improvement Initiatives

Several initiatives focused on seclusion and restraint reduction (embedded in public health prevention continuous quality improvement principles supporting recovery from mental illness and trauma-informed care) have been developed by the American Psychiatric Nurses Association the APA the National Association for Private Health Systems the American Hospital Association the National Alliance on Mental Illness (NAMI) and the Childrens Welfare League of America[2083859798] These initiatives are intended to complement other essential elements such as adequate numbers of well-trained staff and the use of proven psychological and medication treatments

The public health constructs of primary secondary and tertiary prevention create a logical framework and redirect the focus from safer use of seclusion and restraint to interventions that prevent its use[86] The model of recovery espoused by the Surgeon Generals Mental Health report necessitates[99]

System-wide transformation by adopting goals of full recovery in a life outside the hospital

Emphasis on instilling hope

Availability of multiple treatment options and

Development of partnerships with those who seek services

The use of controlling or coercive interventions is counterintuitive in this model and is to be avoided except perhaps as the last alternative in preventing death or significant harm to self or others caused by treatable manifestations of mental illness[94100] A growing understanding of the neurologic biologic psychological and social effects of trauma and its high prevalence in the populations that seek mental health services is informing approaches to assessment diagnosis stabilization and treatment of individuals with mental illness including the use of seclusion and restraint as a means of preventing injury to self or others[101-108]

Data should be analyzed for characteristics of facility usage by

Unit

Shift

Day and

Staff member involved

With rare exception data on individuals should be used confidentially to identify individual staff training needs not for disciplinary actions[88109] The facility needs to highlight data on seclusion and restraint use by graphing and posting this data on all units so that it is clearly visible for staff and consumers of service Facility-generated data on seclusion and restraint used in a non-punitive way provides for healthy competition among treatment units and elevates the general oversight and knowledge of use and outcomes for everyone involved[88109110] It allows and encourages administration to identify successful staff and treatment units so that successful improvements can be shared

A comprehensive national health information infrastructure could be a useful tool in reducing seclusion and restraint events[2111] The National Association of State Mental Health Program Directors Research Institute Inc (NRI) performance improvement system has developed a set of technology standards applications systems and values that include a number of recommendations for reducing seclusion and restraint events and making their occurrence less error prone[112]

Reduction of the use of seclusion and restraint must start with clear leadership and a specific plan that articulates a mission and philosophy about seclusion and restraint reduction and defines the roles and responsibilities of all facility staff[109] One core component is use of an executive on-call function and the daily review of the use of seclusion and restraint by executive leadership[88110]

Creating a treatment environment that prevents seclusion and restraint is based on the principles of recovery and the characteristics of trauma-informed systems of care[88109] Staff education needs to

Include the experiences of consumers and staff

Address the common myths associated with use

Introduce the rationale and characteristics of trauma-informed care

Educate on the neurobiological and psychological effects of trauma and

Describe a prevention-based approach to reduction

Seclusion and Restraint Summary

The use of seclusion and restraint is associated with substantial harm to recipients of care including death Medical errors precede many seclusion and restraint events which in turn cause further errors and substantial harm to both recipients and providers of care Several local and national initiatives are underway to improve the safety of seclusion and restraint events and to decrease its use The results of their successful application can be seen in facilities in[88 109]

Pennsylvania

New York

Massachusetts

Maine

Florida

New Jersey and

South Dakota

Further study of causal antecedent events and of harm resulting from seclusion and restraint events is recommended using the patient safety paradigm and nomenclature

High-Risk Clinical Populations Lacking Adequate Patient Safety Research

Introduction to High-Risk Clinical Populations

There are no empirical data to quantify characterize or confirm medical errors in certain populations with mental illness andor substance abuse where multiple risk factors for error also exist A brief discussion of these populations and their risks for errors is provided below It is hoped that heightened focus on these high-risk populations will be an impetus for medical error research

Persons with Co-occurring Mental Illness and Substance Abuse

Individuals with co-occurring psychiatric and substance disorders have not been studied for medical errors yet they are perhaps at greater risk for harm because of the nature and number of their co-occurring disorders Several studies have reported the common occurrence of comorbidity among persons with a recognized diagnosis of either mental illness or substance abuse For example in 1990 Regier[74] found a lifetime prevalence of substance abuse among 62 of persons with bipolar disorder In 1996 Kessler and colleagues[113] reported a lifetime prevalence of 599 of psychiatric illness among persons with substance abuse disorders while 31 had a concurrent psychiatric disorder

Persons with co-occurring disorders are high utilizers of medical resources and therefore more exposed to systems issues that may predispose to unintended harm In 1995 an estimated 26 million (27) of the 965 million emergency department (ED) visits were related to alcohol abuse alone[114]

In a study by Dickey and associates[115] using data from the Massachusetts Division of Medical Assistance and death records from the Department of Public Health individuals with co-occurring psychiatric and substance use disorders had the highest risk of medical morbidity for 5 of the studied medical disorders Medicaid beneficiaries with dual diagnoses are 6 to 8 times more likely to die of injury primarily poisoning than their counterparts treated for medical conditions only[116117]

It is well-substantiated that persons with psychiatric and substance abuse disorders have higher rates of suicide attempts and death by suicide[118-123] In 2001[124]

20308 deaths were caused by homicide

30622 deaths by suicide and

101537 deaths were caused by accidents

Given the frequency with which substance abuse by itself has been implicated in these 3 causes of death the scope of morbidity and mortality related to co-occurring disorders is staggering

The effects of substance abuse disorders in adults also affected the mortality rates of children during 1985 to 1996 -- 8482 (24) of the 35547 children aged younger than 15 years died in alcohol-related motor vehicle crashes[125]

A subset of those with co-occurring disorders have substance dependence PTSD and chronic pain The presence of chronic pain and the complexities surrounding treatment of individuals with PTSD increase the risk for unintended harm and of a poor fit between clinical needs and the design of current healthcare systems Despite the added risk factors there is little science to direct clinicians A Medline search using substance abuse PTSD and chronic pain as search terms in June 2004 yielded 10 citations There were no incidence studies and no published treatment guidelines

Conclusion regarding co-occurring disorders Individuals with co-occurring disorders are frequently encountered and at risk for multiple diagnostic and treatment errors including

Missed mental health substance abuse and medical diagnoses and

Insufficient or excessive medication treatment of either their substance abuse or psychiatric disorder

Compared with the general population these individuals are at higher risk for

Suicide attempt

Death by suicide and

Death at a younger age by medical illness

There is a paucity of published studies on medical errors among individuals with co-occurring disorders despite several risk factors for unintended harm and high rates of morbidity and mortality

Attention Deficit-Hyperactivity Disorder in Children Excessive or Insufficient Diagnosis and Treatment

Inattentiveness distractibility impulsivity and hyperactivity were recognized as elements of minimal brain dysfunction (now termed attention deficit hyperactivity disorder [ADHD]) and treated with stimulants especially methylphenidate beginning in the late 1960s[101126127] Over the past 3 decades the rate of drug treatment for behavior problems has increased exponentially culminating in the prescription of ADHD drug treatment for at least 5-6 million American children annually[128]

Children diagnosed with ADHD have been the focus of thousands of research studies over the last 40 years yet the diagnosis and treatment of ADHD remain controversial among some within medicine and the general public[129130] Recent prevalence data from the 1998 National Institutes

of Health (NIH) consensus review[131] and reported by Jensen[132] suggest a prevalence of approximately 5 affecting 3 million school-aged children[133134]

ADHD is associated with[135-137]

Increased risk of accidents

Family and social dysfunction

Poor academic achievement

Substance abuse and

Antisocial behavior

Recent treatment data based on the number of methylphenidate prescriptions show an estimated 5-6 million American children receive ADHD-related drug treatment annually[128] Aggregate national methylphenidate use has increased 100-fold from 1960 until 2000 Globally nearly 90 of the worlds stimulant medication supply is consumed by the US population[138139]

Substantial state-to-state and community-to-community variability in methylphenidate use raises concerns about potential pockets of over- and under-diagnosis and over- and under-prescribing Drug Enforcement Association data on stimulant use reflect a 6-fold per capita variation in methylphenidate prescribing between some states[140] and a 20-fold prescribing variation between some communities[130141]

LeFever and colleagues argue that while the data are inconclusive if communities such as Salt Lake City Utah are used as a benchmark of acceptable diagnosis and treatment then children in 36 states may be subject to over-diagnosis and over-treatment Conversely Jensen argues that ADHD is under-diagnosed and under-treated based on national aggregate data allowing for pockets of over-diagnosis and treatment in some geographic areas[142] Given that in 1995 there were approximately 2 million pediatric visits in which ADHD was the focus of treatment and 6 million stimulant prescriptions were written[132] 1 conclusion is that 3 million children with ADHD received an average of 2 prescriptions and 1 outpatient visit during that year suggesting insufficient treatment In another study cited by Jensen the Multimodal Treatment Study of Children with ADHD two thirds of ADHD children from reportedly highly motivated families obtained medication treatments and for an average duration of only 8-14 months[142143]

Despite the number of studies done the strength of conclusions that can be drawn is contingent upon the adequacy of reported data Studies to date are variously limited by data sources sampling accuracy and interpretation[130]

When considered in aggregate national ADHD prevalence rates and numbers of prescriptions written do not suggest excessive diagnosis and treatment However prevalence rates and stimulant use can vary as much as 30-fold when comparing different communities A prevalence rate of 33 among white elementary-aged boys in southeastern Virginia significantly challenges credibility[130] Such variability makes it essential that prevalence rates and stimulant use estimates be linked to sufficient demographics such as

Geography

Age

Race and

Gender

ADHD prevalence rates and stimulant use appear to be

Excessive in some communities

Plausible in other communities and

Perhaps insufficient in yet other communities

Additional epidemiologic studies reporting prevalence rates with specific demographics rather than in aggregate and broader use of practice guidelines promulgated by the American Academy of Pediatrics (AAP) and others that advocate multimodal treatment rather than solely prescribing stimulants or other medications[130144] will help provide evidence of the extent of errors in the diagnosis and treatment of children with ADHD

Electroconvulsive Therapy

Electroconvulsive therapy (ECT) remains a controversial treatment in psychiatry As stated in the 1985 NIH Consensus Statement The nature of the treatment itself its history of abuse unfavorable media presentations compelling testimony of former patients special attention by the legal system uneven distribution of ECT use among practitioners and facilities and uneven access by patients all contribute to the controversial context in which the consensus panel has approached its task[145]

Epidemiologic data reported by Thompson and colleagues in 1994 found that[146]

58667 patients received ECT in 1975

31514 in 1980

36558 in 1986

71 of the patients who received ECT were women and

Individuals older than 65 years of age had the highest rates per number of inpatients

The rate of ECT use has been highly variable For example in 1995 Herman and associates[147] reported that among 202 metropolitan statistical areas annual ECT use varied from 04 to 812 patients per 10000 population

The most common adverse effect from ECT is memory loss In a recent review of patients perspectives as well as clinicians studies Rose and associates[148] concluded that 29 to 55 of ECT treatment recipients experienced persistent memory loss Recent empirical studies of ECT and memory loss continue to find persistent memory loss with bilateral ECT producing more profound memory deficits than right unilateral ECT[149]

In a review of deaths caused by ECT Abrams reported that ECT is 10 times safer than childbirth that approximately 6 times as many deaths annually in the US are caused by lightning as by ECTand that the death rate reported for ECT is an order of magnitude smaller than the spontaneous death rate in the general population[150]

Corroboration of a low ECT death rate has arisen from 1993 legislation in Texas mandating reporting of all ECT-related deaths[151] As a result the risk of death from ECT in Texas has been systematically tracked and reviewed More than 8000 patients received 49048 ECT treatments between 1993 and 1998 However only 1 death could be linked to the associated anesthesia An additional 4 deaths could plausibly have been associated with the anesthesia yielding a mortality rate between 2 and 10 per 100000 and the causes of death most likely were not the ECT stimulus or seizure

Emotional harm and erosion of faith in the medical profession that undermines accepting other needed treatments can come to recipients of care for whom the experience of ECT is frightening

ECT conclusion ECT is effective for severe major affective illness and is associated with a low mortality rate Persistent memory loss is a consistent finding despite attempts to optimize ECT administration and must be expected at an incidence of approximately 25 to 50 by those contemplating and those providing ECT treatment

Despite its relative safety ECT continues to cause alarm in the general public Even within medicine it is described as dangerous and unethical by some[152] Such fears can cause emotional harm among ECT recipients This may be especially true for older women (who comprise the majority of ECT subjects) some of whom may be accustomed to deferring to healthcare providers when consenting to treatment despite insufficient understanding of benefits and risks

Recommendations include

Emphasis on pre-treatment education

Collaborative relationship with ECT recipients

Increased transparency regarding the substantial risk of persistent memory loss when seeking informed consent and

Continued research on its safety

Systems Issues Related to Patient Safety

Outpatient Care

Risk of unintended harm may be increased by the segregated care settings in which psychiatric and substance abuse services are often delivered including solo practitioner offices and free-standing psychiatric and substance abuse treatment facilities[153154] and by insufficient communication and coordination of care between prescribers and psychotherapists[155-157] Despite the recognition of these potential contributing factors there are no existing reports of the association between systems issues and medical errors

Olfson[158] reported that in 1987 there were 84 million outpatient visits with mental health practitioners including

Psychiatrists

Psychologists

Social workers and

Licensed counselors

Kessler[154] reported in 1999 that an estimated 133 of a representative sample of Americans reported used outpatient services for mental health problems in the previous 12 months Clearly there are high numbers of individuals at risk for errors in outpatient mental health and substance abuse treatment

Ethics and Malpractice Risk Management Boundary Violations

A survey of recently published reviews and commentaries on patient safety reveals that for mental health and substance abuse issues such discussion takes place mainly within the context of ethics and malpractice risk management[159-162] Ethics statements from both the APA[162] and the American Psychological Association[163] support the duty to report and protect patients from deviations from the standards of care This approach uses the individual practitioners frame of reference and relies on voluntary reporting from professionals who have been trained to consider confidentiality a critical component of their work Harm caused by clinician boundary violations are understood as issues of professional misconduct not as errors resulting from system failure and that minimize the individual clinicians responsibility and advise against punitive action [164-167]

With the advent of therapeutic exchanges through email and other means of communication additional boundary violations are possible The Internet now has at least 110 million users including 70 million using it for health-related information[168] A recent survey indicated 40 to 50 of physicians use the Internet (or are preparing to use it) for clinical care[169]

There is a risk of errors of omission or commission arising from lack of coordination of care between clinicians Differences in therapeutic orientation and nomenclature used by the following specialists can compound systems issues that increase the risk of medical errors [158]

Social workers

Psychiatric nurse specialists

Psychologists

Licensed counselors and

Psychiatrists

Confidentiality is critical in providing effective treatment within the secure and private setting of the therapists office and in protecting the patient from unauthorized disclosures of sensitive information and potential abuse from a third party[170] However confidentiality can also inhibit disclosure of near misses impasses in treatment (for example when treatment is not working) and preventable adverse events due to avoidance of sharing important clinical information with other professionals and with appropriate family members and other supportive resources[171172]

The solo practice model commonly used by mental health clinicians can also inhibit the adoption of best practices and the development of policies and procedures to reduce risk because all such practice management activities are left to the individual clinician whose focus is more likely to be exclusively clinical

Summary About Systems Issues and Patient Safety

Systems for reliably reporting outpatient psychotherapy medical errors particularly among the large numbers of solo practitioners do not exist The prevailing paradigm for reducing harm arises from risk reduction in order to diminish medical liability exposure Studies that shed light on potential medical errors have arisen from risk management claims medical liability lawsuits and reports of death by suicide not from research intended to examine patient safety per se

Error reporting systems applicable to outpatient mental health settings including incentives for their use need to be developed Professional risk management programs primarily used to diminish medical liability exposure from the following could also be used to promulgate the relevance and value of the patient safety paradigm

Boundary violations

Suicide and

Treatment errors

Most particularly thought needs to be given to developing systems of error prevention applicable to the solo practitioner

Recommendations

Recommendation no 1

Widespread adoption of the IOM patient safety paradigm and nomenclature in mental health and substance abuse treatment settings is recommended

Advantages of its use include

Consistency with the nomenclature used by other medical specialties

Increased leverage in advocating for needed services and resources when the absence of essential treatments are quantified as errors of omission causing near misses or preventable adverse events

Increased likelihood that medication errors in mental health and substance abuse will be researched and a determination made whether such errors are causing preventable adverse events and

Increased awareness among mental health and substance abuse clinicians that patient harm can come from a broader array of errors in diagnosis and treatment than has been studied to date

Widespread adoption will require systematic educational efforts for trainees and current practitioners in mental health and substance abuse including systematic introduction to the IOMs existence mission and safety and quality efforts such as the Quality Chasm Series (Many mental health and substance abuse clinicians and administrators seem unaware of the IOM at all)

Recommendation no 2

Further studies of medical error in mental health and substance disorders are needed

Some areas of potential harm in this field remain largely unexamined For example we found only 2 studies of medication errors in mental health settings and none in substance abuse detoxification and stabilization settings despite multiple risk factors for errors and preventable adverse events The impact of variable education -- in pharmacology physiology and general medicine -- on the safety of prescribing practices has not been studied nor has the clinical consequences of formulary restrictions on clinical outcome and potential patient harm The current acceptance of self-reported hospital error rates must be challenged through a process of independently validating self-reported errors

Recommendation no 3

Integration of mental health and substance abuse services is recommended

High rates of co-occurrence and associated higher rates of morbidity and mortality among those with mental health and substance abuse disorders requires integration of mental health and substance abuse treatment paradigms This has not occurred to date

Recommendation no 4

The IOMs 10 rules for change in healthcare should be adopted

The 10 IOM rules for change in healthcare are as follows[173]

1 Care based on continuous healing relationships

2 Customization based on patient needs and values

3 The patient as the source of control

4 Shared knowledge and the free-flow of information

5 Evidence-based decision-making

6 Safety as a system property

7 The need for transparency

8 Anticipation of needs

9 Continuous decrease in waste

10 Cooperation among clinicians

As an example of adoption of these rules seclusion and restraint remain high risk treatments yet current reporting systems do not permit transparency regarding the rate and types of injuries incurred including mortality rates Such transparency requires a non-punitive work culture yet there is little evidence to suggest its adoption in high-risk environments such as state psychiatric hospitals or inpatient detoxification and stabilization substance abuse treatment settings

Recommendation no 5

Reporting systems in outpatient mental health and substance abuse treatment settings must be adopted

Reliance upon unsubstantiated self-reporting of medication errors in inpatient mental health and substance abuse settings remains a significant flaw when attempting accurate assessment of near misses and preventable adverse events and must be changed A key necessity is anonymous yet authenticated medication error reporting for all staff using available web-based error reporting systems Such systems are cost-savers and make reported error data immediately and continuously available Web-based reporting systems providing anonymity with authentication could be used for further seclusion and restraint data collection and as a means of establishing an outpatient error reporting system of safety and quality data by recipients and providers of outpatient treatment

Recommendation no 6

Resources should be allocated to study and develop practical interventions to improve patient safety

Much current research in mental health and substance abuse and resource appropriation is focused on efficacy of pharmacotherapy and psychotherapy and on establishing neurobiologic evidence to support causal theories of known clinical disorders At a policy level we recommend more consideration be given to funding practical interventions predicted to immediately improve patient safety

References

[ CLOSE WINDOW ]

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Authors and Disclosures

As an organization accredited by the ACCME Medscape LLC requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest The ACCME defines relevant financial relationships as financial relationships in any amount occurring within the past 12 months including financial relationships of a spouse or life partner that could create a conflict of interest

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Author

Benjamin C Grasso MD

Staff Psychiatrist VA Clinic Saco Maine Disclosure Benjamin C Grasso MD has disclosed no relevant financial relationships

Cathryn M Clary MD MBA

Vice President US External Medical Affairs Pfizer Inc New York NY Disclosure Cathryn M Clary MD MBA has disclosed that she is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Benjamin Eng MD MA

Senior Medical Director Group Leader Pfizer Inc New York NY Disclosure Benjamin Eng MD MA has disclosed that he is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Stanley J Evans MD FASAM PA

Assistant Professor of Clinical Medicine St Matthews University Windham Maine

Medical Director Renaissance Institute of Palm Beach Boca Raton Florida Disclosure Stanley J Evans MD has disclosed no relevant financial relationships

Terry J Golash MD

Clinical Instructor Psychiatry Columbia University New York NY Assistant Attending St Lukersquos Roosevelt Hospital Center New York NY Disclosure Terry J Golash MD has disclosed no relevant financial relationships

Kevin Ann Huckshorn RN MSN CAP ICADC

Director Office of Technical Assistance National Association of State mental Health Program Directors Inc Alexandria Virginia Disclosure Kevin Ann Huckshorn RN MSN CAP ICADC has disclosed no relevant financial relationships

Kenneth Minkoff MD

Clinical Assistant Professor Department of Psychiatry Cambridge Hospital Harvard University Acton Massachusetts Consultant ZiaLogic Acton Massachusetts Disclosure Kenneth Minkoff MD has disclosed no relevant financial relationships

Joseph J Parks MD

Assistant Associate Professor Department of Psychiatry University of Missouri Columbia Missouri Disclosure Joseph J Parks MD has disclosed that he has received grants for educational activities from Letters amp Science and Physician Postgraduate Press Dr Parks has also disclosed that he has served as a consultant to the National Association of State Mental Health Program Directors and Bristol-Myers Squibb Dr Parks has also disclosed that he has received funds for services provided to the state of Missouri from Eli Lilly and Abbott

Miles F Shore MD

Bullard Distinguished Professor of Psychiatry Harvard Medical School Needham Massachusetts Junior Consultant Harvard Medical International Boston Massachusetts Disclosure Miles F Shore MD has disclosed no relevant financial relationships

Editor

Jacqueline A Hart MD

Freelance Clinical Editor Medscape LLC New York New York Disclosure Jacqueline A Hart MD has disclosed no relevant financial relationships

Elizabeth Saenger PhD

Editorial Director Medscape LLC New York NY Disclosure Elizabeth Saenger PhD has disclosed no relevant financial relationships

Registration for CME credit the post test and the evaluation must be completed online To access the activity Post Test and Evaluation link please go to httpwwwmedscapecomviewprogram7809_index

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Additional recommendations included local and regional educational efforts through APA district branches and inclusion of patient safety initiatives in medical school and residency programs Its recommendations were approved by the Board of Trustees November 24 2002 and by the Assembly Executive Committee January 24 2003 leading to the inception of the APA Committee on Patient Safety[20]

Some potential harms to mental healthcare recipients have been studied extensively including

Adverse drug reactions such as

o Tardive dyskinesia

o Neuroleptic malignant syndrome

o Obesity and insulin resistance and

o Serotonin syndrome

Harm resulting from seclusion and restraint

The incidence and etiology of suicide and

Inappropriate psychiatrist-patient contact

However errors have not been systematically examined and the contemporary patient safety paradigm and terminology have not been widely incorporated into the lexicon research and daily clinical practice of mental health and substance use treatment[1112]

Terminology

According to the Institute of Medicines nomenclature a medical error is any mistake made in diagnosis or treatment[8] One category of medical errors is medication errors defined as mistakes made in prescribing transcribing dispensing or administering medication Mistaken diagnoses and errors in treatment are examples of errors of commission missed diagnoses and needed treatments not given are errors of omission A mistake that has not caused harm is a near miss When harm is caused by a mistake it is termed a preventable adverse event Adverse drug events that cause harm but have not resulted from an error and could not have been prevented (for example a drug rash when a medication is correctly prescribed to a patient without a history of allergic reaction) are adverse drug reactions

Applying this nomenclature mental health and substance abuse clinicians and researchers have had some success studying medical errors that cause preventable adverse events including errors of commission and omission Examples of errors of commission include the physical and psychological harm caused by excessive seclusion and restraint and by medication errors An example of an error of omission causing preventable adverse events is the under-diagnosis and treatment of depression and subsequent morbidity and mortality

There are only a few studies of medication errors causing near misses and of errors in psychotherapy (including insufficient coordination of care between non-psychiatric prescribers and counselors and psychotherapists) causing near misses

This paper summarizes research on medical errors in mental health and substance abuse and recommends future initiatives Additional areas of potential harm not usually characterized as errors are also considered from a patient safety perspective including

Memory loss from electroconvulsive therapy and

Inappropriate clinician-patient contact

Medication Errors Recap

Medication errors in mental health settings have been reviewed by Grasso and colleagues for IOM[11] and for Medscape[12] and are summarized here Adverse drug events (ADEs) were defined as any patient harm caused by administration of a medication and were categorized as either adverse drug reactions (ADRs) or medication errors The World Health Organization (WHO) definition of an adverse drug reaction was used -- namely a complication caused by a drug when used in the usual manner and dosage[21] Medication errors were defined in accordance with the recommendations of The National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional patient or consumer[22] Such events may be related to professional practice or healthcare products procedures and systems including

Prescribing

Order communication

Product labeling packaging and nomenclature

Compounding

Dispensing

Distribution

Administration

Education

Monitoring and

Use

Methodologically this review involved an extensive literature review English-language studies involving ADEs and medication errors in psychiatry were identified by reviewing the following keywords in MEDLINE from 1966 to 2002 all cross-referenced with the term psychiatry

Medication error

Adverse drug event and

Adverse drug reaction

Studies were included if they contained original data on medication errors or adverse drug events in mental healthcare

Incidence studies of ADEs had been conducted almost exclusively in general medical settings and had primarily examined ADRs not medication errors Only 2 medication error incidence studies in mental health settings were found One was a 1984 epidemiologic study of state psychiatric hospitals which reported that 75 of randomly selected patients experienced ADRs[23] medication errors were not examined

In the only study examining the incidence of medication errors in a mental health setting Grasso and colleagues retrospectively studied 31 state psychiatric inpatients over 2 months of care[1314] Nine errors were self-reported using the usual incident reporting process whereas an independent multidisciplinary review team found 2194 errors for the same 31 patients and episode of care

19 of errors were rated as having a low risk of harm

23 as having a moderate risk and

58 as having a high risk

The absence of studies of medication errors understood as near misses is highlighted This is a significant category of errors which can occur during prescribing transcribing dispensing and administering medications and has the potential to cause significant harm Indeed near misses may sometimes be termed as such because the study did not include assessment of patients and an attempt at drawing causal connections between the observed medical errors and the patients clinical course

The literature review noted above yielded

No reports on medication errors in outpatient mental health settings

No medication error incidence studies in settings where psychologists have prescriptive authority and

No studies on the incidence and characteristics of medication errors in substance abuse settings including medical detoxification for alcohol sedative hypnotic or opiate withdrawal

One important concern rarely addressed in published studies is the exclusive reliance upon self-reporting in psychiatric and medical-surgical hospitals[1112] Only 3 studies were found that compared self-reporting with an independent teams detection and reporting of errors (a methodological factor affecting the validity of reported error rates) In these studies independent review teams detected error rates that ranged from 88 to 1000 times higher than self-reported error rates and that were determined to be more valid that self-reported rates[13141624]

Medication Error Summary

Medication errors in mental health treatment settings have not been adequately studied The potential for errors of omission and commission in mental health however causing either near misses or preventable adverse events is high for each of the following reasons

Volume of outpatient visits

Number of psychiatric medication prescriptions written

Absence of evidence of a contemporary understanding of medication errors and their consequences in both inpatient and outpatient mental health treatment settings

High prevalence of co-occurring substance abuse disorders that complicate diagnosis and treatment and

Greater vulnerability of individuals with mental illness

In addition the validity of reported error rates is limited by self-reporting -- the error reporting method currently used in almost all hospitals

Errors in Diagnosis

Missed Diagnoses and Insufficient Treatment of Mood and Anxiety Disorders in Ambulatory Medical Settings

Introduction to missed diagnosis Over half of patients with a psychiatric problem receive treatment solely from a primary care physician rather than a mental health specialist[25] Of all patients seen in primary care from 15 to 25 have a mood or anxiety disorder[26-29] Because mood and anxiety disorders are common in ambulatory medical settings but providers in these setting are usually non-psychiatric clinicians treatment rendered in this setting may be prone to medical errors

Errors of omission The primary errors of omission in ambulatory medical settings where non-mental health clinicians are the only providers interacting with patients are missed diagnoses and failure to implement a needed treatment

Missed diagnoses Although the reliability of psychiatric diagnoses when made by trained diagnosticians using structured interviews is a good approach for most disorders errors are made even under conditions considered ideal or nearly ideal[30] In primary care medical practice the following factors are likely to increase diagnostic errors of omission

Time constraints

Competing demands

Minimal training in mental health diagnosis and treatment and

Lack of use of a systematic diagnostic interview

The overall missed diagnosis error rate for the detection of any mood or anxiety disorder by primary care physicians compared with a psychiatric interview has been reported to range from 25[26] to almost 67[31] Primary care physicians correctly diagnose only 35 to 57 of the cases of major depressive disorder (MDD) that are identified with a psychiatric interview[32-36] A multinational investigation found that[37]

27 of false-negative cases (that is primary care physician missing the diagnosis of MDD) were due to complete disagreement with a standardized interview diagnosis

397 were due to the primary care physician recognizing some symptoms of depression but underestimating the severity of the condition and therefore not giving the diagnosis and

33 were diagnosed with another condition

Correct identification of MDD by primary care physicians is associated with[38]

Greater familiarity with the patient and

Presence of suggestive clinical cues (eg a history of depression or the presence of vegetative symptoms)

Anxiety disorders also frequently go undetected[313940] In 1 study about 10 of primary care patients with an anxiety disorder were identified by their physician[41] Approximately 70 of the time that a primary care physician identifies an anxiety problem they diagnose an anxiety state unspecified rather than a specific anxiety disorder[42] In 1 study in Israel only 2 of patients with posttraumatic stress disorder (PTSD) were diagnosed correctly by the primary care physician[43] This underdiagnosis may be a result of inadequate education about anxiety disorders for example only 57 of primary care doctors in a study conducted in Germany considered generalized anxiety disorder to be an independent disorder[44]

Insufficient treatment Treatment is absent when mood and anxiety disorders are missed Insufficient treatment may occur even when anxiety and mood disorders are diagnosed correctly Only about half of patients diagnosed in primary care settings with mood or anxiety disorders receive medication treatment[4546] Psychotherapy referrals were not examined in these studies so it remains unclear whether the patients who did not receive medication treatment were offered psychological treatment

Even when a psychiatrist provided a consultation and advised antidepressant treatment only 53 of appropriate primary care patients received antidepressant medication over the next year[47] The National Ambulatory Medical Care Survey database from 1985 to 1998 documented that treatment for anxiety is offered in 60 of visits to primary care physicians compared with over 95 of visits for anxiety to a psychiatrists[42] A recent naturalistic study of anxiety disordered patients in primary care found that 47 were receiving treatment from either the primary care physician or a specialty mental health clinician[48] A study of patients with panic disorder in primary care settings revealed that only 64 were found to be receiving either medication or psychotherapy[49]

Preventable adverse events Missed diagnoses and insufficient treatment of mood and anxiety disorders in medical settings may cause serious preventable adverse events For MDD preventable adverse events include impairment in physical and mental functioning that is comparable to that found with common medical disorders such as hypertension and diabetes[5051] Depression exacerbates the outcomes of chronic medical illnesses[52] and is associated with higher rehospitalization rates[53] and higher mortality rates[5455] following a myocardial infarction

MDD is also associated with a substantial risk of suicide which is increased when treatment is insufficient[56-58] The economic burden in the United States due to MDD has been estimated at about $83 billion as of 2000[59] Of these costs about three-fourths represent indirect costs (vs the direct cost of providing treatment) particularly reduced productivity and absenteeism in the workplace The World Health Organization has ranked MDD as second only to ischemic heart disease in magnitude of disease burden in countries with established market economies[60]

The functional and economic burden of MDD has been an area of focus for payers and employers Less recognized however is the substantial impairment in social and occupational functioning and in physical health documented in mental health treatment settings for individuals with specific anxiety disorders such as

PTSD[6162]

Panic disorder[6364]

Generalized anxiety disorder[65] and

Social anxiety disorder[6667]

Impairment from anxiety disorders is also apparent in those who present to a primary care physician[496869] Generalized anxiety disorder produces impairment in health-related functioning that is equivalent to or significantly greater than patients with diabetes and recent myocardial infarction

Primary care patients with anxiety disorder are high utilizers of general medical services resulting in increased overall healthcare costs compared with primary care patients who have subthreshold disorders or no anxiety disorder[70] The economic burden of anxiety disorders in the United States has been estimated to be $423 billion in 1990 primarily due to increased use of non-psychiatric medical services[71]

However missed diagnoses do not necessarily lead to preventable adverse events Some studies have suggested that patients with unrecognized MDD in the primary care setting are less severely depressed and less functionally impaired[323770] and therefore at less risk for

Loss of employment

Impaired social functioning

Exacerbation of co-occurring medical disorders and

Suicide

When recognized and unrecognized patients with MDD are tracked over time clinical improvement has often been comparable[3770] although greater short-term improvement for recognized cases has also been reported for MDD[34] and anxiety disorders[72]

Errors of commission mistaken diagnoses As described previously for MDD about one-third of the diagnostic errors in primary care are mistaken diagnoses[37] Mistaken diagnoses range from anxiety disorders to alcoholsubstance abuse to psychoticdissociative disorders Conversely when an anxiety disorder is present a mistaken diagnosis of depression is sometimes given[39] The high level of comorbidity between anxiety and mood disorders is likely to contribute substantially to such diagnostic errors[73]

Primary care physicians also occasionally diagnose a mood or anxiety disorder when it is not present (false positive) Among non-depressed patients a false positive rate of 12 in primary care was reported in 1 study[38] and 14 in another[37] About 25 of these MDD false-positives in the Tiemens study actually had an anxiety disorder 20 were the result of overestimation of severity of depression by the primary care physician and 55 were true false positives In the Klinkman study a history of depression was apparent in over half of the false-positive cases

suggesting that physicians might have been unduly influenced by a history of depression rather than the clinical evidence for depression at the time of examination

The implications of these misdiagnoses require more study Because the treatments for most mood and anxiety disorders are similar and because even subsyndromal disorders cause significant distress and functional disability it is possible that imprecision in diagnosis may still result in the use of appropriate medication treatment Of course treatment of an individual without a disorder even subsyndromal causes unneeded exposure to medication errors

Recommendations to diminish misdiagnoses in primary care Since primary care clinicians will most likely continue to be the point of entry and often the sole provider of mental health treatment for patients suffering from mood and anxiety disorders improvements in diagnosis and appropriate treatment of these disorders in primary care should be an important priority Better education of primary care providers about the symptoms and management of depression and anxiety are essential Programs designed to increase primary care clinicians recognition of depression and other psychiatric disorders have not yet proved to improve treatment outcome[7475] However studies that have added training in depression management in addition to education on better recognition of its presence have yielded better outcomes[76]

The feasibility and sustainability of programs focusing on better education of primary care clinicians has not been established Because of the time constraints of standard primary care practice fast efficient methods of screening such as the Primary Care Evaluation of Mental Disorders (PRIME-MD) for anxiety depression and other psychiatric disorders are recommended[77] The Patient Health Questionnaire a 9-item subset of the PRIME-MD is a more concise screen for depression if time constraints preclude use of the full PRIME-MD questionnaire The routine use of such simple methods for screening and ongoing monitoring might provide a sustainable way of reducing diagnostic errors in ambulatory medical settings

A final recommendation is for managed care and insurance companies as well as health systems and provider networks to consider the implementation of incentives for better detection and treatment of mood and anxiety disorders Pilot pay for performance programs such as Bridges to Excellence[78] or the Integrated Healthcare Association initiative in California[79] have focused on physical conditions such as diabetes or asthma Quality measures do exist for the medication treatment and follow up of diagnosed depression such as performance standard and report card measures[80] Adding incentives for better detection and treatment to the use of quality measures is a recommended first step

Errors in the Use of Seclusion and Restraint

In October 1998 The Hartford Courant reported on the death of Andrew McClain an 11-year-old boy who died while restrained and secluded in a psychiatric hospital in Connecticut[81] Thus began the Courants 5-part series based on a 50-state survey that confirmed 142 deaths related to the use of seclusion and restraint in mental health settings over the past decade[82-85] The series cautioned that most deaths related to seclusion and restraints are unreported and that the actual number of annual deaths was possibly much higher

The national response to the Courant exposeacute was far reaching Congress commissioned the US General Accounting Office (USGAO) to report on the use of seclusion and restraint The USGAO responded by releasing a report in 1999 entitled Improper Restraint or Seclusion Places People at Risk[82] The USGAO report confirmed the majority of the Courants allegations including the following

Improper use of seclusion and restraint are dangerous

There is inadequate monitoring and reporting of its use and of resulting harm (or preventable adverse events) to patients

Serious injuries or death can occur and are underreported

Licensing and accreditation of seclusion and restraint standards are inconsistent and insufficient and

Successful strategies for preventing seclusion and restraint as well as reducing the risk of injury when use occurs are not widely used

Seclusion and restraint are commonly used practices intended to prevent adults and children with mental health and substance abuse diagnoses from harming themselves or others in inpatient or residential treatment environments Unfortunately access to incidence data collected by The National Association of State Mental Health Program Directors (NASMHPD) is controlled (and forbidden) by participating hospitals There are no published data interpreted as accurately reflecting the true incidence of seclusion and restraint use

The use of these interventions is intended to be severely restricted to individual situations in which an emergency safety need is identified but as use is generally ordered by staff and based on subjective criteria the use of these emergency interventions has a wide range [86] Restraint is defined in a variety of ways but the term generally refers to a manual method or mechanical device material or equipment attached or adjacent to the patients body that he or she cannot easily remove and that restricts the patients freedom or normal access to ones body[87] Seclusion refers to the involuntary confinement of a person in a room where they are physically prevented from leaving[88] Recent literature reviews of seclusion and restraint reflect the absence of[8990]

Substantiated prevention strategies

Indications for use

Application methods

Monitoring

Post-event activities and

Absence of evidence of its effectiveness in preventing harm

The Centers for Medicare and Medicaid Services (CMS) -- formerly known as the Healthcare Financing Administration (HCFA) the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and state licensing agencies have attempted to regulate the use of seclusion and restraint through licensing and accreditation standards[879192] However the Courant series the USGAO report and others have documented alarming rates of patient harm including death despite the application of such standards[818286] While efforts are underway to resolve these issues the appropriate and safe use of seclusion and restraint is far from assured[8693]

In recent years advocates consumers professional associations provider organizations and the legal field have increasingly recommended a reduction in the use of seclusion and restraint or even its elimination[83-86 94] These recommendations resonate with Recommendation no 1 in the IOMs Crossing the Quality Chasm that states All healthcare organizations professional groups

and private and public health purchasers should adopt as their explicit purpose to continually reduce the burden of illness injury and disability and to improve the health and functioning of the people of the United States[2] Using the IOMs medical error nomenclature reports about seclusion and restraint reflect high rates of medical errors mostly errors of commission perhaps errors of omission causing either near misses or preventable adverse events in routine clinical practice

Safety in healthcare practices is defined as keeping the patient free from accidental injury[2] Although not all errors cause injury accidental injury can be due to error either by the failure of a planned action to be completed as intended or use of the wrong plan to achieve an aim The improper use of seclusion and restraint is not safe and causes serious and preventable adverse injuries including death[8182] The media continues to report adverse events as well[9596] For example in 2000 3 deaths were reported just in Texas including that of 2 boys one 9 and the other 11 years old and a 16-year-old girl In South Carolina in 2003 a 9-year-old boy died after he kicked a staff member in the leg and ran down the hall which resulted in a take down and the boys asphyxiation In Arizona a 32-year-old woman died in restraints for behavior that was later judged as not meeting the threshold of imminent danger[96]

Reducing and Improving Seclusion and Restraint Events Recent Performance Improvement Initiatives

Several initiatives focused on seclusion and restraint reduction (embedded in public health prevention continuous quality improvement principles supporting recovery from mental illness and trauma-informed care) have been developed by the American Psychiatric Nurses Association the APA the National Association for Private Health Systems the American Hospital Association the National Alliance on Mental Illness (NAMI) and the Childrens Welfare League of America[2083859798] These initiatives are intended to complement other essential elements such as adequate numbers of well-trained staff and the use of proven psychological and medication treatments

The public health constructs of primary secondary and tertiary prevention create a logical framework and redirect the focus from safer use of seclusion and restraint to interventions that prevent its use[86] The model of recovery espoused by the Surgeon Generals Mental Health report necessitates[99]

System-wide transformation by adopting goals of full recovery in a life outside the hospital

Emphasis on instilling hope

Availability of multiple treatment options and

Development of partnerships with those who seek services

The use of controlling or coercive interventions is counterintuitive in this model and is to be avoided except perhaps as the last alternative in preventing death or significant harm to self or others caused by treatable manifestations of mental illness[94100] A growing understanding of the neurologic biologic psychological and social effects of trauma and its high prevalence in the populations that seek mental health services is informing approaches to assessment diagnosis stabilization and treatment of individuals with mental illness including the use of seclusion and restraint as a means of preventing injury to self or others[101-108]

Data should be analyzed for characteristics of facility usage by

Unit

Shift

Day and

Staff member involved

With rare exception data on individuals should be used confidentially to identify individual staff training needs not for disciplinary actions[88109] The facility needs to highlight data on seclusion and restraint use by graphing and posting this data on all units so that it is clearly visible for staff and consumers of service Facility-generated data on seclusion and restraint used in a non-punitive way provides for healthy competition among treatment units and elevates the general oversight and knowledge of use and outcomes for everyone involved[88109110] It allows and encourages administration to identify successful staff and treatment units so that successful improvements can be shared

A comprehensive national health information infrastructure could be a useful tool in reducing seclusion and restraint events[2111] The National Association of State Mental Health Program Directors Research Institute Inc (NRI) performance improvement system has developed a set of technology standards applications systems and values that include a number of recommendations for reducing seclusion and restraint events and making their occurrence less error prone[112]

Reduction of the use of seclusion and restraint must start with clear leadership and a specific plan that articulates a mission and philosophy about seclusion and restraint reduction and defines the roles and responsibilities of all facility staff[109] One core component is use of an executive on-call function and the daily review of the use of seclusion and restraint by executive leadership[88110]

Creating a treatment environment that prevents seclusion and restraint is based on the principles of recovery and the characteristics of trauma-informed systems of care[88109] Staff education needs to

Include the experiences of consumers and staff

Address the common myths associated with use

Introduce the rationale and characteristics of trauma-informed care

Educate on the neurobiological and psychological effects of trauma and

Describe a prevention-based approach to reduction

Seclusion and Restraint Summary

The use of seclusion and restraint is associated with substantial harm to recipients of care including death Medical errors precede many seclusion and restraint events which in turn cause further errors and substantial harm to both recipients and providers of care Several local and national initiatives are underway to improve the safety of seclusion and restraint events and to decrease its use The results of their successful application can be seen in facilities in[88 109]

Pennsylvania

New York

Massachusetts

Maine

Florida

New Jersey and

South Dakota

Further study of causal antecedent events and of harm resulting from seclusion and restraint events is recommended using the patient safety paradigm and nomenclature

High-Risk Clinical Populations Lacking Adequate Patient Safety Research

Introduction to High-Risk Clinical Populations

There are no empirical data to quantify characterize or confirm medical errors in certain populations with mental illness andor substance abuse where multiple risk factors for error also exist A brief discussion of these populations and their risks for errors is provided below It is hoped that heightened focus on these high-risk populations will be an impetus for medical error research

Persons with Co-occurring Mental Illness and Substance Abuse

Individuals with co-occurring psychiatric and substance disorders have not been studied for medical errors yet they are perhaps at greater risk for harm because of the nature and number of their co-occurring disorders Several studies have reported the common occurrence of comorbidity among persons with a recognized diagnosis of either mental illness or substance abuse For example in 1990 Regier[74] found a lifetime prevalence of substance abuse among 62 of persons with bipolar disorder In 1996 Kessler and colleagues[113] reported a lifetime prevalence of 599 of psychiatric illness among persons with substance abuse disorders while 31 had a concurrent psychiatric disorder

Persons with co-occurring disorders are high utilizers of medical resources and therefore more exposed to systems issues that may predispose to unintended harm In 1995 an estimated 26 million (27) of the 965 million emergency department (ED) visits were related to alcohol abuse alone[114]

In a study by Dickey and associates[115] using data from the Massachusetts Division of Medical Assistance and death records from the Department of Public Health individuals with co-occurring psychiatric and substance use disorders had the highest risk of medical morbidity for 5 of the studied medical disorders Medicaid beneficiaries with dual diagnoses are 6 to 8 times more likely to die of injury primarily poisoning than their counterparts treated for medical conditions only[116117]

It is well-substantiated that persons with psychiatric and substance abuse disorders have higher rates of suicide attempts and death by suicide[118-123] In 2001[124]

20308 deaths were caused by homicide

30622 deaths by suicide and

101537 deaths were caused by accidents

Given the frequency with which substance abuse by itself has been implicated in these 3 causes of death the scope of morbidity and mortality related to co-occurring disorders is staggering

The effects of substance abuse disorders in adults also affected the mortality rates of children during 1985 to 1996 -- 8482 (24) of the 35547 children aged younger than 15 years died in alcohol-related motor vehicle crashes[125]

A subset of those with co-occurring disorders have substance dependence PTSD and chronic pain The presence of chronic pain and the complexities surrounding treatment of individuals with PTSD increase the risk for unintended harm and of a poor fit between clinical needs and the design of current healthcare systems Despite the added risk factors there is little science to direct clinicians A Medline search using substance abuse PTSD and chronic pain as search terms in June 2004 yielded 10 citations There were no incidence studies and no published treatment guidelines

Conclusion regarding co-occurring disorders Individuals with co-occurring disorders are frequently encountered and at risk for multiple diagnostic and treatment errors including

Missed mental health substance abuse and medical diagnoses and

Insufficient or excessive medication treatment of either their substance abuse or psychiatric disorder

Compared with the general population these individuals are at higher risk for

Suicide attempt

Death by suicide and

Death at a younger age by medical illness

There is a paucity of published studies on medical errors among individuals with co-occurring disorders despite several risk factors for unintended harm and high rates of morbidity and mortality

Attention Deficit-Hyperactivity Disorder in Children Excessive or Insufficient Diagnosis and Treatment

Inattentiveness distractibility impulsivity and hyperactivity were recognized as elements of minimal brain dysfunction (now termed attention deficit hyperactivity disorder [ADHD]) and treated with stimulants especially methylphenidate beginning in the late 1960s[101126127] Over the past 3 decades the rate of drug treatment for behavior problems has increased exponentially culminating in the prescription of ADHD drug treatment for at least 5-6 million American children annually[128]

Children diagnosed with ADHD have been the focus of thousands of research studies over the last 40 years yet the diagnosis and treatment of ADHD remain controversial among some within medicine and the general public[129130] Recent prevalence data from the 1998 National Institutes

of Health (NIH) consensus review[131] and reported by Jensen[132] suggest a prevalence of approximately 5 affecting 3 million school-aged children[133134]

ADHD is associated with[135-137]

Increased risk of accidents

Family and social dysfunction

Poor academic achievement

Substance abuse and

Antisocial behavior

Recent treatment data based on the number of methylphenidate prescriptions show an estimated 5-6 million American children receive ADHD-related drug treatment annually[128] Aggregate national methylphenidate use has increased 100-fold from 1960 until 2000 Globally nearly 90 of the worlds stimulant medication supply is consumed by the US population[138139]

Substantial state-to-state and community-to-community variability in methylphenidate use raises concerns about potential pockets of over- and under-diagnosis and over- and under-prescribing Drug Enforcement Association data on stimulant use reflect a 6-fold per capita variation in methylphenidate prescribing between some states[140] and a 20-fold prescribing variation between some communities[130141]

LeFever and colleagues argue that while the data are inconclusive if communities such as Salt Lake City Utah are used as a benchmark of acceptable diagnosis and treatment then children in 36 states may be subject to over-diagnosis and over-treatment Conversely Jensen argues that ADHD is under-diagnosed and under-treated based on national aggregate data allowing for pockets of over-diagnosis and treatment in some geographic areas[142] Given that in 1995 there were approximately 2 million pediatric visits in which ADHD was the focus of treatment and 6 million stimulant prescriptions were written[132] 1 conclusion is that 3 million children with ADHD received an average of 2 prescriptions and 1 outpatient visit during that year suggesting insufficient treatment In another study cited by Jensen the Multimodal Treatment Study of Children with ADHD two thirds of ADHD children from reportedly highly motivated families obtained medication treatments and for an average duration of only 8-14 months[142143]

Despite the number of studies done the strength of conclusions that can be drawn is contingent upon the adequacy of reported data Studies to date are variously limited by data sources sampling accuracy and interpretation[130]

When considered in aggregate national ADHD prevalence rates and numbers of prescriptions written do not suggest excessive diagnosis and treatment However prevalence rates and stimulant use can vary as much as 30-fold when comparing different communities A prevalence rate of 33 among white elementary-aged boys in southeastern Virginia significantly challenges credibility[130] Such variability makes it essential that prevalence rates and stimulant use estimates be linked to sufficient demographics such as

Geography

Age

Race and

Gender

ADHD prevalence rates and stimulant use appear to be

Excessive in some communities

Plausible in other communities and

Perhaps insufficient in yet other communities

Additional epidemiologic studies reporting prevalence rates with specific demographics rather than in aggregate and broader use of practice guidelines promulgated by the American Academy of Pediatrics (AAP) and others that advocate multimodal treatment rather than solely prescribing stimulants or other medications[130144] will help provide evidence of the extent of errors in the diagnosis and treatment of children with ADHD

Electroconvulsive Therapy

Electroconvulsive therapy (ECT) remains a controversial treatment in psychiatry As stated in the 1985 NIH Consensus Statement The nature of the treatment itself its history of abuse unfavorable media presentations compelling testimony of former patients special attention by the legal system uneven distribution of ECT use among practitioners and facilities and uneven access by patients all contribute to the controversial context in which the consensus panel has approached its task[145]

Epidemiologic data reported by Thompson and colleagues in 1994 found that[146]

58667 patients received ECT in 1975

31514 in 1980

36558 in 1986

71 of the patients who received ECT were women and

Individuals older than 65 years of age had the highest rates per number of inpatients

The rate of ECT use has been highly variable For example in 1995 Herman and associates[147] reported that among 202 metropolitan statistical areas annual ECT use varied from 04 to 812 patients per 10000 population

The most common adverse effect from ECT is memory loss In a recent review of patients perspectives as well as clinicians studies Rose and associates[148] concluded that 29 to 55 of ECT treatment recipients experienced persistent memory loss Recent empirical studies of ECT and memory loss continue to find persistent memory loss with bilateral ECT producing more profound memory deficits than right unilateral ECT[149]

In a review of deaths caused by ECT Abrams reported that ECT is 10 times safer than childbirth that approximately 6 times as many deaths annually in the US are caused by lightning as by ECTand that the death rate reported for ECT is an order of magnitude smaller than the spontaneous death rate in the general population[150]

Corroboration of a low ECT death rate has arisen from 1993 legislation in Texas mandating reporting of all ECT-related deaths[151] As a result the risk of death from ECT in Texas has been systematically tracked and reviewed More than 8000 patients received 49048 ECT treatments between 1993 and 1998 However only 1 death could be linked to the associated anesthesia An additional 4 deaths could plausibly have been associated with the anesthesia yielding a mortality rate between 2 and 10 per 100000 and the causes of death most likely were not the ECT stimulus or seizure

Emotional harm and erosion of faith in the medical profession that undermines accepting other needed treatments can come to recipients of care for whom the experience of ECT is frightening

ECT conclusion ECT is effective for severe major affective illness and is associated with a low mortality rate Persistent memory loss is a consistent finding despite attempts to optimize ECT administration and must be expected at an incidence of approximately 25 to 50 by those contemplating and those providing ECT treatment

Despite its relative safety ECT continues to cause alarm in the general public Even within medicine it is described as dangerous and unethical by some[152] Such fears can cause emotional harm among ECT recipients This may be especially true for older women (who comprise the majority of ECT subjects) some of whom may be accustomed to deferring to healthcare providers when consenting to treatment despite insufficient understanding of benefits and risks

Recommendations include

Emphasis on pre-treatment education

Collaborative relationship with ECT recipients

Increased transparency regarding the substantial risk of persistent memory loss when seeking informed consent and

Continued research on its safety

Systems Issues Related to Patient Safety

Outpatient Care

Risk of unintended harm may be increased by the segregated care settings in which psychiatric and substance abuse services are often delivered including solo practitioner offices and free-standing psychiatric and substance abuse treatment facilities[153154] and by insufficient communication and coordination of care between prescribers and psychotherapists[155-157] Despite the recognition of these potential contributing factors there are no existing reports of the association between systems issues and medical errors

Olfson[158] reported that in 1987 there were 84 million outpatient visits with mental health practitioners including

Psychiatrists

Psychologists

Social workers and

Licensed counselors

Kessler[154] reported in 1999 that an estimated 133 of a representative sample of Americans reported used outpatient services for mental health problems in the previous 12 months Clearly there are high numbers of individuals at risk for errors in outpatient mental health and substance abuse treatment

Ethics and Malpractice Risk Management Boundary Violations

A survey of recently published reviews and commentaries on patient safety reveals that for mental health and substance abuse issues such discussion takes place mainly within the context of ethics and malpractice risk management[159-162] Ethics statements from both the APA[162] and the American Psychological Association[163] support the duty to report and protect patients from deviations from the standards of care This approach uses the individual practitioners frame of reference and relies on voluntary reporting from professionals who have been trained to consider confidentiality a critical component of their work Harm caused by clinician boundary violations are understood as issues of professional misconduct not as errors resulting from system failure and that minimize the individual clinicians responsibility and advise against punitive action [164-167]

With the advent of therapeutic exchanges through email and other means of communication additional boundary violations are possible The Internet now has at least 110 million users including 70 million using it for health-related information[168] A recent survey indicated 40 to 50 of physicians use the Internet (or are preparing to use it) for clinical care[169]

There is a risk of errors of omission or commission arising from lack of coordination of care between clinicians Differences in therapeutic orientation and nomenclature used by the following specialists can compound systems issues that increase the risk of medical errors [158]

Social workers

Psychiatric nurse specialists

Psychologists

Licensed counselors and

Psychiatrists

Confidentiality is critical in providing effective treatment within the secure and private setting of the therapists office and in protecting the patient from unauthorized disclosures of sensitive information and potential abuse from a third party[170] However confidentiality can also inhibit disclosure of near misses impasses in treatment (for example when treatment is not working) and preventable adverse events due to avoidance of sharing important clinical information with other professionals and with appropriate family members and other supportive resources[171172]

The solo practice model commonly used by mental health clinicians can also inhibit the adoption of best practices and the development of policies and procedures to reduce risk because all such practice management activities are left to the individual clinician whose focus is more likely to be exclusively clinical

Summary About Systems Issues and Patient Safety

Systems for reliably reporting outpatient psychotherapy medical errors particularly among the large numbers of solo practitioners do not exist The prevailing paradigm for reducing harm arises from risk reduction in order to diminish medical liability exposure Studies that shed light on potential medical errors have arisen from risk management claims medical liability lawsuits and reports of death by suicide not from research intended to examine patient safety per se

Error reporting systems applicable to outpatient mental health settings including incentives for their use need to be developed Professional risk management programs primarily used to diminish medical liability exposure from the following could also be used to promulgate the relevance and value of the patient safety paradigm

Boundary violations

Suicide and

Treatment errors

Most particularly thought needs to be given to developing systems of error prevention applicable to the solo practitioner

Recommendations

Recommendation no 1

Widespread adoption of the IOM patient safety paradigm and nomenclature in mental health and substance abuse treatment settings is recommended

Advantages of its use include

Consistency with the nomenclature used by other medical specialties

Increased leverage in advocating for needed services and resources when the absence of essential treatments are quantified as errors of omission causing near misses or preventable adverse events

Increased likelihood that medication errors in mental health and substance abuse will be researched and a determination made whether such errors are causing preventable adverse events and

Increased awareness among mental health and substance abuse clinicians that patient harm can come from a broader array of errors in diagnosis and treatment than has been studied to date

Widespread adoption will require systematic educational efforts for trainees and current practitioners in mental health and substance abuse including systematic introduction to the IOMs existence mission and safety and quality efforts such as the Quality Chasm Series (Many mental health and substance abuse clinicians and administrators seem unaware of the IOM at all)

Recommendation no 2

Further studies of medical error in mental health and substance disorders are needed

Some areas of potential harm in this field remain largely unexamined For example we found only 2 studies of medication errors in mental health settings and none in substance abuse detoxification and stabilization settings despite multiple risk factors for errors and preventable adverse events The impact of variable education -- in pharmacology physiology and general medicine -- on the safety of prescribing practices has not been studied nor has the clinical consequences of formulary restrictions on clinical outcome and potential patient harm The current acceptance of self-reported hospital error rates must be challenged through a process of independently validating self-reported errors

Recommendation no 3

Integration of mental health and substance abuse services is recommended

High rates of co-occurrence and associated higher rates of morbidity and mortality among those with mental health and substance abuse disorders requires integration of mental health and substance abuse treatment paradigms This has not occurred to date

Recommendation no 4

The IOMs 10 rules for change in healthcare should be adopted

The 10 IOM rules for change in healthcare are as follows[173]

1 Care based on continuous healing relationships

2 Customization based on patient needs and values

3 The patient as the source of control

4 Shared knowledge and the free-flow of information

5 Evidence-based decision-making

6 Safety as a system property

7 The need for transparency

8 Anticipation of needs

9 Continuous decrease in waste

10 Cooperation among clinicians

As an example of adoption of these rules seclusion and restraint remain high risk treatments yet current reporting systems do not permit transparency regarding the rate and types of injuries incurred including mortality rates Such transparency requires a non-punitive work culture yet there is little evidence to suggest its adoption in high-risk environments such as state psychiatric hospitals or inpatient detoxification and stabilization substance abuse treatment settings

Recommendation no 5

Reporting systems in outpatient mental health and substance abuse treatment settings must be adopted

Reliance upon unsubstantiated self-reporting of medication errors in inpatient mental health and substance abuse settings remains a significant flaw when attempting accurate assessment of near misses and preventable adverse events and must be changed A key necessity is anonymous yet authenticated medication error reporting for all staff using available web-based error reporting systems Such systems are cost-savers and make reported error data immediately and continuously available Web-based reporting systems providing anonymity with authentication could be used for further seclusion and restraint data collection and as a means of establishing an outpatient error reporting system of safety and quality data by recipients and providers of outpatient treatment

Recommendation no 6

Resources should be allocated to study and develop practical interventions to improve patient safety

Much current research in mental health and substance abuse and resource appropriation is focused on efficacy of pharmacotherapy and psychotherapy and on establishing neurobiologic evidence to support causal theories of known clinical disorders At a policy level we recommend more consideration be given to funding practical interventions predicted to immediately improve patient safety

References

[ CLOSE WINDOW ]

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166 Malmquist CP Notman MT Psychiatrist and patient boundary issues following treatment termination Am J Psychiatry 20011581010-1018 Abstract

167 Herman JL Gartell N Olarte S Feldstein M Localio R Psychiatrist-patient sexual contact results of a national survey II Psychiatrists attitudes Am J Psychiatry 1987144164-169 Abstract

168 Risk Management in Cyberspace Rx for Risk 20019 169 Miller RH Hillman JM Given RS Physician use of IT Results from the Deloitte

research survey J Healthc Inf Manag 20041872-80 Abstract 170 Applebaum PS Privacy in psychiatric treatment threats and responses Focus

20031396-406 171 Godolphin W The role of risk communication in shared decision making BMJ

2003327692-693 Abstract 172 Oregon Medical Association Lets talk disclosures after an adverse medical

event(video) Portland OR 2002 Available at httpwwwPatientSafetyStorecom Accessed August 28 2007

173 Institute of Medicine (IOM) Crossing the Quality of Chasm Adaptation to Mental Health and Addictive Disorders April 26 2004 Available at httpwwwiomeduCMS380919405aspx Accessed September 6 2007

Authors and Disclosures

As an organization accredited by the ACCME Medscape LLC requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest The ACCME defines relevant financial relationships as financial relationships in any amount occurring within the past 12 months including financial relationships of a spouse or life partner that could create a conflict of interest

Medscape LLC encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration at first mention and where appropriate in the content

Author

Benjamin C Grasso MD

Staff Psychiatrist VA Clinic Saco Maine Disclosure Benjamin C Grasso MD has disclosed no relevant financial relationships

Cathryn M Clary MD MBA

Vice President US External Medical Affairs Pfizer Inc New York NY Disclosure Cathryn M Clary MD MBA has disclosed that she is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Benjamin Eng MD MA

Senior Medical Director Group Leader Pfizer Inc New York NY Disclosure Benjamin Eng MD MA has disclosed that he is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Stanley J Evans MD FASAM PA

Assistant Professor of Clinical Medicine St Matthews University Windham Maine

Medical Director Renaissance Institute of Palm Beach Boca Raton Florida Disclosure Stanley J Evans MD has disclosed no relevant financial relationships

Terry J Golash MD

Clinical Instructor Psychiatry Columbia University New York NY Assistant Attending St Lukersquos Roosevelt Hospital Center New York NY Disclosure Terry J Golash MD has disclosed no relevant financial relationships

Kevin Ann Huckshorn RN MSN CAP ICADC

Director Office of Technical Assistance National Association of State mental Health Program Directors Inc Alexandria Virginia Disclosure Kevin Ann Huckshorn RN MSN CAP ICADC has disclosed no relevant financial relationships

Kenneth Minkoff MD

Clinical Assistant Professor Department of Psychiatry Cambridge Hospital Harvard University Acton Massachusetts Consultant ZiaLogic Acton Massachusetts Disclosure Kenneth Minkoff MD has disclosed no relevant financial relationships

Joseph J Parks MD

Assistant Associate Professor Department of Psychiatry University of Missouri Columbia Missouri Disclosure Joseph J Parks MD has disclosed that he has received grants for educational activities from Letters amp Science and Physician Postgraduate Press Dr Parks has also disclosed that he has served as a consultant to the National Association of State Mental Health Program Directors and Bristol-Myers Squibb Dr Parks has also disclosed that he has received funds for services provided to the state of Missouri from Eli Lilly and Abbott

Miles F Shore MD

Bullard Distinguished Professor of Psychiatry Harvard Medical School Needham Massachusetts Junior Consultant Harvard Medical International Boston Massachusetts Disclosure Miles F Shore MD has disclosed no relevant financial relationships

Editor

Jacqueline A Hart MD

Freelance Clinical Editor Medscape LLC New York New York Disclosure Jacqueline A Hart MD has disclosed no relevant financial relationships

Elizabeth Saenger PhD

Editorial Director Medscape LLC New York NY Disclosure Elizabeth Saenger PhD has disclosed no relevant financial relationships

Registration for CME credit the post test and the evaluation must be completed online To access the activity Post Test and Evaluation link please go to httpwwwmedscapecomviewprogram7809_index

Page 6: Medication Errors and Patient Safety in Mental Health CME/CE · 2019. 6. 27. · Medication Errors and Patient Safety in Mental Health CME/CE Complete author affiliations and disclosures

Memory loss from electroconvulsive therapy and

Inappropriate clinician-patient contact

Medication Errors Recap

Medication errors in mental health settings have been reviewed by Grasso and colleagues for IOM[11] and for Medscape[12] and are summarized here Adverse drug events (ADEs) were defined as any patient harm caused by administration of a medication and were categorized as either adverse drug reactions (ADRs) or medication errors The World Health Organization (WHO) definition of an adverse drug reaction was used -- namely a complication caused by a drug when used in the usual manner and dosage[21] Medication errors were defined in accordance with the recommendations of The National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional patient or consumer[22] Such events may be related to professional practice or healthcare products procedures and systems including

Prescribing

Order communication

Product labeling packaging and nomenclature

Compounding

Dispensing

Distribution

Administration

Education

Monitoring and

Use

Methodologically this review involved an extensive literature review English-language studies involving ADEs and medication errors in psychiatry were identified by reviewing the following keywords in MEDLINE from 1966 to 2002 all cross-referenced with the term psychiatry

Medication error

Adverse drug event and

Adverse drug reaction

Studies were included if they contained original data on medication errors or adverse drug events in mental healthcare

Incidence studies of ADEs had been conducted almost exclusively in general medical settings and had primarily examined ADRs not medication errors Only 2 medication error incidence studies in mental health settings were found One was a 1984 epidemiologic study of state psychiatric hospitals which reported that 75 of randomly selected patients experienced ADRs[23] medication errors were not examined

In the only study examining the incidence of medication errors in a mental health setting Grasso and colleagues retrospectively studied 31 state psychiatric inpatients over 2 months of care[1314] Nine errors were self-reported using the usual incident reporting process whereas an independent multidisciplinary review team found 2194 errors for the same 31 patients and episode of care

19 of errors were rated as having a low risk of harm

23 as having a moderate risk and

58 as having a high risk

The absence of studies of medication errors understood as near misses is highlighted This is a significant category of errors which can occur during prescribing transcribing dispensing and administering medications and has the potential to cause significant harm Indeed near misses may sometimes be termed as such because the study did not include assessment of patients and an attempt at drawing causal connections between the observed medical errors and the patients clinical course

The literature review noted above yielded

No reports on medication errors in outpatient mental health settings

No medication error incidence studies in settings where psychologists have prescriptive authority and

No studies on the incidence and characteristics of medication errors in substance abuse settings including medical detoxification for alcohol sedative hypnotic or opiate withdrawal

One important concern rarely addressed in published studies is the exclusive reliance upon self-reporting in psychiatric and medical-surgical hospitals[1112] Only 3 studies were found that compared self-reporting with an independent teams detection and reporting of errors (a methodological factor affecting the validity of reported error rates) In these studies independent review teams detected error rates that ranged from 88 to 1000 times higher than self-reported error rates and that were determined to be more valid that self-reported rates[13141624]

Medication Error Summary

Medication errors in mental health treatment settings have not been adequately studied The potential for errors of omission and commission in mental health however causing either near misses or preventable adverse events is high for each of the following reasons

Volume of outpatient visits

Number of psychiatric medication prescriptions written

Absence of evidence of a contemporary understanding of medication errors and their consequences in both inpatient and outpatient mental health treatment settings

High prevalence of co-occurring substance abuse disorders that complicate diagnosis and treatment and

Greater vulnerability of individuals with mental illness

In addition the validity of reported error rates is limited by self-reporting -- the error reporting method currently used in almost all hospitals

Errors in Diagnosis

Missed Diagnoses and Insufficient Treatment of Mood and Anxiety Disorders in Ambulatory Medical Settings

Introduction to missed diagnosis Over half of patients with a psychiatric problem receive treatment solely from a primary care physician rather than a mental health specialist[25] Of all patients seen in primary care from 15 to 25 have a mood or anxiety disorder[26-29] Because mood and anxiety disorders are common in ambulatory medical settings but providers in these setting are usually non-psychiatric clinicians treatment rendered in this setting may be prone to medical errors

Errors of omission The primary errors of omission in ambulatory medical settings where non-mental health clinicians are the only providers interacting with patients are missed diagnoses and failure to implement a needed treatment

Missed diagnoses Although the reliability of psychiatric diagnoses when made by trained diagnosticians using structured interviews is a good approach for most disorders errors are made even under conditions considered ideal or nearly ideal[30] In primary care medical practice the following factors are likely to increase diagnostic errors of omission

Time constraints

Competing demands

Minimal training in mental health diagnosis and treatment and

Lack of use of a systematic diagnostic interview

The overall missed diagnosis error rate for the detection of any mood or anxiety disorder by primary care physicians compared with a psychiatric interview has been reported to range from 25[26] to almost 67[31] Primary care physicians correctly diagnose only 35 to 57 of the cases of major depressive disorder (MDD) that are identified with a psychiatric interview[32-36] A multinational investigation found that[37]

27 of false-negative cases (that is primary care physician missing the diagnosis of MDD) were due to complete disagreement with a standardized interview diagnosis

397 were due to the primary care physician recognizing some symptoms of depression but underestimating the severity of the condition and therefore not giving the diagnosis and

33 were diagnosed with another condition

Correct identification of MDD by primary care physicians is associated with[38]

Greater familiarity with the patient and

Presence of suggestive clinical cues (eg a history of depression or the presence of vegetative symptoms)

Anxiety disorders also frequently go undetected[313940] In 1 study about 10 of primary care patients with an anxiety disorder were identified by their physician[41] Approximately 70 of the time that a primary care physician identifies an anxiety problem they diagnose an anxiety state unspecified rather than a specific anxiety disorder[42] In 1 study in Israel only 2 of patients with posttraumatic stress disorder (PTSD) were diagnosed correctly by the primary care physician[43] This underdiagnosis may be a result of inadequate education about anxiety disorders for example only 57 of primary care doctors in a study conducted in Germany considered generalized anxiety disorder to be an independent disorder[44]

Insufficient treatment Treatment is absent when mood and anxiety disorders are missed Insufficient treatment may occur even when anxiety and mood disorders are diagnosed correctly Only about half of patients diagnosed in primary care settings with mood or anxiety disorders receive medication treatment[4546] Psychotherapy referrals were not examined in these studies so it remains unclear whether the patients who did not receive medication treatment were offered psychological treatment

Even when a psychiatrist provided a consultation and advised antidepressant treatment only 53 of appropriate primary care patients received antidepressant medication over the next year[47] The National Ambulatory Medical Care Survey database from 1985 to 1998 documented that treatment for anxiety is offered in 60 of visits to primary care physicians compared with over 95 of visits for anxiety to a psychiatrists[42] A recent naturalistic study of anxiety disordered patients in primary care found that 47 were receiving treatment from either the primary care physician or a specialty mental health clinician[48] A study of patients with panic disorder in primary care settings revealed that only 64 were found to be receiving either medication or psychotherapy[49]

Preventable adverse events Missed diagnoses and insufficient treatment of mood and anxiety disorders in medical settings may cause serious preventable adverse events For MDD preventable adverse events include impairment in physical and mental functioning that is comparable to that found with common medical disorders such as hypertension and diabetes[5051] Depression exacerbates the outcomes of chronic medical illnesses[52] and is associated with higher rehospitalization rates[53] and higher mortality rates[5455] following a myocardial infarction

MDD is also associated with a substantial risk of suicide which is increased when treatment is insufficient[56-58] The economic burden in the United States due to MDD has been estimated at about $83 billion as of 2000[59] Of these costs about three-fourths represent indirect costs (vs the direct cost of providing treatment) particularly reduced productivity and absenteeism in the workplace The World Health Organization has ranked MDD as second only to ischemic heart disease in magnitude of disease burden in countries with established market economies[60]

The functional and economic burden of MDD has been an area of focus for payers and employers Less recognized however is the substantial impairment in social and occupational functioning and in physical health documented in mental health treatment settings for individuals with specific anxiety disorders such as

PTSD[6162]

Panic disorder[6364]

Generalized anxiety disorder[65] and

Social anxiety disorder[6667]

Impairment from anxiety disorders is also apparent in those who present to a primary care physician[496869] Generalized anxiety disorder produces impairment in health-related functioning that is equivalent to or significantly greater than patients with diabetes and recent myocardial infarction

Primary care patients with anxiety disorder are high utilizers of general medical services resulting in increased overall healthcare costs compared with primary care patients who have subthreshold disorders or no anxiety disorder[70] The economic burden of anxiety disorders in the United States has been estimated to be $423 billion in 1990 primarily due to increased use of non-psychiatric medical services[71]

However missed diagnoses do not necessarily lead to preventable adverse events Some studies have suggested that patients with unrecognized MDD in the primary care setting are less severely depressed and less functionally impaired[323770] and therefore at less risk for

Loss of employment

Impaired social functioning

Exacerbation of co-occurring medical disorders and

Suicide

When recognized and unrecognized patients with MDD are tracked over time clinical improvement has often been comparable[3770] although greater short-term improvement for recognized cases has also been reported for MDD[34] and anxiety disorders[72]

Errors of commission mistaken diagnoses As described previously for MDD about one-third of the diagnostic errors in primary care are mistaken diagnoses[37] Mistaken diagnoses range from anxiety disorders to alcoholsubstance abuse to psychoticdissociative disorders Conversely when an anxiety disorder is present a mistaken diagnosis of depression is sometimes given[39] The high level of comorbidity between anxiety and mood disorders is likely to contribute substantially to such diagnostic errors[73]

Primary care physicians also occasionally diagnose a mood or anxiety disorder when it is not present (false positive) Among non-depressed patients a false positive rate of 12 in primary care was reported in 1 study[38] and 14 in another[37] About 25 of these MDD false-positives in the Tiemens study actually had an anxiety disorder 20 were the result of overestimation of severity of depression by the primary care physician and 55 were true false positives In the Klinkman study a history of depression was apparent in over half of the false-positive cases

suggesting that physicians might have been unduly influenced by a history of depression rather than the clinical evidence for depression at the time of examination

The implications of these misdiagnoses require more study Because the treatments for most mood and anxiety disorders are similar and because even subsyndromal disorders cause significant distress and functional disability it is possible that imprecision in diagnosis may still result in the use of appropriate medication treatment Of course treatment of an individual without a disorder even subsyndromal causes unneeded exposure to medication errors

Recommendations to diminish misdiagnoses in primary care Since primary care clinicians will most likely continue to be the point of entry and often the sole provider of mental health treatment for patients suffering from mood and anxiety disorders improvements in diagnosis and appropriate treatment of these disorders in primary care should be an important priority Better education of primary care providers about the symptoms and management of depression and anxiety are essential Programs designed to increase primary care clinicians recognition of depression and other psychiatric disorders have not yet proved to improve treatment outcome[7475] However studies that have added training in depression management in addition to education on better recognition of its presence have yielded better outcomes[76]

The feasibility and sustainability of programs focusing on better education of primary care clinicians has not been established Because of the time constraints of standard primary care practice fast efficient methods of screening such as the Primary Care Evaluation of Mental Disorders (PRIME-MD) for anxiety depression and other psychiatric disorders are recommended[77] The Patient Health Questionnaire a 9-item subset of the PRIME-MD is a more concise screen for depression if time constraints preclude use of the full PRIME-MD questionnaire The routine use of such simple methods for screening and ongoing monitoring might provide a sustainable way of reducing diagnostic errors in ambulatory medical settings

A final recommendation is for managed care and insurance companies as well as health systems and provider networks to consider the implementation of incentives for better detection and treatment of mood and anxiety disorders Pilot pay for performance programs such as Bridges to Excellence[78] or the Integrated Healthcare Association initiative in California[79] have focused on physical conditions such as diabetes or asthma Quality measures do exist for the medication treatment and follow up of diagnosed depression such as performance standard and report card measures[80] Adding incentives for better detection and treatment to the use of quality measures is a recommended first step

Errors in the Use of Seclusion and Restraint

In October 1998 The Hartford Courant reported on the death of Andrew McClain an 11-year-old boy who died while restrained and secluded in a psychiatric hospital in Connecticut[81] Thus began the Courants 5-part series based on a 50-state survey that confirmed 142 deaths related to the use of seclusion and restraint in mental health settings over the past decade[82-85] The series cautioned that most deaths related to seclusion and restraints are unreported and that the actual number of annual deaths was possibly much higher

The national response to the Courant exposeacute was far reaching Congress commissioned the US General Accounting Office (USGAO) to report on the use of seclusion and restraint The USGAO responded by releasing a report in 1999 entitled Improper Restraint or Seclusion Places People at Risk[82] The USGAO report confirmed the majority of the Courants allegations including the following

Improper use of seclusion and restraint are dangerous

There is inadequate monitoring and reporting of its use and of resulting harm (or preventable adverse events) to patients

Serious injuries or death can occur and are underreported

Licensing and accreditation of seclusion and restraint standards are inconsistent and insufficient and

Successful strategies for preventing seclusion and restraint as well as reducing the risk of injury when use occurs are not widely used

Seclusion and restraint are commonly used practices intended to prevent adults and children with mental health and substance abuse diagnoses from harming themselves or others in inpatient or residential treatment environments Unfortunately access to incidence data collected by The National Association of State Mental Health Program Directors (NASMHPD) is controlled (and forbidden) by participating hospitals There are no published data interpreted as accurately reflecting the true incidence of seclusion and restraint use

The use of these interventions is intended to be severely restricted to individual situations in which an emergency safety need is identified but as use is generally ordered by staff and based on subjective criteria the use of these emergency interventions has a wide range [86] Restraint is defined in a variety of ways but the term generally refers to a manual method or mechanical device material or equipment attached or adjacent to the patients body that he or she cannot easily remove and that restricts the patients freedom or normal access to ones body[87] Seclusion refers to the involuntary confinement of a person in a room where they are physically prevented from leaving[88] Recent literature reviews of seclusion and restraint reflect the absence of[8990]

Substantiated prevention strategies

Indications for use

Application methods

Monitoring

Post-event activities and

Absence of evidence of its effectiveness in preventing harm

The Centers for Medicare and Medicaid Services (CMS) -- formerly known as the Healthcare Financing Administration (HCFA) the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and state licensing agencies have attempted to regulate the use of seclusion and restraint through licensing and accreditation standards[879192] However the Courant series the USGAO report and others have documented alarming rates of patient harm including death despite the application of such standards[818286] While efforts are underway to resolve these issues the appropriate and safe use of seclusion and restraint is far from assured[8693]

In recent years advocates consumers professional associations provider organizations and the legal field have increasingly recommended a reduction in the use of seclusion and restraint or even its elimination[83-86 94] These recommendations resonate with Recommendation no 1 in the IOMs Crossing the Quality Chasm that states All healthcare organizations professional groups

and private and public health purchasers should adopt as their explicit purpose to continually reduce the burden of illness injury and disability and to improve the health and functioning of the people of the United States[2] Using the IOMs medical error nomenclature reports about seclusion and restraint reflect high rates of medical errors mostly errors of commission perhaps errors of omission causing either near misses or preventable adverse events in routine clinical practice

Safety in healthcare practices is defined as keeping the patient free from accidental injury[2] Although not all errors cause injury accidental injury can be due to error either by the failure of a planned action to be completed as intended or use of the wrong plan to achieve an aim The improper use of seclusion and restraint is not safe and causes serious and preventable adverse injuries including death[8182] The media continues to report adverse events as well[9596] For example in 2000 3 deaths were reported just in Texas including that of 2 boys one 9 and the other 11 years old and a 16-year-old girl In South Carolina in 2003 a 9-year-old boy died after he kicked a staff member in the leg and ran down the hall which resulted in a take down and the boys asphyxiation In Arizona a 32-year-old woman died in restraints for behavior that was later judged as not meeting the threshold of imminent danger[96]

Reducing and Improving Seclusion and Restraint Events Recent Performance Improvement Initiatives

Several initiatives focused on seclusion and restraint reduction (embedded in public health prevention continuous quality improvement principles supporting recovery from mental illness and trauma-informed care) have been developed by the American Psychiatric Nurses Association the APA the National Association for Private Health Systems the American Hospital Association the National Alliance on Mental Illness (NAMI) and the Childrens Welfare League of America[2083859798] These initiatives are intended to complement other essential elements such as adequate numbers of well-trained staff and the use of proven psychological and medication treatments

The public health constructs of primary secondary and tertiary prevention create a logical framework and redirect the focus from safer use of seclusion and restraint to interventions that prevent its use[86] The model of recovery espoused by the Surgeon Generals Mental Health report necessitates[99]

System-wide transformation by adopting goals of full recovery in a life outside the hospital

Emphasis on instilling hope

Availability of multiple treatment options and

Development of partnerships with those who seek services

The use of controlling or coercive interventions is counterintuitive in this model and is to be avoided except perhaps as the last alternative in preventing death or significant harm to self or others caused by treatable manifestations of mental illness[94100] A growing understanding of the neurologic biologic psychological and social effects of trauma and its high prevalence in the populations that seek mental health services is informing approaches to assessment diagnosis stabilization and treatment of individuals with mental illness including the use of seclusion and restraint as a means of preventing injury to self or others[101-108]

Data should be analyzed for characteristics of facility usage by

Unit

Shift

Day and

Staff member involved

With rare exception data on individuals should be used confidentially to identify individual staff training needs not for disciplinary actions[88109] The facility needs to highlight data on seclusion and restraint use by graphing and posting this data on all units so that it is clearly visible for staff and consumers of service Facility-generated data on seclusion and restraint used in a non-punitive way provides for healthy competition among treatment units and elevates the general oversight and knowledge of use and outcomes for everyone involved[88109110] It allows and encourages administration to identify successful staff and treatment units so that successful improvements can be shared

A comprehensive national health information infrastructure could be a useful tool in reducing seclusion and restraint events[2111] The National Association of State Mental Health Program Directors Research Institute Inc (NRI) performance improvement system has developed a set of technology standards applications systems and values that include a number of recommendations for reducing seclusion and restraint events and making their occurrence less error prone[112]

Reduction of the use of seclusion and restraint must start with clear leadership and a specific plan that articulates a mission and philosophy about seclusion and restraint reduction and defines the roles and responsibilities of all facility staff[109] One core component is use of an executive on-call function and the daily review of the use of seclusion and restraint by executive leadership[88110]

Creating a treatment environment that prevents seclusion and restraint is based on the principles of recovery and the characteristics of trauma-informed systems of care[88109] Staff education needs to

Include the experiences of consumers and staff

Address the common myths associated with use

Introduce the rationale and characteristics of trauma-informed care

Educate on the neurobiological and psychological effects of trauma and

Describe a prevention-based approach to reduction

Seclusion and Restraint Summary

The use of seclusion and restraint is associated with substantial harm to recipients of care including death Medical errors precede many seclusion and restraint events which in turn cause further errors and substantial harm to both recipients and providers of care Several local and national initiatives are underway to improve the safety of seclusion and restraint events and to decrease its use The results of their successful application can be seen in facilities in[88 109]

Pennsylvania

New York

Massachusetts

Maine

Florida

New Jersey and

South Dakota

Further study of causal antecedent events and of harm resulting from seclusion and restraint events is recommended using the patient safety paradigm and nomenclature

High-Risk Clinical Populations Lacking Adequate Patient Safety Research

Introduction to High-Risk Clinical Populations

There are no empirical data to quantify characterize or confirm medical errors in certain populations with mental illness andor substance abuse where multiple risk factors for error also exist A brief discussion of these populations and their risks for errors is provided below It is hoped that heightened focus on these high-risk populations will be an impetus for medical error research

Persons with Co-occurring Mental Illness and Substance Abuse

Individuals with co-occurring psychiatric and substance disorders have not been studied for medical errors yet they are perhaps at greater risk for harm because of the nature and number of their co-occurring disorders Several studies have reported the common occurrence of comorbidity among persons with a recognized diagnosis of either mental illness or substance abuse For example in 1990 Regier[74] found a lifetime prevalence of substance abuse among 62 of persons with bipolar disorder In 1996 Kessler and colleagues[113] reported a lifetime prevalence of 599 of psychiatric illness among persons with substance abuse disorders while 31 had a concurrent psychiatric disorder

Persons with co-occurring disorders are high utilizers of medical resources and therefore more exposed to systems issues that may predispose to unintended harm In 1995 an estimated 26 million (27) of the 965 million emergency department (ED) visits were related to alcohol abuse alone[114]

In a study by Dickey and associates[115] using data from the Massachusetts Division of Medical Assistance and death records from the Department of Public Health individuals with co-occurring psychiatric and substance use disorders had the highest risk of medical morbidity for 5 of the studied medical disorders Medicaid beneficiaries with dual diagnoses are 6 to 8 times more likely to die of injury primarily poisoning than their counterparts treated for medical conditions only[116117]

It is well-substantiated that persons with psychiatric and substance abuse disorders have higher rates of suicide attempts and death by suicide[118-123] In 2001[124]

20308 deaths were caused by homicide

30622 deaths by suicide and

101537 deaths were caused by accidents

Given the frequency with which substance abuse by itself has been implicated in these 3 causes of death the scope of morbidity and mortality related to co-occurring disorders is staggering

The effects of substance abuse disorders in adults also affected the mortality rates of children during 1985 to 1996 -- 8482 (24) of the 35547 children aged younger than 15 years died in alcohol-related motor vehicle crashes[125]

A subset of those with co-occurring disorders have substance dependence PTSD and chronic pain The presence of chronic pain and the complexities surrounding treatment of individuals with PTSD increase the risk for unintended harm and of a poor fit between clinical needs and the design of current healthcare systems Despite the added risk factors there is little science to direct clinicians A Medline search using substance abuse PTSD and chronic pain as search terms in June 2004 yielded 10 citations There were no incidence studies and no published treatment guidelines

Conclusion regarding co-occurring disorders Individuals with co-occurring disorders are frequently encountered and at risk for multiple diagnostic and treatment errors including

Missed mental health substance abuse and medical diagnoses and

Insufficient or excessive medication treatment of either their substance abuse or psychiatric disorder

Compared with the general population these individuals are at higher risk for

Suicide attempt

Death by suicide and

Death at a younger age by medical illness

There is a paucity of published studies on medical errors among individuals with co-occurring disorders despite several risk factors for unintended harm and high rates of morbidity and mortality

Attention Deficit-Hyperactivity Disorder in Children Excessive or Insufficient Diagnosis and Treatment

Inattentiveness distractibility impulsivity and hyperactivity were recognized as elements of minimal brain dysfunction (now termed attention deficit hyperactivity disorder [ADHD]) and treated with stimulants especially methylphenidate beginning in the late 1960s[101126127] Over the past 3 decades the rate of drug treatment for behavior problems has increased exponentially culminating in the prescription of ADHD drug treatment for at least 5-6 million American children annually[128]

Children diagnosed with ADHD have been the focus of thousands of research studies over the last 40 years yet the diagnosis and treatment of ADHD remain controversial among some within medicine and the general public[129130] Recent prevalence data from the 1998 National Institutes

of Health (NIH) consensus review[131] and reported by Jensen[132] suggest a prevalence of approximately 5 affecting 3 million school-aged children[133134]

ADHD is associated with[135-137]

Increased risk of accidents

Family and social dysfunction

Poor academic achievement

Substance abuse and

Antisocial behavior

Recent treatment data based on the number of methylphenidate prescriptions show an estimated 5-6 million American children receive ADHD-related drug treatment annually[128] Aggregate national methylphenidate use has increased 100-fold from 1960 until 2000 Globally nearly 90 of the worlds stimulant medication supply is consumed by the US population[138139]

Substantial state-to-state and community-to-community variability in methylphenidate use raises concerns about potential pockets of over- and under-diagnosis and over- and under-prescribing Drug Enforcement Association data on stimulant use reflect a 6-fold per capita variation in methylphenidate prescribing between some states[140] and a 20-fold prescribing variation between some communities[130141]

LeFever and colleagues argue that while the data are inconclusive if communities such as Salt Lake City Utah are used as a benchmark of acceptable diagnosis and treatment then children in 36 states may be subject to over-diagnosis and over-treatment Conversely Jensen argues that ADHD is under-diagnosed and under-treated based on national aggregate data allowing for pockets of over-diagnosis and treatment in some geographic areas[142] Given that in 1995 there were approximately 2 million pediatric visits in which ADHD was the focus of treatment and 6 million stimulant prescriptions were written[132] 1 conclusion is that 3 million children with ADHD received an average of 2 prescriptions and 1 outpatient visit during that year suggesting insufficient treatment In another study cited by Jensen the Multimodal Treatment Study of Children with ADHD two thirds of ADHD children from reportedly highly motivated families obtained medication treatments and for an average duration of only 8-14 months[142143]

Despite the number of studies done the strength of conclusions that can be drawn is contingent upon the adequacy of reported data Studies to date are variously limited by data sources sampling accuracy and interpretation[130]

When considered in aggregate national ADHD prevalence rates and numbers of prescriptions written do not suggest excessive diagnosis and treatment However prevalence rates and stimulant use can vary as much as 30-fold when comparing different communities A prevalence rate of 33 among white elementary-aged boys in southeastern Virginia significantly challenges credibility[130] Such variability makes it essential that prevalence rates and stimulant use estimates be linked to sufficient demographics such as

Geography

Age

Race and

Gender

ADHD prevalence rates and stimulant use appear to be

Excessive in some communities

Plausible in other communities and

Perhaps insufficient in yet other communities

Additional epidemiologic studies reporting prevalence rates with specific demographics rather than in aggregate and broader use of practice guidelines promulgated by the American Academy of Pediatrics (AAP) and others that advocate multimodal treatment rather than solely prescribing stimulants or other medications[130144] will help provide evidence of the extent of errors in the diagnosis and treatment of children with ADHD

Electroconvulsive Therapy

Electroconvulsive therapy (ECT) remains a controversial treatment in psychiatry As stated in the 1985 NIH Consensus Statement The nature of the treatment itself its history of abuse unfavorable media presentations compelling testimony of former patients special attention by the legal system uneven distribution of ECT use among practitioners and facilities and uneven access by patients all contribute to the controversial context in which the consensus panel has approached its task[145]

Epidemiologic data reported by Thompson and colleagues in 1994 found that[146]

58667 patients received ECT in 1975

31514 in 1980

36558 in 1986

71 of the patients who received ECT were women and

Individuals older than 65 years of age had the highest rates per number of inpatients

The rate of ECT use has been highly variable For example in 1995 Herman and associates[147] reported that among 202 metropolitan statistical areas annual ECT use varied from 04 to 812 patients per 10000 population

The most common adverse effect from ECT is memory loss In a recent review of patients perspectives as well as clinicians studies Rose and associates[148] concluded that 29 to 55 of ECT treatment recipients experienced persistent memory loss Recent empirical studies of ECT and memory loss continue to find persistent memory loss with bilateral ECT producing more profound memory deficits than right unilateral ECT[149]

In a review of deaths caused by ECT Abrams reported that ECT is 10 times safer than childbirth that approximately 6 times as many deaths annually in the US are caused by lightning as by ECTand that the death rate reported for ECT is an order of magnitude smaller than the spontaneous death rate in the general population[150]

Corroboration of a low ECT death rate has arisen from 1993 legislation in Texas mandating reporting of all ECT-related deaths[151] As a result the risk of death from ECT in Texas has been systematically tracked and reviewed More than 8000 patients received 49048 ECT treatments between 1993 and 1998 However only 1 death could be linked to the associated anesthesia An additional 4 deaths could plausibly have been associated with the anesthesia yielding a mortality rate between 2 and 10 per 100000 and the causes of death most likely were not the ECT stimulus or seizure

Emotional harm and erosion of faith in the medical profession that undermines accepting other needed treatments can come to recipients of care for whom the experience of ECT is frightening

ECT conclusion ECT is effective for severe major affective illness and is associated with a low mortality rate Persistent memory loss is a consistent finding despite attempts to optimize ECT administration and must be expected at an incidence of approximately 25 to 50 by those contemplating and those providing ECT treatment

Despite its relative safety ECT continues to cause alarm in the general public Even within medicine it is described as dangerous and unethical by some[152] Such fears can cause emotional harm among ECT recipients This may be especially true for older women (who comprise the majority of ECT subjects) some of whom may be accustomed to deferring to healthcare providers when consenting to treatment despite insufficient understanding of benefits and risks

Recommendations include

Emphasis on pre-treatment education

Collaborative relationship with ECT recipients

Increased transparency regarding the substantial risk of persistent memory loss when seeking informed consent and

Continued research on its safety

Systems Issues Related to Patient Safety

Outpatient Care

Risk of unintended harm may be increased by the segregated care settings in which psychiatric and substance abuse services are often delivered including solo practitioner offices and free-standing psychiatric and substance abuse treatment facilities[153154] and by insufficient communication and coordination of care between prescribers and psychotherapists[155-157] Despite the recognition of these potential contributing factors there are no existing reports of the association between systems issues and medical errors

Olfson[158] reported that in 1987 there were 84 million outpatient visits with mental health practitioners including

Psychiatrists

Psychologists

Social workers and

Licensed counselors

Kessler[154] reported in 1999 that an estimated 133 of a representative sample of Americans reported used outpatient services for mental health problems in the previous 12 months Clearly there are high numbers of individuals at risk for errors in outpatient mental health and substance abuse treatment

Ethics and Malpractice Risk Management Boundary Violations

A survey of recently published reviews and commentaries on patient safety reveals that for mental health and substance abuse issues such discussion takes place mainly within the context of ethics and malpractice risk management[159-162] Ethics statements from both the APA[162] and the American Psychological Association[163] support the duty to report and protect patients from deviations from the standards of care This approach uses the individual practitioners frame of reference and relies on voluntary reporting from professionals who have been trained to consider confidentiality a critical component of their work Harm caused by clinician boundary violations are understood as issues of professional misconduct not as errors resulting from system failure and that minimize the individual clinicians responsibility and advise against punitive action [164-167]

With the advent of therapeutic exchanges through email and other means of communication additional boundary violations are possible The Internet now has at least 110 million users including 70 million using it for health-related information[168] A recent survey indicated 40 to 50 of physicians use the Internet (or are preparing to use it) for clinical care[169]

There is a risk of errors of omission or commission arising from lack of coordination of care between clinicians Differences in therapeutic orientation and nomenclature used by the following specialists can compound systems issues that increase the risk of medical errors [158]

Social workers

Psychiatric nurse specialists

Psychologists

Licensed counselors and

Psychiatrists

Confidentiality is critical in providing effective treatment within the secure and private setting of the therapists office and in protecting the patient from unauthorized disclosures of sensitive information and potential abuse from a third party[170] However confidentiality can also inhibit disclosure of near misses impasses in treatment (for example when treatment is not working) and preventable adverse events due to avoidance of sharing important clinical information with other professionals and with appropriate family members and other supportive resources[171172]

The solo practice model commonly used by mental health clinicians can also inhibit the adoption of best practices and the development of policies and procedures to reduce risk because all such practice management activities are left to the individual clinician whose focus is more likely to be exclusively clinical

Summary About Systems Issues and Patient Safety

Systems for reliably reporting outpatient psychotherapy medical errors particularly among the large numbers of solo practitioners do not exist The prevailing paradigm for reducing harm arises from risk reduction in order to diminish medical liability exposure Studies that shed light on potential medical errors have arisen from risk management claims medical liability lawsuits and reports of death by suicide not from research intended to examine patient safety per se

Error reporting systems applicable to outpatient mental health settings including incentives for their use need to be developed Professional risk management programs primarily used to diminish medical liability exposure from the following could also be used to promulgate the relevance and value of the patient safety paradigm

Boundary violations

Suicide and

Treatment errors

Most particularly thought needs to be given to developing systems of error prevention applicable to the solo practitioner

Recommendations

Recommendation no 1

Widespread adoption of the IOM patient safety paradigm and nomenclature in mental health and substance abuse treatment settings is recommended

Advantages of its use include

Consistency with the nomenclature used by other medical specialties

Increased leverage in advocating for needed services and resources when the absence of essential treatments are quantified as errors of omission causing near misses or preventable adverse events

Increased likelihood that medication errors in mental health and substance abuse will be researched and a determination made whether such errors are causing preventable adverse events and

Increased awareness among mental health and substance abuse clinicians that patient harm can come from a broader array of errors in diagnosis and treatment than has been studied to date

Widespread adoption will require systematic educational efforts for trainees and current practitioners in mental health and substance abuse including systematic introduction to the IOMs existence mission and safety and quality efforts such as the Quality Chasm Series (Many mental health and substance abuse clinicians and administrators seem unaware of the IOM at all)

Recommendation no 2

Further studies of medical error in mental health and substance disorders are needed

Some areas of potential harm in this field remain largely unexamined For example we found only 2 studies of medication errors in mental health settings and none in substance abuse detoxification and stabilization settings despite multiple risk factors for errors and preventable adverse events The impact of variable education -- in pharmacology physiology and general medicine -- on the safety of prescribing practices has not been studied nor has the clinical consequences of formulary restrictions on clinical outcome and potential patient harm The current acceptance of self-reported hospital error rates must be challenged through a process of independently validating self-reported errors

Recommendation no 3

Integration of mental health and substance abuse services is recommended

High rates of co-occurrence and associated higher rates of morbidity and mortality among those with mental health and substance abuse disorders requires integration of mental health and substance abuse treatment paradigms This has not occurred to date

Recommendation no 4

The IOMs 10 rules for change in healthcare should be adopted

The 10 IOM rules for change in healthcare are as follows[173]

1 Care based on continuous healing relationships

2 Customization based on patient needs and values

3 The patient as the source of control

4 Shared knowledge and the free-flow of information

5 Evidence-based decision-making

6 Safety as a system property

7 The need for transparency

8 Anticipation of needs

9 Continuous decrease in waste

10 Cooperation among clinicians

As an example of adoption of these rules seclusion and restraint remain high risk treatments yet current reporting systems do not permit transparency regarding the rate and types of injuries incurred including mortality rates Such transparency requires a non-punitive work culture yet there is little evidence to suggest its adoption in high-risk environments such as state psychiatric hospitals or inpatient detoxification and stabilization substance abuse treatment settings

Recommendation no 5

Reporting systems in outpatient mental health and substance abuse treatment settings must be adopted

Reliance upon unsubstantiated self-reporting of medication errors in inpatient mental health and substance abuse settings remains a significant flaw when attempting accurate assessment of near misses and preventable adverse events and must be changed A key necessity is anonymous yet authenticated medication error reporting for all staff using available web-based error reporting systems Such systems are cost-savers and make reported error data immediately and continuously available Web-based reporting systems providing anonymity with authentication could be used for further seclusion and restraint data collection and as a means of establishing an outpatient error reporting system of safety and quality data by recipients and providers of outpatient treatment

Recommendation no 6

Resources should be allocated to study and develop practical interventions to improve patient safety

Much current research in mental health and substance abuse and resource appropriation is focused on efficacy of pharmacotherapy and psychotherapy and on establishing neurobiologic evidence to support causal theories of known clinical disorders At a policy level we recommend more consideration be given to funding practical interventions predicted to immediately improve patient safety

References

[ CLOSE WINDOW ]

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163 American Psychological Association Ethical Principles and Code of Conduct June 1 2003 Available at httpwwwapaorgethicscode2002html Accessed August 28 2007

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Authors and Disclosures

As an organization accredited by the ACCME Medscape LLC requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest The ACCME defines relevant financial relationships as financial relationships in any amount occurring within the past 12 months including financial relationships of a spouse or life partner that could create a conflict of interest

Medscape LLC encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration at first mention and where appropriate in the content

Author

Benjamin C Grasso MD

Staff Psychiatrist VA Clinic Saco Maine Disclosure Benjamin C Grasso MD has disclosed no relevant financial relationships

Cathryn M Clary MD MBA

Vice President US External Medical Affairs Pfizer Inc New York NY Disclosure Cathryn M Clary MD MBA has disclosed that she is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Benjamin Eng MD MA

Senior Medical Director Group Leader Pfizer Inc New York NY Disclosure Benjamin Eng MD MA has disclosed that he is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Stanley J Evans MD FASAM PA

Assistant Professor of Clinical Medicine St Matthews University Windham Maine

Medical Director Renaissance Institute of Palm Beach Boca Raton Florida Disclosure Stanley J Evans MD has disclosed no relevant financial relationships

Terry J Golash MD

Clinical Instructor Psychiatry Columbia University New York NY Assistant Attending St Lukersquos Roosevelt Hospital Center New York NY Disclosure Terry J Golash MD has disclosed no relevant financial relationships

Kevin Ann Huckshorn RN MSN CAP ICADC

Director Office of Technical Assistance National Association of State mental Health Program Directors Inc Alexandria Virginia Disclosure Kevin Ann Huckshorn RN MSN CAP ICADC has disclosed no relevant financial relationships

Kenneth Minkoff MD

Clinical Assistant Professor Department of Psychiatry Cambridge Hospital Harvard University Acton Massachusetts Consultant ZiaLogic Acton Massachusetts Disclosure Kenneth Minkoff MD has disclosed no relevant financial relationships

Joseph J Parks MD

Assistant Associate Professor Department of Psychiatry University of Missouri Columbia Missouri Disclosure Joseph J Parks MD has disclosed that he has received grants for educational activities from Letters amp Science and Physician Postgraduate Press Dr Parks has also disclosed that he has served as a consultant to the National Association of State Mental Health Program Directors and Bristol-Myers Squibb Dr Parks has also disclosed that he has received funds for services provided to the state of Missouri from Eli Lilly and Abbott

Miles F Shore MD

Bullard Distinguished Professor of Psychiatry Harvard Medical School Needham Massachusetts Junior Consultant Harvard Medical International Boston Massachusetts Disclosure Miles F Shore MD has disclosed no relevant financial relationships

Editor

Jacqueline A Hart MD

Freelance Clinical Editor Medscape LLC New York New York Disclosure Jacqueline A Hart MD has disclosed no relevant financial relationships

Elizabeth Saenger PhD

Editorial Director Medscape LLC New York NY Disclosure Elizabeth Saenger PhD has disclosed no relevant financial relationships

Registration for CME credit the post test and the evaluation must be completed online To access the activity Post Test and Evaluation link please go to httpwwwmedscapecomviewprogram7809_index

Page 7: Medication Errors and Patient Safety in Mental Health CME/CE · 2019. 6. 27. · Medication Errors and Patient Safety in Mental Health CME/CE Complete author affiliations and disclosures

Incidence studies of ADEs had been conducted almost exclusively in general medical settings and had primarily examined ADRs not medication errors Only 2 medication error incidence studies in mental health settings were found One was a 1984 epidemiologic study of state psychiatric hospitals which reported that 75 of randomly selected patients experienced ADRs[23] medication errors were not examined

In the only study examining the incidence of medication errors in a mental health setting Grasso and colleagues retrospectively studied 31 state psychiatric inpatients over 2 months of care[1314] Nine errors were self-reported using the usual incident reporting process whereas an independent multidisciplinary review team found 2194 errors for the same 31 patients and episode of care

19 of errors were rated as having a low risk of harm

23 as having a moderate risk and

58 as having a high risk

The absence of studies of medication errors understood as near misses is highlighted This is a significant category of errors which can occur during prescribing transcribing dispensing and administering medications and has the potential to cause significant harm Indeed near misses may sometimes be termed as such because the study did not include assessment of patients and an attempt at drawing causal connections between the observed medical errors and the patients clinical course

The literature review noted above yielded

No reports on medication errors in outpatient mental health settings

No medication error incidence studies in settings where psychologists have prescriptive authority and

No studies on the incidence and characteristics of medication errors in substance abuse settings including medical detoxification for alcohol sedative hypnotic or opiate withdrawal

One important concern rarely addressed in published studies is the exclusive reliance upon self-reporting in psychiatric and medical-surgical hospitals[1112] Only 3 studies were found that compared self-reporting with an independent teams detection and reporting of errors (a methodological factor affecting the validity of reported error rates) In these studies independent review teams detected error rates that ranged from 88 to 1000 times higher than self-reported error rates and that were determined to be more valid that self-reported rates[13141624]

Medication Error Summary

Medication errors in mental health treatment settings have not been adequately studied The potential for errors of omission and commission in mental health however causing either near misses or preventable adverse events is high for each of the following reasons

Volume of outpatient visits

Number of psychiatric medication prescriptions written

Absence of evidence of a contemporary understanding of medication errors and their consequences in both inpatient and outpatient mental health treatment settings

High prevalence of co-occurring substance abuse disorders that complicate diagnosis and treatment and

Greater vulnerability of individuals with mental illness

In addition the validity of reported error rates is limited by self-reporting -- the error reporting method currently used in almost all hospitals

Errors in Diagnosis

Missed Diagnoses and Insufficient Treatment of Mood and Anxiety Disorders in Ambulatory Medical Settings

Introduction to missed diagnosis Over half of patients with a psychiatric problem receive treatment solely from a primary care physician rather than a mental health specialist[25] Of all patients seen in primary care from 15 to 25 have a mood or anxiety disorder[26-29] Because mood and anxiety disorders are common in ambulatory medical settings but providers in these setting are usually non-psychiatric clinicians treatment rendered in this setting may be prone to medical errors

Errors of omission The primary errors of omission in ambulatory medical settings where non-mental health clinicians are the only providers interacting with patients are missed diagnoses and failure to implement a needed treatment

Missed diagnoses Although the reliability of psychiatric diagnoses when made by trained diagnosticians using structured interviews is a good approach for most disorders errors are made even under conditions considered ideal or nearly ideal[30] In primary care medical practice the following factors are likely to increase diagnostic errors of omission

Time constraints

Competing demands

Minimal training in mental health diagnosis and treatment and

Lack of use of a systematic diagnostic interview

The overall missed diagnosis error rate for the detection of any mood or anxiety disorder by primary care physicians compared with a psychiatric interview has been reported to range from 25[26] to almost 67[31] Primary care physicians correctly diagnose only 35 to 57 of the cases of major depressive disorder (MDD) that are identified with a psychiatric interview[32-36] A multinational investigation found that[37]

27 of false-negative cases (that is primary care physician missing the diagnosis of MDD) were due to complete disagreement with a standardized interview diagnosis

397 were due to the primary care physician recognizing some symptoms of depression but underestimating the severity of the condition and therefore not giving the diagnosis and

33 were diagnosed with another condition

Correct identification of MDD by primary care physicians is associated with[38]

Greater familiarity with the patient and

Presence of suggestive clinical cues (eg a history of depression or the presence of vegetative symptoms)

Anxiety disorders also frequently go undetected[313940] In 1 study about 10 of primary care patients with an anxiety disorder were identified by their physician[41] Approximately 70 of the time that a primary care physician identifies an anxiety problem they diagnose an anxiety state unspecified rather than a specific anxiety disorder[42] In 1 study in Israel only 2 of patients with posttraumatic stress disorder (PTSD) were diagnosed correctly by the primary care physician[43] This underdiagnosis may be a result of inadequate education about anxiety disorders for example only 57 of primary care doctors in a study conducted in Germany considered generalized anxiety disorder to be an independent disorder[44]

Insufficient treatment Treatment is absent when mood and anxiety disorders are missed Insufficient treatment may occur even when anxiety and mood disorders are diagnosed correctly Only about half of patients diagnosed in primary care settings with mood or anxiety disorders receive medication treatment[4546] Psychotherapy referrals were not examined in these studies so it remains unclear whether the patients who did not receive medication treatment were offered psychological treatment

Even when a psychiatrist provided a consultation and advised antidepressant treatment only 53 of appropriate primary care patients received antidepressant medication over the next year[47] The National Ambulatory Medical Care Survey database from 1985 to 1998 documented that treatment for anxiety is offered in 60 of visits to primary care physicians compared with over 95 of visits for anxiety to a psychiatrists[42] A recent naturalistic study of anxiety disordered patients in primary care found that 47 were receiving treatment from either the primary care physician or a specialty mental health clinician[48] A study of patients with panic disorder in primary care settings revealed that only 64 were found to be receiving either medication or psychotherapy[49]

Preventable adverse events Missed diagnoses and insufficient treatment of mood and anxiety disorders in medical settings may cause serious preventable adverse events For MDD preventable adverse events include impairment in physical and mental functioning that is comparable to that found with common medical disorders such as hypertension and diabetes[5051] Depression exacerbates the outcomes of chronic medical illnesses[52] and is associated with higher rehospitalization rates[53] and higher mortality rates[5455] following a myocardial infarction

MDD is also associated with a substantial risk of suicide which is increased when treatment is insufficient[56-58] The economic burden in the United States due to MDD has been estimated at about $83 billion as of 2000[59] Of these costs about three-fourths represent indirect costs (vs the direct cost of providing treatment) particularly reduced productivity and absenteeism in the workplace The World Health Organization has ranked MDD as second only to ischemic heart disease in magnitude of disease burden in countries with established market economies[60]

The functional and economic burden of MDD has been an area of focus for payers and employers Less recognized however is the substantial impairment in social and occupational functioning and in physical health documented in mental health treatment settings for individuals with specific anxiety disorders such as

PTSD[6162]

Panic disorder[6364]

Generalized anxiety disorder[65] and

Social anxiety disorder[6667]

Impairment from anxiety disorders is also apparent in those who present to a primary care physician[496869] Generalized anxiety disorder produces impairment in health-related functioning that is equivalent to or significantly greater than patients with diabetes and recent myocardial infarction

Primary care patients with anxiety disorder are high utilizers of general medical services resulting in increased overall healthcare costs compared with primary care patients who have subthreshold disorders or no anxiety disorder[70] The economic burden of anxiety disorders in the United States has been estimated to be $423 billion in 1990 primarily due to increased use of non-psychiatric medical services[71]

However missed diagnoses do not necessarily lead to preventable adverse events Some studies have suggested that patients with unrecognized MDD in the primary care setting are less severely depressed and less functionally impaired[323770] and therefore at less risk for

Loss of employment

Impaired social functioning

Exacerbation of co-occurring medical disorders and

Suicide

When recognized and unrecognized patients with MDD are tracked over time clinical improvement has often been comparable[3770] although greater short-term improvement for recognized cases has also been reported for MDD[34] and anxiety disorders[72]

Errors of commission mistaken diagnoses As described previously for MDD about one-third of the diagnostic errors in primary care are mistaken diagnoses[37] Mistaken diagnoses range from anxiety disorders to alcoholsubstance abuse to psychoticdissociative disorders Conversely when an anxiety disorder is present a mistaken diagnosis of depression is sometimes given[39] The high level of comorbidity between anxiety and mood disorders is likely to contribute substantially to such diagnostic errors[73]

Primary care physicians also occasionally diagnose a mood or anxiety disorder when it is not present (false positive) Among non-depressed patients a false positive rate of 12 in primary care was reported in 1 study[38] and 14 in another[37] About 25 of these MDD false-positives in the Tiemens study actually had an anxiety disorder 20 were the result of overestimation of severity of depression by the primary care physician and 55 were true false positives In the Klinkman study a history of depression was apparent in over half of the false-positive cases

suggesting that physicians might have been unduly influenced by a history of depression rather than the clinical evidence for depression at the time of examination

The implications of these misdiagnoses require more study Because the treatments for most mood and anxiety disorders are similar and because even subsyndromal disorders cause significant distress and functional disability it is possible that imprecision in diagnosis may still result in the use of appropriate medication treatment Of course treatment of an individual without a disorder even subsyndromal causes unneeded exposure to medication errors

Recommendations to diminish misdiagnoses in primary care Since primary care clinicians will most likely continue to be the point of entry and often the sole provider of mental health treatment for patients suffering from mood and anxiety disorders improvements in diagnosis and appropriate treatment of these disorders in primary care should be an important priority Better education of primary care providers about the symptoms and management of depression and anxiety are essential Programs designed to increase primary care clinicians recognition of depression and other psychiatric disorders have not yet proved to improve treatment outcome[7475] However studies that have added training in depression management in addition to education on better recognition of its presence have yielded better outcomes[76]

The feasibility and sustainability of programs focusing on better education of primary care clinicians has not been established Because of the time constraints of standard primary care practice fast efficient methods of screening such as the Primary Care Evaluation of Mental Disorders (PRIME-MD) for anxiety depression and other psychiatric disorders are recommended[77] The Patient Health Questionnaire a 9-item subset of the PRIME-MD is a more concise screen for depression if time constraints preclude use of the full PRIME-MD questionnaire The routine use of such simple methods for screening and ongoing monitoring might provide a sustainable way of reducing diagnostic errors in ambulatory medical settings

A final recommendation is for managed care and insurance companies as well as health systems and provider networks to consider the implementation of incentives for better detection and treatment of mood and anxiety disorders Pilot pay for performance programs such as Bridges to Excellence[78] or the Integrated Healthcare Association initiative in California[79] have focused on physical conditions such as diabetes or asthma Quality measures do exist for the medication treatment and follow up of diagnosed depression such as performance standard and report card measures[80] Adding incentives for better detection and treatment to the use of quality measures is a recommended first step

Errors in the Use of Seclusion and Restraint

In October 1998 The Hartford Courant reported on the death of Andrew McClain an 11-year-old boy who died while restrained and secluded in a psychiatric hospital in Connecticut[81] Thus began the Courants 5-part series based on a 50-state survey that confirmed 142 deaths related to the use of seclusion and restraint in mental health settings over the past decade[82-85] The series cautioned that most deaths related to seclusion and restraints are unreported and that the actual number of annual deaths was possibly much higher

The national response to the Courant exposeacute was far reaching Congress commissioned the US General Accounting Office (USGAO) to report on the use of seclusion and restraint The USGAO responded by releasing a report in 1999 entitled Improper Restraint or Seclusion Places People at Risk[82] The USGAO report confirmed the majority of the Courants allegations including the following

Improper use of seclusion and restraint are dangerous

There is inadequate monitoring and reporting of its use and of resulting harm (or preventable adverse events) to patients

Serious injuries or death can occur and are underreported

Licensing and accreditation of seclusion and restraint standards are inconsistent and insufficient and

Successful strategies for preventing seclusion and restraint as well as reducing the risk of injury when use occurs are not widely used

Seclusion and restraint are commonly used practices intended to prevent adults and children with mental health and substance abuse diagnoses from harming themselves or others in inpatient or residential treatment environments Unfortunately access to incidence data collected by The National Association of State Mental Health Program Directors (NASMHPD) is controlled (and forbidden) by participating hospitals There are no published data interpreted as accurately reflecting the true incidence of seclusion and restraint use

The use of these interventions is intended to be severely restricted to individual situations in which an emergency safety need is identified but as use is generally ordered by staff and based on subjective criteria the use of these emergency interventions has a wide range [86] Restraint is defined in a variety of ways but the term generally refers to a manual method or mechanical device material or equipment attached or adjacent to the patients body that he or she cannot easily remove and that restricts the patients freedom or normal access to ones body[87] Seclusion refers to the involuntary confinement of a person in a room where they are physically prevented from leaving[88] Recent literature reviews of seclusion and restraint reflect the absence of[8990]

Substantiated prevention strategies

Indications for use

Application methods

Monitoring

Post-event activities and

Absence of evidence of its effectiveness in preventing harm

The Centers for Medicare and Medicaid Services (CMS) -- formerly known as the Healthcare Financing Administration (HCFA) the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and state licensing agencies have attempted to regulate the use of seclusion and restraint through licensing and accreditation standards[879192] However the Courant series the USGAO report and others have documented alarming rates of patient harm including death despite the application of such standards[818286] While efforts are underway to resolve these issues the appropriate and safe use of seclusion and restraint is far from assured[8693]

In recent years advocates consumers professional associations provider organizations and the legal field have increasingly recommended a reduction in the use of seclusion and restraint or even its elimination[83-86 94] These recommendations resonate with Recommendation no 1 in the IOMs Crossing the Quality Chasm that states All healthcare organizations professional groups

and private and public health purchasers should adopt as their explicit purpose to continually reduce the burden of illness injury and disability and to improve the health and functioning of the people of the United States[2] Using the IOMs medical error nomenclature reports about seclusion and restraint reflect high rates of medical errors mostly errors of commission perhaps errors of omission causing either near misses or preventable adverse events in routine clinical practice

Safety in healthcare practices is defined as keeping the patient free from accidental injury[2] Although not all errors cause injury accidental injury can be due to error either by the failure of a planned action to be completed as intended or use of the wrong plan to achieve an aim The improper use of seclusion and restraint is not safe and causes serious and preventable adverse injuries including death[8182] The media continues to report adverse events as well[9596] For example in 2000 3 deaths were reported just in Texas including that of 2 boys one 9 and the other 11 years old and a 16-year-old girl In South Carolina in 2003 a 9-year-old boy died after he kicked a staff member in the leg and ran down the hall which resulted in a take down and the boys asphyxiation In Arizona a 32-year-old woman died in restraints for behavior that was later judged as not meeting the threshold of imminent danger[96]

Reducing and Improving Seclusion and Restraint Events Recent Performance Improvement Initiatives

Several initiatives focused on seclusion and restraint reduction (embedded in public health prevention continuous quality improvement principles supporting recovery from mental illness and trauma-informed care) have been developed by the American Psychiatric Nurses Association the APA the National Association for Private Health Systems the American Hospital Association the National Alliance on Mental Illness (NAMI) and the Childrens Welfare League of America[2083859798] These initiatives are intended to complement other essential elements such as adequate numbers of well-trained staff and the use of proven psychological and medication treatments

The public health constructs of primary secondary and tertiary prevention create a logical framework and redirect the focus from safer use of seclusion and restraint to interventions that prevent its use[86] The model of recovery espoused by the Surgeon Generals Mental Health report necessitates[99]

System-wide transformation by adopting goals of full recovery in a life outside the hospital

Emphasis on instilling hope

Availability of multiple treatment options and

Development of partnerships with those who seek services

The use of controlling or coercive interventions is counterintuitive in this model and is to be avoided except perhaps as the last alternative in preventing death or significant harm to self or others caused by treatable manifestations of mental illness[94100] A growing understanding of the neurologic biologic psychological and social effects of trauma and its high prevalence in the populations that seek mental health services is informing approaches to assessment diagnosis stabilization and treatment of individuals with mental illness including the use of seclusion and restraint as a means of preventing injury to self or others[101-108]

Data should be analyzed for characteristics of facility usage by

Unit

Shift

Day and

Staff member involved

With rare exception data on individuals should be used confidentially to identify individual staff training needs not for disciplinary actions[88109] The facility needs to highlight data on seclusion and restraint use by graphing and posting this data on all units so that it is clearly visible for staff and consumers of service Facility-generated data on seclusion and restraint used in a non-punitive way provides for healthy competition among treatment units and elevates the general oversight and knowledge of use and outcomes for everyone involved[88109110] It allows and encourages administration to identify successful staff and treatment units so that successful improvements can be shared

A comprehensive national health information infrastructure could be a useful tool in reducing seclusion and restraint events[2111] The National Association of State Mental Health Program Directors Research Institute Inc (NRI) performance improvement system has developed a set of technology standards applications systems and values that include a number of recommendations for reducing seclusion and restraint events and making their occurrence less error prone[112]

Reduction of the use of seclusion and restraint must start with clear leadership and a specific plan that articulates a mission and philosophy about seclusion and restraint reduction and defines the roles and responsibilities of all facility staff[109] One core component is use of an executive on-call function and the daily review of the use of seclusion and restraint by executive leadership[88110]

Creating a treatment environment that prevents seclusion and restraint is based on the principles of recovery and the characteristics of trauma-informed systems of care[88109] Staff education needs to

Include the experiences of consumers and staff

Address the common myths associated with use

Introduce the rationale and characteristics of trauma-informed care

Educate on the neurobiological and psychological effects of trauma and

Describe a prevention-based approach to reduction

Seclusion and Restraint Summary

The use of seclusion and restraint is associated with substantial harm to recipients of care including death Medical errors precede many seclusion and restraint events which in turn cause further errors and substantial harm to both recipients and providers of care Several local and national initiatives are underway to improve the safety of seclusion and restraint events and to decrease its use The results of their successful application can be seen in facilities in[88 109]

Pennsylvania

New York

Massachusetts

Maine

Florida

New Jersey and

South Dakota

Further study of causal antecedent events and of harm resulting from seclusion and restraint events is recommended using the patient safety paradigm and nomenclature

High-Risk Clinical Populations Lacking Adequate Patient Safety Research

Introduction to High-Risk Clinical Populations

There are no empirical data to quantify characterize or confirm medical errors in certain populations with mental illness andor substance abuse where multiple risk factors for error also exist A brief discussion of these populations and their risks for errors is provided below It is hoped that heightened focus on these high-risk populations will be an impetus for medical error research

Persons with Co-occurring Mental Illness and Substance Abuse

Individuals with co-occurring psychiatric and substance disorders have not been studied for medical errors yet they are perhaps at greater risk for harm because of the nature and number of their co-occurring disorders Several studies have reported the common occurrence of comorbidity among persons with a recognized diagnosis of either mental illness or substance abuse For example in 1990 Regier[74] found a lifetime prevalence of substance abuse among 62 of persons with bipolar disorder In 1996 Kessler and colleagues[113] reported a lifetime prevalence of 599 of psychiatric illness among persons with substance abuse disorders while 31 had a concurrent psychiatric disorder

Persons with co-occurring disorders are high utilizers of medical resources and therefore more exposed to systems issues that may predispose to unintended harm In 1995 an estimated 26 million (27) of the 965 million emergency department (ED) visits were related to alcohol abuse alone[114]

In a study by Dickey and associates[115] using data from the Massachusetts Division of Medical Assistance and death records from the Department of Public Health individuals with co-occurring psychiatric and substance use disorders had the highest risk of medical morbidity for 5 of the studied medical disorders Medicaid beneficiaries with dual diagnoses are 6 to 8 times more likely to die of injury primarily poisoning than their counterparts treated for medical conditions only[116117]

It is well-substantiated that persons with psychiatric and substance abuse disorders have higher rates of suicide attempts and death by suicide[118-123] In 2001[124]

20308 deaths were caused by homicide

30622 deaths by suicide and

101537 deaths were caused by accidents

Given the frequency with which substance abuse by itself has been implicated in these 3 causes of death the scope of morbidity and mortality related to co-occurring disorders is staggering

The effects of substance abuse disorders in adults also affected the mortality rates of children during 1985 to 1996 -- 8482 (24) of the 35547 children aged younger than 15 years died in alcohol-related motor vehicle crashes[125]

A subset of those with co-occurring disorders have substance dependence PTSD and chronic pain The presence of chronic pain and the complexities surrounding treatment of individuals with PTSD increase the risk for unintended harm and of a poor fit between clinical needs and the design of current healthcare systems Despite the added risk factors there is little science to direct clinicians A Medline search using substance abuse PTSD and chronic pain as search terms in June 2004 yielded 10 citations There were no incidence studies and no published treatment guidelines

Conclusion regarding co-occurring disorders Individuals with co-occurring disorders are frequently encountered and at risk for multiple diagnostic and treatment errors including

Missed mental health substance abuse and medical diagnoses and

Insufficient or excessive medication treatment of either their substance abuse or psychiatric disorder

Compared with the general population these individuals are at higher risk for

Suicide attempt

Death by suicide and

Death at a younger age by medical illness

There is a paucity of published studies on medical errors among individuals with co-occurring disorders despite several risk factors for unintended harm and high rates of morbidity and mortality

Attention Deficit-Hyperactivity Disorder in Children Excessive or Insufficient Diagnosis and Treatment

Inattentiveness distractibility impulsivity and hyperactivity were recognized as elements of minimal brain dysfunction (now termed attention deficit hyperactivity disorder [ADHD]) and treated with stimulants especially methylphenidate beginning in the late 1960s[101126127] Over the past 3 decades the rate of drug treatment for behavior problems has increased exponentially culminating in the prescription of ADHD drug treatment for at least 5-6 million American children annually[128]

Children diagnosed with ADHD have been the focus of thousands of research studies over the last 40 years yet the diagnosis and treatment of ADHD remain controversial among some within medicine and the general public[129130] Recent prevalence data from the 1998 National Institutes

of Health (NIH) consensus review[131] and reported by Jensen[132] suggest a prevalence of approximately 5 affecting 3 million school-aged children[133134]

ADHD is associated with[135-137]

Increased risk of accidents

Family and social dysfunction

Poor academic achievement

Substance abuse and

Antisocial behavior

Recent treatment data based on the number of methylphenidate prescriptions show an estimated 5-6 million American children receive ADHD-related drug treatment annually[128] Aggregate national methylphenidate use has increased 100-fold from 1960 until 2000 Globally nearly 90 of the worlds stimulant medication supply is consumed by the US population[138139]

Substantial state-to-state and community-to-community variability in methylphenidate use raises concerns about potential pockets of over- and under-diagnosis and over- and under-prescribing Drug Enforcement Association data on stimulant use reflect a 6-fold per capita variation in methylphenidate prescribing between some states[140] and a 20-fold prescribing variation between some communities[130141]

LeFever and colleagues argue that while the data are inconclusive if communities such as Salt Lake City Utah are used as a benchmark of acceptable diagnosis and treatment then children in 36 states may be subject to over-diagnosis and over-treatment Conversely Jensen argues that ADHD is under-diagnosed and under-treated based on national aggregate data allowing for pockets of over-diagnosis and treatment in some geographic areas[142] Given that in 1995 there were approximately 2 million pediatric visits in which ADHD was the focus of treatment and 6 million stimulant prescriptions were written[132] 1 conclusion is that 3 million children with ADHD received an average of 2 prescriptions and 1 outpatient visit during that year suggesting insufficient treatment In another study cited by Jensen the Multimodal Treatment Study of Children with ADHD two thirds of ADHD children from reportedly highly motivated families obtained medication treatments and for an average duration of only 8-14 months[142143]

Despite the number of studies done the strength of conclusions that can be drawn is contingent upon the adequacy of reported data Studies to date are variously limited by data sources sampling accuracy and interpretation[130]

When considered in aggregate national ADHD prevalence rates and numbers of prescriptions written do not suggest excessive diagnosis and treatment However prevalence rates and stimulant use can vary as much as 30-fold when comparing different communities A prevalence rate of 33 among white elementary-aged boys in southeastern Virginia significantly challenges credibility[130] Such variability makes it essential that prevalence rates and stimulant use estimates be linked to sufficient demographics such as

Geography

Age

Race and

Gender

ADHD prevalence rates and stimulant use appear to be

Excessive in some communities

Plausible in other communities and

Perhaps insufficient in yet other communities

Additional epidemiologic studies reporting prevalence rates with specific demographics rather than in aggregate and broader use of practice guidelines promulgated by the American Academy of Pediatrics (AAP) and others that advocate multimodal treatment rather than solely prescribing stimulants or other medications[130144] will help provide evidence of the extent of errors in the diagnosis and treatment of children with ADHD

Electroconvulsive Therapy

Electroconvulsive therapy (ECT) remains a controversial treatment in psychiatry As stated in the 1985 NIH Consensus Statement The nature of the treatment itself its history of abuse unfavorable media presentations compelling testimony of former patients special attention by the legal system uneven distribution of ECT use among practitioners and facilities and uneven access by patients all contribute to the controversial context in which the consensus panel has approached its task[145]

Epidemiologic data reported by Thompson and colleagues in 1994 found that[146]

58667 patients received ECT in 1975

31514 in 1980

36558 in 1986

71 of the patients who received ECT were women and

Individuals older than 65 years of age had the highest rates per number of inpatients

The rate of ECT use has been highly variable For example in 1995 Herman and associates[147] reported that among 202 metropolitan statistical areas annual ECT use varied from 04 to 812 patients per 10000 population

The most common adverse effect from ECT is memory loss In a recent review of patients perspectives as well as clinicians studies Rose and associates[148] concluded that 29 to 55 of ECT treatment recipients experienced persistent memory loss Recent empirical studies of ECT and memory loss continue to find persistent memory loss with bilateral ECT producing more profound memory deficits than right unilateral ECT[149]

In a review of deaths caused by ECT Abrams reported that ECT is 10 times safer than childbirth that approximately 6 times as many deaths annually in the US are caused by lightning as by ECTand that the death rate reported for ECT is an order of magnitude smaller than the spontaneous death rate in the general population[150]

Corroboration of a low ECT death rate has arisen from 1993 legislation in Texas mandating reporting of all ECT-related deaths[151] As a result the risk of death from ECT in Texas has been systematically tracked and reviewed More than 8000 patients received 49048 ECT treatments between 1993 and 1998 However only 1 death could be linked to the associated anesthesia An additional 4 deaths could plausibly have been associated with the anesthesia yielding a mortality rate between 2 and 10 per 100000 and the causes of death most likely were not the ECT stimulus or seizure

Emotional harm and erosion of faith in the medical profession that undermines accepting other needed treatments can come to recipients of care for whom the experience of ECT is frightening

ECT conclusion ECT is effective for severe major affective illness and is associated with a low mortality rate Persistent memory loss is a consistent finding despite attempts to optimize ECT administration and must be expected at an incidence of approximately 25 to 50 by those contemplating and those providing ECT treatment

Despite its relative safety ECT continues to cause alarm in the general public Even within medicine it is described as dangerous and unethical by some[152] Such fears can cause emotional harm among ECT recipients This may be especially true for older women (who comprise the majority of ECT subjects) some of whom may be accustomed to deferring to healthcare providers when consenting to treatment despite insufficient understanding of benefits and risks

Recommendations include

Emphasis on pre-treatment education

Collaborative relationship with ECT recipients

Increased transparency regarding the substantial risk of persistent memory loss when seeking informed consent and

Continued research on its safety

Systems Issues Related to Patient Safety

Outpatient Care

Risk of unintended harm may be increased by the segregated care settings in which psychiatric and substance abuse services are often delivered including solo practitioner offices and free-standing psychiatric and substance abuse treatment facilities[153154] and by insufficient communication and coordination of care between prescribers and psychotherapists[155-157] Despite the recognition of these potential contributing factors there are no existing reports of the association between systems issues and medical errors

Olfson[158] reported that in 1987 there were 84 million outpatient visits with mental health practitioners including

Psychiatrists

Psychologists

Social workers and

Licensed counselors

Kessler[154] reported in 1999 that an estimated 133 of a representative sample of Americans reported used outpatient services for mental health problems in the previous 12 months Clearly there are high numbers of individuals at risk for errors in outpatient mental health and substance abuse treatment

Ethics and Malpractice Risk Management Boundary Violations

A survey of recently published reviews and commentaries on patient safety reveals that for mental health and substance abuse issues such discussion takes place mainly within the context of ethics and malpractice risk management[159-162] Ethics statements from both the APA[162] and the American Psychological Association[163] support the duty to report and protect patients from deviations from the standards of care This approach uses the individual practitioners frame of reference and relies on voluntary reporting from professionals who have been trained to consider confidentiality a critical component of their work Harm caused by clinician boundary violations are understood as issues of professional misconduct not as errors resulting from system failure and that minimize the individual clinicians responsibility and advise against punitive action [164-167]

With the advent of therapeutic exchanges through email and other means of communication additional boundary violations are possible The Internet now has at least 110 million users including 70 million using it for health-related information[168] A recent survey indicated 40 to 50 of physicians use the Internet (or are preparing to use it) for clinical care[169]

There is a risk of errors of omission or commission arising from lack of coordination of care between clinicians Differences in therapeutic orientation and nomenclature used by the following specialists can compound systems issues that increase the risk of medical errors [158]

Social workers

Psychiatric nurse specialists

Psychologists

Licensed counselors and

Psychiatrists

Confidentiality is critical in providing effective treatment within the secure and private setting of the therapists office and in protecting the patient from unauthorized disclosures of sensitive information and potential abuse from a third party[170] However confidentiality can also inhibit disclosure of near misses impasses in treatment (for example when treatment is not working) and preventable adverse events due to avoidance of sharing important clinical information with other professionals and with appropriate family members and other supportive resources[171172]

The solo practice model commonly used by mental health clinicians can also inhibit the adoption of best practices and the development of policies and procedures to reduce risk because all such practice management activities are left to the individual clinician whose focus is more likely to be exclusively clinical

Summary About Systems Issues and Patient Safety

Systems for reliably reporting outpatient psychotherapy medical errors particularly among the large numbers of solo practitioners do not exist The prevailing paradigm for reducing harm arises from risk reduction in order to diminish medical liability exposure Studies that shed light on potential medical errors have arisen from risk management claims medical liability lawsuits and reports of death by suicide not from research intended to examine patient safety per se

Error reporting systems applicable to outpatient mental health settings including incentives for their use need to be developed Professional risk management programs primarily used to diminish medical liability exposure from the following could also be used to promulgate the relevance and value of the patient safety paradigm

Boundary violations

Suicide and

Treatment errors

Most particularly thought needs to be given to developing systems of error prevention applicable to the solo practitioner

Recommendations

Recommendation no 1

Widespread adoption of the IOM patient safety paradigm and nomenclature in mental health and substance abuse treatment settings is recommended

Advantages of its use include

Consistency with the nomenclature used by other medical specialties

Increased leverage in advocating for needed services and resources when the absence of essential treatments are quantified as errors of omission causing near misses or preventable adverse events

Increased likelihood that medication errors in mental health and substance abuse will be researched and a determination made whether such errors are causing preventable adverse events and

Increased awareness among mental health and substance abuse clinicians that patient harm can come from a broader array of errors in diagnosis and treatment than has been studied to date

Widespread adoption will require systematic educational efforts for trainees and current practitioners in mental health and substance abuse including systematic introduction to the IOMs existence mission and safety and quality efforts such as the Quality Chasm Series (Many mental health and substance abuse clinicians and administrators seem unaware of the IOM at all)

Recommendation no 2

Further studies of medical error in mental health and substance disorders are needed

Some areas of potential harm in this field remain largely unexamined For example we found only 2 studies of medication errors in mental health settings and none in substance abuse detoxification and stabilization settings despite multiple risk factors for errors and preventable adverse events The impact of variable education -- in pharmacology physiology and general medicine -- on the safety of prescribing practices has not been studied nor has the clinical consequences of formulary restrictions on clinical outcome and potential patient harm The current acceptance of self-reported hospital error rates must be challenged through a process of independently validating self-reported errors

Recommendation no 3

Integration of mental health and substance abuse services is recommended

High rates of co-occurrence and associated higher rates of morbidity and mortality among those with mental health and substance abuse disorders requires integration of mental health and substance abuse treatment paradigms This has not occurred to date

Recommendation no 4

The IOMs 10 rules for change in healthcare should be adopted

The 10 IOM rules for change in healthcare are as follows[173]

1 Care based on continuous healing relationships

2 Customization based on patient needs and values

3 The patient as the source of control

4 Shared knowledge and the free-flow of information

5 Evidence-based decision-making

6 Safety as a system property

7 The need for transparency

8 Anticipation of needs

9 Continuous decrease in waste

10 Cooperation among clinicians

As an example of adoption of these rules seclusion and restraint remain high risk treatments yet current reporting systems do not permit transparency regarding the rate and types of injuries incurred including mortality rates Such transparency requires a non-punitive work culture yet there is little evidence to suggest its adoption in high-risk environments such as state psychiatric hospitals or inpatient detoxification and stabilization substance abuse treatment settings

Recommendation no 5

Reporting systems in outpatient mental health and substance abuse treatment settings must be adopted

Reliance upon unsubstantiated self-reporting of medication errors in inpatient mental health and substance abuse settings remains a significant flaw when attempting accurate assessment of near misses and preventable adverse events and must be changed A key necessity is anonymous yet authenticated medication error reporting for all staff using available web-based error reporting systems Such systems are cost-savers and make reported error data immediately and continuously available Web-based reporting systems providing anonymity with authentication could be used for further seclusion and restraint data collection and as a means of establishing an outpatient error reporting system of safety and quality data by recipients and providers of outpatient treatment

Recommendation no 6

Resources should be allocated to study and develop practical interventions to improve patient safety

Much current research in mental health and substance abuse and resource appropriation is focused on efficacy of pharmacotherapy and psychotherapy and on establishing neurobiologic evidence to support causal theories of known clinical disorders At a policy level we recommend more consideration be given to funding practical interventions predicted to immediately improve patient safety

References

[ CLOSE WINDOW ]

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166 Malmquist CP Notman MT Psychiatrist and patient boundary issues following treatment termination Am J Psychiatry 20011581010-1018 Abstract

167 Herman JL Gartell N Olarte S Feldstein M Localio R Psychiatrist-patient sexual contact results of a national survey II Psychiatrists attitudes Am J Psychiatry 1987144164-169 Abstract

168 Risk Management in Cyberspace Rx for Risk 20019 169 Miller RH Hillman JM Given RS Physician use of IT Results from the Deloitte

research survey J Healthc Inf Manag 20041872-80 Abstract 170 Applebaum PS Privacy in psychiatric treatment threats and responses Focus

20031396-406 171 Godolphin W The role of risk communication in shared decision making BMJ

2003327692-693 Abstract 172 Oregon Medical Association Lets talk disclosures after an adverse medical

event(video) Portland OR 2002 Available at httpwwwPatientSafetyStorecom Accessed August 28 2007

173 Institute of Medicine (IOM) Crossing the Quality of Chasm Adaptation to Mental Health and Addictive Disorders April 26 2004 Available at httpwwwiomeduCMS380919405aspx Accessed September 6 2007

Authors and Disclosures

As an organization accredited by the ACCME Medscape LLC requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest The ACCME defines relevant financial relationships as financial relationships in any amount occurring within the past 12 months including financial relationships of a spouse or life partner that could create a conflict of interest

Medscape LLC encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration at first mention and where appropriate in the content

Author

Benjamin C Grasso MD

Staff Psychiatrist VA Clinic Saco Maine Disclosure Benjamin C Grasso MD has disclosed no relevant financial relationships

Cathryn M Clary MD MBA

Vice President US External Medical Affairs Pfizer Inc New York NY Disclosure Cathryn M Clary MD MBA has disclosed that she is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Benjamin Eng MD MA

Senior Medical Director Group Leader Pfizer Inc New York NY Disclosure Benjamin Eng MD MA has disclosed that he is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Stanley J Evans MD FASAM PA

Assistant Professor of Clinical Medicine St Matthews University Windham Maine

Medical Director Renaissance Institute of Palm Beach Boca Raton Florida Disclosure Stanley J Evans MD has disclosed no relevant financial relationships

Terry J Golash MD

Clinical Instructor Psychiatry Columbia University New York NY Assistant Attending St Lukersquos Roosevelt Hospital Center New York NY Disclosure Terry J Golash MD has disclosed no relevant financial relationships

Kevin Ann Huckshorn RN MSN CAP ICADC

Director Office of Technical Assistance National Association of State mental Health Program Directors Inc Alexandria Virginia Disclosure Kevin Ann Huckshorn RN MSN CAP ICADC has disclosed no relevant financial relationships

Kenneth Minkoff MD

Clinical Assistant Professor Department of Psychiatry Cambridge Hospital Harvard University Acton Massachusetts Consultant ZiaLogic Acton Massachusetts Disclosure Kenneth Minkoff MD has disclosed no relevant financial relationships

Joseph J Parks MD

Assistant Associate Professor Department of Psychiatry University of Missouri Columbia Missouri Disclosure Joseph J Parks MD has disclosed that he has received grants for educational activities from Letters amp Science and Physician Postgraduate Press Dr Parks has also disclosed that he has served as a consultant to the National Association of State Mental Health Program Directors and Bristol-Myers Squibb Dr Parks has also disclosed that he has received funds for services provided to the state of Missouri from Eli Lilly and Abbott

Miles F Shore MD

Bullard Distinguished Professor of Psychiatry Harvard Medical School Needham Massachusetts Junior Consultant Harvard Medical International Boston Massachusetts Disclosure Miles F Shore MD has disclosed no relevant financial relationships

Editor

Jacqueline A Hart MD

Freelance Clinical Editor Medscape LLC New York New York Disclosure Jacqueline A Hart MD has disclosed no relevant financial relationships

Elizabeth Saenger PhD

Editorial Director Medscape LLC New York NY Disclosure Elizabeth Saenger PhD has disclosed no relevant financial relationships

Registration for CME credit the post test and the evaluation must be completed online To access the activity Post Test and Evaluation link please go to httpwwwmedscapecomviewprogram7809_index

Page 8: Medication Errors and Patient Safety in Mental Health CME/CE · 2019. 6. 27. · Medication Errors and Patient Safety in Mental Health CME/CE Complete author affiliations and disclosures

Absence of evidence of a contemporary understanding of medication errors and their consequences in both inpatient and outpatient mental health treatment settings

High prevalence of co-occurring substance abuse disorders that complicate diagnosis and treatment and

Greater vulnerability of individuals with mental illness

In addition the validity of reported error rates is limited by self-reporting -- the error reporting method currently used in almost all hospitals

Errors in Diagnosis

Missed Diagnoses and Insufficient Treatment of Mood and Anxiety Disorders in Ambulatory Medical Settings

Introduction to missed diagnosis Over half of patients with a psychiatric problem receive treatment solely from a primary care physician rather than a mental health specialist[25] Of all patients seen in primary care from 15 to 25 have a mood or anxiety disorder[26-29] Because mood and anxiety disorders are common in ambulatory medical settings but providers in these setting are usually non-psychiatric clinicians treatment rendered in this setting may be prone to medical errors

Errors of omission The primary errors of omission in ambulatory medical settings where non-mental health clinicians are the only providers interacting with patients are missed diagnoses and failure to implement a needed treatment

Missed diagnoses Although the reliability of psychiatric diagnoses when made by trained diagnosticians using structured interviews is a good approach for most disorders errors are made even under conditions considered ideal or nearly ideal[30] In primary care medical practice the following factors are likely to increase diagnostic errors of omission

Time constraints

Competing demands

Minimal training in mental health diagnosis and treatment and

Lack of use of a systematic diagnostic interview

The overall missed diagnosis error rate for the detection of any mood or anxiety disorder by primary care physicians compared with a psychiatric interview has been reported to range from 25[26] to almost 67[31] Primary care physicians correctly diagnose only 35 to 57 of the cases of major depressive disorder (MDD) that are identified with a psychiatric interview[32-36] A multinational investigation found that[37]

27 of false-negative cases (that is primary care physician missing the diagnosis of MDD) were due to complete disagreement with a standardized interview diagnosis

397 were due to the primary care physician recognizing some symptoms of depression but underestimating the severity of the condition and therefore not giving the diagnosis and

33 were diagnosed with another condition

Correct identification of MDD by primary care physicians is associated with[38]

Greater familiarity with the patient and

Presence of suggestive clinical cues (eg a history of depression or the presence of vegetative symptoms)

Anxiety disorders also frequently go undetected[313940] In 1 study about 10 of primary care patients with an anxiety disorder were identified by their physician[41] Approximately 70 of the time that a primary care physician identifies an anxiety problem they diagnose an anxiety state unspecified rather than a specific anxiety disorder[42] In 1 study in Israel only 2 of patients with posttraumatic stress disorder (PTSD) were diagnosed correctly by the primary care physician[43] This underdiagnosis may be a result of inadequate education about anxiety disorders for example only 57 of primary care doctors in a study conducted in Germany considered generalized anxiety disorder to be an independent disorder[44]

Insufficient treatment Treatment is absent when mood and anxiety disorders are missed Insufficient treatment may occur even when anxiety and mood disorders are diagnosed correctly Only about half of patients diagnosed in primary care settings with mood or anxiety disorders receive medication treatment[4546] Psychotherapy referrals were not examined in these studies so it remains unclear whether the patients who did not receive medication treatment were offered psychological treatment

Even when a psychiatrist provided a consultation and advised antidepressant treatment only 53 of appropriate primary care patients received antidepressant medication over the next year[47] The National Ambulatory Medical Care Survey database from 1985 to 1998 documented that treatment for anxiety is offered in 60 of visits to primary care physicians compared with over 95 of visits for anxiety to a psychiatrists[42] A recent naturalistic study of anxiety disordered patients in primary care found that 47 were receiving treatment from either the primary care physician or a specialty mental health clinician[48] A study of patients with panic disorder in primary care settings revealed that only 64 were found to be receiving either medication or psychotherapy[49]

Preventable adverse events Missed diagnoses and insufficient treatment of mood and anxiety disorders in medical settings may cause serious preventable adverse events For MDD preventable adverse events include impairment in physical and mental functioning that is comparable to that found with common medical disorders such as hypertension and diabetes[5051] Depression exacerbates the outcomes of chronic medical illnesses[52] and is associated with higher rehospitalization rates[53] and higher mortality rates[5455] following a myocardial infarction

MDD is also associated with a substantial risk of suicide which is increased when treatment is insufficient[56-58] The economic burden in the United States due to MDD has been estimated at about $83 billion as of 2000[59] Of these costs about three-fourths represent indirect costs (vs the direct cost of providing treatment) particularly reduced productivity and absenteeism in the workplace The World Health Organization has ranked MDD as second only to ischemic heart disease in magnitude of disease burden in countries with established market economies[60]

The functional and economic burden of MDD has been an area of focus for payers and employers Less recognized however is the substantial impairment in social and occupational functioning and in physical health documented in mental health treatment settings for individuals with specific anxiety disorders such as

PTSD[6162]

Panic disorder[6364]

Generalized anxiety disorder[65] and

Social anxiety disorder[6667]

Impairment from anxiety disorders is also apparent in those who present to a primary care physician[496869] Generalized anxiety disorder produces impairment in health-related functioning that is equivalent to or significantly greater than patients with diabetes and recent myocardial infarction

Primary care patients with anxiety disorder are high utilizers of general medical services resulting in increased overall healthcare costs compared with primary care patients who have subthreshold disorders or no anxiety disorder[70] The economic burden of anxiety disorders in the United States has been estimated to be $423 billion in 1990 primarily due to increased use of non-psychiatric medical services[71]

However missed diagnoses do not necessarily lead to preventable adverse events Some studies have suggested that patients with unrecognized MDD in the primary care setting are less severely depressed and less functionally impaired[323770] and therefore at less risk for

Loss of employment

Impaired social functioning

Exacerbation of co-occurring medical disorders and

Suicide

When recognized and unrecognized patients with MDD are tracked over time clinical improvement has often been comparable[3770] although greater short-term improvement for recognized cases has also been reported for MDD[34] and anxiety disorders[72]

Errors of commission mistaken diagnoses As described previously for MDD about one-third of the diagnostic errors in primary care are mistaken diagnoses[37] Mistaken diagnoses range from anxiety disorders to alcoholsubstance abuse to psychoticdissociative disorders Conversely when an anxiety disorder is present a mistaken diagnosis of depression is sometimes given[39] The high level of comorbidity between anxiety and mood disorders is likely to contribute substantially to such diagnostic errors[73]

Primary care physicians also occasionally diagnose a mood or anxiety disorder when it is not present (false positive) Among non-depressed patients a false positive rate of 12 in primary care was reported in 1 study[38] and 14 in another[37] About 25 of these MDD false-positives in the Tiemens study actually had an anxiety disorder 20 were the result of overestimation of severity of depression by the primary care physician and 55 were true false positives In the Klinkman study a history of depression was apparent in over half of the false-positive cases

suggesting that physicians might have been unduly influenced by a history of depression rather than the clinical evidence for depression at the time of examination

The implications of these misdiagnoses require more study Because the treatments for most mood and anxiety disorders are similar and because even subsyndromal disorders cause significant distress and functional disability it is possible that imprecision in diagnosis may still result in the use of appropriate medication treatment Of course treatment of an individual without a disorder even subsyndromal causes unneeded exposure to medication errors

Recommendations to diminish misdiagnoses in primary care Since primary care clinicians will most likely continue to be the point of entry and often the sole provider of mental health treatment for patients suffering from mood and anxiety disorders improvements in diagnosis and appropriate treatment of these disorders in primary care should be an important priority Better education of primary care providers about the symptoms and management of depression and anxiety are essential Programs designed to increase primary care clinicians recognition of depression and other psychiatric disorders have not yet proved to improve treatment outcome[7475] However studies that have added training in depression management in addition to education on better recognition of its presence have yielded better outcomes[76]

The feasibility and sustainability of programs focusing on better education of primary care clinicians has not been established Because of the time constraints of standard primary care practice fast efficient methods of screening such as the Primary Care Evaluation of Mental Disorders (PRIME-MD) for anxiety depression and other psychiatric disorders are recommended[77] The Patient Health Questionnaire a 9-item subset of the PRIME-MD is a more concise screen for depression if time constraints preclude use of the full PRIME-MD questionnaire The routine use of such simple methods for screening and ongoing monitoring might provide a sustainable way of reducing diagnostic errors in ambulatory medical settings

A final recommendation is for managed care and insurance companies as well as health systems and provider networks to consider the implementation of incentives for better detection and treatment of mood and anxiety disorders Pilot pay for performance programs such as Bridges to Excellence[78] or the Integrated Healthcare Association initiative in California[79] have focused on physical conditions such as diabetes or asthma Quality measures do exist for the medication treatment and follow up of diagnosed depression such as performance standard and report card measures[80] Adding incentives for better detection and treatment to the use of quality measures is a recommended first step

Errors in the Use of Seclusion and Restraint

In October 1998 The Hartford Courant reported on the death of Andrew McClain an 11-year-old boy who died while restrained and secluded in a psychiatric hospital in Connecticut[81] Thus began the Courants 5-part series based on a 50-state survey that confirmed 142 deaths related to the use of seclusion and restraint in mental health settings over the past decade[82-85] The series cautioned that most deaths related to seclusion and restraints are unreported and that the actual number of annual deaths was possibly much higher

The national response to the Courant exposeacute was far reaching Congress commissioned the US General Accounting Office (USGAO) to report on the use of seclusion and restraint The USGAO responded by releasing a report in 1999 entitled Improper Restraint or Seclusion Places People at Risk[82] The USGAO report confirmed the majority of the Courants allegations including the following

Improper use of seclusion and restraint are dangerous

There is inadequate monitoring and reporting of its use and of resulting harm (or preventable adverse events) to patients

Serious injuries or death can occur and are underreported

Licensing and accreditation of seclusion and restraint standards are inconsistent and insufficient and

Successful strategies for preventing seclusion and restraint as well as reducing the risk of injury when use occurs are not widely used

Seclusion and restraint are commonly used practices intended to prevent adults and children with mental health and substance abuse diagnoses from harming themselves or others in inpatient or residential treatment environments Unfortunately access to incidence data collected by The National Association of State Mental Health Program Directors (NASMHPD) is controlled (and forbidden) by participating hospitals There are no published data interpreted as accurately reflecting the true incidence of seclusion and restraint use

The use of these interventions is intended to be severely restricted to individual situations in which an emergency safety need is identified but as use is generally ordered by staff and based on subjective criteria the use of these emergency interventions has a wide range [86] Restraint is defined in a variety of ways but the term generally refers to a manual method or mechanical device material or equipment attached or adjacent to the patients body that he or she cannot easily remove and that restricts the patients freedom or normal access to ones body[87] Seclusion refers to the involuntary confinement of a person in a room where they are physically prevented from leaving[88] Recent literature reviews of seclusion and restraint reflect the absence of[8990]

Substantiated prevention strategies

Indications for use

Application methods

Monitoring

Post-event activities and

Absence of evidence of its effectiveness in preventing harm

The Centers for Medicare and Medicaid Services (CMS) -- formerly known as the Healthcare Financing Administration (HCFA) the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and state licensing agencies have attempted to regulate the use of seclusion and restraint through licensing and accreditation standards[879192] However the Courant series the USGAO report and others have documented alarming rates of patient harm including death despite the application of such standards[818286] While efforts are underway to resolve these issues the appropriate and safe use of seclusion and restraint is far from assured[8693]

In recent years advocates consumers professional associations provider organizations and the legal field have increasingly recommended a reduction in the use of seclusion and restraint or even its elimination[83-86 94] These recommendations resonate with Recommendation no 1 in the IOMs Crossing the Quality Chasm that states All healthcare organizations professional groups

and private and public health purchasers should adopt as their explicit purpose to continually reduce the burden of illness injury and disability and to improve the health and functioning of the people of the United States[2] Using the IOMs medical error nomenclature reports about seclusion and restraint reflect high rates of medical errors mostly errors of commission perhaps errors of omission causing either near misses or preventable adverse events in routine clinical practice

Safety in healthcare practices is defined as keeping the patient free from accidental injury[2] Although not all errors cause injury accidental injury can be due to error either by the failure of a planned action to be completed as intended or use of the wrong plan to achieve an aim The improper use of seclusion and restraint is not safe and causes serious and preventable adverse injuries including death[8182] The media continues to report adverse events as well[9596] For example in 2000 3 deaths were reported just in Texas including that of 2 boys one 9 and the other 11 years old and a 16-year-old girl In South Carolina in 2003 a 9-year-old boy died after he kicked a staff member in the leg and ran down the hall which resulted in a take down and the boys asphyxiation In Arizona a 32-year-old woman died in restraints for behavior that was later judged as not meeting the threshold of imminent danger[96]

Reducing and Improving Seclusion and Restraint Events Recent Performance Improvement Initiatives

Several initiatives focused on seclusion and restraint reduction (embedded in public health prevention continuous quality improvement principles supporting recovery from mental illness and trauma-informed care) have been developed by the American Psychiatric Nurses Association the APA the National Association for Private Health Systems the American Hospital Association the National Alliance on Mental Illness (NAMI) and the Childrens Welfare League of America[2083859798] These initiatives are intended to complement other essential elements such as adequate numbers of well-trained staff and the use of proven psychological and medication treatments

The public health constructs of primary secondary and tertiary prevention create a logical framework and redirect the focus from safer use of seclusion and restraint to interventions that prevent its use[86] The model of recovery espoused by the Surgeon Generals Mental Health report necessitates[99]

System-wide transformation by adopting goals of full recovery in a life outside the hospital

Emphasis on instilling hope

Availability of multiple treatment options and

Development of partnerships with those who seek services

The use of controlling or coercive interventions is counterintuitive in this model and is to be avoided except perhaps as the last alternative in preventing death or significant harm to self or others caused by treatable manifestations of mental illness[94100] A growing understanding of the neurologic biologic psychological and social effects of trauma and its high prevalence in the populations that seek mental health services is informing approaches to assessment diagnosis stabilization and treatment of individuals with mental illness including the use of seclusion and restraint as a means of preventing injury to self or others[101-108]

Data should be analyzed for characteristics of facility usage by

Unit

Shift

Day and

Staff member involved

With rare exception data on individuals should be used confidentially to identify individual staff training needs not for disciplinary actions[88109] The facility needs to highlight data on seclusion and restraint use by graphing and posting this data on all units so that it is clearly visible for staff and consumers of service Facility-generated data on seclusion and restraint used in a non-punitive way provides for healthy competition among treatment units and elevates the general oversight and knowledge of use and outcomes for everyone involved[88109110] It allows and encourages administration to identify successful staff and treatment units so that successful improvements can be shared

A comprehensive national health information infrastructure could be a useful tool in reducing seclusion and restraint events[2111] The National Association of State Mental Health Program Directors Research Institute Inc (NRI) performance improvement system has developed a set of technology standards applications systems and values that include a number of recommendations for reducing seclusion and restraint events and making their occurrence less error prone[112]

Reduction of the use of seclusion and restraint must start with clear leadership and a specific plan that articulates a mission and philosophy about seclusion and restraint reduction and defines the roles and responsibilities of all facility staff[109] One core component is use of an executive on-call function and the daily review of the use of seclusion and restraint by executive leadership[88110]

Creating a treatment environment that prevents seclusion and restraint is based on the principles of recovery and the characteristics of trauma-informed systems of care[88109] Staff education needs to

Include the experiences of consumers and staff

Address the common myths associated with use

Introduce the rationale and characteristics of trauma-informed care

Educate on the neurobiological and psychological effects of trauma and

Describe a prevention-based approach to reduction

Seclusion and Restraint Summary

The use of seclusion and restraint is associated with substantial harm to recipients of care including death Medical errors precede many seclusion and restraint events which in turn cause further errors and substantial harm to both recipients and providers of care Several local and national initiatives are underway to improve the safety of seclusion and restraint events and to decrease its use The results of their successful application can be seen in facilities in[88 109]

Pennsylvania

New York

Massachusetts

Maine

Florida

New Jersey and

South Dakota

Further study of causal antecedent events and of harm resulting from seclusion and restraint events is recommended using the patient safety paradigm and nomenclature

High-Risk Clinical Populations Lacking Adequate Patient Safety Research

Introduction to High-Risk Clinical Populations

There are no empirical data to quantify characterize or confirm medical errors in certain populations with mental illness andor substance abuse where multiple risk factors for error also exist A brief discussion of these populations and their risks for errors is provided below It is hoped that heightened focus on these high-risk populations will be an impetus for medical error research

Persons with Co-occurring Mental Illness and Substance Abuse

Individuals with co-occurring psychiatric and substance disorders have not been studied for medical errors yet they are perhaps at greater risk for harm because of the nature and number of their co-occurring disorders Several studies have reported the common occurrence of comorbidity among persons with a recognized diagnosis of either mental illness or substance abuse For example in 1990 Regier[74] found a lifetime prevalence of substance abuse among 62 of persons with bipolar disorder In 1996 Kessler and colleagues[113] reported a lifetime prevalence of 599 of psychiatric illness among persons with substance abuse disorders while 31 had a concurrent psychiatric disorder

Persons with co-occurring disorders are high utilizers of medical resources and therefore more exposed to systems issues that may predispose to unintended harm In 1995 an estimated 26 million (27) of the 965 million emergency department (ED) visits were related to alcohol abuse alone[114]

In a study by Dickey and associates[115] using data from the Massachusetts Division of Medical Assistance and death records from the Department of Public Health individuals with co-occurring psychiatric and substance use disorders had the highest risk of medical morbidity for 5 of the studied medical disorders Medicaid beneficiaries with dual diagnoses are 6 to 8 times more likely to die of injury primarily poisoning than their counterparts treated for medical conditions only[116117]

It is well-substantiated that persons with psychiatric and substance abuse disorders have higher rates of suicide attempts and death by suicide[118-123] In 2001[124]

20308 deaths were caused by homicide

30622 deaths by suicide and

101537 deaths were caused by accidents

Given the frequency with which substance abuse by itself has been implicated in these 3 causes of death the scope of morbidity and mortality related to co-occurring disorders is staggering

The effects of substance abuse disorders in adults also affected the mortality rates of children during 1985 to 1996 -- 8482 (24) of the 35547 children aged younger than 15 years died in alcohol-related motor vehicle crashes[125]

A subset of those with co-occurring disorders have substance dependence PTSD and chronic pain The presence of chronic pain and the complexities surrounding treatment of individuals with PTSD increase the risk for unintended harm and of a poor fit between clinical needs and the design of current healthcare systems Despite the added risk factors there is little science to direct clinicians A Medline search using substance abuse PTSD and chronic pain as search terms in June 2004 yielded 10 citations There were no incidence studies and no published treatment guidelines

Conclusion regarding co-occurring disorders Individuals with co-occurring disorders are frequently encountered and at risk for multiple diagnostic and treatment errors including

Missed mental health substance abuse and medical diagnoses and

Insufficient or excessive medication treatment of either their substance abuse or psychiatric disorder

Compared with the general population these individuals are at higher risk for

Suicide attempt

Death by suicide and

Death at a younger age by medical illness

There is a paucity of published studies on medical errors among individuals with co-occurring disorders despite several risk factors for unintended harm and high rates of morbidity and mortality

Attention Deficit-Hyperactivity Disorder in Children Excessive or Insufficient Diagnosis and Treatment

Inattentiveness distractibility impulsivity and hyperactivity were recognized as elements of minimal brain dysfunction (now termed attention deficit hyperactivity disorder [ADHD]) and treated with stimulants especially methylphenidate beginning in the late 1960s[101126127] Over the past 3 decades the rate of drug treatment for behavior problems has increased exponentially culminating in the prescription of ADHD drug treatment for at least 5-6 million American children annually[128]

Children diagnosed with ADHD have been the focus of thousands of research studies over the last 40 years yet the diagnosis and treatment of ADHD remain controversial among some within medicine and the general public[129130] Recent prevalence data from the 1998 National Institutes

of Health (NIH) consensus review[131] and reported by Jensen[132] suggest a prevalence of approximately 5 affecting 3 million school-aged children[133134]

ADHD is associated with[135-137]

Increased risk of accidents

Family and social dysfunction

Poor academic achievement

Substance abuse and

Antisocial behavior

Recent treatment data based on the number of methylphenidate prescriptions show an estimated 5-6 million American children receive ADHD-related drug treatment annually[128] Aggregate national methylphenidate use has increased 100-fold from 1960 until 2000 Globally nearly 90 of the worlds stimulant medication supply is consumed by the US population[138139]

Substantial state-to-state and community-to-community variability in methylphenidate use raises concerns about potential pockets of over- and under-diagnosis and over- and under-prescribing Drug Enforcement Association data on stimulant use reflect a 6-fold per capita variation in methylphenidate prescribing between some states[140] and a 20-fold prescribing variation between some communities[130141]

LeFever and colleagues argue that while the data are inconclusive if communities such as Salt Lake City Utah are used as a benchmark of acceptable diagnosis and treatment then children in 36 states may be subject to over-diagnosis and over-treatment Conversely Jensen argues that ADHD is under-diagnosed and under-treated based on national aggregate data allowing for pockets of over-diagnosis and treatment in some geographic areas[142] Given that in 1995 there were approximately 2 million pediatric visits in which ADHD was the focus of treatment and 6 million stimulant prescriptions were written[132] 1 conclusion is that 3 million children with ADHD received an average of 2 prescriptions and 1 outpatient visit during that year suggesting insufficient treatment In another study cited by Jensen the Multimodal Treatment Study of Children with ADHD two thirds of ADHD children from reportedly highly motivated families obtained medication treatments and for an average duration of only 8-14 months[142143]

Despite the number of studies done the strength of conclusions that can be drawn is contingent upon the adequacy of reported data Studies to date are variously limited by data sources sampling accuracy and interpretation[130]

When considered in aggregate national ADHD prevalence rates and numbers of prescriptions written do not suggest excessive diagnosis and treatment However prevalence rates and stimulant use can vary as much as 30-fold when comparing different communities A prevalence rate of 33 among white elementary-aged boys in southeastern Virginia significantly challenges credibility[130] Such variability makes it essential that prevalence rates and stimulant use estimates be linked to sufficient demographics such as

Geography

Age

Race and

Gender

ADHD prevalence rates and stimulant use appear to be

Excessive in some communities

Plausible in other communities and

Perhaps insufficient in yet other communities

Additional epidemiologic studies reporting prevalence rates with specific demographics rather than in aggregate and broader use of practice guidelines promulgated by the American Academy of Pediatrics (AAP) and others that advocate multimodal treatment rather than solely prescribing stimulants or other medications[130144] will help provide evidence of the extent of errors in the diagnosis and treatment of children with ADHD

Electroconvulsive Therapy

Electroconvulsive therapy (ECT) remains a controversial treatment in psychiatry As stated in the 1985 NIH Consensus Statement The nature of the treatment itself its history of abuse unfavorable media presentations compelling testimony of former patients special attention by the legal system uneven distribution of ECT use among practitioners and facilities and uneven access by patients all contribute to the controversial context in which the consensus panel has approached its task[145]

Epidemiologic data reported by Thompson and colleagues in 1994 found that[146]

58667 patients received ECT in 1975

31514 in 1980

36558 in 1986

71 of the patients who received ECT were women and

Individuals older than 65 years of age had the highest rates per number of inpatients

The rate of ECT use has been highly variable For example in 1995 Herman and associates[147] reported that among 202 metropolitan statistical areas annual ECT use varied from 04 to 812 patients per 10000 population

The most common adverse effect from ECT is memory loss In a recent review of patients perspectives as well as clinicians studies Rose and associates[148] concluded that 29 to 55 of ECT treatment recipients experienced persistent memory loss Recent empirical studies of ECT and memory loss continue to find persistent memory loss with bilateral ECT producing more profound memory deficits than right unilateral ECT[149]

In a review of deaths caused by ECT Abrams reported that ECT is 10 times safer than childbirth that approximately 6 times as many deaths annually in the US are caused by lightning as by ECTand that the death rate reported for ECT is an order of magnitude smaller than the spontaneous death rate in the general population[150]

Corroboration of a low ECT death rate has arisen from 1993 legislation in Texas mandating reporting of all ECT-related deaths[151] As a result the risk of death from ECT in Texas has been systematically tracked and reviewed More than 8000 patients received 49048 ECT treatments between 1993 and 1998 However only 1 death could be linked to the associated anesthesia An additional 4 deaths could plausibly have been associated with the anesthesia yielding a mortality rate between 2 and 10 per 100000 and the causes of death most likely were not the ECT stimulus or seizure

Emotional harm and erosion of faith in the medical profession that undermines accepting other needed treatments can come to recipients of care for whom the experience of ECT is frightening

ECT conclusion ECT is effective for severe major affective illness and is associated with a low mortality rate Persistent memory loss is a consistent finding despite attempts to optimize ECT administration and must be expected at an incidence of approximately 25 to 50 by those contemplating and those providing ECT treatment

Despite its relative safety ECT continues to cause alarm in the general public Even within medicine it is described as dangerous and unethical by some[152] Such fears can cause emotional harm among ECT recipients This may be especially true for older women (who comprise the majority of ECT subjects) some of whom may be accustomed to deferring to healthcare providers when consenting to treatment despite insufficient understanding of benefits and risks

Recommendations include

Emphasis on pre-treatment education

Collaborative relationship with ECT recipients

Increased transparency regarding the substantial risk of persistent memory loss when seeking informed consent and

Continued research on its safety

Systems Issues Related to Patient Safety

Outpatient Care

Risk of unintended harm may be increased by the segregated care settings in which psychiatric and substance abuse services are often delivered including solo practitioner offices and free-standing psychiatric and substance abuse treatment facilities[153154] and by insufficient communication and coordination of care between prescribers and psychotherapists[155-157] Despite the recognition of these potential contributing factors there are no existing reports of the association between systems issues and medical errors

Olfson[158] reported that in 1987 there were 84 million outpatient visits with mental health practitioners including

Psychiatrists

Psychologists

Social workers and

Licensed counselors

Kessler[154] reported in 1999 that an estimated 133 of a representative sample of Americans reported used outpatient services for mental health problems in the previous 12 months Clearly there are high numbers of individuals at risk for errors in outpatient mental health and substance abuse treatment

Ethics and Malpractice Risk Management Boundary Violations

A survey of recently published reviews and commentaries on patient safety reveals that for mental health and substance abuse issues such discussion takes place mainly within the context of ethics and malpractice risk management[159-162] Ethics statements from both the APA[162] and the American Psychological Association[163] support the duty to report and protect patients from deviations from the standards of care This approach uses the individual practitioners frame of reference and relies on voluntary reporting from professionals who have been trained to consider confidentiality a critical component of their work Harm caused by clinician boundary violations are understood as issues of professional misconduct not as errors resulting from system failure and that minimize the individual clinicians responsibility and advise against punitive action [164-167]

With the advent of therapeutic exchanges through email and other means of communication additional boundary violations are possible The Internet now has at least 110 million users including 70 million using it for health-related information[168] A recent survey indicated 40 to 50 of physicians use the Internet (or are preparing to use it) for clinical care[169]

There is a risk of errors of omission or commission arising from lack of coordination of care between clinicians Differences in therapeutic orientation and nomenclature used by the following specialists can compound systems issues that increase the risk of medical errors [158]

Social workers

Psychiatric nurse specialists

Psychologists

Licensed counselors and

Psychiatrists

Confidentiality is critical in providing effective treatment within the secure and private setting of the therapists office and in protecting the patient from unauthorized disclosures of sensitive information and potential abuse from a third party[170] However confidentiality can also inhibit disclosure of near misses impasses in treatment (for example when treatment is not working) and preventable adverse events due to avoidance of sharing important clinical information with other professionals and with appropriate family members and other supportive resources[171172]

The solo practice model commonly used by mental health clinicians can also inhibit the adoption of best practices and the development of policies and procedures to reduce risk because all such practice management activities are left to the individual clinician whose focus is more likely to be exclusively clinical

Summary About Systems Issues and Patient Safety

Systems for reliably reporting outpatient psychotherapy medical errors particularly among the large numbers of solo practitioners do not exist The prevailing paradigm for reducing harm arises from risk reduction in order to diminish medical liability exposure Studies that shed light on potential medical errors have arisen from risk management claims medical liability lawsuits and reports of death by suicide not from research intended to examine patient safety per se

Error reporting systems applicable to outpatient mental health settings including incentives for their use need to be developed Professional risk management programs primarily used to diminish medical liability exposure from the following could also be used to promulgate the relevance and value of the patient safety paradigm

Boundary violations

Suicide and

Treatment errors

Most particularly thought needs to be given to developing systems of error prevention applicable to the solo practitioner

Recommendations

Recommendation no 1

Widespread adoption of the IOM patient safety paradigm and nomenclature in mental health and substance abuse treatment settings is recommended

Advantages of its use include

Consistency with the nomenclature used by other medical specialties

Increased leverage in advocating for needed services and resources when the absence of essential treatments are quantified as errors of omission causing near misses or preventable adverse events

Increased likelihood that medication errors in mental health and substance abuse will be researched and a determination made whether such errors are causing preventable adverse events and

Increased awareness among mental health and substance abuse clinicians that patient harm can come from a broader array of errors in diagnosis and treatment than has been studied to date

Widespread adoption will require systematic educational efforts for trainees and current practitioners in mental health and substance abuse including systematic introduction to the IOMs existence mission and safety and quality efforts such as the Quality Chasm Series (Many mental health and substance abuse clinicians and administrators seem unaware of the IOM at all)

Recommendation no 2

Further studies of medical error in mental health and substance disorders are needed

Some areas of potential harm in this field remain largely unexamined For example we found only 2 studies of medication errors in mental health settings and none in substance abuse detoxification and stabilization settings despite multiple risk factors for errors and preventable adverse events The impact of variable education -- in pharmacology physiology and general medicine -- on the safety of prescribing practices has not been studied nor has the clinical consequences of formulary restrictions on clinical outcome and potential patient harm The current acceptance of self-reported hospital error rates must be challenged through a process of independently validating self-reported errors

Recommendation no 3

Integration of mental health and substance abuse services is recommended

High rates of co-occurrence and associated higher rates of morbidity and mortality among those with mental health and substance abuse disorders requires integration of mental health and substance abuse treatment paradigms This has not occurred to date

Recommendation no 4

The IOMs 10 rules for change in healthcare should be adopted

The 10 IOM rules for change in healthcare are as follows[173]

1 Care based on continuous healing relationships

2 Customization based on patient needs and values

3 The patient as the source of control

4 Shared knowledge and the free-flow of information

5 Evidence-based decision-making

6 Safety as a system property

7 The need for transparency

8 Anticipation of needs

9 Continuous decrease in waste

10 Cooperation among clinicians

As an example of adoption of these rules seclusion and restraint remain high risk treatments yet current reporting systems do not permit transparency regarding the rate and types of injuries incurred including mortality rates Such transparency requires a non-punitive work culture yet there is little evidence to suggest its adoption in high-risk environments such as state psychiatric hospitals or inpatient detoxification and stabilization substance abuse treatment settings

Recommendation no 5

Reporting systems in outpatient mental health and substance abuse treatment settings must be adopted

Reliance upon unsubstantiated self-reporting of medication errors in inpatient mental health and substance abuse settings remains a significant flaw when attempting accurate assessment of near misses and preventable adverse events and must be changed A key necessity is anonymous yet authenticated medication error reporting for all staff using available web-based error reporting systems Such systems are cost-savers and make reported error data immediately and continuously available Web-based reporting systems providing anonymity with authentication could be used for further seclusion and restraint data collection and as a means of establishing an outpatient error reporting system of safety and quality data by recipients and providers of outpatient treatment

Recommendation no 6

Resources should be allocated to study and develop practical interventions to improve patient safety

Much current research in mental health and substance abuse and resource appropriation is focused on efficacy of pharmacotherapy and psychotherapy and on establishing neurobiologic evidence to support causal theories of known clinical disorders At a policy level we recommend more consideration be given to funding practical interventions predicted to immediately improve patient safety

References

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Authors and Disclosures

As an organization accredited by the ACCME Medscape LLC requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest The ACCME defines relevant financial relationships as financial relationships in any amount occurring within the past 12 months including financial relationships of a spouse or life partner that could create a conflict of interest

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Author

Benjamin C Grasso MD

Staff Psychiatrist VA Clinic Saco Maine Disclosure Benjamin C Grasso MD has disclosed no relevant financial relationships

Cathryn M Clary MD MBA

Vice President US External Medical Affairs Pfizer Inc New York NY Disclosure Cathryn M Clary MD MBA has disclosed that she is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Benjamin Eng MD MA

Senior Medical Director Group Leader Pfizer Inc New York NY Disclosure Benjamin Eng MD MA has disclosed that he is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Stanley J Evans MD FASAM PA

Assistant Professor of Clinical Medicine St Matthews University Windham Maine

Medical Director Renaissance Institute of Palm Beach Boca Raton Florida Disclosure Stanley J Evans MD has disclosed no relevant financial relationships

Terry J Golash MD

Clinical Instructor Psychiatry Columbia University New York NY Assistant Attending St Lukersquos Roosevelt Hospital Center New York NY Disclosure Terry J Golash MD has disclosed no relevant financial relationships

Kevin Ann Huckshorn RN MSN CAP ICADC

Director Office of Technical Assistance National Association of State mental Health Program Directors Inc Alexandria Virginia Disclosure Kevin Ann Huckshorn RN MSN CAP ICADC has disclosed no relevant financial relationships

Kenneth Minkoff MD

Clinical Assistant Professor Department of Psychiatry Cambridge Hospital Harvard University Acton Massachusetts Consultant ZiaLogic Acton Massachusetts Disclosure Kenneth Minkoff MD has disclosed no relevant financial relationships

Joseph J Parks MD

Assistant Associate Professor Department of Psychiatry University of Missouri Columbia Missouri Disclosure Joseph J Parks MD has disclosed that he has received grants for educational activities from Letters amp Science and Physician Postgraduate Press Dr Parks has also disclosed that he has served as a consultant to the National Association of State Mental Health Program Directors and Bristol-Myers Squibb Dr Parks has also disclosed that he has received funds for services provided to the state of Missouri from Eli Lilly and Abbott

Miles F Shore MD

Bullard Distinguished Professor of Psychiatry Harvard Medical School Needham Massachusetts Junior Consultant Harvard Medical International Boston Massachusetts Disclosure Miles F Shore MD has disclosed no relevant financial relationships

Editor

Jacqueline A Hart MD

Freelance Clinical Editor Medscape LLC New York New York Disclosure Jacqueline A Hart MD has disclosed no relevant financial relationships

Elizabeth Saenger PhD

Editorial Director Medscape LLC New York NY Disclosure Elizabeth Saenger PhD has disclosed no relevant financial relationships

Registration for CME credit the post test and the evaluation must be completed online To access the activity Post Test and Evaluation link please go to httpwwwmedscapecomviewprogram7809_index

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397 were due to the primary care physician recognizing some symptoms of depression but underestimating the severity of the condition and therefore not giving the diagnosis and

33 were diagnosed with another condition

Correct identification of MDD by primary care physicians is associated with[38]

Greater familiarity with the patient and

Presence of suggestive clinical cues (eg a history of depression or the presence of vegetative symptoms)

Anxiety disorders also frequently go undetected[313940] In 1 study about 10 of primary care patients with an anxiety disorder were identified by their physician[41] Approximately 70 of the time that a primary care physician identifies an anxiety problem they diagnose an anxiety state unspecified rather than a specific anxiety disorder[42] In 1 study in Israel only 2 of patients with posttraumatic stress disorder (PTSD) were diagnosed correctly by the primary care physician[43] This underdiagnosis may be a result of inadequate education about anxiety disorders for example only 57 of primary care doctors in a study conducted in Germany considered generalized anxiety disorder to be an independent disorder[44]

Insufficient treatment Treatment is absent when mood and anxiety disorders are missed Insufficient treatment may occur even when anxiety and mood disorders are diagnosed correctly Only about half of patients diagnosed in primary care settings with mood or anxiety disorders receive medication treatment[4546] Psychotherapy referrals were not examined in these studies so it remains unclear whether the patients who did not receive medication treatment were offered psychological treatment

Even when a psychiatrist provided a consultation and advised antidepressant treatment only 53 of appropriate primary care patients received antidepressant medication over the next year[47] The National Ambulatory Medical Care Survey database from 1985 to 1998 documented that treatment for anxiety is offered in 60 of visits to primary care physicians compared with over 95 of visits for anxiety to a psychiatrists[42] A recent naturalistic study of anxiety disordered patients in primary care found that 47 were receiving treatment from either the primary care physician or a specialty mental health clinician[48] A study of patients with panic disorder in primary care settings revealed that only 64 were found to be receiving either medication or psychotherapy[49]

Preventable adverse events Missed diagnoses and insufficient treatment of mood and anxiety disorders in medical settings may cause serious preventable adverse events For MDD preventable adverse events include impairment in physical and mental functioning that is comparable to that found with common medical disorders such as hypertension and diabetes[5051] Depression exacerbates the outcomes of chronic medical illnesses[52] and is associated with higher rehospitalization rates[53] and higher mortality rates[5455] following a myocardial infarction

MDD is also associated with a substantial risk of suicide which is increased when treatment is insufficient[56-58] The economic burden in the United States due to MDD has been estimated at about $83 billion as of 2000[59] Of these costs about three-fourths represent indirect costs (vs the direct cost of providing treatment) particularly reduced productivity and absenteeism in the workplace The World Health Organization has ranked MDD as second only to ischemic heart disease in magnitude of disease burden in countries with established market economies[60]

The functional and economic burden of MDD has been an area of focus for payers and employers Less recognized however is the substantial impairment in social and occupational functioning and in physical health documented in mental health treatment settings for individuals with specific anxiety disorders such as

PTSD[6162]

Panic disorder[6364]

Generalized anxiety disorder[65] and

Social anxiety disorder[6667]

Impairment from anxiety disorders is also apparent in those who present to a primary care physician[496869] Generalized anxiety disorder produces impairment in health-related functioning that is equivalent to or significantly greater than patients with diabetes and recent myocardial infarction

Primary care patients with anxiety disorder are high utilizers of general medical services resulting in increased overall healthcare costs compared with primary care patients who have subthreshold disorders or no anxiety disorder[70] The economic burden of anxiety disorders in the United States has been estimated to be $423 billion in 1990 primarily due to increased use of non-psychiatric medical services[71]

However missed diagnoses do not necessarily lead to preventable adverse events Some studies have suggested that patients with unrecognized MDD in the primary care setting are less severely depressed and less functionally impaired[323770] and therefore at less risk for

Loss of employment

Impaired social functioning

Exacerbation of co-occurring medical disorders and

Suicide

When recognized and unrecognized patients with MDD are tracked over time clinical improvement has often been comparable[3770] although greater short-term improvement for recognized cases has also been reported for MDD[34] and anxiety disorders[72]

Errors of commission mistaken diagnoses As described previously for MDD about one-third of the diagnostic errors in primary care are mistaken diagnoses[37] Mistaken diagnoses range from anxiety disorders to alcoholsubstance abuse to psychoticdissociative disorders Conversely when an anxiety disorder is present a mistaken diagnosis of depression is sometimes given[39] The high level of comorbidity between anxiety and mood disorders is likely to contribute substantially to such diagnostic errors[73]

Primary care physicians also occasionally diagnose a mood or anxiety disorder when it is not present (false positive) Among non-depressed patients a false positive rate of 12 in primary care was reported in 1 study[38] and 14 in another[37] About 25 of these MDD false-positives in the Tiemens study actually had an anxiety disorder 20 were the result of overestimation of severity of depression by the primary care physician and 55 were true false positives In the Klinkman study a history of depression was apparent in over half of the false-positive cases

suggesting that physicians might have been unduly influenced by a history of depression rather than the clinical evidence for depression at the time of examination

The implications of these misdiagnoses require more study Because the treatments for most mood and anxiety disorders are similar and because even subsyndromal disorders cause significant distress and functional disability it is possible that imprecision in diagnosis may still result in the use of appropriate medication treatment Of course treatment of an individual without a disorder even subsyndromal causes unneeded exposure to medication errors

Recommendations to diminish misdiagnoses in primary care Since primary care clinicians will most likely continue to be the point of entry and often the sole provider of mental health treatment for patients suffering from mood and anxiety disorders improvements in diagnosis and appropriate treatment of these disorders in primary care should be an important priority Better education of primary care providers about the symptoms and management of depression and anxiety are essential Programs designed to increase primary care clinicians recognition of depression and other psychiatric disorders have not yet proved to improve treatment outcome[7475] However studies that have added training in depression management in addition to education on better recognition of its presence have yielded better outcomes[76]

The feasibility and sustainability of programs focusing on better education of primary care clinicians has not been established Because of the time constraints of standard primary care practice fast efficient methods of screening such as the Primary Care Evaluation of Mental Disorders (PRIME-MD) for anxiety depression and other psychiatric disorders are recommended[77] The Patient Health Questionnaire a 9-item subset of the PRIME-MD is a more concise screen for depression if time constraints preclude use of the full PRIME-MD questionnaire The routine use of such simple methods for screening and ongoing monitoring might provide a sustainable way of reducing diagnostic errors in ambulatory medical settings

A final recommendation is for managed care and insurance companies as well as health systems and provider networks to consider the implementation of incentives for better detection and treatment of mood and anxiety disorders Pilot pay for performance programs such as Bridges to Excellence[78] or the Integrated Healthcare Association initiative in California[79] have focused on physical conditions such as diabetes or asthma Quality measures do exist for the medication treatment and follow up of diagnosed depression such as performance standard and report card measures[80] Adding incentives for better detection and treatment to the use of quality measures is a recommended first step

Errors in the Use of Seclusion and Restraint

In October 1998 The Hartford Courant reported on the death of Andrew McClain an 11-year-old boy who died while restrained and secluded in a psychiatric hospital in Connecticut[81] Thus began the Courants 5-part series based on a 50-state survey that confirmed 142 deaths related to the use of seclusion and restraint in mental health settings over the past decade[82-85] The series cautioned that most deaths related to seclusion and restraints are unreported and that the actual number of annual deaths was possibly much higher

The national response to the Courant exposeacute was far reaching Congress commissioned the US General Accounting Office (USGAO) to report on the use of seclusion and restraint The USGAO responded by releasing a report in 1999 entitled Improper Restraint or Seclusion Places People at Risk[82] The USGAO report confirmed the majority of the Courants allegations including the following

Improper use of seclusion and restraint are dangerous

There is inadequate monitoring and reporting of its use and of resulting harm (or preventable adverse events) to patients

Serious injuries or death can occur and are underreported

Licensing and accreditation of seclusion and restraint standards are inconsistent and insufficient and

Successful strategies for preventing seclusion and restraint as well as reducing the risk of injury when use occurs are not widely used

Seclusion and restraint are commonly used practices intended to prevent adults and children with mental health and substance abuse diagnoses from harming themselves or others in inpatient or residential treatment environments Unfortunately access to incidence data collected by The National Association of State Mental Health Program Directors (NASMHPD) is controlled (and forbidden) by participating hospitals There are no published data interpreted as accurately reflecting the true incidence of seclusion and restraint use

The use of these interventions is intended to be severely restricted to individual situations in which an emergency safety need is identified but as use is generally ordered by staff and based on subjective criteria the use of these emergency interventions has a wide range [86] Restraint is defined in a variety of ways but the term generally refers to a manual method or mechanical device material or equipment attached or adjacent to the patients body that he or she cannot easily remove and that restricts the patients freedom or normal access to ones body[87] Seclusion refers to the involuntary confinement of a person in a room where they are physically prevented from leaving[88] Recent literature reviews of seclusion and restraint reflect the absence of[8990]

Substantiated prevention strategies

Indications for use

Application methods

Monitoring

Post-event activities and

Absence of evidence of its effectiveness in preventing harm

The Centers for Medicare and Medicaid Services (CMS) -- formerly known as the Healthcare Financing Administration (HCFA) the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and state licensing agencies have attempted to regulate the use of seclusion and restraint through licensing and accreditation standards[879192] However the Courant series the USGAO report and others have documented alarming rates of patient harm including death despite the application of such standards[818286] While efforts are underway to resolve these issues the appropriate and safe use of seclusion and restraint is far from assured[8693]

In recent years advocates consumers professional associations provider organizations and the legal field have increasingly recommended a reduction in the use of seclusion and restraint or even its elimination[83-86 94] These recommendations resonate with Recommendation no 1 in the IOMs Crossing the Quality Chasm that states All healthcare organizations professional groups

and private and public health purchasers should adopt as their explicit purpose to continually reduce the burden of illness injury and disability and to improve the health and functioning of the people of the United States[2] Using the IOMs medical error nomenclature reports about seclusion and restraint reflect high rates of medical errors mostly errors of commission perhaps errors of omission causing either near misses or preventable adverse events in routine clinical practice

Safety in healthcare practices is defined as keeping the patient free from accidental injury[2] Although not all errors cause injury accidental injury can be due to error either by the failure of a planned action to be completed as intended or use of the wrong plan to achieve an aim The improper use of seclusion and restraint is not safe and causes serious and preventable adverse injuries including death[8182] The media continues to report adverse events as well[9596] For example in 2000 3 deaths were reported just in Texas including that of 2 boys one 9 and the other 11 years old and a 16-year-old girl In South Carolina in 2003 a 9-year-old boy died after he kicked a staff member in the leg and ran down the hall which resulted in a take down and the boys asphyxiation In Arizona a 32-year-old woman died in restraints for behavior that was later judged as not meeting the threshold of imminent danger[96]

Reducing and Improving Seclusion and Restraint Events Recent Performance Improvement Initiatives

Several initiatives focused on seclusion and restraint reduction (embedded in public health prevention continuous quality improvement principles supporting recovery from mental illness and trauma-informed care) have been developed by the American Psychiatric Nurses Association the APA the National Association for Private Health Systems the American Hospital Association the National Alliance on Mental Illness (NAMI) and the Childrens Welfare League of America[2083859798] These initiatives are intended to complement other essential elements such as adequate numbers of well-trained staff and the use of proven psychological and medication treatments

The public health constructs of primary secondary and tertiary prevention create a logical framework and redirect the focus from safer use of seclusion and restraint to interventions that prevent its use[86] The model of recovery espoused by the Surgeon Generals Mental Health report necessitates[99]

System-wide transformation by adopting goals of full recovery in a life outside the hospital

Emphasis on instilling hope

Availability of multiple treatment options and

Development of partnerships with those who seek services

The use of controlling or coercive interventions is counterintuitive in this model and is to be avoided except perhaps as the last alternative in preventing death or significant harm to self or others caused by treatable manifestations of mental illness[94100] A growing understanding of the neurologic biologic psychological and social effects of trauma and its high prevalence in the populations that seek mental health services is informing approaches to assessment diagnosis stabilization and treatment of individuals with mental illness including the use of seclusion and restraint as a means of preventing injury to self or others[101-108]

Data should be analyzed for characteristics of facility usage by

Unit

Shift

Day and

Staff member involved

With rare exception data on individuals should be used confidentially to identify individual staff training needs not for disciplinary actions[88109] The facility needs to highlight data on seclusion and restraint use by graphing and posting this data on all units so that it is clearly visible for staff and consumers of service Facility-generated data on seclusion and restraint used in a non-punitive way provides for healthy competition among treatment units and elevates the general oversight and knowledge of use and outcomes for everyone involved[88109110] It allows and encourages administration to identify successful staff and treatment units so that successful improvements can be shared

A comprehensive national health information infrastructure could be a useful tool in reducing seclusion and restraint events[2111] The National Association of State Mental Health Program Directors Research Institute Inc (NRI) performance improvement system has developed a set of technology standards applications systems and values that include a number of recommendations for reducing seclusion and restraint events and making their occurrence less error prone[112]

Reduction of the use of seclusion and restraint must start with clear leadership and a specific plan that articulates a mission and philosophy about seclusion and restraint reduction and defines the roles and responsibilities of all facility staff[109] One core component is use of an executive on-call function and the daily review of the use of seclusion and restraint by executive leadership[88110]

Creating a treatment environment that prevents seclusion and restraint is based on the principles of recovery and the characteristics of trauma-informed systems of care[88109] Staff education needs to

Include the experiences of consumers and staff

Address the common myths associated with use

Introduce the rationale and characteristics of trauma-informed care

Educate on the neurobiological and psychological effects of trauma and

Describe a prevention-based approach to reduction

Seclusion and Restraint Summary

The use of seclusion and restraint is associated with substantial harm to recipients of care including death Medical errors precede many seclusion and restraint events which in turn cause further errors and substantial harm to both recipients and providers of care Several local and national initiatives are underway to improve the safety of seclusion and restraint events and to decrease its use The results of their successful application can be seen in facilities in[88 109]

Pennsylvania

New York

Massachusetts

Maine

Florida

New Jersey and

South Dakota

Further study of causal antecedent events and of harm resulting from seclusion and restraint events is recommended using the patient safety paradigm and nomenclature

High-Risk Clinical Populations Lacking Adequate Patient Safety Research

Introduction to High-Risk Clinical Populations

There are no empirical data to quantify characterize or confirm medical errors in certain populations with mental illness andor substance abuse where multiple risk factors for error also exist A brief discussion of these populations and their risks for errors is provided below It is hoped that heightened focus on these high-risk populations will be an impetus for medical error research

Persons with Co-occurring Mental Illness and Substance Abuse

Individuals with co-occurring psychiatric and substance disorders have not been studied for medical errors yet they are perhaps at greater risk for harm because of the nature and number of their co-occurring disorders Several studies have reported the common occurrence of comorbidity among persons with a recognized diagnosis of either mental illness or substance abuse For example in 1990 Regier[74] found a lifetime prevalence of substance abuse among 62 of persons with bipolar disorder In 1996 Kessler and colleagues[113] reported a lifetime prevalence of 599 of psychiatric illness among persons with substance abuse disorders while 31 had a concurrent psychiatric disorder

Persons with co-occurring disorders are high utilizers of medical resources and therefore more exposed to systems issues that may predispose to unintended harm In 1995 an estimated 26 million (27) of the 965 million emergency department (ED) visits were related to alcohol abuse alone[114]

In a study by Dickey and associates[115] using data from the Massachusetts Division of Medical Assistance and death records from the Department of Public Health individuals with co-occurring psychiatric and substance use disorders had the highest risk of medical morbidity for 5 of the studied medical disorders Medicaid beneficiaries with dual diagnoses are 6 to 8 times more likely to die of injury primarily poisoning than their counterparts treated for medical conditions only[116117]

It is well-substantiated that persons with psychiatric and substance abuse disorders have higher rates of suicide attempts and death by suicide[118-123] In 2001[124]

20308 deaths were caused by homicide

30622 deaths by suicide and

101537 deaths were caused by accidents

Given the frequency with which substance abuse by itself has been implicated in these 3 causes of death the scope of morbidity and mortality related to co-occurring disorders is staggering

The effects of substance abuse disorders in adults also affected the mortality rates of children during 1985 to 1996 -- 8482 (24) of the 35547 children aged younger than 15 years died in alcohol-related motor vehicle crashes[125]

A subset of those with co-occurring disorders have substance dependence PTSD and chronic pain The presence of chronic pain and the complexities surrounding treatment of individuals with PTSD increase the risk for unintended harm and of a poor fit between clinical needs and the design of current healthcare systems Despite the added risk factors there is little science to direct clinicians A Medline search using substance abuse PTSD and chronic pain as search terms in June 2004 yielded 10 citations There were no incidence studies and no published treatment guidelines

Conclusion regarding co-occurring disorders Individuals with co-occurring disorders are frequently encountered and at risk for multiple diagnostic and treatment errors including

Missed mental health substance abuse and medical diagnoses and

Insufficient or excessive medication treatment of either their substance abuse or psychiatric disorder

Compared with the general population these individuals are at higher risk for

Suicide attempt

Death by suicide and

Death at a younger age by medical illness

There is a paucity of published studies on medical errors among individuals with co-occurring disorders despite several risk factors for unintended harm and high rates of morbidity and mortality

Attention Deficit-Hyperactivity Disorder in Children Excessive or Insufficient Diagnosis and Treatment

Inattentiveness distractibility impulsivity and hyperactivity were recognized as elements of minimal brain dysfunction (now termed attention deficit hyperactivity disorder [ADHD]) and treated with stimulants especially methylphenidate beginning in the late 1960s[101126127] Over the past 3 decades the rate of drug treatment for behavior problems has increased exponentially culminating in the prescription of ADHD drug treatment for at least 5-6 million American children annually[128]

Children diagnosed with ADHD have been the focus of thousands of research studies over the last 40 years yet the diagnosis and treatment of ADHD remain controversial among some within medicine and the general public[129130] Recent prevalence data from the 1998 National Institutes

of Health (NIH) consensus review[131] and reported by Jensen[132] suggest a prevalence of approximately 5 affecting 3 million school-aged children[133134]

ADHD is associated with[135-137]

Increased risk of accidents

Family and social dysfunction

Poor academic achievement

Substance abuse and

Antisocial behavior

Recent treatment data based on the number of methylphenidate prescriptions show an estimated 5-6 million American children receive ADHD-related drug treatment annually[128] Aggregate national methylphenidate use has increased 100-fold from 1960 until 2000 Globally nearly 90 of the worlds stimulant medication supply is consumed by the US population[138139]

Substantial state-to-state and community-to-community variability in methylphenidate use raises concerns about potential pockets of over- and under-diagnosis and over- and under-prescribing Drug Enforcement Association data on stimulant use reflect a 6-fold per capita variation in methylphenidate prescribing between some states[140] and a 20-fold prescribing variation between some communities[130141]

LeFever and colleagues argue that while the data are inconclusive if communities such as Salt Lake City Utah are used as a benchmark of acceptable diagnosis and treatment then children in 36 states may be subject to over-diagnosis and over-treatment Conversely Jensen argues that ADHD is under-diagnosed and under-treated based on national aggregate data allowing for pockets of over-diagnosis and treatment in some geographic areas[142] Given that in 1995 there were approximately 2 million pediatric visits in which ADHD was the focus of treatment and 6 million stimulant prescriptions were written[132] 1 conclusion is that 3 million children with ADHD received an average of 2 prescriptions and 1 outpatient visit during that year suggesting insufficient treatment In another study cited by Jensen the Multimodal Treatment Study of Children with ADHD two thirds of ADHD children from reportedly highly motivated families obtained medication treatments and for an average duration of only 8-14 months[142143]

Despite the number of studies done the strength of conclusions that can be drawn is contingent upon the adequacy of reported data Studies to date are variously limited by data sources sampling accuracy and interpretation[130]

When considered in aggregate national ADHD prevalence rates and numbers of prescriptions written do not suggest excessive diagnosis and treatment However prevalence rates and stimulant use can vary as much as 30-fold when comparing different communities A prevalence rate of 33 among white elementary-aged boys in southeastern Virginia significantly challenges credibility[130] Such variability makes it essential that prevalence rates and stimulant use estimates be linked to sufficient demographics such as

Geography

Age

Race and

Gender

ADHD prevalence rates and stimulant use appear to be

Excessive in some communities

Plausible in other communities and

Perhaps insufficient in yet other communities

Additional epidemiologic studies reporting prevalence rates with specific demographics rather than in aggregate and broader use of practice guidelines promulgated by the American Academy of Pediatrics (AAP) and others that advocate multimodal treatment rather than solely prescribing stimulants or other medications[130144] will help provide evidence of the extent of errors in the diagnosis and treatment of children with ADHD

Electroconvulsive Therapy

Electroconvulsive therapy (ECT) remains a controversial treatment in psychiatry As stated in the 1985 NIH Consensus Statement The nature of the treatment itself its history of abuse unfavorable media presentations compelling testimony of former patients special attention by the legal system uneven distribution of ECT use among practitioners and facilities and uneven access by patients all contribute to the controversial context in which the consensus panel has approached its task[145]

Epidemiologic data reported by Thompson and colleagues in 1994 found that[146]

58667 patients received ECT in 1975

31514 in 1980

36558 in 1986

71 of the patients who received ECT were women and

Individuals older than 65 years of age had the highest rates per number of inpatients

The rate of ECT use has been highly variable For example in 1995 Herman and associates[147] reported that among 202 metropolitan statistical areas annual ECT use varied from 04 to 812 patients per 10000 population

The most common adverse effect from ECT is memory loss In a recent review of patients perspectives as well as clinicians studies Rose and associates[148] concluded that 29 to 55 of ECT treatment recipients experienced persistent memory loss Recent empirical studies of ECT and memory loss continue to find persistent memory loss with bilateral ECT producing more profound memory deficits than right unilateral ECT[149]

In a review of deaths caused by ECT Abrams reported that ECT is 10 times safer than childbirth that approximately 6 times as many deaths annually in the US are caused by lightning as by ECTand that the death rate reported for ECT is an order of magnitude smaller than the spontaneous death rate in the general population[150]

Corroboration of a low ECT death rate has arisen from 1993 legislation in Texas mandating reporting of all ECT-related deaths[151] As a result the risk of death from ECT in Texas has been systematically tracked and reviewed More than 8000 patients received 49048 ECT treatments between 1993 and 1998 However only 1 death could be linked to the associated anesthesia An additional 4 deaths could plausibly have been associated with the anesthesia yielding a mortality rate between 2 and 10 per 100000 and the causes of death most likely were not the ECT stimulus or seizure

Emotional harm and erosion of faith in the medical profession that undermines accepting other needed treatments can come to recipients of care for whom the experience of ECT is frightening

ECT conclusion ECT is effective for severe major affective illness and is associated with a low mortality rate Persistent memory loss is a consistent finding despite attempts to optimize ECT administration and must be expected at an incidence of approximately 25 to 50 by those contemplating and those providing ECT treatment

Despite its relative safety ECT continues to cause alarm in the general public Even within medicine it is described as dangerous and unethical by some[152] Such fears can cause emotional harm among ECT recipients This may be especially true for older women (who comprise the majority of ECT subjects) some of whom may be accustomed to deferring to healthcare providers when consenting to treatment despite insufficient understanding of benefits and risks

Recommendations include

Emphasis on pre-treatment education

Collaborative relationship with ECT recipients

Increased transparency regarding the substantial risk of persistent memory loss when seeking informed consent and

Continued research on its safety

Systems Issues Related to Patient Safety

Outpatient Care

Risk of unintended harm may be increased by the segregated care settings in which psychiatric and substance abuse services are often delivered including solo practitioner offices and free-standing psychiatric and substance abuse treatment facilities[153154] and by insufficient communication and coordination of care between prescribers and psychotherapists[155-157] Despite the recognition of these potential contributing factors there are no existing reports of the association between systems issues and medical errors

Olfson[158] reported that in 1987 there were 84 million outpatient visits with mental health practitioners including

Psychiatrists

Psychologists

Social workers and

Licensed counselors

Kessler[154] reported in 1999 that an estimated 133 of a representative sample of Americans reported used outpatient services for mental health problems in the previous 12 months Clearly there are high numbers of individuals at risk for errors in outpatient mental health and substance abuse treatment

Ethics and Malpractice Risk Management Boundary Violations

A survey of recently published reviews and commentaries on patient safety reveals that for mental health and substance abuse issues such discussion takes place mainly within the context of ethics and malpractice risk management[159-162] Ethics statements from both the APA[162] and the American Psychological Association[163] support the duty to report and protect patients from deviations from the standards of care This approach uses the individual practitioners frame of reference and relies on voluntary reporting from professionals who have been trained to consider confidentiality a critical component of their work Harm caused by clinician boundary violations are understood as issues of professional misconduct not as errors resulting from system failure and that minimize the individual clinicians responsibility and advise against punitive action [164-167]

With the advent of therapeutic exchanges through email and other means of communication additional boundary violations are possible The Internet now has at least 110 million users including 70 million using it for health-related information[168] A recent survey indicated 40 to 50 of physicians use the Internet (or are preparing to use it) for clinical care[169]

There is a risk of errors of omission or commission arising from lack of coordination of care between clinicians Differences in therapeutic orientation and nomenclature used by the following specialists can compound systems issues that increase the risk of medical errors [158]

Social workers

Psychiatric nurse specialists

Psychologists

Licensed counselors and

Psychiatrists

Confidentiality is critical in providing effective treatment within the secure and private setting of the therapists office and in protecting the patient from unauthorized disclosures of sensitive information and potential abuse from a third party[170] However confidentiality can also inhibit disclosure of near misses impasses in treatment (for example when treatment is not working) and preventable adverse events due to avoidance of sharing important clinical information with other professionals and with appropriate family members and other supportive resources[171172]

The solo practice model commonly used by mental health clinicians can also inhibit the adoption of best practices and the development of policies and procedures to reduce risk because all such practice management activities are left to the individual clinician whose focus is more likely to be exclusively clinical

Summary About Systems Issues and Patient Safety

Systems for reliably reporting outpatient psychotherapy medical errors particularly among the large numbers of solo practitioners do not exist The prevailing paradigm for reducing harm arises from risk reduction in order to diminish medical liability exposure Studies that shed light on potential medical errors have arisen from risk management claims medical liability lawsuits and reports of death by suicide not from research intended to examine patient safety per se

Error reporting systems applicable to outpatient mental health settings including incentives for their use need to be developed Professional risk management programs primarily used to diminish medical liability exposure from the following could also be used to promulgate the relevance and value of the patient safety paradigm

Boundary violations

Suicide and

Treatment errors

Most particularly thought needs to be given to developing systems of error prevention applicable to the solo practitioner

Recommendations

Recommendation no 1

Widespread adoption of the IOM patient safety paradigm and nomenclature in mental health and substance abuse treatment settings is recommended

Advantages of its use include

Consistency with the nomenclature used by other medical specialties

Increased leverage in advocating for needed services and resources when the absence of essential treatments are quantified as errors of omission causing near misses or preventable adverse events

Increased likelihood that medication errors in mental health and substance abuse will be researched and a determination made whether such errors are causing preventable adverse events and

Increased awareness among mental health and substance abuse clinicians that patient harm can come from a broader array of errors in diagnosis and treatment than has been studied to date

Widespread adoption will require systematic educational efforts for trainees and current practitioners in mental health and substance abuse including systematic introduction to the IOMs existence mission and safety and quality efforts such as the Quality Chasm Series (Many mental health and substance abuse clinicians and administrators seem unaware of the IOM at all)

Recommendation no 2

Further studies of medical error in mental health and substance disorders are needed

Some areas of potential harm in this field remain largely unexamined For example we found only 2 studies of medication errors in mental health settings and none in substance abuse detoxification and stabilization settings despite multiple risk factors for errors and preventable adverse events The impact of variable education -- in pharmacology physiology and general medicine -- on the safety of prescribing practices has not been studied nor has the clinical consequences of formulary restrictions on clinical outcome and potential patient harm The current acceptance of self-reported hospital error rates must be challenged through a process of independently validating self-reported errors

Recommendation no 3

Integration of mental health and substance abuse services is recommended

High rates of co-occurrence and associated higher rates of morbidity and mortality among those with mental health and substance abuse disorders requires integration of mental health and substance abuse treatment paradigms This has not occurred to date

Recommendation no 4

The IOMs 10 rules for change in healthcare should be adopted

The 10 IOM rules for change in healthcare are as follows[173]

1 Care based on continuous healing relationships

2 Customization based on patient needs and values

3 The patient as the source of control

4 Shared knowledge and the free-flow of information

5 Evidence-based decision-making

6 Safety as a system property

7 The need for transparency

8 Anticipation of needs

9 Continuous decrease in waste

10 Cooperation among clinicians

As an example of adoption of these rules seclusion and restraint remain high risk treatments yet current reporting systems do not permit transparency regarding the rate and types of injuries incurred including mortality rates Such transparency requires a non-punitive work culture yet there is little evidence to suggest its adoption in high-risk environments such as state psychiatric hospitals or inpatient detoxification and stabilization substance abuse treatment settings

Recommendation no 5

Reporting systems in outpatient mental health and substance abuse treatment settings must be adopted

Reliance upon unsubstantiated self-reporting of medication errors in inpatient mental health and substance abuse settings remains a significant flaw when attempting accurate assessment of near misses and preventable adverse events and must be changed A key necessity is anonymous yet authenticated medication error reporting for all staff using available web-based error reporting systems Such systems are cost-savers and make reported error data immediately and continuously available Web-based reporting systems providing anonymity with authentication could be used for further seclusion and restraint data collection and as a means of establishing an outpatient error reporting system of safety and quality data by recipients and providers of outpatient treatment

Recommendation no 6

Resources should be allocated to study and develop practical interventions to improve patient safety

Much current research in mental health and substance abuse and resource appropriation is focused on efficacy of pharmacotherapy and psychotherapy and on establishing neurobiologic evidence to support causal theories of known clinical disorders At a policy level we recommend more consideration be given to funding practical interventions predicted to immediately improve patient safety

References

[ CLOSE WINDOW ]

References

1 Institute of Medicine To Err Is Human Building a Safer Health System Washington DC The National Academies Press 2000

2 Institute of Medicine Crossing the Quality Chasm A New Health System for the 21stCentury Washington DC The National Academies Press 2001

3 Institute of Medicine Fostering Rapid Advances in Healthcare Learning From System Demonstrations Washington DC The National Academies Press 2002

4 Institute of Medicine Leadership by Example Coordinating Government Roles in Improving Healthcare Quality Washington DC The National Academies Press 2002

5 Institute of Medicine Key Capabilities of an Electronic Health Record System Letter Report Washington DC The National Academies Press 2003

6 Institute of Medicine Priority Areas for National Action Transforming Healthcare Quality Washington DC The National Academies Press 2003

7 Institute of Medicine Keeping Patients Safe Transforming the Work Environment of Nurses Washington DC The National Academies Press 2003

8 Institute of Medicine Patient Safety Achieving a New Standard of Care Washington DC The National Academies Press 2004

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Author

Benjamin C Grasso MD

Staff Psychiatrist VA Clinic Saco Maine Disclosure Benjamin C Grasso MD has disclosed no relevant financial relationships

Cathryn M Clary MD MBA

Vice President US External Medical Affairs Pfizer Inc New York NY Disclosure Cathryn M Clary MD MBA has disclosed that she is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Benjamin Eng MD MA

Senior Medical Director Group Leader Pfizer Inc New York NY Disclosure Benjamin Eng MD MA has disclosed that he is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Stanley J Evans MD FASAM PA

Assistant Professor of Clinical Medicine St Matthews University Windham Maine

Medical Director Renaissance Institute of Palm Beach Boca Raton Florida Disclosure Stanley J Evans MD has disclosed no relevant financial relationships

Terry J Golash MD

Clinical Instructor Psychiatry Columbia University New York NY Assistant Attending St Lukersquos Roosevelt Hospital Center New York NY Disclosure Terry J Golash MD has disclosed no relevant financial relationships

Kevin Ann Huckshorn RN MSN CAP ICADC

Director Office of Technical Assistance National Association of State mental Health Program Directors Inc Alexandria Virginia Disclosure Kevin Ann Huckshorn RN MSN CAP ICADC has disclosed no relevant financial relationships

Kenneth Minkoff MD

Clinical Assistant Professor Department of Psychiatry Cambridge Hospital Harvard University Acton Massachusetts Consultant ZiaLogic Acton Massachusetts Disclosure Kenneth Minkoff MD has disclosed no relevant financial relationships

Joseph J Parks MD

Assistant Associate Professor Department of Psychiatry University of Missouri Columbia Missouri Disclosure Joseph J Parks MD has disclosed that he has received grants for educational activities from Letters amp Science and Physician Postgraduate Press Dr Parks has also disclosed that he has served as a consultant to the National Association of State Mental Health Program Directors and Bristol-Myers Squibb Dr Parks has also disclosed that he has received funds for services provided to the state of Missouri from Eli Lilly and Abbott

Miles F Shore MD

Bullard Distinguished Professor of Psychiatry Harvard Medical School Needham Massachusetts Junior Consultant Harvard Medical International Boston Massachusetts Disclosure Miles F Shore MD has disclosed no relevant financial relationships

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The functional and economic burden of MDD has been an area of focus for payers and employers Less recognized however is the substantial impairment in social and occupational functioning and in physical health documented in mental health treatment settings for individuals with specific anxiety disorders such as

PTSD[6162]

Panic disorder[6364]

Generalized anxiety disorder[65] and

Social anxiety disorder[6667]

Impairment from anxiety disorders is also apparent in those who present to a primary care physician[496869] Generalized anxiety disorder produces impairment in health-related functioning that is equivalent to or significantly greater than patients with diabetes and recent myocardial infarction

Primary care patients with anxiety disorder are high utilizers of general medical services resulting in increased overall healthcare costs compared with primary care patients who have subthreshold disorders or no anxiety disorder[70] The economic burden of anxiety disorders in the United States has been estimated to be $423 billion in 1990 primarily due to increased use of non-psychiatric medical services[71]

However missed diagnoses do not necessarily lead to preventable adverse events Some studies have suggested that patients with unrecognized MDD in the primary care setting are less severely depressed and less functionally impaired[323770] and therefore at less risk for

Loss of employment

Impaired social functioning

Exacerbation of co-occurring medical disorders and

Suicide

When recognized and unrecognized patients with MDD are tracked over time clinical improvement has often been comparable[3770] although greater short-term improvement for recognized cases has also been reported for MDD[34] and anxiety disorders[72]

Errors of commission mistaken diagnoses As described previously for MDD about one-third of the diagnostic errors in primary care are mistaken diagnoses[37] Mistaken diagnoses range from anxiety disorders to alcoholsubstance abuse to psychoticdissociative disorders Conversely when an anxiety disorder is present a mistaken diagnosis of depression is sometimes given[39] The high level of comorbidity between anxiety and mood disorders is likely to contribute substantially to such diagnostic errors[73]

Primary care physicians also occasionally diagnose a mood or anxiety disorder when it is not present (false positive) Among non-depressed patients a false positive rate of 12 in primary care was reported in 1 study[38] and 14 in another[37] About 25 of these MDD false-positives in the Tiemens study actually had an anxiety disorder 20 were the result of overestimation of severity of depression by the primary care physician and 55 were true false positives In the Klinkman study a history of depression was apparent in over half of the false-positive cases

suggesting that physicians might have been unduly influenced by a history of depression rather than the clinical evidence for depression at the time of examination

The implications of these misdiagnoses require more study Because the treatments for most mood and anxiety disorders are similar and because even subsyndromal disorders cause significant distress and functional disability it is possible that imprecision in diagnosis may still result in the use of appropriate medication treatment Of course treatment of an individual without a disorder even subsyndromal causes unneeded exposure to medication errors

Recommendations to diminish misdiagnoses in primary care Since primary care clinicians will most likely continue to be the point of entry and often the sole provider of mental health treatment for patients suffering from mood and anxiety disorders improvements in diagnosis and appropriate treatment of these disorders in primary care should be an important priority Better education of primary care providers about the symptoms and management of depression and anxiety are essential Programs designed to increase primary care clinicians recognition of depression and other psychiatric disorders have not yet proved to improve treatment outcome[7475] However studies that have added training in depression management in addition to education on better recognition of its presence have yielded better outcomes[76]

The feasibility and sustainability of programs focusing on better education of primary care clinicians has not been established Because of the time constraints of standard primary care practice fast efficient methods of screening such as the Primary Care Evaluation of Mental Disorders (PRIME-MD) for anxiety depression and other psychiatric disorders are recommended[77] The Patient Health Questionnaire a 9-item subset of the PRIME-MD is a more concise screen for depression if time constraints preclude use of the full PRIME-MD questionnaire The routine use of such simple methods for screening and ongoing monitoring might provide a sustainable way of reducing diagnostic errors in ambulatory medical settings

A final recommendation is for managed care and insurance companies as well as health systems and provider networks to consider the implementation of incentives for better detection and treatment of mood and anxiety disorders Pilot pay for performance programs such as Bridges to Excellence[78] or the Integrated Healthcare Association initiative in California[79] have focused on physical conditions such as diabetes or asthma Quality measures do exist for the medication treatment and follow up of diagnosed depression such as performance standard and report card measures[80] Adding incentives for better detection and treatment to the use of quality measures is a recommended first step

Errors in the Use of Seclusion and Restraint

In October 1998 The Hartford Courant reported on the death of Andrew McClain an 11-year-old boy who died while restrained and secluded in a psychiatric hospital in Connecticut[81] Thus began the Courants 5-part series based on a 50-state survey that confirmed 142 deaths related to the use of seclusion and restraint in mental health settings over the past decade[82-85] The series cautioned that most deaths related to seclusion and restraints are unreported and that the actual number of annual deaths was possibly much higher

The national response to the Courant exposeacute was far reaching Congress commissioned the US General Accounting Office (USGAO) to report on the use of seclusion and restraint The USGAO responded by releasing a report in 1999 entitled Improper Restraint or Seclusion Places People at Risk[82] The USGAO report confirmed the majority of the Courants allegations including the following

Improper use of seclusion and restraint are dangerous

There is inadequate monitoring and reporting of its use and of resulting harm (or preventable adverse events) to patients

Serious injuries or death can occur and are underreported

Licensing and accreditation of seclusion and restraint standards are inconsistent and insufficient and

Successful strategies for preventing seclusion and restraint as well as reducing the risk of injury when use occurs are not widely used

Seclusion and restraint are commonly used practices intended to prevent adults and children with mental health and substance abuse diagnoses from harming themselves or others in inpatient or residential treatment environments Unfortunately access to incidence data collected by The National Association of State Mental Health Program Directors (NASMHPD) is controlled (and forbidden) by participating hospitals There are no published data interpreted as accurately reflecting the true incidence of seclusion and restraint use

The use of these interventions is intended to be severely restricted to individual situations in which an emergency safety need is identified but as use is generally ordered by staff and based on subjective criteria the use of these emergency interventions has a wide range [86] Restraint is defined in a variety of ways but the term generally refers to a manual method or mechanical device material or equipment attached or adjacent to the patients body that he or she cannot easily remove and that restricts the patients freedom or normal access to ones body[87] Seclusion refers to the involuntary confinement of a person in a room where they are physically prevented from leaving[88] Recent literature reviews of seclusion and restraint reflect the absence of[8990]

Substantiated prevention strategies

Indications for use

Application methods

Monitoring

Post-event activities and

Absence of evidence of its effectiveness in preventing harm

The Centers for Medicare and Medicaid Services (CMS) -- formerly known as the Healthcare Financing Administration (HCFA) the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and state licensing agencies have attempted to regulate the use of seclusion and restraint through licensing and accreditation standards[879192] However the Courant series the USGAO report and others have documented alarming rates of patient harm including death despite the application of such standards[818286] While efforts are underway to resolve these issues the appropriate and safe use of seclusion and restraint is far from assured[8693]

In recent years advocates consumers professional associations provider organizations and the legal field have increasingly recommended a reduction in the use of seclusion and restraint or even its elimination[83-86 94] These recommendations resonate with Recommendation no 1 in the IOMs Crossing the Quality Chasm that states All healthcare organizations professional groups

and private and public health purchasers should adopt as their explicit purpose to continually reduce the burden of illness injury and disability and to improve the health and functioning of the people of the United States[2] Using the IOMs medical error nomenclature reports about seclusion and restraint reflect high rates of medical errors mostly errors of commission perhaps errors of omission causing either near misses or preventable adverse events in routine clinical practice

Safety in healthcare practices is defined as keeping the patient free from accidental injury[2] Although not all errors cause injury accidental injury can be due to error either by the failure of a planned action to be completed as intended or use of the wrong plan to achieve an aim The improper use of seclusion and restraint is not safe and causes serious and preventable adverse injuries including death[8182] The media continues to report adverse events as well[9596] For example in 2000 3 deaths were reported just in Texas including that of 2 boys one 9 and the other 11 years old and a 16-year-old girl In South Carolina in 2003 a 9-year-old boy died after he kicked a staff member in the leg and ran down the hall which resulted in a take down and the boys asphyxiation In Arizona a 32-year-old woman died in restraints for behavior that was later judged as not meeting the threshold of imminent danger[96]

Reducing and Improving Seclusion and Restraint Events Recent Performance Improvement Initiatives

Several initiatives focused on seclusion and restraint reduction (embedded in public health prevention continuous quality improvement principles supporting recovery from mental illness and trauma-informed care) have been developed by the American Psychiatric Nurses Association the APA the National Association for Private Health Systems the American Hospital Association the National Alliance on Mental Illness (NAMI) and the Childrens Welfare League of America[2083859798] These initiatives are intended to complement other essential elements such as adequate numbers of well-trained staff and the use of proven psychological and medication treatments

The public health constructs of primary secondary and tertiary prevention create a logical framework and redirect the focus from safer use of seclusion and restraint to interventions that prevent its use[86] The model of recovery espoused by the Surgeon Generals Mental Health report necessitates[99]

System-wide transformation by adopting goals of full recovery in a life outside the hospital

Emphasis on instilling hope

Availability of multiple treatment options and

Development of partnerships with those who seek services

The use of controlling or coercive interventions is counterintuitive in this model and is to be avoided except perhaps as the last alternative in preventing death or significant harm to self or others caused by treatable manifestations of mental illness[94100] A growing understanding of the neurologic biologic psychological and social effects of trauma and its high prevalence in the populations that seek mental health services is informing approaches to assessment diagnosis stabilization and treatment of individuals with mental illness including the use of seclusion and restraint as a means of preventing injury to self or others[101-108]

Data should be analyzed for characteristics of facility usage by

Unit

Shift

Day and

Staff member involved

With rare exception data on individuals should be used confidentially to identify individual staff training needs not for disciplinary actions[88109] The facility needs to highlight data on seclusion and restraint use by graphing and posting this data on all units so that it is clearly visible for staff and consumers of service Facility-generated data on seclusion and restraint used in a non-punitive way provides for healthy competition among treatment units and elevates the general oversight and knowledge of use and outcomes for everyone involved[88109110] It allows and encourages administration to identify successful staff and treatment units so that successful improvements can be shared

A comprehensive national health information infrastructure could be a useful tool in reducing seclusion and restraint events[2111] The National Association of State Mental Health Program Directors Research Institute Inc (NRI) performance improvement system has developed a set of technology standards applications systems and values that include a number of recommendations for reducing seclusion and restraint events and making their occurrence less error prone[112]

Reduction of the use of seclusion and restraint must start with clear leadership and a specific plan that articulates a mission and philosophy about seclusion and restraint reduction and defines the roles and responsibilities of all facility staff[109] One core component is use of an executive on-call function and the daily review of the use of seclusion and restraint by executive leadership[88110]

Creating a treatment environment that prevents seclusion and restraint is based on the principles of recovery and the characteristics of trauma-informed systems of care[88109] Staff education needs to

Include the experiences of consumers and staff

Address the common myths associated with use

Introduce the rationale and characteristics of trauma-informed care

Educate on the neurobiological and psychological effects of trauma and

Describe a prevention-based approach to reduction

Seclusion and Restraint Summary

The use of seclusion and restraint is associated with substantial harm to recipients of care including death Medical errors precede many seclusion and restraint events which in turn cause further errors and substantial harm to both recipients and providers of care Several local and national initiatives are underway to improve the safety of seclusion and restraint events and to decrease its use The results of their successful application can be seen in facilities in[88 109]

Pennsylvania

New York

Massachusetts

Maine

Florida

New Jersey and

South Dakota

Further study of causal antecedent events and of harm resulting from seclusion and restraint events is recommended using the patient safety paradigm and nomenclature

High-Risk Clinical Populations Lacking Adequate Patient Safety Research

Introduction to High-Risk Clinical Populations

There are no empirical data to quantify characterize or confirm medical errors in certain populations with mental illness andor substance abuse where multiple risk factors for error also exist A brief discussion of these populations and their risks for errors is provided below It is hoped that heightened focus on these high-risk populations will be an impetus for medical error research

Persons with Co-occurring Mental Illness and Substance Abuse

Individuals with co-occurring psychiatric and substance disorders have not been studied for medical errors yet they are perhaps at greater risk for harm because of the nature and number of their co-occurring disorders Several studies have reported the common occurrence of comorbidity among persons with a recognized diagnosis of either mental illness or substance abuse For example in 1990 Regier[74] found a lifetime prevalence of substance abuse among 62 of persons with bipolar disorder In 1996 Kessler and colleagues[113] reported a lifetime prevalence of 599 of psychiatric illness among persons with substance abuse disorders while 31 had a concurrent psychiatric disorder

Persons with co-occurring disorders are high utilizers of medical resources and therefore more exposed to systems issues that may predispose to unintended harm In 1995 an estimated 26 million (27) of the 965 million emergency department (ED) visits were related to alcohol abuse alone[114]

In a study by Dickey and associates[115] using data from the Massachusetts Division of Medical Assistance and death records from the Department of Public Health individuals with co-occurring psychiatric and substance use disorders had the highest risk of medical morbidity for 5 of the studied medical disorders Medicaid beneficiaries with dual diagnoses are 6 to 8 times more likely to die of injury primarily poisoning than their counterparts treated for medical conditions only[116117]

It is well-substantiated that persons with psychiatric and substance abuse disorders have higher rates of suicide attempts and death by suicide[118-123] In 2001[124]

20308 deaths were caused by homicide

30622 deaths by suicide and

101537 deaths were caused by accidents

Given the frequency with which substance abuse by itself has been implicated in these 3 causes of death the scope of morbidity and mortality related to co-occurring disorders is staggering

The effects of substance abuse disorders in adults also affected the mortality rates of children during 1985 to 1996 -- 8482 (24) of the 35547 children aged younger than 15 years died in alcohol-related motor vehicle crashes[125]

A subset of those with co-occurring disorders have substance dependence PTSD and chronic pain The presence of chronic pain and the complexities surrounding treatment of individuals with PTSD increase the risk for unintended harm and of a poor fit between clinical needs and the design of current healthcare systems Despite the added risk factors there is little science to direct clinicians A Medline search using substance abuse PTSD and chronic pain as search terms in June 2004 yielded 10 citations There were no incidence studies and no published treatment guidelines

Conclusion regarding co-occurring disorders Individuals with co-occurring disorders are frequently encountered and at risk for multiple diagnostic and treatment errors including

Missed mental health substance abuse and medical diagnoses and

Insufficient or excessive medication treatment of either their substance abuse or psychiatric disorder

Compared with the general population these individuals are at higher risk for

Suicide attempt

Death by suicide and

Death at a younger age by medical illness

There is a paucity of published studies on medical errors among individuals with co-occurring disorders despite several risk factors for unintended harm and high rates of morbidity and mortality

Attention Deficit-Hyperactivity Disorder in Children Excessive or Insufficient Diagnosis and Treatment

Inattentiveness distractibility impulsivity and hyperactivity were recognized as elements of minimal brain dysfunction (now termed attention deficit hyperactivity disorder [ADHD]) and treated with stimulants especially methylphenidate beginning in the late 1960s[101126127] Over the past 3 decades the rate of drug treatment for behavior problems has increased exponentially culminating in the prescription of ADHD drug treatment for at least 5-6 million American children annually[128]

Children diagnosed with ADHD have been the focus of thousands of research studies over the last 40 years yet the diagnosis and treatment of ADHD remain controversial among some within medicine and the general public[129130] Recent prevalence data from the 1998 National Institutes

of Health (NIH) consensus review[131] and reported by Jensen[132] suggest a prevalence of approximately 5 affecting 3 million school-aged children[133134]

ADHD is associated with[135-137]

Increased risk of accidents

Family and social dysfunction

Poor academic achievement

Substance abuse and

Antisocial behavior

Recent treatment data based on the number of methylphenidate prescriptions show an estimated 5-6 million American children receive ADHD-related drug treatment annually[128] Aggregate national methylphenidate use has increased 100-fold from 1960 until 2000 Globally nearly 90 of the worlds stimulant medication supply is consumed by the US population[138139]

Substantial state-to-state and community-to-community variability in methylphenidate use raises concerns about potential pockets of over- and under-diagnosis and over- and under-prescribing Drug Enforcement Association data on stimulant use reflect a 6-fold per capita variation in methylphenidate prescribing between some states[140] and a 20-fold prescribing variation between some communities[130141]

LeFever and colleagues argue that while the data are inconclusive if communities such as Salt Lake City Utah are used as a benchmark of acceptable diagnosis and treatment then children in 36 states may be subject to over-diagnosis and over-treatment Conversely Jensen argues that ADHD is under-diagnosed and under-treated based on national aggregate data allowing for pockets of over-diagnosis and treatment in some geographic areas[142] Given that in 1995 there were approximately 2 million pediatric visits in which ADHD was the focus of treatment and 6 million stimulant prescriptions were written[132] 1 conclusion is that 3 million children with ADHD received an average of 2 prescriptions and 1 outpatient visit during that year suggesting insufficient treatment In another study cited by Jensen the Multimodal Treatment Study of Children with ADHD two thirds of ADHD children from reportedly highly motivated families obtained medication treatments and for an average duration of only 8-14 months[142143]

Despite the number of studies done the strength of conclusions that can be drawn is contingent upon the adequacy of reported data Studies to date are variously limited by data sources sampling accuracy and interpretation[130]

When considered in aggregate national ADHD prevalence rates and numbers of prescriptions written do not suggest excessive diagnosis and treatment However prevalence rates and stimulant use can vary as much as 30-fold when comparing different communities A prevalence rate of 33 among white elementary-aged boys in southeastern Virginia significantly challenges credibility[130] Such variability makes it essential that prevalence rates and stimulant use estimates be linked to sufficient demographics such as

Geography

Age

Race and

Gender

ADHD prevalence rates and stimulant use appear to be

Excessive in some communities

Plausible in other communities and

Perhaps insufficient in yet other communities

Additional epidemiologic studies reporting prevalence rates with specific demographics rather than in aggregate and broader use of practice guidelines promulgated by the American Academy of Pediatrics (AAP) and others that advocate multimodal treatment rather than solely prescribing stimulants or other medications[130144] will help provide evidence of the extent of errors in the diagnosis and treatment of children with ADHD

Electroconvulsive Therapy

Electroconvulsive therapy (ECT) remains a controversial treatment in psychiatry As stated in the 1985 NIH Consensus Statement The nature of the treatment itself its history of abuse unfavorable media presentations compelling testimony of former patients special attention by the legal system uneven distribution of ECT use among practitioners and facilities and uneven access by patients all contribute to the controversial context in which the consensus panel has approached its task[145]

Epidemiologic data reported by Thompson and colleagues in 1994 found that[146]

58667 patients received ECT in 1975

31514 in 1980

36558 in 1986

71 of the patients who received ECT were women and

Individuals older than 65 years of age had the highest rates per number of inpatients

The rate of ECT use has been highly variable For example in 1995 Herman and associates[147] reported that among 202 metropolitan statistical areas annual ECT use varied from 04 to 812 patients per 10000 population

The most common adverse effect from ECT is memory loss In a recent review of patients perspectives as well as clinicians studies Rose and associates[148] concluded that 29 to 55 of ECT treatment recipients experienced persistent memory loss Recent empirical studies of ECT and memory loss continue to find persistent memory loss with bilateral ECT producing more profound memory deficits than right unilateral ECT[149]

In a review of deaths caused by ECT Abrams reported that ECT is 10 times safer than childbirth that approximately 6 times as many deaths annually in the US are caused by lightning as by ECTand that the death rate reported for ECT is an order of magnitude smaller than the spontaneous death rate in the general population[150]

Corroboration of a low ECT death rate has arisen from 1993 legislation in Texas mandating reporting of all ECT-related deaths[151] As a result the risk of death from ECT in Texas has been systematically tracked and reviewed More than 8000 patients received 49048 ECT treatments between 1993 and 1998 However only 1 death could be linked to the associated anesthesia An additional 4 deaths could plausibly have been associated with the anesthesia yielding a mortality rate between 2 and 10 per 100000 and the causes of death most likely were not the ECT stimulus or seizure

Emotional harm and erosion of faith in the medical profession that undermines accepting other needed treatments can come to recipients of care for whom the experience of ECT is frightening

ECT conclusion ECT is effective for severe major affective illness and is associated with a low mortality rate Persistent memory loss is a consistent finding despite attempts to optimize ECT administration and must be expected at an incidence of approximately 25 to 50 by those contemplating and those providing ECT treatment

Despite its relative safety ECT continues to cause alarm in the general public Even within medicine it is described as dangerous and unethical by some[152] Such fears can cause emotional harm among ECT recipients This may be especially true for older women (who comprise the majority of ECT subjects) some of whom may be accustomed to deferring to healthcare providers when consenting to treatment despite insufficient understanding of benefits and risks

Recommendations include

Emphasis on pre-treatment education

Collaborative relationship with ECT recipients

Increased transparency regarding the substantial risk of persistent memory loss when seeking informed consent and

Continued research on its safety

Systems Issues Related to Patient Safety

Outpatient Care

Risk of unintended harm may be increased by the segregated care settings in which psychiatric and substance abuse services are often delivered including solo practitioner offices and free-standing psychiatric and substance abuse treatment facilities[153154] and by insufficient communication and coordination of care between prescribers and psychotherapists[155-157] Despite the recognition of these potential contributing factors there are no existing reports of the association between systems issues and medical errors

Olfson[158] reported that in 1987 there were 84 million outpatient visits with mental health practitioners including

Psychiatrists

Psychologists

Social workers and

Licensed counselors

Kessler[154] reported in 1999 that an estimated 133 of a representative sample of Americans reported used outpatient services for mental health problems in the previous 12 months Clearly there are high numbers of individuals at risk for errors in outpatient mental health and substance abuse treatment

Ethics and Malpractice Risk Management Boundary Violations

A survey of recently published reviews and commentaries on patient safety reveals that for mental health and substance abuse issues such discussion takes place mainly within the context of ethics and malpractice risk management[159-162] Ethics statements from both the APA[162] and the American Psychological Association[163] support the duty to report and protect patients from deviations from the standards of care This approach uses the individual practitioners frame of reference and relies on voluntary reporting from professionals who have been trained to consider confidentiality a critical component of their work Harm caused by clinician boundary violations are understood as issues of professional misconduct not as errors resulting from system failure and that minimize the individual clinicians responsibility and advise against punitive action [164-167]

With the advent of therapeutic exchanges through email and other means of communication additional boundary violations are possible The Internet now has at least 110 million users including 70 million using it for health-related information[168] A recent survey indicated 40 to 50 of physicians use the Internet (or are preparing to use it) for clinical care[169]

There is a risk of errors of omission or commission arising from lack of coordination of care between clinicians Differences in therapeutic orientation and nomenclature used by the following specialists can compound systems issues that increase the risk of medical errors [158]

Social workers

Psychiatric nurse specialists

Psychologists

Licensed counselors and

Psychiatrists

Confidentiality is critical in providing effective treatment within the secure and private setting of the therapists office and in protecting the patient from unauthorized disclosures of sensitive information and potential abuse from a third party[170] However confidentiality can also inhibit disclosure of near misses impasses in treatment (for example when treatment is not working) and preventable adverse events due to avoidance of sharing important clinical information with other professionals and with appropriate family members and other supportive resources[171172]

The solo practice model commonly used by mental health clinicians can also inhibit the adoption of best practices and the development of policies and procedures to reduce risk because all such practice management activities are left to the individual clinician whose focus is more likely to be exclusively clinical

Summary About Systems Issues and Patient Safety

Systems for reliably reporting outpatient psychotherapy medical errors particularly among the large numbers of solo practitioners do not exist The prevailing paradigm for reducing harm arises from risk reduction in order to diminish medical liability exposure Studies that shed light on potential medical errors have arisen from risk management claims medical liability lawsuits and reports of death by suicide not from research intended to examine patient safety per se

Error reporting systems applicable to outpatient mental health settings including incentives for their use need to be developed Professional risk management programs primarily used to diminish medical liability exposure from the following could also be used to promulgate the relevance and value of the patient safety paradigm

Boundary violations

Suicide and

Treatment errors

Most particularly thought needs to be given to developing systems of error prevention applicable to the solo practitioner

Recommendations

Recommendation no 1

Widespread adoption of the IOM patient safety paradigm and nomenclature in mental health and substance abuse treatment settings is recommended

Advantages of its use include

Consistency with the nomenclature used by other medical specialties

Increased leverage in advocating for needed services and resources when the absence of essential treatments are quantified as errors of omission causing near misses or preventable adverse events

Increased likelihood that medication errors in mental health and substance abuse will be researched and a determination made whether such errors are causing preventable adverse events and

Increased awareness among mental health and substance abuse clinicians that patient harm can come from a broader array of errors in diagnosis and treatment than has been studied to date

Widespread adoption will require systematic educational efforts for trainees and current practitioners in mental health and substance abuse including systematic introduction to the IOMs existence mission and safety and quality efforts such as the Quality Chasm Series (Many mental health and substance abuse clinicians and administrators seem unaware of the IOM at all)

Recommendation no 2

Further studies of medical error in mental health and substance disorders are needed

Some areas of potential harm in this field remain largely unexamined For example we found only 2 studies of medication errors in mental health settings and none in substance abuse detoxification and stabilization settings despite multiple risk factors for errors and preventable adverse events The impact of variable education -- in pharmacology physiology and general medicine -- on the safety of prescribing practices has not been studied nor has the clinical consequences of formulary restrictions on clinical outcome and potential patient harm The current acceptance of self-reported hospital error rates must be challenged through a process of independently validating self-reported errors

Recommendation no 3

Integration of mental health and substance abuse services is recommended

High rates of co-occurrence and associated higher rates of morbidity and mortality among those with mental health and substance abuse disorders requires integration of mental health and substance abuse treatment paradigms This has not occurred to date

Recommendation no 4

The IOMs 10 rules for change in healthcare should be adopted

The 10 IOM rules for change in healthcare are as follows[173]

1 Care based on continuous healing relationships

2 Customization based on patient needs and values

3 The patient as the source of control

4 Shared knowledge and the free-flow of information

5 Evidence-based decision-making

6 Safety as a system property

7 The need for transparency

8 Anticipation of needs

9 Continuous decrease in waste

10 Cooperation among clinicians

As an example of adoption of these rules seclusion and restraint remain high risk treatments yet current reporting systems do not permit transparency regarding the rate and types of injuries incurred including mortality rates Such transparency requires a non-punitive work culture yet there is little evidence to suggest its adoption in high-risk environments such as state psychiatric hospitals or inpatient detoxification and stabilization substance abuse treatment settings

Recommendation no 5

Reporting systems in outpatient mental health and substance abuse treatment settings must be adopted

Reliance upon unsubstantiated self-reporting of medication errors in inpatient mental health and substance abuse settings remains a significant flaw when attempting accurate assessment of near misses and preventable adverse events and must be changed A key necessity is anonymous yet authenticated medication error reporting for all staff using available web-based error reporting systems Such systems are cost-savers and make reported error data immediately and continuously available Web-based reporting systems providing anonymity with authentication could be used for further seclusion and restraint data collection and as a means of establishing an outpatient error reporting system of safety and quality data by recipients and providers of outpatient treatment

Recommendation no 6

Resources should be allocated to study and develop practical interventions to improve patient safety

Much current research in mental health and substance abuse and resource appropriation is focused on efficacy of pharmacotherapy and psychotherapy and on establishing neurobiologic evidence to support causal theories of known clinical disorders At a policy level we recommend more consideration be given to funding practical interventions predicted to immediately improve patient safety

References

[ CLOSE WINDOW ]

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Authors and Disclosures

As an organization accredited by the ACCME Medscape LLC requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest The ACCME defines relevant financial relationships as financial relationships in any amount occurring within the past 12 months including financial relationships of a spouse or life partner that could create a conflict of interest

Medscape LLC encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration at first mention and where appropriate in the content

Author

Benjamin C Grasso MD

Staff Psychiatrist VA Clinic Saco Maine Disclosure Benjamin C Grasso MD has disclosed no relevant financial relationships

Cathryn M Clary MD MBA

Vice President US External Medical Affairs Pfizer Inc New York NY Disclosure Cathryn M Clary MD MBA has disclosed that she is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Benjamin Eng MD MA

Senior Medical Director Group Leader Pfizer Inc New York NY Disclosure Benjamin Eng MD MA has disclosed that he is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Stanley J Evans MD FASAM PA

Assistant Professor of Clinical Medicine St Matthews University Windham Maine

Medical Director Renaissance Institute of Palm Beach Boca Raton Florida Disclosure Stanley J Evans MD has disclosed no relevant financial relationships

Terry J Golash MD

Clinical Instructor Psychiatry Columbia University New York NY Assistant Attending St Lukersquos Roosevelt Hospital Center New York NY Disclosure Terry J Golash MD has disclosed no relevant financial relationships

Kevin Ann Huckshorn RN MSN CAP ICADC

Director Office of Technical Assistance National Association of State mental Health Program Directors Inc Alexandria Virginia Disclosure Kevin Ann Huckshorn RN MSN CAP ICADC has disclosed no relevant financial relationships

Kenneth Minkoff MD

Clinical Assistant Professor Department of Psychiatry Cambridge Hospital Harvard University Acton Massachusetts Consultant ZiaLogic Acton Massachusetts Disclosure Kenneth Minkoff MD has disclosed no relevant financial relationships

Joseph J Parks MD

Assistant Associate Professor Department of Psychiatry University of Missouri Columbia Missouri Disclosure Joseph J Parks MD has disclosed that he has received grants for educational activities from Letters amp Science and Physician Postgraduate Press Dr Parks has also disclosed that he has served as a consultant to the National Association of State Mental Health Program Directors and Bristol-Myers Squibb Dr Parks has also disclosed that he has received funds for services provided to the state of Missouri from Eli Lilly and Abbott

Miles F Shore MD

Bullard Distinguished Professor of Psychiatry Harvard Medical School Needham Massachusetts Junior Consultant Harvard Medical International Boston Massachusetts Disclosure Miles F Shore MD has disclosed no relevant financial relationships

Editor

Jacqueline A Hart MD

Freelance Clinical Editor Medscape LLC New York New York Disclosure Jacqueline A Hart MD has disclosed no relevant financial relationships

Elizabeth Saenger PhD

Editorial Director Medscape LLC New York NY Disclosure Elizabeth Saenger PhD has disclosed no relevant financial relationships

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suggesting that physicians might have been unduly influenced by a history of depression rather than the clinical evidence for depression at the time of examination

The implications of these misdiagnoses require more study Because the treatments for most mood and anxiety disorders are similar and because even subsyndromal disorders cause significant distress and functional disability it is possible that imprecision in diagnosis may still result in the use of appropriate medication treatment Of course treatment of an individual without a disorder even subsyndromal causes unneeded exposure to medication errors

Recommendations to diminish misdiagnoses in primary care Since primary care clinicians will most likely continue to be the point of entry and often the sole provider of mental health treatment for patients suffering from mood and anxiety disorders improvements in diagnosis and appropriate treatment of these disorders in primary care should be an important priority Better education of primary care providers about the symptoms and management of depression and anxiety are essential Programs designed to increase primary care clinicians recognition of depression and other psychiatric disorders have not yet proved to improve treatment outcome[7475] However studies that have added training in depression management in addition to education on better recognition of its presence have yielded better outcomes[76]

The feasibility and sustainability of programs focusing on better education of primary care clinicians has not been established Because of the time constraints of standard primary care practice fast efficient methods of screening such as the Primary Care Evaluation of Mental Disorders (PRIME-MD) for anxiety depression and other psychiatric disorders are recommended[77] The Patient Health Questionnaire a 9-item subset of the PRIME-MD is a more concise screen for depression if time constraints preclude use of the full PRIME-MD questionnaire The routine use of such simple methods for screening and ongoing monitoring might provide a sustainable way of reducing diagnostic errors in ambulatory medical settings

A final recommendation is for managed care and insurance companies as well as health systems and provider networks to consider the implementation of incentives for better detection and treatment of mood and anxiety disorders Pilot pay for performance programs such as Bridges to Excellence[78] or the Integrated Healthcare Association initiative in California[79] have focused on physical conditions such as diabetes or asthma Quality measures do exist for the medication treatment and follow up of diagnosed depression such as performance standard and report card measures[80] Adding incentives for better detection and treatment to the use of quality measures is a recommended first step

Errors in the Use of Seclusion and Restraint

In October 1998 The Hartford Courant reported on the death of Andrew McClain an 11-year-old boy who died while restrained and secluded in a psychiatric hospital in Connecticut[81] Thus began the Courants 5-part series based on a 50-state survey that confirmed 142 deaths related to the use of seclusion and restraint in mental health settings over the past decade[82-85] The series cautioned that most deaths related to seclusion and restraints are unreported and that the actual number of annual deaths was possibly much higher

The national response to the Courant exposeacute was far reaching Congress commissioned the US General Accounting Office (USGAO) to report on the use of seclusion and restraint The USGAO responded by releasing a report in 1999 entitled Improper Restraint or Seclusion Places People at Risk[82] The USGAO report confirmed the majority of the Courants allegations including the following

Improper use of seclusion and restraint are dangerous

There is inadequate monitoring and reporting of its use and of resulting harm (or preventable adverse events) to patients

Serious injuries or death can occur and are underreported

Licensing and accreditation of seclusion and restraint standards are inconsistent and insufficient and

Successful strategies for preventing seclusion and restraint as well as reducing the risk of injury when use occurs are not widely used

Seclusion and restraint are commonly used practices intended to prevent adults and children with mental health and substance abuse diagnoses from harming themselves or others in inpatient or residential treatment environments Unfortunately access to incidence data collected by The National Association of State Mental Health Program Directors (NASMHPD) is controlled (and forbidden) by participating hospitals There are no published data interpreted as accurately reflecting the true incidence of seclusion and restraint use

The use of these interventions is intended to be severely restricted to individual situations in which an emergency safety need is identified but as use is generally ordered by staff and based on subjective criteria the use of these emergency interventions has a wide range [86] Restraint is defined in a variety of ways but the term generally refers to a manual method or mechanical device material or equipment attached or adjacent to the patients body that he or she cannot easily remove and that restricts the patients freedom or normal access to ones body[87] Seclusion refers to the involuntary confinement of a person in a room where they are physically prevented from leaving[88] Recent literature reviews of seclusion and restraint reflect the absence of[8990]

Substantiated prevention strategies

Indications for use

Application methods

Monitoring

Post-event activities and

Absence of evidence of its effectiveness in preventing harm

The Centers for Medicare and Medicaid Services (CMS) -- formerly known as the Healthcare Financing Administration (HCFA) the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and state licensing agencies have attempted to regulate the use of seclusion and restraint through licensing and accreditation standards[879192] However the Courant series the USGAO report and others have documented alarming rates of patient harm including death despite the application of such standards[818286] While efforts are underway to resolve these issues the appropriate and safe use of seclusion and restraint is far from assured[8693]

In recent years advocates consumers professional associations provider organizations and the legal field have increasingly recommended a reduction in the use of seclusion and restraint or even its elimination[83-86 94] These recommendations resonate with Recommendation no 1 in the IOMs Crossing the Quality Chasm that states All healthcare organizations professional groups

and private and public health purchasers should adopt as their explicit purpose to continually reduce the burden of illness injury and disability and to improve the health and functioning of the people of the United States[2] Using the IOMs medical error nomenclature reports about seclusion and restraint reflect high rates of medical errors mostly errors of commission perhaps errors of omission causing either near misses or preventable adverse events in routine clinical practice

Safety in healthcare practices is defined as keeping the patient free from accidental injury[2] Although not all errors cause injury accidental injury can be due to error either by the failure of a planned action to be completed as intended or use of the wrong plan to achieve an aim The improper use of seclusion and restraint is not safe and causes serious and preventable adverse injuries including death[8182] The media continues to report adverse events as well[9596] For example in 2000 3 deaths were reported just in Texas including that of 2 boys one 9 and the other 11 years old and a 16-year-old girl In South Carolina in 2003 a 9-year-old boy died after he kicked a staff member in the leg and ran down the hall which resulted in a take down and the boys asphyxiation In Arizona a 32-year-old woman died in restraints for behavior that was later judged as not meeting the threshold of imminent danger[96]

Reducing and Improving Seclusion and Restraint Events Recent Performance Improvement Initiatives

Several initiatives focused on seclusion and restraint reduction (embedded in public health prevention continuous quality improvement principles supporting recovery from mental illness and trauma-informed care) have been developed by the American Psychiatric Nurses Association the APA the National Association for Private Health Systems the American Hospital Association the National Alliance on Mental Illness (NAMI) and the Childrens Welfare League of America[2083859798] These initiatives are intended to complement other essential elements such as adequate numbers of well-trained staff and the use of proven psychological and medication treatments

The public health constructs of primary secondary and tertiary prevention create a logical framework and redirect the focus from safer use of seclusion and restraint to interventions that prevent its use[86] The model of recovery espoused by the Surgeon Generals Mental Health report necessitates[99]

System-wide transformation by adopting goals of full recovery in a life outside the hospital

Emphasis on instilling hope

Availability of multiple treatment options and

Development of partnerships with those who seek services

The use of controlling or coercive interventions is counterintuitive in this model and is to be avoided except perhaps as the last alternative in preventing death or significant harm to self or others caused by treatable manifestations of mental illness[94100] A growing understanding of the neurologic biologic psychological and social effects of trauma and its high prevalence in the populations that seek mental health services is informing approaches to assessment diagnosis stabilization and treatment of individuals with mental illness including the use of seclusion and restraint as a means of preventing injury to self or others[101-108]

Data should be analyzed for characteristics of facility usage by

Unit

Shift

Day and

Staff member involved

With rare exception data on individuals should be used confidentially to identify individual staff training needs not for disciplinary actions[88109] The facility needs to highlight data on seclusion and restraint use by graphing and posting this data on all units so that it is clearly visible for staff and consumers of service Facility-generated data on seclusion and restraint used in a non-punitive way provides for healthy competition among treatment units and elevates the general oversight and knowledge of use and outcomes for everyone involved[88109110] It allows and encourages administration to identify successful staff and treatment units so that successful improvements can be shared

A comprehensive national health information infrastructure could be a useful tool in reducing seclusion and restraint events[2111] The National Association of State Mental Health Program Directors Research Institute Inc (NRI) performance improvement system has developed a set of technology standards applications systems and values that include a number of recommendations for reducing seclusion and restraint events and making their occurrence less error prone[112]

Reduction of the use of seclusion and restraint must start with clear leadership and a specific plan that articulates a mission and philosophy about seclusion and restraint reduction and defines the roles and responsibilities of all facility staff[109] One core component is use of an executive on-call function and the daily review of the use of seclusion and restraint by executive leadership[88110]

Creating a treatment environment that prevents seclusion and restraint is based on the principles of recovery and the characteristics of trauma-informed systems of care[88109] Staff education needs to

Include the experiences of consumers and staff

Address the common myths associated with use

Introduce the rationale and characteristics of trauma-informed care

Educate on the neurobiological and psychological effects of trauma and

Describe a prevention-based approach to reduction

Seclusion and Restraint Summary

The use of seclusion and restraint is associated with substantial harm to recipients of care including death Medical errors precede many seclusion and restraint events which in turn cause further errors and substantial harm to both recipients and providers of care Several local and national initiatives are underway to improve the safety of seclusion and restraint events and to decrease its use The results of their successful application can be seen in facilities in[88 109]

Pennsylvania

New York

Massachusetts

Maine

Florida

New Jersey and

South Dakota

Further study of causal antecedent events and of harm resulting from seclusion and restraint events is recommended using the patient safety paradigm and nomenclature

High-Risk Clinical Populations Lacking Adequate Patient Safety Research

Introduction to High-Risk Clinical Populations

There are no empirical data to quantify characterize or confirm medical errors in certain populations with mental illness andor substance abuse where multiple risk factors for error also exist A brief discussion of these populations and their risks for errors is provided below It is hoped that heightened focus on these high-risk populations will be an impetus for medical error research

Persons with Co-occurring Mental Illness and Substance Abuse

Individuals with co-occurring psychiatric and substance disorders have not been studied for medical errors yet they are perhaps at greater risk for harm because of the nature and number of their co-occurring disorders Several studies have reported the common occurrence of comorbidity among persons with a recognized diagnosis of either mental illness or substance abuse For example in 1990 Regier[74] found a lifetime prevalence of substance abuse among 62 of persons with bipolar disorder In 1996 Kessler and colleagues[113] reported a lifetime prevalence of 599 of psychiatric illness among persons with substance abuse disorders while 31 had a concurrent psychiatric disorder

Persons with co-occurring disorders are high utilizers of medical resources and therefore more exposed to systems issues that may predispose to unintended harm In 1995 an estimated 26 million (27) of the 965 million emergency department (ED) visits were related to alcohol abuse alone[114]

In a study by Dickey and associates[115] using data from the Massachusetts Division of Medical Assistance and death records from the Department of Public Health individuals with co-occurring psychiatric and substance use disorders had the highest risk of medical morbidity for 5 of the studied medical disorders Medicaid beneficiaries with dual diagnoses are 6 to 8 times more likely to die of injury primarily poisoning than their counterparts treated for medical conditions only[116117]

It is well-substantiated that persons with psychiatric and substance abuse disorders have higher rates of suicide attempts and death by suicide[118-123] In 2001[124]

20308 deaths were caused by homicide

30622 deaths by suicide and

101537 deaths were caused by accidents

Given the frequency with which substance abuse by itself has been implicated in these 3 causes of death the scope of morbidity and mortality related to co-occurring disorders is staggering

The effects of substance abuse disorders in adults also affected the mortality rates of children during 1985 to 1996 -- 8482 (24) of the 35547 children aged younger than 15 years died in alcohol-related motor vehicle crashes[125]

A subset of those with co-occurring disorders have substance dependence PTSD and chronic pain The presence of chronic pain and the complexities surrounding treatment of individuals with PTSD increase the risk for unintended harm and of a poor fit between clinical needs and the design of current healthcare systems Despite the added risk factors there is little science to direct clinicians A Medline search using substance abuse PTSD and chronic pain as search terms in June 2004 yielded 10 citations There were no incidence studies and no published treatment guidelines

Conclusion regarding co-occurring disorders Individuals with co-occurring disorders are frequently encountered and at risk for multiple diagnostic and treatment errors including

Missed mental health substance abuse and medical diagnoses and

Insufficient or excessive medication treatment of either their substance abuse or psychiatric disorder

Compared with the general population these individuals are at higher risk for

Suicide attempt

Death by suicide and

Death at a younger age by medical illness

There is a paucity of published studies on medical errors among individuals with co-occurring disorders despite several risk factors for unintended harm and high rates of morbidity and mortality

Attention Deficit-Hyperactivity Disorder in Children Excessive or Insufficient Diagnosis and Treatment

Inattentiveness distractibility impulsivity and hyperactivity were recognized as elements of minimal brain dysfunction (now termed attention deficit hyperactivity disorder [ADHD]) and treated with stimulants especially methylphenidate beginning in the late 1960s[101126127] Over the past 3 decades the rate of drug treatment for behavior problems has increased exponentially culminating in the prescription of ADHD drug treatment for at least 5-6 million American children annually[128]

Children diagnosed with ADHD have been the focus of thousands of research studies over the last 40 years yet the diagnosis and treatment of ADHD remain controversial among some within medicine and the general public[129130] Recent prevalence data from the 1998 National Institutes

of Health (NIH) consensus review[131] and reported by Jensen[132] suggest a prevalence of approximately 5 affecting 3 million school-aged children[133134]

ADHD is associated with[135-137]

Increased risk of accidents

Family and social dysfunction

Poor academic achievement

Substance abuse and

Antisocial behavior

Recent treatment data based on the number of methylphenidate prescriptions show an estimated 5-6 million American children receive ADHD-related drug treatment annually[128] Aggregate national methylphenidate use has increased 100-fold from 1960 until 2000 Globally nearly 90 of the worlds stimulant medication supply is consumed by the US population[138139]

Substantial state-to-state and community-to-community variability in methylphenidate use raises concerns about potential pockets of over- and under-diagnosis and over- and under-prescribing Drug Enforcement Association data on stimulant use reflect a 6-fold per capita variation in methylphenidate prescribing between some states[140] and a 20-fold prescribing variation between some communities[130141]

LeFever and colleagues argue that while the data are inconclusive if communities such as Salt Lake City Utah are used as a benchmark of acceptable diagnosis and treatment then children in 36 states may be subject to over-diagnosis and over-treatment Conversely Jensen argues that ADHD is under-diagnosed and under-treated based on national aggregate data allowing for pockets of over-diagnosis and treatment in some geographic areas[142] Given that in 1995 there were approximately 2 million pediatric visits in which ADHD was the focus of treatment and 6 million stimulant prescriptions were written[132] 1 conclusion is that 3 million children with ADHD received an average of 2 prescriptions and 1 outpatient visit during that year suggesting insufficient treatment In another study cited by Jensen the Multimodal Treatment Study of Children with ADHD two thirds of ADHD children from reportedly highly motivated families obtained medication treatments and for an average duration of only 8-14 months[142143]

Despite the number of studies done the strength of conclusions that can be drawn is contingent upon the adequacy of reported data Studies to date are variously limited by data sources sampling accuracy and interpretation[130]

When considered in aggregate national ADHD prevalence rates and numbers of prescriptions written do not suggest excessive diagnosis and treatment However prevalence rates and stimulant use can vary as much as 30-fold when comparing different communities A prevalence rate of 33 among white elementary-aged boys in southeastern Virginia significantly challenges credibility[130] Such variability makes it essential that prevalence rates and stimulant use estimates be linked to sufficient demographics such as

Geography

Age

Race and

Gender

ADHD prevalence rates and stimulant use appear to be

Excessive in some communities

Plausible in other communities and

Perhaps insufficient in yet other communities

Additional epidemiologic studies reporting prevalence rates with specific demographics rather than in aggregate and broader use of practice guidelines promulgated by the American Academy of Pediatrics (AAP) and others that advocate multimodal treatment rather than solely prescribing stimulants or other medications[130144] will help provide evidence of the extent of errors in the diagnosis and treatment of children with ADHD

Electroconvulsive Therapy

Electroconvulsive therapy (ECT) remains a controversial treatment in psychiatry As stated in the 1985 NIH Consensus Statement The nature of the treatment itself its history of abuse unfavorable media presentations compelling testimony of former patients special attention by the legal system uneven distribution of ECT use among practitioners and facilities and uneven access by patients all contribute to the controversial context in which the consensus panel has approached its task[145]

Epidemiologic data reported by Thompson and colleagues in 1994 found that[146]

58667 patients received ECT in 1975

31514 in 1980

36558 in 1986

71 of the patients who received ECT were women and

Individuals older than 65 years of age had the highest rates per number of inpatients

The rate of ECT use has been highly variable For example in 1995 Herman and associates[147] reported that among 202 metropolitan statistical areas annual ECT use varied from 04 to 812 patients per 10000 population

The most common adverse effect from ECT is memory loss In a recent review of patients perspectives as well as clinicians studies Rose and associates[148] concluded that 29 to 55 of ECT treatment recipients experienced persistent memory loss Recent empirical studies of ECT and memory loss continue to find persistent memory loss with bilateral ECT producing more profound memory deficits than right unilateral ECT[149]

In a review of deaths caused by ECT Abrams reported that ECT is 10 times safer than childbirth that approximately 6 times as many deaths annually in the US are caused by lightning as by ECTand that the death rate reported for ECT is an order of magnitude smaller than the spontaneous death rate in the general population[150]

Corroboration of a low ECT death rate has arisen from 1993 legislation in Texas mandating reporting of all ECT-related deaths[151] As a result the risk of death from ECT in Texas has been systematically tracked and reviewed More than 8000 patients received 49048 ECT treatments between 1993 and 1998 However only 1 death could be linked to the associated anesthesia An additional 4 deaths could plausibly have been associated with the anesthesia yielding a mortality rate between 2 and 10 per 100000 and the causes of death most likely were not the ECT stimulus or seizure

Emotional harm and erosion of faith in the medical profession that undermines accepting other needed treatments can come to recipients of care for whom the experience of ECT is frightening

ECT conclusion ECT is effective for severe major affective illness and is associated with a low mortality rate Persistent memory loss is a consistent finding despite attempts to optimize ECT administration and must be expected at an incidence of approximately 25 to 50 by those contemplating and those providing ECT treatment

Despite its relative safety ECT continues to cause alarm in the general public Even within medicine it is described as dangerous and unethical by some[152] Such fears can cause emotional harm among ECT recipients This may be especially true for older women (who comprise the majority of ECT subjects) some of whom may be accustomed to deferring to healthcare providers when consenting to treatment despite insufficient understanding of benefits and risks

Recommendations include

Emphasis on pre-treatment education

Collaborative relationship with ECT recipients

Increased transparency regarding the substantial risk of persistent memory loss when seeking informed consent and

Continued research on its safety

Systems Issues Related to Patient Safety

Outpatient Care

Risk of unintended harm may be increased by the segregated care settings in which psychiatric and substance abuse services are often delivered including solo practitioner offices and free-standing psychiatric and substance abuse treatment facilities[153154] and by insufficient communication and coordination of care between prescribers and psychotherapists[155-157] Despite the recognition of these potential contributing factors there are no existing reports of the association between systems issues and medical errors

Olfson[158] reported that in 1987 there were 84 million outpatient visits with mental health practitioners including

Psychiatrists

Psychologists

Social workers and

Licensed counselors

Kessler[154] reported in 1999 that an estimated 133 of a representative sample of Americans reported used outpatient services for mental health problems in the previous 12 months Clearly there are high numbers of individuals at risk for errors in outpatient mental health and substance abuse treatment

Ethics and Malpractice Risk Management Boundary Violations

A survey of recently published reviews and commentaries on patient safety reveals that for mental health and substance abuse issues such discussion takes place mainly within the context of ethics and malpractice risk management[159-162] Ethics statements from both the APA[162] and the American Psychological Association[163] support the duty to report and protect patients from deviations from the standards of care This approach uses the individual practitioners frame of reference and relies on voluntary reporting from professionals who have been trained to consider confidentiality a critical component of their work Harm caused by clinician boundary violations are understood as issues of professional misconduct not as errors resulting from system failure and that minimize the individual clinicians responsibility and advise against punitive action [164-167]

With the advent of therapeutic exchanges through email and other means of communication additional boundary violations are possible The Internet now has at least 110 million users including 70 million using it for health-related information[168] A recent survey indicated 40 to 50 of physicians use the Internet (or are preparing to use it) for clinical care[169]

There is a risk of errors of omission or commission arising from lack of coordination of care between clinicians Differences in therapeutic orientation and nomenclature used by the following specialists can compound systems issues that increase the risk of medical errors [158]

Social workers

Psychiatric nurse specialists

Psychologists

Licensed counselors and

Psychiatrists

Confidentiality is critical in providing effective treatment within the secure and private setting of the therapists office and in protecting the patient from unauthorized disclosures of sensitive information and potential abuse from a third party[170] However confidentiality can also inhibit disclosure of near misses impasses in treatment (for example when treatment is not working) and preventable adverse events due to avoidance of sharing important clinical information with other professionals and with appropriate family members and other supportive resources[171172]

The solo practice model commonly used by mental health clinicians can also inhibit the adoption of best practices and the development of policies and procedures to reduce risk because all such practice management activities are left to the individual clinician whose focus is more likely to be exclusively clinical

Summary About Systems Issues and Patient Safety

Systems for reliably reporting outpatient psychotherapy medical errors particularly among the large numbers of solo practitioners do not exist The prevailing paradigm for reducing harm arises from risk reduction in order to diminish medical liability exposure Studies that shed light on potential medical errors have arisen from risk management claims medical liability lawsuits and reports of death by suicide not from research intended to examine patient safety per se

Error reporting systems applicable to outpatient mental health settings including incentives for their use need to be developed Professional risk management programs primarily used to diminish medical liability exposure from the following could also be used to promulgate the relevance and value of the patient safety paradigm

Boundary violations

Suicide and

Treatment errors

Most particularly thought needs to be given to developing systems of error prevention applicable to the solo practitioner

Recommendations

Recommendation no 1

Widespread adoption of the IOM patient safety paradigm and nomenclature in mental health and substance abuse treatment settings is recommended

Advantages of its use include

Consistency with the nomenclature used by other medical specialties

Increased leverage in advocating for needed services and resources when the absence of essential treatments are quantified as errors of omission causing near misses or preventable adverse events

Increased likelihood that medication errors in mental health and substance abuse will be researched and a determination made whether such errors are causing preventable adverse events and

Increased awareness among mental health and substance abuse clinicians that patient harm can come from a broader array of errors in diagnosis and treatment than has been studied to date

Widespread adoption will require systematic educational efforts for trainees and current practitioners in mental health and substance abuse including systematic introduction to the IOMs existence mission and safety and quality efforts such as the Quality Chasm Series (Many mental health and substance abuse clinicians and administrators seem unaware of the IOM at all)

Recommendation no 2

Further studies of medical error in mental health and substance disorders are needed

Some areas of potential harm in this field remain largely unexamined For example we found only 2 studies of medication errors in mental health settings and none in substance abuse detoxification and stabilization settings despite multiple risk factors for errors and preventable adverse events The impact of variable education -- in pharmacology physiology and general medicine -- on the safety of prescribing practices has not been studied nor has the clinical consequences of formulary restrictions on clinical outcome and potential patient harm The current acceptance of self-reported hospital error rates must be challenged through a process of independently validating self-reported errors

Recommendation no 3

Integration of mental health and substance abuse services is recommended

High rates of co-occurrence and associated higher rates of morbidity and mortality among those with mental health and substance abuse disorders requires integration of mental health and substance abuse treatment paradigms This has not occurred to date

Recommendation no 4

The IOMs 10 rules for change in healthcare should be adopted

The 10 IOM rules for change in healthcare are as follows[173]

1 Care based on continuous healing relationships

2 Customization based on patient needs and values

3 The patient as the source of control

4 Shared knowledge and the free-flow of information

5 Evidence-based decision-making

6 Safety as a system property

7 The need for transparency

8 Anticipation of needs

9 Continuous decrease in waste

10 Cooperation among clinicians

As an example of adoption of these rules seclusion and restraint remain high risk treatments yet current reporting systems do not permit transparency regarding the rate and types of injuries incurred including mortality rates Such transparency requires a non-punitive work culture yet there is little evidence to suggest its adoption in high-risk environments such as state psychiatric hospitals or inpatient detoxification and stabilization substance abuse treatment settings

Recommendation no 5

Reporting systems in outpatient mental health and substance abuse treatment settings must be adopted

Reliance upon unsubstantiated self-reporting of medication errors in inpatient mental health and substance abuse settings remains a significant flaw when attempting accurate assessment of near misses and preventable adverse events and must be changed A key necessity is anonymous yet authenticated medication error reporting for all staff using available web-based error reporting systems Such systems are cost-savers and make reported error data immediately and continuously available Web-based reporting systems providing anonymity with authentication could be used for further seclusion and restraint data collection and as a means of establishing an outpatient error reporting system of safety and quality data by recipients and providers of outpatient treatment

Recommendation no 6

Resources should be allocated to study and develop practical interventions to improve patient safety

Much current research in mental health and substance abuse and resource appropriation is focused on efficacy of pharmacotherapy and psychotherapy and on establishing neurobiologic evidence to support causal theories of known clinical disorders At a policy level we recommend more consideration be given to funding practical interventions predicted to immediately improve patient safety

References

[ CLOSE WINDOW ]

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Authors and Disclosures

As an organization accredited by the ACCME Medscape LLC requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest The ACCME defines relevant financial relationships as financial relationships in any amount occurring within the past 12 months including financial relationships of a spouse or life partner that could create a conflict of interest

Medscape LLC encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration at first mention and where appropriate in the content

Author

Benjamin C Grasso MD

Staff Psychiatrist VA Clinic Saco Maine Disclosure Benjamin C Grasso MD has disclosed no relevant financial relationships

Cathryn M Clary MD MBA

Vice President US External Medical Affairs Pfizer Inc New York NY Disclosure Cathryn M Clary MD MBA has disclosed that she is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Benjamin Eng MD MA

Senior Medical Director Group Leader Pfizer Inc New York NY Disclosure Benjamin Eng MD MA has disclosed that he is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Stanley J Evans MD FASAM PA

Assistant Professor of Clinical Medicine St Matthews University Windham Maine

Medical Director Renaissance Institute of Palm Beach Boca Raton Florida Disclosure Stanley J Evans MD has disclosed no relevant financial relationships

Terry J Golash MD

Clinical Instructor Psychiatry Columbia University New York NY Assistant Attending St Lukersquos Roosevelt Hospital Center New York NY Disclosure Terry J Golash MD has disclosed no relevant financial relationships

Kevin Ann Huckshorn RN MSN CAP ICADC

Director Office of Technical Assistance National Association of State mental Health Program Directors Inc Alexandria Virginia Disclosure Kevin Ann Huckshorn RN MSN CAP ICADC has disclosed no relevant financial relationships

Kenneth Minkoff MD

Clinical Assistant Professor Department of Psychiatry Cambridge Hospital Harvard University Acton Massachusetts Consultant ZiaLogic Acton Massachusetts Disclosure Kenneth Minkoff MD has disclosed no relevant financial relationships

Joseph J Parks MD

Assistant Associate Professor Department of Psychiatry University of Missouri Columbia Missouri Disclosure Joseph J Parks MD has disclosed that he has received grants for educational activities from Letters amp Science and Physician Postgraduate Press Dr Parks has also disclosed that he has served as a consultant to the National Association of State Mental Health Program Directors and Bristol-Myers Squibb Dr Parks has also disclosed that he has received funds for services provided to the state of Missouri from Eli Lilly and Abbott

Miles F Shore MD

Bullard Distinguished Professor of Psychiatry Harvard Medical School Needham Massachusetts Junior Consultant Harvard Medical International Boston Massachusetts Disclosure Miles F Shore MD has disclosed no relevant financial relationships

Editor

Jacqueline A Hart MD

Freelance Clinical Editor Medscape LLC New York New York Disclosure Jacqueline A Hart MD has disclosed no relevant financial relationships

Elizabeth Saenger PhD

Editorial Director Medscape LLC New York NY Disclosure Elizabeth Saenger PhD has disclosed no relevant financial relationships

Registration for CME credit the post test and the evaluation must be completed online To access the activity Post Test and Evaluation link please go to httpwwwmedscapecomviewprogram7809_index

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Improper use of seclusion and restraint are dangerous

There is inadequate monitoring and reporting of its use and of resulting harm (or preventable adverse events) to patients

Serious injuries or death can occur and are underreported

Licensing and accreditation of seclusion and restraint standards are inconsistent and insufficient and

Successful strategies for preventing seclusion and restraint as well as reducing the risk of injury when use occurs are not widely used

Seclusion and restraint are commonly used practices intended to prevent adults and children with mental health and substance abuse diagnoses from harming themselves or others in inpatient or residential treatment environments Unfortunately access to incidence data collected by The National Association of State Mental Health Program Directors (NASMHPD) is controlled (and forbidden) by participating hospitals There are no published data interpreted as accurately reflecting the true incidence of seclusion and restraint use

The use of these interventions is intended to be severely restricted to individual situations in which an emergency safety need is identified but as use is generally ordered by staff and based on subjective criteria the use of these emergency interventions has a wide range [86] Restraint is defined in a variety of ways but the term generally refers to a manual method or mechanical device material or equipment attached or adjacent to the patients body that he or she cannot easily remove and that restricts the patients freedom or normal access to ones body[87] Seclusion refers to the involuntary confinement of a person in a room where they are physically prevented from leaving[88] Recent literature reviews of seclusion and restraint reflect the absence of[8990]

Substantiated prevention strategies

Indications for use

Application methods

Monitoring

Post-event activities and

Absence of evidence of its effectiveness in preventing harm

The Centers for Medicare and Medicaid Services (CMS) -- formerly known as the Healthcare Financing Administration (HCFA) the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and state licensing agencies have attempted to regulate the use of seclusion and restraint through licensing and accreditation standards[879192] However the Courant series the USGAO report and others have documented alarming rates of patient harm including death despite the application of such standards[818286] While efforts are underway to resolve these issues the appropriate and safe use of seclusion and restraint is far from assured[8693]

In recent years advocates consumers professional associations provider organizations and the legal field have increasingly recommended a reduction in the use of seclusion and restraint or even its elimination[83-86 94] These recommendations resonate with Recommendation no 1 in the IOMs Crossing the Quality Chasm that states All healthcare organizations professional groups

and private and public health purchasers should adopt as their explicit purpose to continually reduce the burden of illness injury and disability and to improve the health and functioning of the people of the United States[2] Using the IOMs medical error nomenclature reports about seclusion and restraint reflect high rates of medical errors mostly errors of commission perhaps errors of omission causing either near misses or preventable adverse events in routine clinical practice

Safety in healthcare practices is defined as keeping the patient free from accidental injury[2] Although not all errors cause injury accidental injury can be due to error either by the failure of a planned action to be completed as intended or use of the wrong plan to achieve an aim The improper use of seclusion and restraint is not safe and causes serious and preventable adverse injuries including death[8182] The media continues to report adverse events as well[9596] For example in 2000 3 deaths were reported just in Texas including that of 2 boys one 9 and the other 11 years old and a 16-year-old girl In South Carolina in 2003 a 9-year-old boy died after he kicked a staff member in the leg and ran down the hall which resulted in a take down and the boys asphyxiation In Arizona a 32-year-old woman died in restraints for behavior that was later judged as not meeting the threshold of imminent danger[96]

Reducing and Improving Seclusion and Restraint Events Recent Performance Improvement Initiatives

Several initiatives focused on seclusion and restraint reduction (embedded in public health prevention continuous quality improvement principles supporting recovery from mental illness and trauma-informed care) have been developed by the American Psychiatric Nurses Association the APA the National Association for Private Health Systems the American Hospital Association the National Alliance on Mental Illness (NAMI) and the Childrens Welfare League of America[2083859798] These initiatives are intended to complement other essential elements such as adequate numbers of well-trained staff and the use of proven psychological and medication treatments

The public health constructs of primary secondary and tertiary prevention create a logical framework and redirect the focus from safer use of seclusion and restraint to interventions that prevent its use[86] The model of recovery espoused by the Surgeon Generals Mental Health report necessitates[99]

System-wide transformation by adopting goals of full recovery in a life outside the hospital

Emphasis on instilling hope

Availability of multiple treatment options and

Development of partnerships with those who seek services

The use of controlling or coercive interventions is counterintuitive in this model and is to be avoided except perhaps as the last alternative in preventing death or significant harm to self or others caused by treatable manifestations of mental illness[94100] A growing understanding of the neurologic biologic psychological and social effects of trauma and its high prevalence in the populations that seek mental health services is informing approaches to assessment diagnosis stabilization and treatment of individuals with mental illness including the use of seclusion and restraint as a means of preventing injury to self or others[101-108]

Data should be analyzed for characteristics of facility usage by

Unit

Shift

Day and

Staff member involved

With rare exception data on individuals should be used confidentially to identify individual staff training needs not for disciplinary actions[88109] The facility needs to highlight data on seclusion and restraint use by graphing and posting this data on all units so that it is clearly visible for staff and consumers of service Facility-generated data on seclusion and restraint used in a non-punitive way provides for healthy competition among treatment units and elevates the general oversight and knowledge of use and outcomes for everyone involved[88109110] It allows and encourages administration to identify successful staff and treatment units so that successful improvements can be shared

A comprehensive national health information infrastructure could be a useful tool in reducing seclusion and restraint events[2111] The National Association of State Mental Health Program Directors Research Institute Inc (NRI) performance improvement system has developed a set of technology standards applications systems and values that include a number of recommendations for reducing seclusion and restraint events and making their occurrence less error prone[112]

Reduction of the use of seclusion and restraint must start with clear leadership and a specific plan that articulates a mission and philosophy about seclusion and restraint reduction and defines the roles and responsibilities of all facility staff[109] One core component is use of an executive on-call function and the daily review of the use of seclusion and restraint by executive leadership[88110]

Creating a treatment environment that prevents seclusion and restraint is based on the principles of recovery and the characteristics of trauma-informed systems of care[88109] Staff education needs to

Include the experiences of consumers and staff

Address the common myths associated with use

Introduce the rationale and characteristics of trauma-informed care

Educate on the neurobiological and psychological effects of trauma and

Describe a prevention-based approach to reduction

Seclusion and Restraint Summary

The use of seclusion and restraint is associated with substantial harm to recipients of care including death Medical errors precede many seclusion and restraint events which in turn cause further errors and substantial harm to both recipients and providers of care Several local and national initiatives are underway to improve the safety of seclusion and restraint events and to decrease its use The results of their successful application can be seen in facilities in[88 109]

Pennsylvania

New York

Massachusetts

Maine

Florida

New Jersey and

South Dakota

Further study of causal antecedent events and of harm resulting from seclusion and restraint events is recommended using the patient safety paradigm and nomenclature

High-Risk Clinical Populations Lacking Adequate Patient Safety Research

Introduction to High-Risk Clinical Populations

There are no empirical data to quantify characterize or confirm medical errors in certain populations with mental illness andor substance abuse where multiple risk factors for error also exist A brief discussion of these populations and their risks for errors is provided below It is hoped that heightened focus on these high-risk populations will be an impetus for medical error research

Persons with Co-occurring Mental Illness and Substance Abuse

Individuals with co-occurring psychiatric and substance disorders have not been studied for medical errors yet they are perhaps at greater risk for harm because of the nature and number of their co-occurring disorders Several studies have reported the common occurrence of comorbidity among persons with a recognized diagnosis of either mental illness or substance abuse For example in 1990 Regier[74] found a lifetime prevalence of substance abuse among 62 of persons with bipolar disorder In 1996 Kessler and colleagues[113] reported a lifetime prevalence of 599 of psychiatric illness among persons with substance abuse disorders while 31 had a concurrent psychiatric disorder

Persons with co-occurring disorders are high utilizers of medical resources and therefore more exposed to systems issues that may predispose to unintended harm In 1995 an estimated 26 million (27) of the 965 million emergency department (ED) visits were related to alcohol abuse alone[114]

In a study by Dickey and associates[115] using data from the Massachusetts Division of Medical Assistance and death records from the Department of Public Health individuals with co-occurring psychiatric and substance use disorders had the highest risk of medical morbidity for 5 of the studied medical disorders Medicaid beneficiaries with dual diagnoses are 6 to 8 times more likely to die of injury primarily poisoning than their counterparts treated for medical conditions only[116117]

It is well-substantiated that persons with psychiatric and substance abuse disorders have higher rates of suicide attempts and death by suicide[118-123] In 2001[124]

20308 deaths were caused by homicide

30622 deaths by suicide and

101537 deaths were caused by accidents

Given the frequency with which substance abuse by itself has been implicated in these 3 causes of death the scope of morbidity and mortality related to co-occurring disorders is staggering

The effects of substance abuse disorders in adults also affected the mortality rates of children during 1985 to 1996 -- 8482 (24) of the 35547 children aged younger than 15 years died in alcohol-related motor vehicle crashes[125]

A subset of those with co-occurring disorders have substance dependence PTSD and chronic pain The presence of chronic pain and the complexities surrounding treatment of individuals with PTSD increase the risk for unintended harm and of a poor fit between clinical needs and the design of current healthcare systems Despite the added risk factors there is little science to direct clinicians A Medline search using substance abuse PTSD and chronic pain as search terms in June 2004 yielded 10 citations There were no incidence studies and no published treatment guidelines

Conclusion regarding co-occurring disorders Individuals with co-occurring disorders are frequently encountered and at risk for multiple diagnostic and treatment errors including

Missed mental health substance abuse and medical diagnoses and

Insufficient or excessive medication treatment of either their substance abuse or psychiatric disorder

Compared with the general population these individuals are at higher risk for

Suicide attempt

Death by suicide and

Death at a younger age by medical illness

There is a paucity of published studies on medical errors among individuals with co-occurring disorders despite several risk factors for unintended harm and high rates of morbidity and mortality

Attention Deficit-Hyperactivity Disorder in Children Excessive or Insufficient Diagnosis and Treatment

Inattentiveness distractibility impulsivity and hyperactivity were recognized as elements of minimal brain dysfunction (now termed attention deficit hyperactivity disorder [ADHD]) and treated with stimulants especially methylphenidate beginning in the late 1960s[101126127] Over the past 3 decades the rate of drug treatment for behavior problems has increased exponentially culminating in the prescription of ADHD drug treatment for at least 5-6 million American children annually[128]

Children diagnosed with ADHD have been the focus of thousands of research studies over the last 40 years yet the diagnosis and treatment of ADHD remain controversial among some within medicine and the general public[129130] Recent prevalence data from the 1998 National Institutes

of Health (NIH) consensus review[131] and reported by Jensen[132] suggest a prevalence of approximately 5 affecting 3 million school-aged children[133134]

ADHD is associated with[135-137]

Increased risk of accidents

Family and social dysfunction

Poor academic achievement

Substance abuse and

Antisocial behavior

Recent treatment data based on the number of methylphenidate prescriptions show an estimated 5-6 million American children receive ADHD-related drug treatment annually[128] Aggregate national methylphenidate use has increased 100-fold from 1960 until 2000 Globally nearly 90 of the worlds stimulant medication supply is consumed by the US population[138139]

Substantial state-to-state and community-to-community variability in methylphenidate use raises concerns about potential pockets of over- and under-diagnosis and over- and under-prescribing Drug Enforcement Association data on stimulant use reflect a 6-fold per capita variation in methylphenidate prescribing between some states[140] and a 20-fold prescribing variation between some communities[130141]

LeFever and colleagues argue that while the data are inconclusive if communities such as Salt Lake City Utah are used as a benchmark of acceptable diagnosis and treatment then children in 36 states may be subject to over-diagnosis and over-treatment Conversely Jensen argues that ADHD is under-diagnosed and under-treated based on national aggregate data allowing for pockets of over-diagnosis and treatment in some geographic areas[142] Given that in 1995 there were approximately 2 million pediatric visits in which ADHD was the focus of treatment and 6 million stimulant prescriptions were written[132] 1 conclusion is that 3 million children with ADHD received an average of 2 prescriptions and 1 outpatient visit during that year suggesting insufficient treatment In another study cited by Jensen the Multimodal Treatment Study of Children with ADHD two thirds of ADHD children from reportedly highly motivated families obtained medication treatments and for an average duration of only 8-14 months[142143]

Despite the number of studies done the strength of conclusions that can be drawn is contingent upon the adequacy of reported data Studies to date are variously limited by data sources sampling accuracy and interpretation[130]

When considered in aggregate national ADHD prevalence rates and numbers of prescriptions written do not suggest excessive diagnosis and treatment However prevalence rates and stimulant use can vary as much as 30-fold when comparing different communities A prevalence rate of 33 among white elementary-aged boys in southeastern Virginia significantly challenges credibility[130] Such variability makes it essential that prevalence rates and stimulant use estimates be linked to sufficient demographics such as

Geography

Age

Race and

Gender

ADHD prevalence rates and stimulant use appear to be

Excessive in some communities

Plausible in other communities and

Perhaps insufficient in yet other communities

Additional epidemiologic studies reporting prevalence rates with specific demographics rather than in aggregate and broader use of practice guidelines promulgated by the American Academy of Pediatrics (AAP) and others that advocate multimodal treatment rather than solely prescribing stimulants or other medications[130144] will help provide evidence of the extent of errors in the diagnosis and treatment of children with ADHD

Electroconvulsive Therapy

Electroconvulsive therapy (ECT) remains a controversial treatment in psychiatry As stated in the 1985 NIH Consensus Statement The nature of the treatment itself its history of abuse unfavorable media presentations compelling testimony of former patients special attention by the legal system uneven distribution of ECT use among practitioners and facilities and uneven access by patients all contribute to the controversial context in which the consensus panel has approached its task[145]

Epidemiologic data reported by Thompson and colleagues in 1994 found that[146]

58667 patients received ECT in 1975

31514 in 1980

36558 in 1986

71 of the patients who received ECT were women and

Individuals older than 65 years of age had the highest rates per number of inpatients

The rate of ECT use has been highly variable For example in 1995 Herman and associates[147] reported that among 202 metropolitan statistical areas annual ECT use varied from 04 to 812 patients per 10000 population

The most common adverse effect from ECT is memory loss In a recent review of patients perspectives as well as clinicians studies Rose and associates[148] concluded that 29 to 55 of ECT treatment recipients experienced persistent memory loss Recent empirical studies of ECT and memory loss continue to find persistent memory loss with bilateral ECT producing more profound memory deficits than right unilateral ECT[149]

In a review of deaths caused by ECT Abrams reported that ECT is 10 times safer than childbirth that approximately 6 times as many deaths annually in the US are caused by lightning as by ECTand that the death rate reported for ECT is an order of magnitude smaller than the spontaneous death rate in the general population[150]

Corroboration of a low ECT death rate has arisen from 1993 legislation in Texas mandating reporting of all ECT-related deaths[151] As a result the risk of death from ECT in Texas has been systematically tracked and reviewed More than 8000 patients received 49048 ECT treatments between 1993 and 1998 However only 1 death could be linked to the associated anesthesia An additional 4 deaths could plausibly have been associated with the anesthesia yielding a mortality rate between 2 and 10 per 100000 and the causes of death most likely were not the ECT stimulus or seizure

Emotional harm and erosion of faith in the medical profession that undermines accepting other needed treatments can come to recipients of care for whom the experience of ECT is frightening

ECT conclusion ECT is effective for severe major affective illness and is associated with a low mortality rate Persistent memory loss is a consistent finding despite attempts to optimize ECT administration and must be expected at an incidence of approximately 25 to 50 by those contemplating and those providing ECT treatment

Despite its relative safety ECT continues to cause alarm in the general public Even within medicine it is described as dangerous and unethical by some[152] Such fears can cause emotional harm among ECT recipients This may be especially true for older women (who comprise the majority of ECT subjects) some of whom may be accustomed to deferring to healthcare providers when consenting to treatment despite insufficient understanding of benefits and risks

Recommendations include

Emphasis on pre-treatment education

Collaborative relationship with ECT recipients

Increased transparency regarding the substantial risk of persistent memory loss when seeking informed consent and

Continued research on its safety

Systems Issues Related to Patient Safety

Outpatient Care

Risk of unintended harm may be increased by the segregated care settings in which psychiatric and substance abuse services are often delivered including solo practitioner offices and free-standing psychiatric and substance abuse treatment facilities[153154] and by insufficient communication and coordination of care between prescribers and psychotherapists[155-157] Despite the recognition of these potential contributing factors there are no existing reports of the association between systems issues and medical errors

Olfson[158] reported that in 1987 there were 84 million outpatient visits with mental health practitioners including

Psychiatrists

Psychologists

Social workers and

Licensed counselors

Kessler[154] reported in 1999 that an estimated 133 of a representative sample of Americans reported used outpatient services for mental health problems in the previous 12 months Clearly there are high numbers of individuals at risk for errors in outpatient mental health and substance abuse treatment

Ethics and Malpractice Risk Management Boundary Violations

A survey of recently published reviews and commentaries on patient safety reveals that for mental health and substance abuse issues such discussion takes place mainly within the context of ethics and malpractice risk management[159-162] Ethics statements from both the APA[162] and the American Psychological Association[163] support the duty to report and protect patients from deviations from the standards of care This approach uses the individual practitioners frame of reference and relies on voluntary reporting from professionals who have been trained to consider confidentiality a critical component of their work Harm caused by clinician boundary violations are understood as issues of professional misconduct not as errors resulting from system failure and that minimize the individual clinicians responsibility and advise against punitive action [164-167]

With the advent of therapeutic exchanges through email and other means of communication additional boundary violations are possible The Internet now has at least 110 million users including 70 million using it for health-related information[168] A recent survey indicated 40 to 50 of physicians use the Internet (or are preparing to use it) for clinical care[169]

There is a risk of errors of omission or commission arising from lack of coordination of care between clinicians Differences in therapeutic orientation and nomenclature used by the following specialists can compound systems issues that increase the risk of medical errors [158]

Social workers

Psychiatric nurse specialists

Psychologists

Licensed counselors and

Psychiatrists

Confidentiality is critical in providing effective treatment within the secure and private setting of the therapists office and in protecting the patient from unauthorized disclosures of sensitive information and potential abuse from a third party[170] However confidentiality can also inhibit disclosure of near misses impasses in treatment (for example when treatment is not working) and preventable adverse events due to avoidance of sharing important clinical information with other professionals and with appropriate family members and other supportive resources[171172]

The solo practice model commonly used by mental health clinicians can also inhibit the adoption of best practices and the development of policies and procedures to reduce risk because all such practice management activities are left to the individual clinician whose focus is more likely to be exclusively clinical

Summary About Systems Issues and Patient Safety

Systems for reliably reporting outpatient psychotherapy medical errors particularly among the large numbers of solo practitioners do not exist The prevailing paradigm for reducing harm arises from risk reduction in order to diminish medical liability exposure Studies that shed light on potential medical errors have arisen from risk management claims medical liability lawsuits and reports of death by suicide not from research intended to examine patient safety per se

Error reporting systems applicable to outpatient mental health settings including incentives for their use need to be developed Professional risk management programs primarily used to diminish medical liability exposure from the following could also be used to promulgate the relevance and value of the patient safety paradigm

Boundary violations

Suicide and

Treatment errors

Most particularly thought needs to be given to developing systems of error prevention applicable to the solo practitioner

Recommendations

Recommendation no 1

Widespread adoption of the IOM patient safety paradigm and nomenclature in mental health and substance abuse treatment settings is recommended

Advantages of its use include

Consistency with the nomenclature used by other medical specialties

Increased leverage in advocating for needed services and resources when the absence of essential treatments are quantified as errors of omission causing near misses or preventable adverse events

Increased likelihood that medication errors in mental health and substance abuse will be researched and a determination made whether such errors are causing preventable adverse events and

Increased awareness among mental health and substance abuse clinicians that patient harm can come from a broader array of errors in diagnosis and treatment than has been studied to date

Widespread adoption will require systematic educational efforts for trainees and current practitioners in mental health and substance abuse including systematic introduction to the IOMs existence mission and safety and quality efforts such as the Quality Chasm Series (Many mental health and substance abuse clinicians and administrators seem unaware of the IOM at all)

Recommendation no 2

Further studies of medical error in mental health and substance disorders are needed

Some areas of potential harm in this field remain largely unexamined For example we found only 2 studies of medication errors in mental health settings and none in substance abuse detoxification and stabilization settings despite multiple risk factors for errors and preventable adverse events The impact of variable education -- in pharmacology physiology and general medicine -- on the safety of prescribing practices has not been studied nor has the clinical consequences of formulary restrictions on clinical outcome and potential patient harm The current acceptance of self-reported hospital error rates must be challenged through a process of independently validating self-reported errors

Recommendation no 3

Integration of mental health and substance abuse services is recommended

High rates of co-occurrence and associated higher rates of morbidity and mortality among those with mental health and substance abuse disorders requires integration of mental health and substance abuse treatment paradigms This has not occurred to date

Recommendation no 4

The IOMs 10 rules for change in healthcare should be adopted

The 10 IOM rules for change in healthcare are as follows[173]

1 Care based on continuous healing relationships

2 Customization based on patient needs and values

3 The patient as the source of control

4 Shared knowledge and the free-flow of information

5 Evidence-based decision-making

6 Safety as a system property

7 The need for transparency

8 Anticipation of needs

9 Continuous decrease in waste

10 Cooperation among clinicians

As an example of adoption of these rules seclusion and restraint remain high risk treatments yet current reporting systems do not permit transparency regarding the rate and types of injuries incurred including mortality rates Such transparency requires a non-punitive work culture yet there is little evidence to suggest its adoption in high-risk environments such as state psychiatric hospitals or inpatient detoxification and stabilization substance abuse treatment settings

Recommendation no 5

Reporting systems in outpatient mental health and substance abuse treatment settings must be adopted

Reliance upon unsubstantiated self-reporting of medication errors in inpatient mental health and substance abuse settings remains a significant flaw when attempting accurate assessment of near misses and preventable adverse events and must be changed A key necessity is anonymous yet authenticated medication error reporting for all staff using available web-based error reporting systems Such systems are cost-savers and make reported error data immediately and continuously available Web-based reporting systems providing anonymity with authentication could be used for further seclusion and restraint data collection and as a means of establishing an outpatient error reporting system of safety and quality data by recipients and providers of outpatient treatment

Recommendation no 6

Resources should be allocated to study and develop practical interventions to improve patient safety

Much current research in mental health and substance abuse and resource appropriation is focused on efficacy of pharmacotherapy and psychotherapy and on establishing neurobiologic evidence to support causal theories of known clinical disorders At a policy level we recommend more consideration be given to funding practical interventions predicted to immediately improve patient safety

References

[ CLOSE WINDOW ]

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Authors and Disclosures

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Author

Benjamin C Grasso MD

Staff Psychiatrist VA Clinic Saco Maine Disclosure Benjamin C Grasso MD has disclosed no relevant financial relationships

Cathryn M Clary MD MBA

Vice President US External Medical Affairs Pfizer Inc New York NY Disclosure Cathryn M Clary MD MBA has disclosed that she is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Benjamin Eng MD MA

Senior Medical Director Group Leader Pfizer Inc New York NY Disclosure Benjamin Eng MD MA has disclosed that he is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Stanley J Evans MD FASAM PA

Assistant Professor of Clinical Medicine St Matthews University Windham Maine

Medical Director Renaissance Institute of Palm Beach Boca Raton Florida Disclosure Stanley J Evans MD has disclosed no relevant financial relationships

Terry J Golash MD

Clinical Instructor Psychiatry Columbia University New York NY Assistant Attending St Lukersquos Roosevelt Hospital Center New York NY Disclosure Terry J Golash MD has disclosed no relevant financial relationships

Kevin Ann Huckshorn RN MSN CAP ICADC

Director Office of Technical Assistance National Association of State mental Health Program Directors Inc Alexandria Virginia Disclosure Kevin Ann Huckshorn RN MSN CAP ICADC has disclosed no relevant financial relationships

Kenneth Minkoff MD

Clinical Assistant Professor Department of Psychiatry Cambridge Hospital Harvard University Acton Massachusetts Consultant ZiaLogic Acton Massachusetts Disclosure Kenneth Minkoff MD has disclosed no relevant financial relationships

Joseph J Parks MD

Assistant Associate Professor Department of Psychiatry University of Missouri Columbia Missouri Disclosure Joseph J Parks MD has disclosed that he has received grants for educational activities from Letters amp Science and Physician Postgraduate Press Dr Parks has also disclosed that he has served as a consultant to the National Association of State Mental Health Program Directors and Bristol-Myers Squibb Dr Parks has also disclosed that he has received funds for services provided to the state of Missouri from Eli Lilly and Abbott

Miles F Shore MD

Bullard Distinguished Professor of Psychiatry Harvard Medical School Needham Massachusetts Junior Consultant Harvard Medical International Boston Massachusetts Disclosure Miles F Shore MD has disclosed no relevant financial relationships

Editor

Jacqueline A Hart MD

Freelance Clinical Editor Medscape LLC New York New York Disclosure Jacqueline A Hart MD has disclosed no relevant financial relationships

Elizabeth Saenger PhD

Editorial Director Medscape LLC New York NY Disclosure Elizabeth Saenger PhD has disclosed no relevant financial relationships

Registration for CME credit the post test and the evaluation must be completed online To access the activity Post Test and Evaluation link please go to httpwwwmedscapecomviewprogram7809_index

Page 13: Medication Errors and Patient Safety in Mental Health CME/CE · 2019. 6. 27. · Medication Errors and Patient Safety in Mental Health CME/CE Complete author affiliations and disclosures

and private and public health purchasers should adopt as their explicit purpose to continually reduce the burden of illness injury and disability and to improve the health and functioning of the people of the United States[2] Using the IOMs medical error nomenclature reports about seclusion and restraint reflect high rates of medical errors mostly errors of commission perhaps errors of omission causing either near misses or preventable adverse events in routine clinical practice

Safety in healthcare practices is defined as keeping the patient free from accidental injury[2] Although not all errors cause injury accidental injury can be due to error either by the failure of a planned action to be completed as intended or use of the wrong plan to achieve an aim The improper use of seclusion and restraint is not safe and causes serious and preventable adverse injuries including death[8182] The media continues to report adverse events as well[9596] For example in 2000 3 deaths were reported just in Texas including that of 2 boys one 9 and the other 11 years old and a 16-year-old girl In South Carolina in 2003 a 9-year-old boy died after he kicked a staff member in the leg and ran down the hall which resulted in a take down and the boys asphyxiation In Arizona a 32-year-old woman died in restraints for behavior that was later judged as not meeting the threshold of imminent danger[96]

Reducing and Improving Seclusion and Restraint Events Recent Performance Improvement Initiatives

Several initiatives focused on seclusion and restraint reduction (embedded in public health prevention continuous quality improvement principles supporting recovery from mental illness and trauma-informed care) have been developed by the American Psychiatric Nurses Association the APA the National Association for Private Health Systems the American Hospital Association the National Alliance on Mental Illness (NAMI) and the Childrens Welfare League of America[2083859798] These initiatives are intended to complement other essential elements such as adequate numbers of well-trained staff and the use of proven psychological and medication treatments

The public health constructs of primary secondary and tertiary prevention create a logical framework and redirect the focus from safer use of seclusion and restraint to interventions that prevent its use[86] The model of recovery espoused by the Surgeon Generals Mental Health report necessitates[99]

System-wide transformation by adopting goals of full recovery in a life outside the hospital

Emphasis on instilling hope

Availability of multiple treatment options and

Development of partnerships with those who seek services

The use of controlling or coercive interventions is counterintuitive in this model and is to be avoided except perhaps as the last alternative in preventing death or significant harm to self or others caused by treatable manifestations of mental illness[94100] A growing understanding of the neurologic biologic psychological and social effects of trauma and its high prevalence in the populations that seek mental health services is informing approaches to assessment diagnosis stabilization and treatment of individuals with mental illness including the use of seclusion and restraint as a means of preventing injury to self or others[101-108]

Data should be analyzed for characteristics of facility usage by

Unit

Shift

Day and

Staff member involved

With rare exception data on individuals should be used confidentially to identify individual staff training needs not for disciplinary actions[88109] The facility needs to highlight data on seclusion and restraint use by graphing and posting this data on all units so that it is clearly visible for staff and consumers of service Facility-generated data on seclusion and restraint used in a non-punitive way provides for healthy competition among treatment units and elevates the general oversight and knowledge of use and outcomes for everyone involved[88109110] It allows and encourages administration to identify successful staff and treatment units so that successful improvements can be shared

A comprehensive national health information infrastructure could be a useful tool in reducing seclusion and restraint events[2111] The National Association of State Mental Health Program Directors Research Institute Inc (NRI) performance improvement system has developed a set of technology standards applications systems and values that include a number of recommendations for reducing seclusion and restraint events and making their occurrence less error prone[112]

Reduction of the use of seclusion and restraint must start with clear leadership and a specific plan that articulates a mission and philosophy about seclusion and restraint reduction and defines the roles and responsibilities of all facility staff[109] One core component is use of an executive on-call function and the daily review of the use of seclusion and restraint by executive leadership[88110]

Creating a treatment environment that prevents seclusion and restraint is based on the principles of recovery and the characteristics of trauma-informed systems of care[88109] Staff education needs to

Include the experiences of consumers and staff

Address the common myths associated with use

Introduce the rationale and characteristics of trauma-informed care

Educate on the neurobiological and psychological effects of trauma and

Describe a prevention-based approach to reduction

Seclusion and Restraint Summary

The use of seclusion and restraint is associated with substantial harm to recipients of care including death Medical errors precede many seclusion and restraint events which in turn cause further errors and substantial harm to both recipients and providers of care Several local and national initiatives are underway to improve the safety of seclusion and restraint events and to decrease its use The results of their successful application can be seen in facilities in[88 109]

Pennsylvania

New York

Massachusetts

Maine

Florida

New Jersey and

South Dakota

Further study of causal antecedent events and of harm resulting from seclusion and restraint events is recommended using the patient safety paradigm and nomenclature

High-Risk Clinical Populations Lacking Adequate Patient Safety Research

Introduction to High-Risk Clinical Populations

There are no empirical data to quantify characterize or confirm medical errors in certain populations with mental illness andor substance abuse where multiple risk factors for error also exist A brief discussion of these populations and their risks for errors is provided below It is hoped that heightened focus on these high-risk populations will be an impetus for medical error research

Persons with Co-occurring Mental Illness and Substance Abuse

Individuals with co-occurring psychiatric and substance disorders have not been studied for medical errors yet they are perhaps at greater risk for harm because of the nature and number of their co-occurring disorders Several studies have reported the common occurrence of comorbidity among persons with a recognized diagnosis of either mental illness or substance abuse For example in 1990 Regier[74] found a lifetime prevalence of substance abuse among 62 of persons with bipolar disorder In 1996 Kessler and colleagues[113] reported a lifetime prevalence of 599 of psychiatric illness among persons with substance abuse disorders while 31 had a concurrent psychiatric disorder

Persons with co-occurring disorders are high utilizers of medical resources and therefore more exposed to systems issues that may predispose to unintended harm In 1995 an estimated 26 million (27) of the 965 million emergency department (ED) visits were related to alcohol abuse alone[114]

In a study by Dickey and associates[115] using data from the Massachusetts Division of Medical Assistance and death records from the Department of Public Health individuals with co-occurring psychiatric and substance use disorders had the highest risk of medical morbidity for 5 of the studied medical disorders Medicaid beneficiaries with dual diagnoses are 6 to 8 times more likely to die of injury primarily poisoning than their counterparts treated for medical conditions only[116117]

It is well-substantiated that persons with psychiatric and substance abuse disorders have higher rates of suicide attempts and death by suicide[118-123] In 2001[124]

20308 deaths were caused by homicide

30622 deaths by suicide and

101537 deaths were caused by accidents

Given the frequency with which substance abuse by itself has been implicated in these 3 causes of death the scope of morbidity and mortality related to co-occurring disorders is staggering

The effects of substance abuse disorders in adults also affected the mortality rates of children during 1985 to 1996 -- 8482 (24) of the 35547 children aged younger than 15 years died in alcohol-related motor vehicle crashes[125]

A subset of those with co-occurring disorders have substance dependence PTSD and chronic pain The presence of chronic pain and the complexities surrounding treatment of individuals with PTSD increase the risk for unintended harm and of a poor fit between clinical needs and the design of current healthcare systems Despite the added risk factors there is little science to direct clinicians A Medline search using substance abuse PTSD and chronic pain as search terms in June 2004 yielded 10 citations There were no incidence studies and no published treatment guidelines

Conclusion regarding co-occurring disorders Individuals with co-occurring disorders are frequently encountered and at risk for multiple diagnostic and treatment errors including

Missed mental health substance abuse and medical diagnoses and

Insufficient or excessive medication treatment of either their substance abuse or psychiatric disorder

Compared with the general population these individuals are at higher risk for

Suicide attempt

Death by suicide and

Death at a younger age by medical illness

There is a paucity of published studies on medical errors among individuals with co-occurring disorders despite several risk factors for unintended harm and high rates of morbidity and mortality

Attention Deficit-Hyperactivity Disorder in Children Excessive or Insufficient Diagnosis and Treatment

Inattentiveness distractibility impulsivity and hyperactivity were recognized as elements of minimal brain dysfunction (now termed attention deficit hyperactivity disorder [ADHD]) and treated with stimulants especially methylphenidate beginning in the late 1960s[101126127] Over the past 3 decades the rate of drug treatment for behavior problems has increased exponentially culminating in the prescription of ADHD drug treatment for at least 5-6 million American children annually[128]

Children diagnosed with ADHD have been the focus of thousands of research studies over the last 40 years yet the diagnosis and treatment of ADHD remain controversial among some within medicine and the general public[129130] Recent prevalence data from the 1998 National Institutes

of Health (NIH) consensus review[131] and reported by Jensen[132] suggest a prevalence of approximately 5 affecting 3 million school-aged children[133134]

ADHD is associated with[135-137]

Increased risk of accidents

Family and social dysfunction

Poor academic achievement

Substance abuse and

Antisocial behavior

Recent treatment data based on the number of methylphenidate prescriptions show an estimated 5-6 million American children receive ADHD-related drug treatment annually[128] Aggregate national methylphenidate use has increased 100-fold from 1960 until 2000 Globally nearly 90 of the worlds stimulant medication supply is consumed by the US population[138139]

Substantial state-to-state and community-to-community variability in methylphenidate use raises concerns about potential pockets of over- and under-diagnosis and over- and under-prescribing Drug Enforcement Association data on stimulant use reflect a 6-fold per capita variation in methylphenidate prescribing between some states[140] and a 20-fold prescribing variation between some communities[130141]

LeFever and colleagues argue that while the data are inconclusive if communities such as Salt Lake City Utah are used as a benchmark of acceptable diagnosis and treatment then children in 36 states may be subject to over-diagnosis and over-treatment Conversely Jensen argues that ADHD is under-diagnosed and under-treated based on national aggregate data allowing for pockets of over-diagnosis and treatment in some geographic areas[142] Given that in 1995 there were approximately 2 million pediatric visits in which ADHD was the focus of treatment and 6 million stimulant prescriptions were written[132] 1 conclusion is that 3 million children with ADHD received an average of 2 prescriptions and 1 outpatient visit during that year suggesting insufficient treatment In another study cited by Jensen the Multimodal Treatment Study of Children with ADHD two thirds of ADHD children from reportedly highly motivated families obtained medication treatments and for an average duration of only 8-14 months[142143]

Despite the number of studies done the strength of conclusions that can be drawn is contingent upon the adequacy of reported data Studies to date are variously limited by data sources sampling accuracy and interpretation[130]

When considered in aggregate national ADHD prevalence rates and numbers of prescriptions written do not suggest excessive diagnosis and treatment However prevalence rates and stimulant use can vary as much as 30-fold when comparing different communities A prevalence rate of 33 among white elementary-aged boys in southeastern Virginia significantly challenges credibility[130] Such variability makes it essential that prevalence rates and stimulant use estimates be linked to sufficient demographics such as

Geography

Age

Race and

Gender

ADHD prevalence rates and stimulant use appear to be

Excessive in some communities

Plausible in other communities and

Perhaps insufficient in yet other communities

Additional epidemiologic studies reporting prevalence rates with specific demographics rather than in aggregate and broader use of practice guidelines promulgated by the American Academy of Pediatrics (AAP) and others that advocate multimodal treatment rather than solely prescribing stimulants or other medications[130144] will help provide evidence of the extent of errors in the diagnosis and treatment of children with ADHD

Electroconvulsive Therapy

Electroconvulsive therapy (ECT) remains a controversial treatment in psychiatry As stated in the 1985 NIH Consensus Statement The nature of the treatment itself its history of abuse unfavorable media presentations compelling testimony of former patients special attention by the legal system uneven distribution of ECT use among practitioners and facilities and uneven access by patients all contribute to the controversial context in which the consensus panel has approached its task[145]

Epidemiologic data reported by Thompson and colleagues in 1994 found that[146]

58667 patients received ECT in 1975

31514 in 1980

36558 in 1986

71 of the patients who received ECT were women and

Individuals older than 65 years of age had the highest rates per number of inpatients

The rate of ECT use has been highly variable For example in 1995 Herman and associates[147] reported that among 202 metropolitan statistical areas annual ECT use varied from 04 to 812 patients per 10000 population

The most common adverse effect from ECT is memory loss In a recent review of patients perspectives as well as clinicians studies Rose and associates[148] concluded that 29 to 55 of ECT treatment recipients experienced persistent memory loss Recent empirical studies of ECT and memory loss continue to find persistent memory loss with bilateral ECT producing more profound memory deficits than right unilateral ECT[149]

In a review of deaths caused by ECT Abrams reported that ECT is 10 times safer than childbirth that approximately 6 times as many deaths annually in the US are caused by lightning as by ECTand that the death rate reported for ECT is an order of magnitude smaller than the spontaneous death rate in the general population[150]

Corroboration of a low ECT death rate has arisen from 1993 legislation in Texas mandating reporting of all ECT-related deaths[151] As a result the risk of death from ECT in Texas has been systematically tracked and reviewed More than 8000 patients received 49048 ECT treatments between 1993 and 1998 However only 1 death could be linked to the associated anesthesia An additional 4 deaths could plausibly have been associated with the anesthesia yielding a mortality rate between 2 and 10 per 100000 and the causes of death most likely were not the ECT stimulus or seizure

Emotional harm and erosion of faith in the medical profession that undermines accepting other needed treatments can come to recipients of care for whom the experience of ECT is frightening

ECT conclusion ECT is effective for severe major affective illness and is associated with a low mortality rate Persistent memory loss is a consistent finding despite attempts to optimize ECT administration and must be expected at an incidence of approximately 25 to 50 by those contemplating and those providing ECT treatment

Despite its relative safety ECT continues to cause alarm in the general public Even within medicine it is described as dangerous and unethical by some[152] Such fears can cause emotional harm among ECT recipients This may be especially true for older women (who comprise the majority of ECT subjects) some of whom may be accustomed to deferring to healthcare providers when consenting to treatment despite insufficient understanding of benefits and risks

Recommendations include

Emphasis on pre-treatment education

Collaborative relationship with ECT recipients

Increased transparency regarding the substantial risk of persistent memory loss when seeking informed consent and

Continued research on its safety

Systems Issues Related to Patient Safety

Outpatient Care

Risk of unintended harm may be increased by the segregated care settings in which psychiatric and substance abuse services are often delivered including solo practitioner offices and free-standing psychiatric and substance abuse treatment facilities[153154] and by insufficient communication and coordination of care between prescribers and psychotherapists[155-157] Despite the recognition of these potential contributing factors there are no existing reports of the association between systems issues and medical errors

Olfson[158] reported that in 1987 there were 84 million outpatient visits with mental health practitioners including

Psychiatrists

Psychologists

Social workers and

Licensed counselors

Kessler[154] reported in 1999 that an estimated 133 of a representative sample of Americans reported used outpatient services for mental health problems in the previous 12 months Clearly there are high numbers of individuals at risk for errors in outpatient mental health and substance abuse treatment

Ethics and Malpractice Risk Management Boundary Violations

A survey of recently published reviews and commentaries on patient safety reveals that for mental health and substance abuse issues such discussion takes place mainly within the context of ethics and malpractice risk management[159-162] Ethics statements from both the APA[162] and the American Psychological Association[163] support the duty to report and protect patients from deviations from the standards of care This approach uses the individual practitioners frame of reference and relies on voluntary reporting from professionals who have been trained to consider confidentiality a critical component of their work Harm caused by clinician boundary violations are understood as issues of professional misconduct not as errors resulting from system failure and that minimize the individual clinicians responsibility and advise against punitive action [164-167]

With the advent of therapeutic exchanges through email and other means of communication additional boundary violations are possible The Internet now has at least 110 million users including 70 million using it for health-related information[168] A recent survey indicated 40 to 50 of physicians use the Internet (or are preparing to use it) for clinical care[169]

There is a risk of errors of omission or commission arising from lack of coordination of care between clinicians Differences in therapeutic orientation and nomenclature used by the following specialists can compound systems issues that increase the risk of medical errors [158]

Social workers

Psychiatric nurse specialists

Psychologists

Licensed counselors and

Psychiatrists

Confidentiality is critical in providing effective treatment within the secure and private setting of the therapists office and in protecting the patient from unauthorized disclosures of sensitive information and potential abuse from a third party[170] However confidentiality can also inhibit disclosure of near misses impasses in treatment (for example when treatment is not working) and preventable adverse events due to avoidance of sharing important clinical information with other professionals and with appropriate family members and other supportive resources[171172]

The solo practice model commonly used by mental health clinicians can also inhibit the adoption of best practices and the development of policies and procedures to reduce risk because all such practice management activities are left to the individual clinician whose focus is more likely to be exclusively clinical

Summary About Systems Issues and Patient Safety

Systems for reliably reporting outpatient psychotherapy medical errors particularly among the large numbers of solo practitioners do not exist The prevailing paradigm for reducing harm arises from risk reduction in order to diminish medical liability exposure Studies that shed light on potential medical errors have arisen from risk management claims medical liability lawsuits and reports of death by suicide not from research intended to examine patient safety per se

Error reporting systems applicable to outpatient mental health settings including incentives for their use need to be developed Professional risk management programs primarily used to diminish medical liability exposure from the following could also be used to promulgate the relevance and value of the patient safety paradigm

Boundary violations

Suicide and

Treatment errors

Most particularly thought needs to be given to developing systems of error prevention applicable to the solo practitioner

Recommendations

Recommendation no 1

Widespread adoption of the IOM patient safety paradigm and nomenclature in mental health and substance abuse treatment settings is recommended

Advantages of its use include

Consistency with the nomenclature used by other medical specialties

Increased leverage in advocating for needed services and resources when the absence of essential treatments are quantified as errors of omission causing near misses or preventable adverse events

Increased likelihood that medication errors in mental health and substance abuse will be researched and a determination made whether such errors are causing preventable adverse events and

Increased awareness among mental health and substance abuse clinicians that patient harm can come from a broader array of errors in diagnosis and treatment than has been studied to date

Widespread adoption will require systematic educational efforts for trainees and current practitioners in mental health and substance abuse including systematic introduction to the IOMs existence mission and safety and quality efforts such as the Quality Chasm Series (Many mental health and substance abuse clinicians and administrators seem unaware of the IOM at all)

Recommendation no 2

Further studies of medical error in mental health and substance disorders are needed

Some areas of potential harm in this field remain largely unexamined For example we found only 2 studies of medication errors in mental health settings and none in substance abuse detoxification and stabilization settings despite multiple risk factors for errors and preventable adverse events The impact of variable education -- in pharmacology physiology and general medicine -- on the safety of prescribing practices has not been studied nor has the clinical consequences of formulary restrictions on clinical outcome and potential patient harm The current acceptance of self-reported hospital error rates must be challenged through a process of independently validating self-reported errors

Recommendation no 3

Integration of mental health and substance abuse services is recommended

High rates of co-occurrence and associated higher rates of morbidity and mortality among those with mental health and substance abuse disorders requires integration of mental health and substance abuse treatment paradigms This has not occurred to date

Recommendation no 4

The IOMs 10 rules for change in healthcare should be adopted

The 10 IOM rules for change in healthcare are as follows[173]

1 Care based on continuous healing relationships

2 Customization based on patient needs and values

3 The patient as the source of control

4 Shared knowledge and the free-flow of information

5 Evidence-based decision-making

6 Safety as a system property

7 The need for transparency

8 Anticipation of needs

9 Continuous decrease in waste

10 Cooperation among clinicians

As an example of adoption of these rules seclusion and restraint remain high risk treatments yet current reporting systems do not permit transparency regarding the rate and types of injuries incurred including mortality rates Such transparency requires a non-punitive work culture yet there is little evidence to suggest its adoption in high-risk environments such as state psychiatric hospitals or inpatient detoxification and stabilization substance abuse treatment settings

Recommendation no 5

Reporting systems in outpatient mental health and substance abuse treatment settings must be adopted

Reliance upon unsubstantiated self-reporting of medication errors in inpatient mental health and substance abuse settings remains a significant flaw when attempting accurate assessment of near misses and preventable adverse events and must be changed A key necessity is anonymous yet authenticated medication error reporting for all staff using available web-based error reporting systems Such systems are cost-savers and make reported error data immediately and continuously available Web-based reporting systems providing anonymity with authentication could be used for further seclusion and restraint data collection and as a means of establishing an outpatient error reporting system of safety and quality data by recipients and providers of outpatient treatment

Recommendation no 6

Resources should be allocated to study and develop practical interventions to improve patient safety

Much current research in mental health and substance abuse and resource appropriation is focused on efficacy of pharmacotherapy and psychotherapy and on establishing neurobiologic evidence to support causal theories of known clinical disorders At a policy level we recommend more consideration be given to funding practical interventions predicted to immediately improve patient safety

References

[ CLOSE WINDOW ]

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Authors and Disclosures

As an organization accredited by the ACCME Medscape LLC requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest The ACCME defines relevant financial relationships as financial relationships in any amount occurring within the past 12 months including financial relationships of a spouse or life partner that could create a conflict of interest

Medscape LLC encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration at first mention and where appropriate in the content

Author

Benjamin C Grasso MD

Staff Psychiatrist VA Clinic Saco Maine Disclosure Benjamin C Grasso MD has disclosed no relevant financial relationships

Cathryn M Clary MD MBA

Vice President US External Medical Affairs Pfizer Inc New York NY Disclosure Cathryn M Clary MD MBA has disclosed that she is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Benjamin Eng MD MA

Senior Medical Director Group Leader Pfizer Inc New York NY Disclosure Benjamin Eng MD MA has disclosed that he is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Stanley J Evans MD FASAM PA

Assistant Professor of Clinical Medicine St Matthews University Windham Maine

Medical Director Renaissance Institute of Palm Beach Boca Raton Florida Disclosure Stanley J Evans MD has disclosed no relevant financial relationships

Terry J Golash MD

Clinical Instructor Psychiatry Columbia University New York NY Assistant Attending St Lukersquos Roosevelt Hospital Center New York NY Disclosure Terry J Golash MD has disclosed no relevant financial relationships

Kevin Ann Huckshorn RN MSN CAP ICADC

Director Office of Technical Assistance National Association of State mental Health Program Directors Inc Alexandria Virginia Disclosure Kevin Ann Huckshorn RN MSN CAP ICADC has disclosed no relevant financial relationships

Kenneth Minkoff MD

Clinical Assistant Professor Department of Psychiatry Cambridge Hospital Harvard University Acton Massachusetts Consultant ZiaLogic Acton Massachusetts Disclosure Kenneth Minkoff MD has disclosed no relevant financial relationships

Joseph J Parks MD

Assistant Associate Professor Department of Psychiatry University of Missouri Columbia Missouri Disclosure Joseph J Parks MD has disclosed that he has received grants for educational activities from Letters amp Science and Physician Postgraduate Press Dr Parks has also disclosed that he has served as a consultant to the National Association of State Mental Health Program Directors and Bristol-Myers Squibb Dr Parks has also disclosed that he has received funds for services provided to the state of Missouri from Eli Lilly and Abbott

Miles F Shore MD

Bullard Distinguished Professor of Psychiatry Harvard Medical School Needham Massachusetts Junior Consultant Harvard Medical International Boston Massachusetts Disclosure Miles F Shore MD has disclosed no relevant financial relationships

Editor

Jacqueline A Hart MD

Freelance Clinical Editor Medscape LLC New York New York Disclosure Jacqueline A Hart MD has disclosed no relevant financial relationships

Elizabeth Saenger PhD

Editorial Director Medscape LLC New York NY Disclosure Elizabeth Saenger PhD has disclosed no relevant financial relationships

Registration for CME credit the post test and the evaluation must be completed online To access the activity Post Test and Evaluation link please go to httpwwwmedscapecomviewprogram7809_index

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Unit

Shift

Day and

Staff member involved

With rare exception data on individuals should be used confidentially to identify individual staff training needs not for disciplinary actions[88109] The facility needs to highlight data on seclusion and restraint use by graphing and posting this data on all units so that it is clearly visible for staff and consumers of service Facility-generated data on seclusion and restraint used in a non-punitive way provides for healthy competition among treatment units and elevates the general oversight and knowledge of use and outcomes for everyone involved[88109110] It allows and encourages administration to identify successful staff and treatment units so that successful improvements can be shared

A comprehensive national health information infrastructure could be a useful tool in reducing seclusion and restraint events[2111] The National Association of State Mental Health Program Directors Research Institute Inc (NRI) performance improvement system has developed a set of technology standards applications systems and values that include a number of recommendations for reducing seclusion and restraint events and making their occurrence less error prone[112]

Reduction of the use of seclusion and restraint must start with clear leadership and a specific plan that articulates a mission and philosophy about seclusion and restraint reduction and defines the roles and responsibilities of all facility staff[109] One core component is use of an executive on-call function and the daily review of the use of seclusion and restraint by executive leadership[88110]

Creating a treatment environment that prevents seclusion and restraint is based on the principles of recovery and the characteristics of trauma-informed systems of care[88109] Staff education needs to

Include the experiences of consumers and staff

Address the common myths associated with use

Introduce the rationale and characteristics of trauma-informed care

Educate on the neurobiological and psychological effects of trauma and

Describe a prevention-based approach to reduction

Seclusion and Restraint Summary

The use of seclusion and restraint is associated with substantial harm to recipients of care including death Medical errors precede many seclusion and restraint events which in turn cause further errors and substantial harm to both recipients and providers of care Several local and national initiatives are underway to improve the safety of seclusion and restraint events and to decrease its use The results of their successful application can be seen in facilities in[88 109]

Pennsylvania

New York

Massachusetts

Maine

Florida

New Jersey and

South Dakota

Further study of causal antecedent events and of harm resulting from seclusion and restraint events is recommended using the patient safety paradigm and nomenclature

High-Risk Clinical Populations Lacking Adequate Patient Safety Research

Introduction to High-Risk Clinical Populations

There are no empirical data to quantify characterize or confirm medical errors in certain populations with mental illness andor substance abuse where multiple risk factors for error also exist A brief discussion of these populations and their risks for errors is provided below It is hoped that heightened focus on these high-risk populations will be an impetus for medical error research

Persons with Co-occurring Mental Illness and Substance Abuse

Individuals with co-occurring psychiatric and substance disorders have not been studied for medical errors yet they are perhaps at greater risk for harm because of the nature and number of their co-occurring disorders Several studies have reported the common occurrence of comorbidity among persons with a recognized diagnosis of either mental illness or substance abuse For example in 1990 Regier[74] found a lifetime prevalence of substance abuse among 62 of persons with bipolar disorder In 1996 Kessler and colleagues[113] reported a lifetime prevalence of 599 of psychiatric illness among persons with substance abuse disorders while 31 had a concurrent psychiatric disorder

Persons with co-occurring disorders are high utilizers of medical resources and therefore more exposed to systems issues that may predispose to unintended harm In 1995 an estimated 26 million (27) of the 965 million emergency department (ED) visits were related to alcohol abuse alone[114]

In a study by Dickey and associates[115] using data from the Massachusetts Division of Medical Assistance and death records from the Department of Public Health individuals with co-occurring psychiatric and substance use disorders had the highest risk of medical morbidity for 5 of the studied medical disorders Medicaid beneficiaries with dual diagnoses are 6 to 8 times more likely to die of injury primarily poisoning than their counterparts treated for medical conditions only[116117]

It is well-substantiated that persons with psychiatric and substance abuse disorders have higher rates of suicide attempts and death by suicide[118-123] In 2001[124]

20308 deaths were caused by homicide

30622 deaths by suicide and

101537 deaths were caused by accidents

Given the frequency with which substance abuse by itself has been implicated in these 3 causes of death the scope of morbidity and mortality related to co-occurring disorders is staggering

The effects of substance abuse disorders in adults also affected the mortality rates of children during 1985 to 1996 -- 8482 (24) of the 35547 children aged younger than 15 years died in alcohol-related motor vehicle crashes[125]

A subset of those with co-occurring disorders have substance dependence PTSD and chronic pain The presence of chronic pain and the complexities surrounding treatment of individuals with PTSD increase the risk for unintended harm and of a poor fit between clinical needs and the design of current healthcare systems Despite the added risk factors there is little science to direct clinicians A Medline search using substance abuse PTSD and chronic pain as search terms in June 2004 yielded 10 citations There were no incidence studies and no published treatment guidelines

Conclusion regarding co-occurring disorders Individuals with co-occurring disorders are frequently encountered and at risk for multiple diagnostic and treatment errors including

Missed mental health substance abuse and medical diagnoses and

Insufficient or excessive medication treatment of either their substance abuse or psychiatric disorder

Compared with the general population these individuals are at higher risk for

Suicide attempt

Death by suicide and

Death at a younger age by medical illness

There is a paucity of published studies on medical errors among individuals with co-occurring disorders despite several risk factors for unintended harm and high rates of morbidity and mortality

Attention Deficit-Hyperactivity Disorder in Children Excessive or Insufficient Diagnosis and Treatment

Inattentiveness distractibility impulsivity and hyperactivity were recognized as elements of minimal brain dysfunction (now termed attention deficit hyperactivity disorder [ADHD]) and treated with stimulants especially methylphenidate beginning in the late 1960s[101126127] Over the past 3 decades the rate of drug treatment for behavior problems has increased exponentially culminating in the prescription of ADHD drug treatment for at least 5-6 million American children annually[128]

Children diagnosed with ADHD have been the focus of thousands of research studies over the last 40 years yet the diagnosis and treatment of ADHD remain controversial among some within medicine and the general public[129130] Recent prevalence data from the 1998 National Institutes

of Health (NIH) consensus review[131] and reported by Jensen[132] suggest a prevalence of approximately 5 affecting 3 million school-aged children[133134]

ADHD is associated with[135-137]

Increased risk of accidents

Family and social dysfunction

Poor academic achievement

Substance abuse and

Antisocial behavior

Recent treatment data based on the number of methylphenidate prescriptions show an estimated 5-6 million American children receive ADHD-related drug treatment annually[128] Aggregate national methylphenidate use has increased 100-fold from 1960 until 2000 Globally nearly 90 of the worlds stimulant medication supply is consumed by the US population[138139]

Substantial state-to-state and community-to-community variability in methylphenidate use raises concerns about potential pockets of over- and under-diagnosis and over- and under-prescribing Drug Enforcement Association data on stimulant use reflect a 6-fold per capita variation in methylphenidate prescribing between some states[140] and a 20-fold prescribing variation between some communities[130141]

LeFever and colleagues argue that while the data are inconclusive if communities such as Salt Lake City Utah are used as a benchmark of acceptable diagnosis and treatment then children in 36 states may be subject to over-diagnosis and over-treatment Conversely Jensen argues that ADHD is under-diagnosed and under-treated based on national aggregate data allowing for pockets of over-diagnosis and treatment in some geographic areas[142] Given that in 1995 there were approximately 2 million pediatric visits in which ADHD was the focus of treatment and 6 million stimulant prescriptions were written[132] 1 conclusion is that 3 million children with ADHD received an average of 2 prescriptions and 1 outpatient visit during that year suggesting insufficient treatment In another study cited by Jensen the Multimodal Treatment Study of Children with ADHD two thirds of ADHD children from reportedly highly motivated families obtained medication treatments and for an average duration of only 8-14 months[142143]

Despite the number of studies done the strength of conclusions that can be drawn is contingent upon the adequacy of reported data Studies to date are variously limited by data sources sampling accuracy and interpretation[130]

When considered in aggregate national ADHD prevalence rates and numbers of prescriptions written do not suggest excessive diagnosis and treatment However prevalence rates and stimulant use can vary as much as 30-fold when comparing different communities A prevalence rate of 33 among white elementary-aged boys in southeastern Virginia significantly challenges credibility[130] Such variability makes it essential that prevalence rates and stimulant use estimates be linked to sufficient demographics such as

Geography

Age

Race and

Gender

ADHD prevalence rates and stimulant use appear to be

Excessive in some communities

Plausible in other communities and

Perhaps insufficient in yet other communities

Additional epidemiologic studies reporting prevalence rates with specific demographics rather than in aggregate and broader use of practice guidelines promulgated by the American Academy of Pediatrics (AAP) and others that advocate multimodal treatment rather than solely prescribing stimulants or other medications[130144] will help provide evidence of the extent of errors in the diagnosis and treatment of children with ADHD

Electroconvulsive Therapy

Electroconvulsive therapy (ECT) remains a controversial treatment in psychiatry As stated in the 1985 NIH Consensus Statement The nature of the treatment itself its history of abuse unfavorable media presentations compelling testimony of former patients special attention by the legal system uneven distribution of ECT use among practitioners and facilities and uneven access by patients all contribute to the controversial context in which the consensus panel has approached its task[145]

Epidemiologic data reported by Thompson and colleagues in 1994 found that[146]

58667 patients received ECT in 1975

31514 in 1980

36558 in 1986

71 of the patients who received ECT were women and

Individuals older than 65 years of age had the highest rates per number of inpatients

The rate of ECT use has been highly variable For example in 1995 Herman and associates[147] reported that among 202 metropolitan statistical areas annual ECT use varied from 04 to 812 patients per 10000 population

The most common adverse effect from ECT is memory loss In a recent review of patients perspectives as well as clinicians studies Rose and associates[148] concluded that 29 to 55 of ECT treatment recipients experienced persistent memory loss Recent empirical studies of ECT and memory loss continue to find persistent memory loss with bilateral ECT producing more profound memory deficits than right unilateral ECT[149]

In a review of deaths caused by ECT Abrams reported that ECT is 10 times safer than childbirth that approximately 6 times as many deaths annually in the US are caused by lightning as by ECTand that the death rate reported for ECT is an order of magnitude smaller than the spontaneous death rate in the general population[150]

Corroboration of a low ECT death rate has arisen from 1993 legislation in Texas mandating reporting of all ECT-related deaths[151] As a result the risk of death from ECT in Texas has been systematically tracked and reviewed More than 8000 patients received 49048 ECT treatments between 1993 and 1998 However only 1 death could be linked to the associated anesthesia An additional 4 deaths could plausibly have been associated with the anesthesia yielding a mortality rate between 2 and 10 per 100000 and the causes of death most likely were not the ECT stimulus or seizure

Emotional harm and erosion of faith in the medical profession that undermines accepting other needed treatments can come to recipients of care for whom the experience of ECT is frightening

ECT conclusion ECT is effective for severe major affective illness and is associated with a low mortality rate Persistent memory loss is a consistent finding despite attempts to optimize ECT administration and must be expected at an incidence of approximately 25 to 50 by those contemplating and those providing ECT treatment

Despite its relative safety ECT continues to cause alarm in the general public Even within medicine it is described as dangerous and unethical by some[152] Such fears can cause emotional harm among ECT recipients This may be especially true for older women (who comprise the majority of ECT subjects) some of whom may be accustomed to deferring to healthcare providers when consenting to treatment despite insufficient understanding of benefits and risks

Recommendations include

Emphasis on pre-treatment education

Collaborative relationship with ECT recipients

Increased transparency regarding the substantial risk of persistent memory loss when seeking informed consent and

Continued research on its safety

Systems Issues Related to Patient Safety

Outpatient Care

Risk of unintended harm may be increased by the segregated care settings in which psychiatric and substance abuse services are often delivered including solo practitioner offices and free-standing psychiatric and substance abuse treatment facilities[153154] and by insufficient communication and coordination of care between prescribers and psychotherapists[155-157] Despite the recognition of these potential contributing factors there are no existing reports of the association between systems issues and medical errors

Olfson[158] reported that in 1987 there were 84 million outpatient visits with mental health practitioners including

Psychiatrists

Psychologists

Social workers and

Licensed counselors

Kessler[154] reported in 1999 that an estimated 133 of a representative sample of Americans reported used outpatient services for mental health problems in the previous 12 months Clearly there are high numbers of individuals at risk for errors in outpatient mental health and substance abuse treatment

Ethics and Malpractice Risk Management Boundary Violations

A survey of recently published reviews and commentaries on patient safety reveals that for mental health and substance abuse issues such discussion takes place mainly within the context of ethics and malpractice risk management[159-162] Ethics statements from both the APA[162] and the American Psychological Association[163] support the duty to report and protect patients from deviations from the standards of care This approach uses the individual practitioners frame of reference and relies on voluntary reporting from professionals who have been trained to consider confidentiality a critical component of their work Harm caused by clinician boundary violations are understood as issues of professional misconduct not as errors resulting from system failure and that minimize the individual clinicians responsibility and advise against punitive action [164-167]

With the advent of therapeutic exchanges through email and other means of communication additional boundary violations are possible The Internet now has at least 110 million users including 70 million using it for health-related information[168] A recent survey indicated 40 to 50 of physicians use the Internet (or are preparing to use it) for clinical care[169]

There is a risk of errors of omission or commission arising from lack of coordination of care between clinicians Differences in therapeutic orientation and nomenclature used by the following specialists can compound systems issues that increase the risk of medical errors [158]

Social workers

Psychiatric nurse specialists

Psychologists

Licensed counselors and

Psychiatrists

Confidentiality is critical in providing effective treatment within the secure and private setting of the therapists office and in protecting the patient from unauthorized disclosures of sensitive information and potential abuse from a third party[170] However confidentiality can also inhibit disclosure of near misses impasses in treatment (for example when treatment is not working) and preventable adverse events due to avoidance of sharing important clinical information with other professionals and with appropriate family members and other supportive resources[171172]

The solo practice model commonly used by mental health clinicians can also inhibit the adoption of best practices and the development of policies and procedures to reduce risk because all such practice management activities are left to the individual clinician whose focus is more likely to be exclusively clinical

Summary About Systems Issues and Patient Safety

Systems for reliably reporting outpatient psychotherapy medical errors particularly among the large numbers of solo practitioners do not exist The prevailing paradigm for reducing harm arises from risk reduction in order to diminish medical liability exposure Studies that shed light on potential medical errors have arisen from risk management claims medical liability lawsuits and reports of death by suicide not from research intended to examine patient safety per se

Error reporting systems applicable to outpatient mental health settings including incentives for their use need to be developed Professional risk management programs primarily used to diminish medical liability exposure from the following could also be used to promulgate the relevance and value of the patient safety paradigm

Boundary violations

Suicide and

Treatment errors

Most particularly thought needs to be given to developing systems of error prevention applicable to the solo practitioner

Recommendations

Recommendation no 1

Widespread adoption of the IOM patient safety paradigm and nomenclature in mental health and substance abuse treatment settings is recommended

Advantages of its use include

Consistency with the nomenclature used by other medical specialties

Increased leverage in advocating for needed services and resources when the absence of essential treatments are quantified as errors of omission causing near misses or preventable adverse events

Increased likelihood that medication errors in mental health and substance abuse will be researched and a determination made whether such errors are causing preventable adverse events and

Increased awareness among mental health and substance abuse clinicians that patient harm can come from a broader array of errors in diagnosis and treatment than has been studied to date

Widespread adoption will require systematic educational efforts for trainees and current practitioners in mental health and substance abuse including systematic introduction to the IOMs existence mission and safety and quality efforts such as the Quality Chasm Series (Many mental health and substance abuse clinicians and administrators seem unaware of the IOM at all)

Recommendation no 2

Further studies of medical error in mental health and substance disorders are needed

Some areas of potential harm in this field remain largely unexamined For example we found only 2 studies of medication errors in mental health settings and none in substance abuse detoxification and stabilization settings despite multiple risk factors for errors and preventable adverse events The impact of variable education -- in pharmacology physiology and general medicine -- on the safety of prescribing practices has not been studied nor has the clinical consequences of formulary restrictions on clinical outcome and potential patient harm The current acceptance of self-reported hospital error rates must be challenged through a process of independently validating self-reported errors

Recommendation no 3

Integration of mental health and substance abuse services is recommended

High rates of co-occurrence and associated higher rates of morbidity and mortality among those with mental health and substance abuse disorders requires integration of mental health and substance abuse treatment paradigms This has not occurred to date

Recommendation no 4

The IOMs 10 rules for change in healthcare should be adopted

The 10 IOM rules for change in healthcare are as follows[173]

1 Care based on continuous healing relationships

2 Customization based on patient needs and values

3 The patient as the source of control

4 Shared knowledge and the free-flow of information

5 Evidence-based decision-making

6 Safety as a system property

7 The need for transparency

8 Anticipation of needs

9 Continuous decrease in waste

10 Cooperation among clinicians

As an example of adoption of these rules seclusion and restraint remain high risk treatments yet current reporting systems do not permit transparency regarding the rate and types of injuries incurred including mortality rates Such transparency requires a non-punitive work culture yet there is little evidence to suggest its adoption in high-risk environments such as state psychiatric hospitals or inpatient detoxification and stabilization substance abuse treatment settings

Recommendation no 5

Reporting systems in outpatient mental health and substance abuse treatment settings must be adopted

Reliance upon unsubstantiated self-reporting of medication errors in inpatient mental health and substance abuse settings remains a significant flaw when attempting accurate assessment of near misses and preventable adverse events and must be changed A key necessity is anonymous yet authenticated medication error reporting for all staff using available web-based error reporting systems Such systems are cost-savers and make reported error data immediately and continuously available Web-based reporting systems providing anonymity with authentication could be used for further seclusion and restraint data collection and as a means of establishing an outpatient error reporting system of safety and quality data by recipients and providers of outpatient treatment

Recommendation no 6

Resources should be allocated to study and develop practical interventions to improve patient safety

Much current research in mental health and substance abuse and resource appropriation is focused on efficacy of pharmacotherapy and psychotherapy and on establishing neurobiologic evidence to support causal theories of known clinical disorders At a policy level we recommend more consideration be given to funding practical interventions predicted to immediately improve patient safety

References

[ CLOSE WINDOW ]

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155 Pulier ML Ciccone DS Castellano C Marcus K Schleifer SJ Medical versus non-medical mental health referral clinical decision-making by telephone access center staff J Behav Health Serv Res 200330444-451 Abstract

156 Simon GE Katon WJ VonKorff M et al Cost-effectiveness of a collaborative care program for primary care patients with persistent depression Am J Psychiatry 20011581638-1644 Abstract

157 Lazarus J Macbeth J Wheeler N Divided treatment in managed care Psychiatr Pract Managed Care 1997

158 Olfson M Pincus HA Outpatient mental healthcare in non hospital settings distribution of patients across provider groups Am J Psychiatry 19961531353-1356 Abstract

159 Levinson W Physician-patient communication -- a key to malpractice prevention JAMA 1994201619-1620

160 Smith D 10 ways practitioners can avoid frequent ethical pitfalls Monitor on Psychology 20033450 Available at httpapaorgmonitorjan0310wayshtml Accessed on August 28 2007

161 Fishalow SE The tort liability of the psychiatrist Bull Am Acad Psychiatric Law 19753191-230

162 American Psychiatric Association The principles of medical ethics with annotations especially applicable to psychiatry 2001 Available at httpwwwpsychorgpsych_practethicsmedicalethics2001_42001cfm Accessed August 28 2007

163 American Psychological Association Ethical Principles and Code of Conduct June 1 2003 Available at httpwwwapaorgethicscode2002html Accessed August 28 2007

164 Gutheil TG Gabbard GO The concept of boundaries in clinical practice theoretical and risk management dimensions Am J Psychiatry 1993150188-196 Abstract

165 Gutheil TG Gabbard GO Misuses and misunderstandings of boundary theory in clinical and regulatory settings Am J Psychiatry 1998155409-414

166 Malmquist CP Notman MT Psychiatrist and patient boundary issues following treatment termination Am J Psychiatry 20011581010-1018 Abstract

167 Herman JL Gartell N Olarte S Feldstein M Localio R Psychiatrist-patient sexual contact results of a national survey II Psychiatrists attitudes Am J Psychiatry 1987144164-169 Abstract

168 Risk Management in Cyberspace Rx for Risk 20019 169 Miller RH Hillman JM Given RS Physician use of IT Results from the Deloitte

research survey J Healthc Inf Manag 20041872-80 Abstract 170 Applebaum PS Privacy in psychiatric treatment threats and responses Focus

20031396-406 171 Godolphin W The role of risk communication in shared decision making BMJ

2003327692-693 Abstract 172 Oregon Medical Association Lets talk disclosures after an adverse medical

event(video) Portland OR 2002 Available at httpwwwPatientSafetyStorecom Accessed August 28 2007

173 Institute of Medicine (IOM) Crossing the Quality of Chasm Adaptation to Mental Health and Addictive Disorders April 26 2004 Available at httpwwwiomeduCMS380919405aspx Accessed September 6 2007

Authors and Disclosures

As an organization accredited by the ACCME Medscape LLC requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest The ACCME defines relevant financial relationships as financial relationships in any amount occurring within the past 12 months including financial relationships of a spouse or life partner that could create a conflict of interest

Medscape LLC encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration at first mention and where appropriate in the content

Author

Benjamin C Grasso MD

Staff Psychiatrist VA Clinic Saco Maine Disclosure Benjamin C Grasso MD has disclosed no relevant financial relationships

Cathryn M Clary MD MBA

Vice President US External Medical Affairs Pfizer Inc New York NY Disclosure Cathryn M Clary MD MBA has disclosed that she is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Benjamin Eng MD MA

Senior Medical Director Group Leader Pfizer Inc New York NY Disclosure Benjamin Eng MD MA has disclosed that he is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Stanley J Evans MD FASAM PA

Assistant Professor of Clinical Medicine St Matthews University Windham Maine

Medical Director Renaissance Institute of Palm Beach Boca Raton Florida Disclosure Stanley J Evans MD has disclosed no relevant financial relationships

Terry J Golash MD

Clinical Instructor Psychiatry Columbia University New York NY Assistant Attending St Lukersquos Roosevelt Hospital Center New York NY Disclosure Terry J Golash MD has disclosed no relevant financial relationships

Kevin Ann Huckshorn RN MSN CAP ICADC

Director Office of Technical Assistance National Association of State mental Health Program Directors Inc Alexandria Virginia Disclosure Kevin Ann Huckshorn RN MSN CAP ICADC has disclosed no relevant financial relationships

Kenneth Minkoff MD

Clinical Assistant Professor Department of Psychiatry Cambridge Hospital Harvard University Acton Massachusetts Consultant ZiaLogic Acton Massachusetts Disclosure Kenneth Minkoff MD has disclosed no relevant financial relationships

Joseph J Parks MD

Assistant Associate Professor Department of Psychiatry University of Missouri Columbia Missouri Disclosure Joseph J Parks MD has disclosed that he has received grants for educational activities from Letters amp Science and Physician Postgraduate Press Dr Parks has also disclosed that he has served as a consultant to the National Association of State Mental Health Program Directors and Bristol-Myers Squibb Dr Parks has also disclosed that he has received funds for services provided to the state of Missouri from Eli Lilly and Abbott

Miles F Shore MD

Bullard Distinguished Professor of Psychiatry Harvard Medical School Needham Massachusetts Junior Consultant Harvard Medical International Boston Massachusetts Disclosure Miles F Shore MD has disclosed no relevant financial relationships

Editor

Jacqueline A Hart MD

Freelance Clinical Editor Medscape LLC New York New York Disclosure Jacqueline A Hart MD has disclosed no relevant financial relationships

Elizabeth Saenger PhD

Editorial Director Medscape LLC New York NY Disclosure Elizabeth Saenger PhD has disclosed no relevant financial relationships

Registration for CME credit the post test and the evaluation must be completed online To access the activity Post Test and Evaluation link please go to httpwwwmedscapecomviewprogram7809_index

Page 15: Medication Errors and Patient Safety in Mental Health CME/CE · 2019. 6. 27. · Medication Errors and Patient Safety in Mental Health CME/CE Complete author affiliations and disclosures

New York

Massachusetts

Maine

Florida

New Jersey and

South Dakota

Further study of causal antecedent events and of harm resulting from seclusion and restraint events is recommended using the patient safety paradigm and nomenclature

High-Risk Clinical Populations Lacking Adequate Patient Safety Research

Introduction to High-Risk Clinical Populations

There are no empirical data to quantify characterize or confirm medical errors in certain populations with mental illness andor substance abuse where multiple risk factors for error also exist A brief discussion of these populations and their risks for errors is provided below It is hoped that heightened focus on these high-risk populations will be an impetus for medical error research

Persons with Co-occurring Mental Illness and Substance Abuse

Individuals with co-occurring psychiatric and substance disorders have not been studied for medical errors yet they are perhaps at greater risk for harm because of the nature and number of their co-occurring disorders Several studies have reported the common occurrence of comorbidity among persons with a recognized diagnosis of either mental illness or substance abuse For example in 1990 Regier[74] found a lifetime prevalence of substance abuse among 62 of persons with bipolar disorder In 1996 Kessler and colleagues[113] reported a lifetime prevalence of 599 of psychiatric illness among persons with substance abuse disorders while 31 had a concurrent psychiatric disorder

Persons with co-occurring disorders are high utilizers of medical resources and therefore more exposed to systems issues that may predispose to unintended harm In 1995 an estimated 26 million (27) of the 965 million emergency department (ED) visits were related to alcohol abuse alone[114]

In a study by Dickey and associates[115] using data from the Massachusetts Division of Medical Assistance and death records from the Department of Public Health individuals with co-occurring psychiatric and substance use disorders had the highest risk of medical morbidity for 5 of the studied medical disorders Medicaid beneficiaries with dual diagnoses are 6 to 8 times more likely to die of injury primarily poisoning than their counterparts treated for medical conditions only[116117]

It is well-substantiated that persons with psychiatric and substance abuse disorders have higher rates of suicide attempts and death by suicide[118-123] In 2001[124]

20308 deaths were caused by homicide

30622 deaths by suicide and

101537 deaths were caused by accidents

Given the frequency with which substance abuse by itself has been implicated in these 3 causes of death the scope of morbidity and mortality related to co-occurring disorders is staggering

The effects of substance abuse disorders in adults also affected the mortality rates of children during 1985 to 1996 -- 8482 (24) of the 35547 children aged younger than 15 years died in alcohol-related motor vehicle crashes[125]

A subset of those with co-occurring disorders have substance dependence PTSD and chronic pain The presence of chronic pain and the complexities surrounding treatment of individuals with PTSD increase the risk for unintended harm and of a poor fit between clinical needs and the design of current healthcare systems Despite the added risk factors there is little science to direct clinicians A Medline search using substance abuse PTSD and chronic pain as search terms in June 2004 yielded 10 citations There were no incidence studies and no published treatment guidelines

Conclusion regarding co-occurring disorders Individuals with co-occurring disorders are frequently encountered and at risk for multiple diagnostic and treatment errors including

Missed mental health substance abuse and medical diagnoses and

Insufficient or excessive medication treatment of either their substance abuse or psychiatric disorder

Compared with the general population these individuals are at higher risk for

Suicide attempt

Death by suicide and

Death at a younger age by medical illness

There is a paucity of published studies on medical errors among individuals with co-occurring disorders despite several risk factors for unintended harm and high rates of morbidity and mortality

Attention Deficit-Hyperactivity Disorder in Children Excessive or Insufficient Diagnosis and Treatment

Inattentiveness distractibility impulsivity and hyperactivity were recognized as elements of minimal brain dysfunction (now termed attention deficit hyperactivity disorder [ADHD]) and treated with stimulants especially methylphenidate beginning in the late 1960s[101126127] Over the past 3 decades the rate of drug treatment for behavior problems has increased exponentially culminating in the prescription of ADHD drug treatment for at least 5-6 million American children annually[128]

Children diagnosed with ADHD have been the focus of thousands of research studies over the last 40 years yet the diagnosis and treatment of ADHD remain controversial among some within medicine and the general public[129130] Recent prevalence data from the 1998 National Institutes

of Health (NIH) consensus review[131] and reported by Jensen[132] suggest a prevalence of approximately 5 affecting 3 million school-aged children[133134]

ADHD is associated with[135-137]

Increased risk of accidents

Family and social dysfunction

Poor academic achievement

Substance abuse and

Antisocial behavior

Recent treatment data based on the number of methylphenidate prescriptions show an estimated 5-6 million American children receive ADHD-related drug treatment annually[128] Aggregate national methylphenidate use has increased 100-fold from 1960 until 2000 Globally nearly 90 of the worlds stimulant medication supply is consumed by the US population[138139]

Substantial state-to-state and community-to-community variability in methylphenidate use raises concerns about potential pockets of over- and under-diagnosis and over- and under-prescribing Drug Enforcement Association data on stimulant use reflect a 6-fold per capita variation in methylphenidate prescribing between some states[140] and a 20-fold prescribing variation between some communities[130141]

LeFever and colleagues argue that while the data are inconclusive if communities such as Salt Lake City Utah are used as a benchmark of acceptable diagnosis and treatment then children in 36 states may be subject to over-diagnosis and over-treatment Conversely Jensen argues that ADHD is under-diagnosed and under-treated based on national aggregate data allowing for pockets of over-diagnosis and treatment in some geographic areas[142] Given that in 1995 there were approximately 2 million pediatric visits in which ADHD was the focus of treatment and 6 million stimulant prescriptions were written[132] 1 conclusion is that 3 million children with ADHD received an average of 2 prescriptions and 1 outpatient visit during that year suggesting insufficient treatment In another study cited by Jensen the Multimodal Treatment Study of Children with ADHD two thirds of ADHD children from reportedly highly motivated families obtained medication treatments and for an average duration of only 8-14 months[142143]

Despite the number of studies done the strength of conclusions that can be drawn is contingent upon the adequacy of reported data Studies to date are variously limited by data sources sampling accuracy and interpretation[130]

When considered in aggregate national ADHD prevalence rates and numbers of prescriptions written do not suggest excessive diagnosis and treatment However prevalence rates and stimulant use can vary as much as 30-fold when comparing different communities A prevalence rate of 33 among white elementary-aged boys in southeastern Virginia significantly challenges credibility[130] Such variability makes it essential that prevalence rates and stimulant use estimates be linked to sufficient demographics such as

Geography

Age

Race and

Gender

ADHD prevalence rates and stimulant use appear to be

Excessive in some communities

Plausible in other communities and

Perhaps insufficient in yet other communities

Additional epidemiologic studies reporting prevalence rates with specific demographics rather than in aggregate and broader use of practice guidelines promulgated by the American Academy of Pediatrics (AAP) and others that advocate multimodal treatment rather than solely prescribing stimulants or other medications[130144] will help provide evidence of the extent of errors in the diagnosis and treatment of children with ADHD

Electroconvulsive Therapy

Electroconvulsive therapy (ECT) remains a controversial treatment in psychiatry As stated in the 1985 NIH Consensus Statement The nature of the treatment itself its history of abuse unfavorable media presentations compelling testimony of former patients special attention by the legal system uneven distribution of ECT use among practitioners and facilities and uneven access by patients all contribute to the controversial context in which the consensus panel has approached its task[145]

Epidemiologic data reported by Thompson and colleagues in 1994 found that[146]

58667 patients received ECT in 1975

31514 in 1980

36558 in 1986

71 of the patients who received ECT were women and

Individuals older than 65 years of age had the highest rates per number of inpatients

The rate of ECT use has been highly variable For example in 1995 Herman and associates[147] reported that among 202 metropolitan statistical areas annual ECT use varied from 04 to 812 patients per 10000 population

The most common adverse effect from ECT is memory loss In a recent review of patients perspectives as well as clinicians studies Rose and associates[148] concluded that 29 to 55 of ECT treatment recipients experienced persistent memory loss Recent empirical studies of ECT and memory loss continue to find persistent memory loss with bilateral ECT producing more profound memory deficits than right unilateral ECT[149]

In a review of deaths caused by ECT Abrams reported that ECT is 10 times safer than childbirth that approximately 6 times as many deaths annually in the US are caused by lightning as by ECTand that the death rate reported for ECT is an order of magnitude smaller than the spontaneous death rate in the general population[150]

Corroboration of a low ECT death rate has arisen from 1993 legislation in Texas mandating reporting of all ECT-related deaths[151] As a result the risk of death from ECT in Texas has been systematically tracked and reviewed More than 8000 patients received 49048 ECT treatments between 1993 and 1998 However only 1 death could be linked to the associated anesthesia An additional 4 deaths could plausibly have been associated with the anesthesia yielding a mortality rate between 2 and 10 per 100000 and the causes of death most likely were not the ECT stimulus or seizure

Emotional harm and erosion of faith in the medical profession that undermines accepting other needed treatments can come to recipients of care for whom the experience of ECT is frightening

ECT conclusion ECT is effective for severe major affective illness and is associated with a low mortality rate Persistent memory loss is a consistent finding despite attempts to optimize ECT administration and must be expected at an incidence of approximately 25 to 50 by those contemplating and those providing ECT treatment

Despite its relative safety ECT continues to cause alarm in the general public Even within medicine it is described as dangerous and unethical by some[152] Such fears can cause emotional harm among ECT recipients This may be especially true for older women (who comprise the majority of ECT subjects) some of whom may be accustomed to deferring to healthcare providers when consenting to treatment despite insufficient understanding of benefits and risks

Recommendations include

Emphasis on pre-treatment education

Collaborative relationship with ECT recipients

Increased transparency regarding the substantial risk of persistent memory loss when seeking informed consent and

Continued research on its safety

Systems Issues Related to Patient Safety

Outpatient Care

Risk of unintended harm may be increased by the segregated care settings in which psychiatric and substance abuse services are often delivered including solo practitioner offices and free-standing psychiatric and substance abuse treatment facilities[153154] and by insufficient communication and coordination of care between prescribers and psychotherapists[155-157] Despite the recognition of these potential contributing factors there are no existing reports of the association between systems issues and medical errors

Olfson[158] reported that in 1987 there were 84 million outpatient visits with mental health practitioners including

Psychiatrists

Psychologists

Social workers and

Licensed counselors

Kessler[154] reported in 1999 that an estimated 133 of a representative sample of Americans reported used outpatient services for mental health problems in the previous 12 months Clearly there are high numbers of individuals at risk for errors in outpatient mental health and substance abuse treatment

Ethics and Malpractice Risk Management Boundary Violations

A survey of recently published reviews and commentaries on patient safety reveals that for mental health and substance abuse issues such discussion takes place mainly within the context of ethics and malpractice risk management[159-162] Ethics statements from both the APA[162] and the American Psychological Association[163] support the duty to report and protect patients from deviations from the standards of care This approach uses the individual practitioners frame of reference and relies on voluntary reporting from professionals who have been trained to consider confidentiality a critical component of their work Harm caused by clinician boundary violations are understood as issues of professional misconduct not as errors resulting from system failure and that minimize the individual clinicians responsibility and advise against punitive action [164-167]

With the advent of therapeutic exchanges through email and other means of communication additional boundary violations are possible The Internet now has at least 110 million users including 70 million using it for health-related information[168] A recent survey indicated 40 to 50 of physicians use the Internet (or are preparing to use it) for clinical care[169]

There is a risk of errors of omission or commission arising from lack of coordination of care between clinicians Differences in therapeutic orientation and nomenclature used by the following specialists can compound systems issues that increase the risk of medical errors [158]

Social workers

Psychiatric nurse specialists

Psychologists

Licensed counselors and

Psychiatrists

Confidentiality is critical in providing effective treatment within the secure and private setting of the therapists office and in protecting the patient from unauthorized disclosures of sensitive information and potential abuse from a third party[170] However confidentiality can also inhibit disclosure of near misses impasses in treatment (for example when treatment is not working) and preventable adverse events due to avoidance of sharing important clinical information with other professionals and with appropriate family members and other supportive resources[171172]

The solo practice model commonly used by mental health clinicians can also inhibit the adoption of best practices and the development of policies and procedures to reduce risk because all such practice management activities are left to the individual clinician whose focus is more likely to be exclusively clinical

Summary About Systems Issues and Patient Safety

Systems for reliably reporting outpatient psychotherapy medical errors particularly among the large numbers of solo practitioners do not exist The prevailing paradigm for reducing harm arises from risk reduction in order to diminish medical liability exposure Studies that shed light on potential medical errors have arisen from risk management claims medical liability lawsuits and reports of death by suicide not from research intended to examine patient safety per se

Error reporting systems applicable to outpatient mental health settings including incentives for their use need to be developed Professional risk management programs primarily used to diminish medical liability exposure from the following could also be used to promulgate the relevance and value of the patient safety paradigm

Boundary violations

Suicide and

Treatment errors

Most particularly thought needs to be given to developing systems of error prevention applicable to the solo practitioner

Recommendations

Recommendation no 1

Widespread adoption of the IOM patient safety paradigm and nomenclature in mental health and substance abuse treatment settings is recommended

Advantages of its use include

Consistency with the nomenclature used by other medical specialties

Increased leverage in advocating for needed services and resources when the absence of essential treatments are quantified as errors of omission causing near misses or preventable adverse events

Increased likelihood that medication errors in mental health and substance abuse will be researched and a determination made whether such errors are causing preventable adverse events and

Increased awareness among mental health and substance abuse clinicians that patient harm can come from a broader array of errors in diagnosis and treatment than has been studied to date

Widespread adoption will require systematic educational efforts for trainees and current practitioners in mental health and substance abuse including systematic introduction to the IOMs existence mission and safety and quality efforts such as the Quality Chasm Series (Many mental health and substance abuse clinicians and administrators seem unaware of the IOM at all)

Recommendation no 2

Further studies of medical error in mental health and substance disorders are needed

Some areas of potential harm in this field remain largely unexamined For example we found only 2 studies of medication errors in mental health settings and none in substance abuse detoxification and stabilization settings despite multiple risk factors for errors and preventable adverse events The impact of variable education -- in pharmacology physiology and general medicine -- on the safety of prescribing practices has not been studied nor has the clinical consequences of formulary restrictions on clinical outcome and potential patient harm The current acceptance of self-reported hospital error rates must be challenged through a process of independently validating self-reported errors

Recommendation no 3

Integration of mental health and substance abuse services is recommended

High rates of co-occurrence and associated higher rates of morbidity and mortality among those with mental health and substance abuse disorders requires integration of mental health and substance abuse treatment paradigms This has not occurred to date

Recommendation no 4

The IOMs 10 rules for change in healthcare should be adopted

The 10 IOM rules for change in healthcare are as follows[173]

1 Care based on continuous healing relationships

2 Customization based on patient needs and values

3 The patient as the source of control

4 Shared knowledge and the free-flow of information

5 Evidence-based decision-making

6 Safety as a system property

7 The need for transparency

8 Anticipation of needs

9 Continuous decrease in waste

10 Cooperation among clinicians

As an example of adoption of these rules seclusion and restraint remain high risk treatments yet current reporting systems do not permit transparency regarding the rate and types of injuries incurred including mortality rates Such transparency requires a non-punitive work culture yet there is little evidence to suggest its adoption in high-risk environments such as state psychiatric hospitals or inpatient detoxification and stabilization substance abuse treatment settings

Recommendation no 5

Reporting systems in outpatient mental health and substance abuse treatment settings must be adopted

Reliance upon unsubstantiated self-reporting of medication errors in inpatient mental health and substance abuse settings remains a significant flaw when attempting accurate assessment of near misses and preventable adverse events and must be changed A key necessity is anonymous yet authenticated medication error reporting for all staff using available web-based error reporting systems Such systems are cost-savers and make reported error data immediately and continuously available Web-based reporting systems providing anonymity with authentication could be used for further seclusion and restraint data collection and as a means of establishing an outpatient error reporting system of safety and quality data by recipients and providers of outpatient treatment

Recommendation no 6

Resources should be allocated to study and develop practical interventions to improve patient safety

Much current research in mental health and substance abuse and resource appropriation is focused on efficacy of pharmacotherapy and psychotherapy and on establishing neurobiologic evidence to support causal theories of known clinical disorders At a policy level we recommend more consideration be given to funding practical interventions predicted to immediately improve patient safety

References

[ CLOSE WINDOW ]

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Authors and Disclosures

As an organization accredited by the ACCME Medscape LLC requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest The ACCME defines relevant financial relationships as financial relationships in any amount occurring within the past 12 months including financial relationships of a spouse or life partner that could create a conflict of interest

Medscape LLC encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration at first mention and where appropriate in the content

Author

Benjamin C Grasso MD

Staff Psychiatrist VA Clinic Saco Maine Disclosure Benjamin C Grasso MD has disclosed no relevant financial relationships

Cathryn M Clary MD MBA

Vice President US External Medical Affairs Pfizer Inc New York NY Disclosure Cathryn M Clary MD MBA has disclosed that she is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Benjamin Eng MD MA

Senior Medical Director Group Leader Pfizer Inc New York NY Disclosure Benjamin Eng MD MA has disclosed that he is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Stanley J Evans MD FASAM PA

Assistant Professor of Clinical Medicine St Matthews University Windham Maine

Medical Director Renaissance Institute of Palm Beach Boca Raton Florida Disclosure Stanley J Evans MD has disclosed no relevant financial relationships

Terry J Golash MD

Clinical Instructor Psychiatry Columbia University New York NY Assistant Attending St Lukersquos Roosevelt Hospital Center New York NY Disclosure Terry J Golash MD has disclosed no relevant financial relationships

Kevin Ann Huckshorn RN MSN CAP ICADC

Director Office of Technical Assistance National Association of State mental Health Program Directors Inc Alexandria Virginia Disclosure Kevin Ann Huckshorn RN MSN CAP ICADC has disclosed no relevant financial relationships

Kenneth Minkoff MD

Clinical Assistant Professor Department of Psychiatry Cambridge Hospital Harvard University Acton Massachusetts Consultant ZiaLogic Acton Massachusetts Disclosure Kenneth Minkoff MD has disclosed no relevant financial relationships

Joseph J Parks MD

Assistant Associate Professor Department of Psychiatry University of Missouri Columbia Missouri Disclosure Joseph J Parks MD has disclosed that he has received grants for educational activities from Letters amp Science and Physician Postgraduate Press Dr Parks has also disclosed that he has served as a consultant to the National Association of State Mental Health Program Directors and Bristol-Myers Squibb Dr Parks has also disclosed that he has received funds for services provided to the state of Missouri from Eli Lilly and Abbott

Miles F Shore MD

Bullard Distinguished Professor of Psychiatry Harvard Medical School Needham Massachusetts Junior Consultant Harvard Medical International Boston Massachusetts Disclosure Miles F Shore MD has disclosed no relevant financial relationships

Editor

Jacqueline A Hart MD

Freelance Clinical Editor Medscape LLC New York New York Disclosure Jacqueline A Hart MD has disclosed no relevant financial relationships

Elizabeth Saenger PhD

Editorial Director Medscape LLC New York NY Disclosure Elizabeth Saenger PhD has disclosed no relevant financial relationships

Registration for CME credit the post test and the evaluation must be completed online To access the activity Post Test and Evaluation link please go to httpwwwmedscapecomviewprogram7809_index

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30622 deaths by suicide and

101537 deaths were caused by accidents

Given the frequency with which substance abuse by itself has been implicated in these 3 causes of death the scope of morbidity and mortality related to co-occurring disorders is staggering

The effects of substance abuse disorders in adults also affected the mortality rates of children during 1985 to 1996 -- 8482 (24) of the 35547 children aged younger than 15 years died in alcohol-related motor vehicle crashes[125]

A subset of those with co-occurring disorders have substance dependence PTSD and chronic pain The presence of chronic pain and the complexities surrounding treatment of individuals with PTSD increase the risk for unintended harm and of a poor fit between clinical needs and the design of current healthcare systems Despite the added risk factors there is little science to direct clinicians A Medline search using substance abuse PTSD and chronic pain as search terms in June 2004 yielded 10 citations There were no incidence studies and no published treatment guidelines

Conclusion regarding co-occurring disorders Individuals with co-occurring disorders are frequently encountered and at risk for multiple diagnostic and treatment errors including

Missed mental health substance abuse and medical diagnoses and

Insufficient or excessive medication treatment of either their substance abuse or psychiatric disorder

Compared with the general population these individuals are at higher risk for

Suicide attempt

Death by suicide and

Death at a younger age by medical illness

There is a paucity of published studies on medical errors among individuals with co-occurring disorders despite several risk factors for unintended harm and high rates of morbidity and mortality

Attention Deficit-Hyperactivity Disorder in Children Excessive or Insufficient Diagnosis and Treatment

Inattentiveness distractibility impulsivity and hyperactivity were recognized as elements of minimal brain dysfunction (now termed attention deficit hyperactivity disorder [ADHD]) and treated with stimulants especially methylphenidate beginning in the late 1960s[101126127] Over the past 3 decades the rate of drug treatment for behavior problems has increased exponentially culminating in the prescription of ADHD drug treatment for at least 5-6 million American children annually[128]

Children diagnosed with ADHD have been the focus of thousands of research studies over the last 40 years yet the diagnosis and treatment of ADHD remain controversial among some within medicine and the general public[129130] Recent prevalence data from the 1998 National Institutes

of Health (NIH) consensus review[131] and reported by Jensen[132] suggest a prevalence of approximately 5 affecting 3 million school-aged children[133134]

ADHD is associated with[135-137]

Increased risk of accidents

Family and social dysfunction

Poor academic achievement

Substance abuse and

Antisocial behavior

Recent treatment data based on the number of methylphenidate prescriptions show an estimated 5-6 million American children receive ADHD-related drug treatment annually[128] Aggregate national methylphenidate use has increased 100-fold from 1960 until 2000 Globally nearly 90 of the worlds stimulant medication supply is consumed by the US population[138139]

Substantial state-to-state and community-to-community variability in methylphenidate use raises concerns about potential pockets of over- and under-diagnosis and over- and under-prescribing Drug Enforcement Association data on stimulant use reflect a 6-fold per capita variation in methylphenidate prescribing between some states[140] and a 20-fold prescribing variation between some communities[130141]

LeFever and colleagues argue that while the data are inconclusive if communities such as Salt Lake City Utah are used as a benchmark of acceptable diagnosis and treatment then children in 36 states may be subject to over-diagnosis and over-treatment Conversely Jensen argues that ADHD is under-diagnosed and under-treated based on national aggregate data allowing for pockets of over-diagnosis and treatment in some geographic areas[142] Given that in 1995 there were approximately 2 million pediatric visits in which ADHD was the focus of treatment and 6 million stimulant prescriptions were written[132] 1 conclusion is that 3 million children with ADHD received an average of 2 prescriptions and 1 outpatient visit during that year suggesting insufficient treatment In another study cited by Jensen the Multimodal Treatment Study of Children with ADHD two thirds of ADHD children from reportedly highly motivated families obtained medication treatments and for an average duration of only 8-14 months[142143]

Despite the number of studies done the strength of conclusions that can be drawn is contingent upon the adequacy of reported data Studies to date are variously limited by data sources sampling accuracy and interpretation[130]

When considered in aggregate national ADHD prevalence rates and numbers of prescriptions written do not suggest excessive diagnosis and treatment However prevalence rates and stimulant use can vary as much as 30-fold when comparing different communities A prevalence rate of 33 among white elementary-aged boys in southeastern Virginia significantly challenges credibility[130] Such variability makes it essential that prevalence rates and stimulant use estimates be linked to sufficient demographics such as

Geography

Age

Race and

Gender

ADHD prevalence rates and stimulant use appear to be

Excessive in some communities

Plausible in other communities and

Perhaps insufficient in yet other communities

Additional epidemiologic studies reporting prevalence rates with specific demographics rather than in aggregate and broader use of practice guidelines promulgated by the American Academy of Pediatrics (AAP) and others that advocate multimodal treatment rather than solely prescribing stimulants or other medications[130144] will help provide evidence of the extent of errors in the diagnosis and treatment of children with ADHD

Electroconvulsive Therapy

Electroconvulsive therapy (ECT) remains a controversial treatment in psychiatry As stated in the 1985 NIH Consensus Statement The nature of the treatment itself its history of abuse unfavorable media presentations compelling testimony of former patients special attention by the legal system uneven distribution of ECT use among practitioners and facilities and uneven access by patients all contribute to the controversial context in which the consensus panel has approached its task[145]

Epidemiologic data reported by Thompson and colleagues in 1994 found that[146]

58667 patients received ECT in 1975

31514 in 1980

36558 in 1986

71 of the patients who received ECT were women and

Individuals older than 65 years of age had the highest rates per number of inpatients

The rate of ECT use has been highly variable For example in 1995 Herman and associates[147] reported that among 202 metropolitan statistical areas annual ECT use varied from 04 to 812 patients per 10000 population

The most common adverse effect from ECT is memory loss In a recent review of patients perspectives as well as clinicians studies Rose and associates[148] concluded that 29 to 55 of ECT treatment recipients experienced persistent memory loss Recent empirical studies of ECT and memory loss continue to find persistent memory loss with bilateral ECT producing more profound memory deficits than right unilateral ECT[149]

In a review of deaths caused by ECT Abrams reported that ECT is 10 times safer than childbirth that approximately 6 times as many deaths annually in the US are caused by lightning as by ECTand that the death rate reported for ECT is an order of magnitude smaller than the spontaneous death rate in the general population[150]

Corroboration of a low ECT death rate has arisen from 1993 legislation in Texas mandating reporting of all ECT-related deaths[151] As a result the risk of death from ECT in Texas has been systematically tracked and reviewed More than 8000 patients received 49048 ECT treatments between 1993 and 1998 However only 1 death could be linked to the associated anesthesia An additional 4 deaths could plausibly have been associated with the anesthesia yielding a mortality rate between 2 and 10 per 100000 and the causes of death most likely were not the ECT stimulus or seizure

Emotional harm and erosion of faith in the medical profession that undermines accepting other needed treatments can come to recipients of care for whom the experience of ECT is frightening

ECT conclusion ECT is effective for severe major affective illness and is associated with a low mortality rate Persistent memory loss is a consistent finding despite attempts to optimize ECT administration and must be expected at an incidence of approximately 25 to 50 by those contemplating and those providing ECT treatment

Despite its relative safety ECT continues to cause alarm in the general public Even within medicine it is described as dangerous and unethical by some[152] Such fears can cause emotional harm among ECT recipients This may be especially true for older women (who comprise the majority of ECT subjects) some of whom may be accustomed to deferring to healthcare providers when consenting to treatment despite insufficient understanding of benefits and risks

Recommendations include

Emphasis on pre-treatment education

Collaborative relationship with ECT recipients

Increased transparency regarding the substantial risk of persistent memory loss when seeking informed consent and

Continued research on its safety

Systems Issues Related to Patient Safety

Outpatient Care

Risk of unintended harm may be increased by the segregated care settings in which psychiatric and substance abuse services are often delivered including solo practitioner offices and free-standing psychiatric and substance abuse treatment facilities[153154] and by insufficient communication and coordination of care between prescribers and psychotherapists[155-157] Despite the recognition of these potential contributing factors there are no existing reports of the association between systems issues and medical errors

Olfson[158] reported that in 1987 there were 84 million outpatient visits with mental health practitioners including

Psychiatrists

Psychologists

Social workers and

Licensed counselors

Kessler[154] reported in 1999 that an estimated 133 of a representative sample of Americans reported used outpatient services for mental health problems in the previous 12 months Clearly there are high numbers of individuals at risk for errors in outpatient mental health and substance abuse treatment

Ethics and Malpractice Risk Management Boundary Violations

A survey of recently published reviews and commentaries on patient safety reveals that for mental health and substance abuse issues such discussion takes place mainly within the context of ethics and malpractice risk management[159-162] Ethics statements from both the APA[162] and the American Psychological Association[163] support the duty to report and protect patients from deviations from the standards of care This approach uses the individual practitioners frame of reference and relies on voluntary reporting from professionals who have been trained to consider confidentiality a critical component of their work Harm caused by clinician boundary violations are understood as issues of professional misconduct not as errors resulting from system failure and that minimize the individual clinicians responsibility and advise against punitive action [164-167]

With the advent of therapeutic exchanges through email and other means of communication additional boundary violations are possible The Internet now has at least 110 million users including 70 million using it for health-related information[168] A recent survey indicated 40 to 50 of physicians use the Internet (or are preparing to use it) for clinical care[169]

There is a risk of errors of omission or commission arising from lack of coordination of care between clinicians Differences in therapeutic orientation and nomenclature used by the following specialists can compound systems issues that increase the risk of medical errors [158]

Social workers

Psychiatric nurse specialists

Psychologists

Licensed counselors and

Psychiatrists

Confidentiality is critical in providing effective treatment within the secure and private setting of the therapists office and in protecting the patient from unauthorized disclosures of sensitive information and potential abuse from a third party[170] However confidentiality can also inhibit disclosure of near misses impasses in treatment (for example when treatment is not working) and preventable adverse events due to avoidance of sharing important clinical information with other professionals and with appropriate family members and other supportive resources[171172]

The solo practice model commonly used by mental health clinicians can also inhibit the adoption of best practices and the development of policies and procedures to reduce risk because all such practice management activities are left to the individual clinician whose focus is more likely to be exclusively clinical

Summary About Systems Issues and Patient Safety

Systems for reliably reporting outpatient psychotherapy medical errors particularly among the large numbers of solo practitioners do not exist The prevailing paradigm for reducing harm arises from risk reduction in order to diminish medical liability exposure Studies that shed light on potential medical errors have arisen from risk management claims medical liability lawsuits and reports of death by suicide not from research intended to examine patient safety per se

Error reporting systems applicable to outpatient mental health settings including incentives for their use need to be developed Professional risk management programs primarily used to diminish medical liability exposure from the following could also be used to promulgate the relevance and value of the patient safety paradigm

Boundary violations

Suicide and

Treatment errors

Most particularly thought needs to be given to developing systems of error prevention applicable to the solo practitioner

Recommendations

Recommendation no 1

Widespread adoption of the IOM patient safety paradigm and nomenclature in mental health and substance abuse treatment settings is recommended

Advantages of its use include

Consistency with the nomenclature used by other medical specialties

Increased leverage in advocating for needed services and resources when the absence of essential treatments are quantified as errors of omission causing near misses or preventable adverse events

Increased likelihood that medication errors in mental health and substance abuse will be researched and a determination made whether such errors are causing preventable adverse events and

Increased awareness among mental health and substance abuse clinicians that patient harm can come from a broader array of errors in diagnosis and treatment than has been studied to date

Widespread adoption will require systematic educational efforts for trainees and current practitioners in mental health and substance abuse including systematic introduction to the IOMs existence mission and safety and quality efforts such as the Quality Chasm Series (Many mental health and substance abuse clinicians and administrators seem unaware of the IOM at all)

Recommendation no 2

Further studies of medical error in mental health and substance disorders are needed

Some areas of potential harm in this field remain largely unexamined For example we found only 2 studies of medication errors in mental health settings and none in substance abuse detoxification and stabilization settings despite multiple risk factors for errors and preventable adverse events The impact of variable education -- in pharmacology physiology and general medicine -- on the safety of prescribing practices has not been studied nor has the clinical consequences of formulary restrictions on clinical outcome and potential patient harm The current acceptance of self-reported hospital error rates must be challenged through a process of independently validating self-reported errors

Recommendation no 3

Integration of mental health and substance abuse services is recommended

High rates of co-occurrence and associated higher rates of morbidity and mortality among those with mental health and substance abuse disorders requires integration of mental health and substance abuse treatment paradigms This has not occurred to date

Recommendation no 4

The IOMs 10 rules for change in healthcare should be adopted

The 10 IOM rules for change in healthcare are as follows[173]

1 Care based on continuous healing relationships

2 Customization based on patient needs and values

3 The patient as the source of control

4 Shared knowledge and the free-flow of information

5 Evidence-based decision-making

6 Safety as a system property

7 The need for transparency

8 Anticipation of needs

9 Continuous decrease in waste

10 Cooperation among clinicians

As an example of adoption of these rules seclusion and restraint remain high risk treatments yet current reporting systems do not permit transparency regarding the rate and types of injuries incurred including mortality rates Such transparency requires a non-punitive work culture yet there is little evidence to suggest its adoption in high-risk environments such as state psychiatric hospitals or inpatient detoxification and stabilization substance abuse treatment settings

Recommendation no 5

Reporting systems in outpatient mental health and substance abuse treatment settings must be adopted

Reliance upon unsubstantiated self-reporting of medication errors in inpatient mental health and substance abuse settings remains a significant flaw when attempting accurate assessment of near misses and preventable adverse events and must be changed A key necessity is anonymous yet authenticated medication error reporting for all staff using available web-based error reporting systems Such systems are cost-savers and make reported error data immediately and continuously available Web-based reporting systems providing anonymity with authentication could be used for further seclusion and restraint data collection and as a means of establishing an outpatient error reporting system of safety and quality data by recipients and providers of outpatient treatment

Recommendation no 6

Resources should be allocated to study and develop practical interventions to improve patient safety

Much current research in mental health and substance abuse and resource appropriation is focused on efficacy of pharmacotherapy and psychotherapy and on establishing neurobiologic evidence to support causal theories of known clinical disorders At a policy level we recommend more consideration be given to funding practical interventions predicted to immediately improve patient safety

References

[ CLOSE WINDOW ]

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Authors and Disclosures

As an organization accredited by the ACCME Medscape LLC requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest The ACCME defines relevant financial relationships as financial relationships in any amount occurring within the past 12 months including financial relationships of a spouse or life partner that could create a conflict of interest

Medscape LLC encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration at first mention and where appropriate in the content

Author

Benjamin C Grasso MD

Staff Psychiatrist VA Clinic Saco Maine Disclosure Benjamin C Grasso MD has disclosed no relevant financial relationships

Cathryn M Clary MD MBA

Vice President US External Medical Affairs Pfizer Inc New York NY Disclosure Cathryn M Clary MD MBA has disclosed that she is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Benjamin Eng MD MA

Senior Medical Director Group Leader Pfizer Inc New York NY Disclosure Benjamin Eng MD MA has disclosed that he is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Stanley J Evans MD FASAM PA

Assistant Professor of Clinical Medicine St Matthews University Windham Maine

Medical Director Renaissance Institute of Palm Beach Boca Raton Florida Disclosure Stanley J Evans MD has disclosed no relevant financial relationships

Terry J Golash MD

Clinical Instructor Psychiatry Columbia University New York NY Assistant Attending St Lukersquos Roosevelt Hospital Center New York NY Disclosure Terry J Golash MD has disclosed no relevant financial relationships

Kevin Ann Huckshorn RN MSN CAP ICADC

Director Office of Technical Assistance National Association of State mental Health Program Directors Inc Alexandria Virginia Disclosure Kevin Ann Huckshorn RN MSN CAP ICADC has disclosed no relevant financial relationships

Kenneth Minkoff MD

Clinical Assistant Professor Department of Psychiatry Cambridge Hospital Harvard University Acton Massachusetts Consultant ZiaLogic Acton Massachusetts Disclosure Kenneth Minkoff MD has disclosed no relevant financial relationships

Joseph J Parks MD

Assistant Associate Professor Department of Psychiatry University of Missouri Columbia Missouri Disclosure Joseph J Parks MD has disclosed that he has received grants for educational activities from Letters amp Science and Physician Postgraduate Press Dr Parks has also disclosed that he has served as a consultant to the National Association of State Mental Health Program Directors and Bristol-Myers Squibb Dr Parks has also disclosed that he has received funds for services provided to the state of Missouri from Eli Lilly and Abbott

Miles F Shore MD

Bullard Distinguished Professor of Psychiatry Harvard Medical School Needham Massachusetts Junior Consultant Harvard Medical International Boston Massachusetts Disclosure Miles F Shore MD has disclosed no relevant financial relationships

Editor

Jacqueline A Hart MD

Freelance Clinical Editor Medscape LLC New York New York Disclosure Jacqueline A Hart MD has disclosed no relevant financial relationships

Elizabeth Saenger PhD

Editorial Director Medscape LLC New York NY Disclosure Elizabeth Saenger PhD has disclosed no relevant financial relationships

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of Health (NIH) consensus review[131] and reported by Jensen[132] suggest a prevalence of approximately 5 affecting 3 million school-aged children[133134]

ADHD is associated with[135-137]

Increased risk of accidents

Family and social dysfunction

Poor academic achievement

Substance abuse and

Antisocial behavior

Recent treatment data based on the number of methylphenidate prescriptions show an estimated 5-6 million American children receive ADHD-related drug treatment annually[128] Aggregate national methylphenidate use has increased 100-fold from 1960 until 2000 Globally nearly 90 of the worlds stimulant medication supply is consumed by the US population[138139]

Substantial state-to-state and community-to-community variability in methylphenidate use raises concerns about potential pockets of over- and under-diagnosis and over- and under-prescribing Drug Enforcement Association data on stimulant use reflect a 6-fold per capita variation in methylphenidate prescribing between some states[140] and a 20-fold prescribing variation between some communities[130141]

LeFever and colleagues argue that while the data are inconclusive if communities such as Salt Lake City Utah are used as a benchmark of acceptable diagnosis and treatment then children in 36 states may be subject to over-diagnosis and over-treatment Conversely Jensen argues that ADHD is under-diagnosed and under-treated based on national aggregate data allowing for pockets of over-diagnosis and treatment in some geographic areas[142] Given that in 1995 there were approximately 2 million pediatric visits in which ADHD was the focus of treatment and 6 million stimulant prescriptions were written[132] 1 conclusion is that 3 million children with ADHD received an average of 2 prescriptions and 1 outpatient visit during that year suggesting insufficient treatment In another study cited by Jensen the Multimodal Treatment Study of Children with ADHD two thirds of ADHD children from reportedly highly motivated families obtained medication treatments and for an average duration of only 8-14 months[142143]

Despite the number of studies done the strength of conclusions that can be drawn is contingent upon the adequacy of reported data Studies to date are variously limited by data sources sampling accuracy and interpretation[130]

When considered in aggregate national ADHD prevalence rates and numbers of prescriptions written do not suggest excessive diagnosis and treatment However prevalence rates and stimulant use can vary as much as 30-fold when comparing different communities A prevalence rate of 33 among white elementary-aged boys in southeastern Virginia significantly challenges credibility[130] Such variability makes it essential that prevalence rates and stimulant use estimates be linked to sufficient demographics such as

Geography

Age

Race and

Gender

ADHD prevalence rates and stimulant use appear to be

Excessive in some communities

Plausible in other communities and

Perhaps insufficient in yet other communities

Additional epidemiologic studies reporting prevalence rates with specific demographics rather than in aggregate and broader use of practice guidelines promulgated by the American Academy of Pediatrics (AAP) and others that advocate multimodal treatment rather than solely prescribing stimulants or other medications[130144] will help provide evidence of the extent of errors in the diagnosis and treatment of children with ADHD

Electroconvulsive Therapy

Electroconvulsive therapy (ECT) remains a controversial treatment in psychiatry As stated in the 1985 NIH Consensus Statement The nature of the treatment itself its history of abuse unfavorable media presentations compelling testimony of former patients special attention by the legal system uneven distribution of ECT use among practitioners and facilities and uneven access by patients all contribute to the controversial context in which the consensus panel has approached its task[145]

Epidemiologic data reported by Thompson and colleagues in 1994 found that[146]

58667 patients received ECT in 1975

31514 in 1980

36558 in 1986

71 of the patients who received ECT were women and

Individuals older than 65 years of age had the highest rates per number of inpatients

The rate of ECT use has been highly variable For example in 1995 Herman and associates[147] reported that among 202 metropolitan statistical areas annual ECT use varied from 04 to 812 patients per 10000 population

The most common adverse effect from ECT is memory loss In a recent review of patients perspectives as well as clinicians studies Rose and associates[148] concluded that 29 to 55 of ECT treatment recipients experienced persistent memory loss Recent empirical studies of ECT and memory loss continue to find persistent memory loss with bilateral ECT producing more profound memory deficits than right unilateral ECT[149]

In a review of deaths caused by ECT Abrams reported that ECT is 10 times safer than childbirth that approximately 6 times as many deaths annually in the US are caused by lightning as by ECTand that the death rate reported for ECT is an order of magnitude smaller than the spontaneous death rate in the general population[150]

Corroboration of a low ECT death rate has arisen from 1993 legislation in Texas mandating reporting of all ECT-related deaths[151] As a result the risk of death from ECT in Texas has been systematically tracked and reviewed More than 8000 patients received 49048 ECT treatments between 1993 and 1998 However only 1 death could be linked to the associated anesthesia An additional 4 deaths could plausibly have been associated with the anesthesia yielding a mortality rate between 2 and 10 per 100000 and the causes of death most likely were not the ECT stimulus or seizure

Emotional harm and erosion of faith in the medical profession that undermines accepting other needed treatments can come to recipients of care for whom the experience of ECT is frightening

ECT conclusion ECT is effective for severe major affective illness and is associated with a low mortality rate Persistent memory loss is a consistent finding despite attempts to optimize ECT administration and must be expected at an incidence of approximately 25 to 50 by those contemplating and those providing ECT treatment

Despite its relative safety ECT continues to cause alarm in the general public Even within medicine it is described as dangerous and unethical by some[152] Such fears can cause emotional harm among ECT recipients This may be especially true for older women (who comprise the majority of ECT subjects) some of whom may be accustomed to deferring to healthcare providers when consenting to treatment despite insufficient understanding of benefits and risks

Recommendations include

Emphasis on pre-treatment education

Collaborative relationship with ECT recipients

Increased transparency regarding the substantial risk of persistent memory loss when seeking informed consent and

Continued research on its safety

Systems Issues Related to Patient Safety

Outpatient Care

Risk of unintended harm may be increased by the segregated care settings in which psychiatric and substance abuse services are often delivered including solo practitioner offices and free-standing psychiatric and substance abuse treatment facilities[153154] and by insufficient communication and coordination of care between prescribers and psychotherapists[155-157] Despite the recognition of these potential contributing factors there are no existing reports of the association between systems issues and medical errors

Olfson[158] reported that in 1987 there were 84 million outpatient visits with mental health practitioners including

Psychiatrists

Psychologists

Social workers and

Licensed counselors

Kessler[154] reported in 1999 that an estimated 133 of a representative sample of Americans reported used outpatient services for mental health problems in the previous 12 months Clearly there are high numbers of individuals at risk for errors in outpatient mental health and substance abuse treatment

Ethics and Malpractice Risk Management Boundary Violations

A survey of recently published reviews and commentaries on patient safety reveals that for mental health and substance abuse issues such discussion takes place mainly within the context of ethics and malpractice risk management[159-162] Ethics statements from both the APA[162] and the American Psychological Association[163] support the duty to report and protect patients from deviations from the standards of care This approach uses the individual practitioners frame of reference and relies on voluntary reporting from professionals who have been trained to consider confidentiality a critical component of their work Harm caused by clinician boundary violations are understood as issues of professional misconduct not as errors resulting from system failure and that minimize the individual clinicians responsibility and advise against punitive action [164-167]

With the advent of therapeutic exchanges through email and other means of communication additional boundary violations are possible The Internet now has at least 110 million users including 70 million using it for health-related information[168] A recent survey indicated 40 to 50 of physicians use the Internet (or are preparing to use it) for clinical care[169]

There is a risk of errors of omission or commission arising from lack of coordination of care between clinicians Differences in therapeutic orientation and nomenclature used by the following specialists can compound systems issues that increase the risk of medical errors [158]

Social workers

Psychiatric nurse specialists

Psychologists

Licensed counselors and

Psychiatrists

Confidentiality is critical in providing effective treatment within the secure and private setting of the therapists office and in protecting the patient from unauthorized disclosures of sensitive information and potential abuse from a third party[170] However confidentiality can also inhibit disclosure of near misses impasses in treatment (for example when treatment is not working) and preventable adverse events due to avoidance of sharing important clinical information with other professionals and with appropriate family members and other supportive resources[171172]

The solo practice model commonly used by mental health clinicians can also inhibit the adoption of best practices and the development of policies and procedures to reduce risk because all such practice management activities are left to the individual clinician whose focus is more likely to be exclusively clinical

Summary About Systems Issues and Patient Safety

Systems for reliably reporting outpatient psychotherapy medical errors particularly among the large numbers of solo practitioners do not exist The prevailing paradigm for reducing harm arises from risk reduction in order to diminish medical liability exposure Studies that shed light on potential medical errors have arisen from risk management claims medical liability lawsuits and reports of death by suicide not from research intended to examine patient safety per se

Error reporting systems applicable to outpatient mental health settings including incentives for their use need to be developed Professional risk management programs primarily used to diminish medical liability exposure from the following could also be used to promulgate the relevance and value of the patient safety paradigm

Boundary violations

Suicide and

Treatment errors

Most particularly thought needs to be given to developing systems of error prevention applicable to the solo practitioner

Recommendations

Recommendation no 1

Widespread adoption of the IOM patient safety paradigm and nomenclature in mental health and substance abuse treatment settings is recommended

Advantages of its use include

Consistency with the nomenclature used by other medical specialties

Increased leverage in advocating for needed services and resources when the absence of essential treatments are quantified as errors of omission causing near misses or preventable adverse events

Increased likelihood that medication errors in mental health and substance abuse will be researched and a determination made whether such errors are causing preventable adverse events and

Increased awareness among mental health and substance abuse clinicians that patient harm can come from a broader array of errors in diagnosis and treatment than has been studied to date

Widespread adoption will require systematic educational efforts for trainees and current practitioners in mental health and substance abuse including systematic introduction to the IOMs existence mission and safety and quality efforts such as the Quality Chasm Series (Many mental health and substance abuse clinicians and administrators seem unaware of the IOM at all)

Recommendation no 2

Further studies of medical error in mental health and substance disorders are needed

Some areas of potential harm in this field remain largely unexamined For example we found only 2 studies of medication errors in mental health settings and none in substance abuse detoxification and stabilization settings despite multiple risk factors for errors and preventable adverse events The impact of variable education -- in pharmacology physiology and general medicine -- on the safety of prescribing practices has not been studied nor has the clinical consequences of formulary restrictions on clinical outcome and potential patient harm The current acceptance of self-reported hospital error rates must be challenged through a process of independently validating self-reported errors

Recommendation no 3

Integration of mental health and substance abuse services is recommended

High rates of co-occurrence and associated higher rates of morbidity and mortality among those with mental health and substance abuse disorders requires integration of mental health and substance abuse treatment paradigms This has not occurred to date

Recommendation no 4

The IOMs 10 rules for change in healthcare should be adopted

The 10 IOM rules for change in healthcare are as follows[173]

1 Care based on continuous healing relationships

2 Customization based on patient needs and values

3 The patient as the source of control

4 Shared knowledge and the free-flow of information

5 Evidence-based decision-making

6 Safety as a system property

7 The need for transparency

8 Anticipation of needs

9 Continuous decrease in waste

10 Cooperation among clinicians

As an example of adoption of these rules seclusion and restraint remain high risk treatments yet current reporting systems do not permit transparency regarding the rate and types of injuries incurred including mortality rates Such transparency requires a non-punitive work culture yet there is little evidence to suggest its adoption in high-risk environments such as state psychiatric hospitals or inpatient detoxification and stabilization substance abuse treatment settings

Recommendation no 5

Reporting systems in outpatient mental health and substance abuse treatment settings must be adopted

Reliance upon unsubstantiated self-reporting of medication errors in inpatient mental health and substance abuse settings remains a significant flaw when attempting accurate assessment of near misses and preventable adverse events and must be changed A key necessity is anonymous yet authenticated medication error reporting for all staff using available web-based error reporting systems Such systems are cost-savers and make reported error data immediately and continuously available Web-based reporting systems providing anonymity with authentication could be used for further seclusion and restraint data collection and as a means of establishing an outpatient error reporting system of safety and quality data by recipients and providers of outpatient treatment

Recommendation no 6

Resources should be allocated to study and develop practical interventions to improve patient safety

Much current research in mental health and substance abuse and resource appropriation is focused on efficacy of pharmacotherapy and psychotherapy and on establishing neurobiologic evidence to support causal theories of known clinical disorders At a policy level we recommend more consideration be given to funding practical interventions predicted to immediately improve patient safety

References

[ CLOSE WINDOW ]

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Authors and Disclosures

As an organization accredited by the ACCME Medscape LLC requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest The ACCME defines relevant financial relationships as financial relationships in any amount occurring within the past 12 months including financial relationships of a spouse or life partner that could create a conflict of interest

Medscape LLC encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration at first mention and where appropriate in the content

Author

Benjamin C Grasso MD

Staff Psychiatrist VA Clinic Saco Maine Disclosure Benjamin C Grasso MD has disclosed no relevant financial relationships

Cathryn M Clary MD MBA

Vice President US External Medical Affairs Pfizer Inc New York NY Disclosure Cathryn M Clary MD MBA has disclosed that she is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Benjamin Eng MD MA

Senior Medical Director Group Leader Pfizer Inc New York NY Disclosure Benjamin Eng MD MA has disclosed that he is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Stanley J Evans MD FASAM PA

Assistant Professor of Clinical Medicine St Matthews University Windham Maine

Medical Director Renaissance Institute of Palm Beach Boca Raton Florida Disclosure Stanley J Evans MD has disclosed no relevant financial relationships

Terry J Golash MD

Clinical Instructor Psychiatry Columbia University New York NY Assistant Attending St Lukersquos Roosevelt Hospital Center New York NY Disclosure Terry J Golash MD has disclosed no relevant financial relationships

Kevin Ann Huckshorn RN MSN CAP ICADC

Director Office of Technical Assistance National Association of State mental Health Program Directors Inc Alexandria Virginia Disclosure Kevin Ann Huckshorn RN MSN CAP ICADC has disclosed no relevant financial relationships

Kenneth Minkoff MD

Clinical Assistant Professor Department of Psychiatry Cambridge Hospital Harvard University Acton Massachusetts Consultant ZiaLogic Acton Massachusetts Disclosure Kenneth Minkoff MD has disclosed no relevant financial relationships

Joseph J Parks MD

Assistant Associate Professor Department of Psychiatry University of Missouri Columbia Missouri Disclosure Joseph J Parks MD has disclosed that he has received grants for educational activities from Letters amp Science and Physician Postgraduate Press Dr Parks has also disclosed that he has served as a consultant to the National Association of State Mental Health Program Directors and Bristol-Myers Squibb Dr Parks has also disclosed that he has received funds for services provided to the state of Missouri from Eli Lilly and Abbott

Miles F Shore MD

Bullard Distinguished Professor of Psychiatry Harvard Medical School Needham Massachusetts Junior Consultant Harvard Medical International Boston Massachusetts Disclosure Miles F Shore MD has disclosed no relevant financial relationships

Editor

Jacqueline A Hart MD

Freelance Clinical Editor Medscape LLC New York New York Disclosure Jacqueline A Hart MD has disclosed no relevant financial relationships

Elizabeth Saenger PhD

Editorial Director Medscape LLC New York NY Disclosure Elizabeth Saenger PhD has disclosed no relevant financial relationships

Registration for CME credit the post test and the evaluation must be completed online To access the activity Post Test and Evaluation link please go to httpwwwmedscapecomviewprogram7809_index

Page 18: Medication Errors and Patient Safety in Mental Health CME/CE · 2019. 6. 27. · Medication Errors and Patient Safety in Mental Health CME/CE Complete author affiliations and disclosures

Race and

Gender

ADHD prevalence rates and stimulant use appear to be

Excessive in some communities

Plausible in other communities and

Perhaps insufficient in yet other communities

Additional epidemiologic studies reporting prevalence rates with specific demographics rather than in aggregate and broader use of practice guidelines promulgated by the American Academy of Pediatrics (AAP) and others that advocate multimodal treatment rather than solely prescribing stimulants or other medications[130144] will help provide evidence of the extent of errors in the diagnosis and treatment of children with ADHD

Electroconvulsive Therapy

Electroconvulsive therapy (ECT) remains a controversial treatment in psychiatry As stated in the 1985 NIH Consensus Statement The nature of the treatment itself its history of abuse unfavorable media presentations compelling testimony of former patients special attention by the legal system uneven distribution of ECT use among practitioners and facilities and uneven access by patients all contribute to the controversial context in which the consensus panel has approached its task[145]

Epidemiologic data reported by Thompson and colleagues in 1994 found that[146]

58667 patients received ECT in 1975

31514 in 1980

36558 in 1986

71 of the patients who received ECT were women and

Individuals older than 65 years of age had the highest rates per number of inpatients

The rate of ECT use has been highly variable For example in 1995 Herman and associates[147] reported that among 202 metropolitan statistical areas annual ECT use varied from 04 to 812 patients per 10000 population

The most common adverse effect from ECT is memory loss In a recent review of patients perspectives as well as clinicians studies Rose and associates[148] concluded that 29 to 55 of ECT treatment recipients experienced persistent memory loss Recent empirical studies of ECT and memory loss continue to find persistent memory loss with bilateral ECT producing more profound memory deficits than right unilateral ECT[149]

In a review of deaths caused by ECT Abrams reported that ECT is 10 times safer than childbirth that approximately 6 times as many deaths annually in the US are caused by lightning as by ECTand that the death rate reported for ECT is an order of magnitude smaller than the spontaneous death rate in the general population[150]

Corroboration of a low ECT death rate has arisen from 1993 legislation in Texas mandating reporting of all ECT-related deaths[151] As a result the risk of death from ECT in Texas has been systematically tracked and reviewed More than 8000 patients received 49048 ECT treatments between 1993 and 1998 However only 1 death could be linked to the associated anesthesia An additional 4 deaths could plausibly have been associated with the anesthesia yielding a mortality rate between 2 and 10 per 100000 and the causes of death most likely were not the ECT stimulus or seizure

Emotional harm and erosion of faith in the medical profession that undermines accepting other needed treatments can come to recipients of care for whom the experience of ECT is frightening

ECT conclusion ECT is effective for severe major affective illness and is associated with a low mortality rate Persistent memory loss is a consistent finding despite attempts to optimize ECT administration and must be expected at an incidence of approximately 25 to 50 by those contemplating and those providing ECT treatment

Despite its relative safety ECT continues to cause alarm in the general public Even within medicine it is described as dangerous and unethical by some[152] Such fears can cause emotional harm among ECT recipients This may be especially true for older women (who comprise the majority of ECT subjects) some of whom may be accustomed to deferring to healthcare providers when consenting to treatment despite insufficient understanding of benefits and risks

Recommendations include

Emphasis on pre-treatment education

Collaborative relationship with ECT recipients

Increased transparency regarding the substantial risk of persistent memory loss when seeking informed consent and

Continued research on its safety

Systems Issues Related to Patient Safety

Outpatient Care

Risk of unintended harm may be increased by the segregated care settings in which psychiatric and substance abuse services are often delivered including solo practitioner offices and free-standing psychiatric and substance abuse treatment facilities[153154] and by insufficient communication and coordination of care between prescribers and psychotherapists[155-157] Despite the recognition of these potential contributing factors there are no existing reports of the association between systems issues and medical errors

Olfson[158] reported that in 1987 there were 84 million outpatient visits with mental health practitioners including

Psychiatrists

Psychologists

Social workers and

Licensed counselors

Kessler[154] reported in 1999 that an estimated 133 of a representative sample of Americans reported used outpatient services for mental health problems in the previous 12 months Clearly there are high numbers of individuals at risk for errors in outpatient mental health and substance abuse treatment

Ethics and Malpractice Risk Management Boundary Violations

A survey of recently published reviews and commentaries on patient safety reveals that for mental health and substance abuse issues such discussion takes place mainly within the context of ethics and malpractice risk management[159-162] Ethics statements from both the APA[162] and the American Psychological Association[163] support the duty to report and protect patients from deviations from the standards of care This approach uses the individual practitioners frame of reference and relies on voluntary reporting from professionals who have been trained to consider confidentiality a critical component of their work Harm caused by clinician boundary violations are understood as issues of professional misconduct not as errors resulting from system failure and that minimize the individual clinicians responsibility and advise against punitive action [164-167]

With the advent of therapeutic exchanges through email and other means of communication additional boundary violations are possible The Internet now has at least 110 million users including 70 million using it for health-related information[168] A recent survey indicated 40 to 50 of physicians use the Internet (or are preparing to use it) for clinical care[169]

There is a risk of errors of omission or commission arising from lack of coordination of care between clinicians Differences in therapeutic orientation and nomenclature used by the following specialists can compound systems issues that increase the risk of medical errors [158]

Social workers

Psychiatric nurse specialists

Psychologists

Licensed counselors and

Psychiatrists

Confidentiality is critical in providing effective treatment within the secure and private setting of the therapists office and in protecting the patient from unauthorized disclosures of sensitive information and potential abuse from a third party[170] However confidentiality can also inhibit disclosure of near misses impasses in treatment (for example when treatment is not working) and preventable adverse events due to avoidance of sharing important clinical information with other professionals and with appropriate family members and other supportive resources[171172]

The solo practice model commonly used by mental health clinicians can also inhibit the adoption of best practices and the development of policies and procedures to reduce risk because all such practice management activities are left to the individual clinician whose focus is more likely to be exclusively clinical

Summary About Systems Issues and Patient Safety

Systems for reliably reporting outpatient psychotherapy medical errors particularly among the large numbers of solo practitioners do not exist The prevailing paradigm for reducing harm arises from risk reduction in order to diminish medical liability exposure Studies that shed light on potential medical errors have arisen from risk management claims medical liability lawsuits and reports of death by suicide not from research intended to examine patient safety per se

Error reporting systems applicable to outpatient mental health settings including incentives for their use need to be developed Professional risk management programs primarily used to diminish medical liability exposure from the following could also be used to promulgate the relevance and value of the patient safety paradigm

Boundary violations

Suicide and

Treatment errors

Most particularly thought needs to be given to developing systems of error prevention applicable to the solo practitioner

Recommendations

Recommendation no 1

Widespread adoption of the IOM patient safety paradigm and nomenclature in mental health and substance abuse treatment settings is recommended

Advantages of its use include

Consistency with the nomenclature used by other medical specialties

Increased leverage in advocating for needed services and resources when the absence of essential treatments are quantified as errors of omission causing near misses or preventable adverse events

Increased likelihood that medication errors in mental health and substance abuse will be researched and a determination made whether such errors are causing preventable adverse events and

Increased awareness among mental health and substance abuse clinicians that patient harm can come from a broader array of errors in diagnosis and treatment than has been studied to date

Widespread adoption will require systematic educational efforts for trainees and current practitioners in mental health and substance abuse including systematic introduction to the IOMs existence mission and safety and quality efforts such as the Quality Chasm Series (Many mental health and substance abuse clinicians and administrators seem unaware of the IOM at all)

Recommendation no 2

Further studies of medical error in mental health and substance disorders are needed

Some areas of potential harm in this field remain largely unexamined For example we found only 2 studies of medication errors in mental health settings and none in substance abuse detoxification and stabilization settings despite multiple risk factors for errors and preventable adverse events The impact of variable education -- in pharmacology physiology and general medicine -- on the safety of prescribing practices has not been studied nor has the clinical consequences of formulary restrictions on clinical outcome and potential patient harm The current acceptance of self-reported hospital error rates must be challenged through a process of independently validating self-reported errors

Recommendation no 3

Integration of mental health and substance abuse services is recommended

High rates of co-occurrence and associated higher rates of morbidity and mortality among those with mental health and substance abuse disorders requires integration of mental health and substance abuse treatment paradigms This has not occurred to date

Recommendation no 4

The IOMs 10 rules for change in healthcare should be adopted

The 10 IOM rules for change in healthcare are as follows[173]

1 Care based on continuous healing relationships

2 Customization based on patient needs and values

3 The patient as the source of control

4 Shared knowledge and the free-flow of information

5 Evidence-based decision-making

6 Safety as a system property

7 The need for transparency

8 Anticipation of needs

9 Continuous decrease in waste

10 Cooperation among clinicians

As an example of adoption of these rules seclusion and restraint remain high risk treatments yet current reporting systems do not permit transparency regarding the rate and types of injuries incurred including mortality rates Such transparency requires a non-punitive work culture yet there is little evidence to suggest its adoption in high-risk environments such as state psychiatric hospitals or inpatient detoxification and stabilization substance abuse treatment settings

Recommendation no 5

Reporting systems in outpatient mental health and substance abuse treatment settings must be adopted

Reliance upon unsubstantiated self-reporting of medication errors in inpatient mental health and substance abuse settings remains a significant flaw when attempting accurate assessment of near misses and preventable adverse events and must be changed A key necessity is anonymous yet authenticated medication error reporting for all staff using available web-based error reporting systems Such systems are cost-savers and make reported error data immediately and continuously available Web-based reporting systems providing anonymity with authentication could be used for further seclusion and restraint data collection and as a means of establishing an outpatient error reporting system of safety and quality data by recipients and providers of outpatient treatment

Recommendation no 6

Resources should be allocated to study and develop practical interventions to improve patient safety

Much current research in mental health and substance abuse and resource appropriation is focused on efficacy of pharmacotherapy and psychotherapy and on establishing neurobiologic evidence to support causal theories of known clinical disorders At a policy level we recommend more consideration be given to funding practical interventions predicted to immediately improve patient safety

References

[ CLOSE WINDOW ]

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Authors and Disclosures

As an organization accredited by the ACCME Medscape LLC requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest The ACCME defines relevant financial relationships as financial relationships in any amount occurring within the past 12 months including financial relationships of a spouse or life partner that could create a conflict of interest

Medscape LLC encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration at first mention and where appropriate in the content

Author

Benjamin C Grasso MD

Staff Psychiatrist VA Clinic Saco Maine Disclosure Benjamin C Grasso MD has disclosed no relevant financial relationships

Cathryn M Clary MD MBA

Vice President US External Medical Affairs Pfizer Inc New York NY Disclosure Cathryn M Clary MD MBA has disclosed that she is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Benjamin Eng MD MA

Senior Medical Director Group Leader Pfizer Inc New York NY Disclosure Benjamin Eng MD MA has disclosed that he is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Stanley J Evans MD FASAM PA

Assistant Professor of Clinical Medicine St Matthews University Windham Maine

Medical Director Renaissance Institute of Palm Beach Boca Raton Florida Disclosure Stanley J Evans MD has disclosed no relevant financial relationships

Terry J Golash MD

Clinical Instructor Psychiatry Columbia University New York NY Assistant Attending St Lukersquos Roosevelt Hospital Center New York NY Disclosure Terry J Golash MD has disclosed no relevant financial relationships

Kevin Ann Huckshorn RN MSN CAP ICADC

Director Office of Technical Assistance National Association of State mental Health Program Directors Inc Alexandria Virginia Disclosure Kevin Ann Huckshorn RN MSN CAP ICADC has disclosed no relevant financial relationships

Kenneth Minkoff MD

Clinical Assistant Professor Department of Psychiatry Cambridge Hospital Harvard University Acton Massachusetts Consultant ZiaLogic Acton Massachusetts Disclosure Kenneth Minkoff MD has disclosed no relevant financial relationships

Joseph J Parks MD

Assistant Associate Professor Department of Psychiatry University of Missouri Columbia Missouri Disclosure Joseph J Parks MD has disclosed that he has received grants for educational activities from Letters amp Science and Physician Postgraduate Press Dr Parks has also disclosed that he has served as a consultant to the National Association of State Mental Health Program Directors and Bristol-Myers Squibb Dr Parks has also disclosed that he has received funds for services provided to the state of Missouri from Eli Lilly and Abbott

Miles F Shore MD

Bullard Distinguished Professor of Psychiatry Harvard Medical School Needham Massachusetts Junior Consultant Harvard Medical International Boston Massachusetts Disclosure Miles F Shore MD has disclosed no relevant financial relationships

Editor

Jacqueline A Hart MD

Freelance Clinical Editor Medscape LLC New York New York Disclosure Jacqueline A Hart MD has disclosed no relevant financial relationships

Elizabeth Saenger PhD

Editorial Director Medscape LLC New York NY Disclosure Elizabeth Saenger PhD has disclosed no relevant financial relationships

Registration for CME credit the post test and the evaluation must be completed online To access the activity Post Test and Evaluation link please go to httpwwwmedscapecomviewprogram7809_index

Page 19: Medication Errors and Patient Safety in Mental Health CME/CE · 2019. 6. 27. · Medication Errors and Patient Safety in Mental Health CME/CE Complete author affiliations and disclosures

Corroboration of a low ECT death rate has arisen from 1993 legislation in Texas mandating reporting of all ECT-related deaths[151] As a result the risk of death from ECT in Texas has been systematically tracked and reviewed More than 8000 patients received 49048 ECT treatments between 1993 and 1998 However only 1 death could be linked to the associated anesthesia An additional 4 deaths could plausibly have been associated with the anesthesia yielding a mortality rate between 2 and 10 per 100000 and the causes of death most likely were not the ECT stimulus or seizure

Emotional harm and erosion of faith in the medical profession that undermines accepting other needed treatments can come to recipients of care for whom the experience of ECT is frightening

ECT conclusion ECT is effective for severe major affective illness and is associated with a low mortality rate Persistent memory loss is a consistent finding despite attempts to optimize ECT administration and must be expected at an incidence of approximately 25 to 50 by those contemplating and those providing ECT treatment

Despite its relative safety ECT continues to cause alarm in the general public Even within medicine it is described as dangerous and unethical by some[152] Such fears can cause emotional harm among ECT recipients This may be especially true for older women (who comprise the majority of ECT subjects) some of whom may be accustomed to deferring to healthcare providers when consenting to treatment despite insufficient understanding of benefits and risks

Recommendations include

Emphasis on pre-treatment education

Collaborative relationship with ECT recipients

Increased transparency regarding the substantial risk of persistent memory loss when seeking informed consent and

Continued research on its safety

Systems Issues Related to Patient Safety

Outpatient Care

Risk of unintended harm may be increased by the segregated care settings in which psychiatric and substance abuse services are often delivered including solo practitioner offices and free-standing psychiatric and substance abuse treatment facilities[153154] and by insufficient communication and coordination of care between prescribers and psychotherapists[155-157] Despite the recognition of these potential contributing factors there are no existing reports of the association between systems issues and medical errors

Olfson[158] reported that in 1987 there were 84 million outpatient visits with mental health practitioners including

Psychiatrists

Psychologists

Social workers and

Licensed counselors

Kessler[154] reported in 1999 that an estimated 133 of a representative sample of Americans reported used outpatient services for mental health problems in the previous 12 months Clearly there are high numbers of individuals at risk for errors in outpatient mental health and substance abuse treatment

Ethics and Malpractice Risk Management Boundary Violations

A survey of recently published reviews and commentaries on patient safety reveals that for mental health and substance abuse issues such discussion takes place mainly within the context of ethics and malpractice risk management[159-162] Ethics statements from both the APA[162] and the American Psychological Association[163] support the duty to report and protect patients from deviations from the standards of care This approach uses the individual practitioners frame of reference and relies on voluntary reporting from professionals who have been trained to consider confidentiality a critical component of their work Harm caused by clinician boundary violations are understood as issues of professional misconduct not as errors resulting from system failure and that minimize the individual clinicians responsibility and advise against punitive action [164-167]

With the advent of therapeutic exchanges through email and other means of communication additional boundary violations are possible The Internet now has at least 110 million users including 70 million using it for health-related information[168] A recent survey indicated 40 to 50 of physicians use the Internet (or are preparing to use it) for clinical care[169]

There is a risk of errors of omission or commission arising from lack of coordination of care between clinicians Differences in therapeutic orientation and nomenclature used by the following specialists can compound systems issues that increase the risk of medical errors [158]

Social workers

Psychiatric nurse specialists

Psychologists

Licensed counselors and

Psychiatrists

Confidentiality is critical in providing effective treatment within the secure and private setting of the therapists office and in protecting the patient from unauthorized disclosures of sensitive information and potential abuse from a third party[170] However confidentiality can also inhibit disclosure of near misses impasses in treatment (for example when treatment is not working) and preventable adverse events due to avoidance of sharing important clinical information with other professionals and with appropriate family members and other supportive resources[171172]

The solo practice model commonly used by mental health clinicians can also inhibit the adoption of best practices and the development of policies and procedures to reduce risk because all such practice management activities are left to the individual clinician whose focus is more likely to be exclusively clinical

Summary About Systems Issues and Patient Safety

Systems for reliably reporting outpatient psychotherapy medical errors particularly among the large numbers of solo practitioners do not exist The prevailing paradigm for reducing harm arises from risk reduction in order to diminish medical liability exposure Studies that shed light on potential medical errors have arisen from risk management claims medical liability lawsuits and reports of death by suicide not from research intended to examine patient safety per se

Error reporting systems applicable to outpatient mental health settings including incentives for their use need to be developed Professional risk management programs primarily used to diminish medical liability exposure from the following could also be used to promulgate the relevance and value of the patient safety paradigm

Boundary violations

Suicide and

Treatment errors

Most particularly thought needs to be given to developing systems of error prevention applicable to the solo practitioner

Recommendations

Recommendation no 1

Widespread adoption of the IOM patient safety paradigm and nomenclature in mental health and substance abuse treatment settings is recommended

Advantages of its use include

Consistency with the nomenclature used by other medical specialties

Increased leverage in advocating for needed services and resources when the absence of essential treatments are quantified as errors of omission causing near misses or preventable adverse events

Increased likelihood that medication errors in mental health and substance abuse will be researched and a determination made whether such errors are causing preventable adverse events and

Increased awareness among mental health and substance abuse clinicians that patient harm can come from a broader array of errors in diagnosis and treatment than has been studied to date

Widespread adoption will require systematic educational efforts for trainees and current practitioners in mental health and substance abuse including systematic introduction to the IOMs existence mission and safety and quality efforts such as the Quality Chasm Series (Many mental health and substance abuse clinicians and administrators seem unaware of the IOM at all)

Recommendation no 2

Further studies of medical error in mental health and substance disorders are needed

Some areas of potential harm in this field remain largely unexamined For example we found only 2 studies of medication errors in mental health settings and none in substance abuse detoxification and stabilization settings despite multiple risk factors for errors and preventable adverse events The impact of variable education -- in pharmacology physiology and general medicine -- on the safety of prescribing practices has not been studied nor has the clinical consequences of formulary restrictions on clinical outcome and potential patient harm The current acceptance of self-reported hospital error rates must be challenged through a process of independently validating self-reported errors

Recommendation no 3

Integration of mental health and substance abuse services is recommended

High rates of co-occurrence and associated higher rates of morbidity and mortality among those with mental health and substance abuse disorders requires integration of mental health and substance abuse treatment paradigms This has not occurred to date

Recommendation no 4

The IOMs 10 rules for change in healthcare should be adopted

The 10 IOM rules for change in healthcare are as follows[173]

1 Care based on continuous healing relationships

2 Customization based on patient needs and values

3 The patient as the source of control

4 Shared knowledge and the free-flow of information

5 Evidence-based decision-making

6 Safety as a system property

7 The need for transparency

8 Anticipation of needs

9 Continuous decrease in waste

10 Cooperation among clinicians

As an example of adoption of these rules seclusion and restraint remain high risk treatments yet current reporting systems do not permit transparency regarding the rate and types of injuries incurred including mortality rates Such transparency requires a non-punitive work culture yet there is little evidence to suggest its adoption in high-risk environments such as state psychiatric hospitals or inpatient detoxification and stabilization substance abuse treatment settings

Recommendation no 5

Reporting systems in outpatient mental health and substance abuse treatment settings must be adopted

Reliance upon unsubstantiated self-reporting of medication errors in inpatient mental health and substance abuse settings remains a significant flaw when attempting accurate assessment of near misses and preventable adverse events and must be changed A key necessity is anonymous yet authenticated medication error reporting for all staff using available web-based error reporting systems Such systems are cost-savers and make reported error data immediately and continuously available Web-based reporting systems providing anonymity with authentication could be used for further seclusion and restraint data collection and as a means of establishing an outpatient error reporting system of safety and quality data by recipients and providers of outpatient treatment

Recommendation no 6

Resources should be allocated to study and develop practical interventions to improve patient safety

Much current research in mental health and substance abuse and resource appropriation is focused on efficacy of pharmacotherapy and psychotherapy and on establishing neurobiologic evidence to support causal theories of known clinical disorders At a policy level we recommend more consideration be given to funding practical interventions predicted to immediately improve patient safety

References

[ CLOSE WINDOW ]

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Authors and Disclosures

As an organization accredited by the ACCME Medscape LLC requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest The ACCME defines relevant financial relationships as financial relationships in any amount occurring within the past 12 months including financial relationships of a spouse or life partner that could create a conflict of interest

Medscape LLC encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration at first mention and where appropriate in the content

Author

Benjamin C Grasso MD

Staff Psychiatrist VA Clinic Saco Maine Disclosure Benjamin C Grasso MD has disclosed no relevant financial relationships

Cathryn M Clary MD MBA

Vice President US External Medical Affairs Pfizer Inc New York NY Disclosure Cathryn M Clary MD MBA has disclosed that she is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Benjamin Eng MD MA

Senior Medical Director Group Leader Pfizer Inc New York NY Disclosure Benjamin Eng MD MA has disclosed that he is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Stanley J Evans MD FASAM PA

Assistant Professor of Clinical Medicine St Matthews University Windham Maine

Medical Director Renaissance Institute of Palm Beach Boca Raton Florida Disclosure Stanley J Evans MD has disclosed no relevant financial relationships

Terry J Golash MD

Clinical Instructor Psychiatry Columbia University New York NY Assistant Attending St Lukersquos Roosevelt Hospital Center New York NY Disclosure Terry J Golash MD has disclosed no relevant financial relationships

Kevin Ann Huckshorn RN MSN CAP ICADC

Director Office of Technical Assistance National Association of State mental Health Program Directors Inc Alexandria Virginia Disclosure Kevin Ann Huckshorn RN MSN CAP ICADC has disclosed no relevant financial relationships

Kenneth Minkoff MD

Clinical Assistant Professor Department of Psychiatry Cambridge Hospital Harvard University Acton Massachusetts Consultant ZiaLogic Acton Massachusetts Disclosure Kenneth Minkoff MD has disclosed no relevant financial relationships

Joseph J Parks MD

Assistant Associate Professor Department of Psychiatry University of Missouri Columbia Missouri Disclosure Joseph J Parks MD has disclosed that he has received grants for educational activities from Letters amp Science and Physician Postgraduate Press Dr Parks has also disclosed that he has served as a consultant to the National Association of State Mental Health Program Directors and Bristol-Myers Squibb Dr Parks has also disclosed that he has received funds for services provided to the state of Missouri from Eli Lilly and Abbott

Miles F Shore MD

Bullard Distinguished Professor of Psychiatry Harvard Medical School Needham Massachusetts Junior Consultant Harvard Medical International Boston Massachusetts Disclosure Miles F Shore MD has disclosed no relevant financial relationships

Editor

Jacqueline A Hart MD

Freelance Clinical Editor Medscape LLC New York New York Disclosure Jacqueline A Hart MD has disclosed no relevant financial relationships

Elizabeth Saenger PhD

Editorial Director Medscape LLC New York NY Disclosure Elizabeth Saenger PhD has disclosed no relevant financial relationships

Registration for CME credit the post test and the evaluation must be completed online To access the activity Post Test and Evaluation link please go to httpwwwmedscapecomviewprogram7809_index

Page 20: Medication Errors and Patient Safety in Mental Health CME/CE · 2019. 6. 27. · Medication Errors and Patient Safety in Mental Health CME/CE Complete author affiliations and disclosures

Licensed counselors

Kessler[154] reported in 1999 that an estimated 133 of a representative sample of Americans reported used outpatient services for mental health problems in the previous 12 months Clearly there are high numbers of individuals at risk for errors in outpatient mental health and substance abuse treatment

Ethics and Malpractice Risk Management Boundary Violations

A survey of recently published reviews and commentaries on patient safety reveals that for mental health and substance abuse issues such discussion takes place mainly within the context of ethics and malpractice risk management[159-162] Ethics statements from both the APA[162] and the American Psychological Association[163] support the duty to report and protect patients from deviations from the standards of care This approach uses the individual practitioners frame of reference and relies on voluntary reporting from professionals who have been trained to consider confidentiality a critical component of their work Harm caused by clinician boundary violations are understood as issues of professional misconduct not as errors resulting from system failure and that minimize the individual clinicians responsibility and advise against punitive action [164-167]

With the advent of therapeutic exchanges through email and other means of communication additional boundary violations are possible The Internet now has at least 110 million users including 70 million using it for health-related information[168] A recent survey indicated 40 to 50 of physicians use the Internet (or are preparing to use it) for clinical care[169]

There is a risk of errors of omission or commission arising from lack of coordination of care between clinicians Differences in therapeutic orientation and nomenclature used by the following specialists can compound systems issues that increase the risk of medical errors [158]

Social workers

Psychiatric nurse specialists

Psychologists

Licensed counselors and

Psychiatrists

Confidentiality is critical in providing effective treatment within the secure and private setting of the therapists office and in protecting the patient from unauthorized disclosures of sensitive information and potential abuse from a third party[170] However confidentiality can also inhibit disclosure of near misses impasses in treatment (for example when treatment is not working) and preventable adverse events due to avoidance of sharing important clinical information with other professionals and with appropriate family members and other supportive resources[171172]

The solo practice model commonly used by mental health clinicians can also inhibit the adoption of best practices and the development of policies and procedures to reduce risk because all such practice management activities are left to the individual clinician whose focus is more likely to be exclusively clinical

Summary About Systems Issues and Patient Safety

Systems for reliably reporting outpatient psychotherapy medical errors particularly among the large numbers of solo practitioners do not exist The prevailing paradigm for reducing harm arises from risk reduction in order to diminish medical liability exposure Studies that shed light on potential medical errors have arisen from risk management claims medical liability lawsuits and reports of death by suicide not from research intended to examine patient safety per se

Error reporting systems applicable to outpatient mental health settings including incentives for their use need to be developed Professional risk management programs primarily used to diminish medical liability exposure from the following could also be used to promulgate the relevance and value of the patient safety paradigm

Boundary violations

Suicide and

Treatment errors

Most particularly thought needs to be given to developing systems of error prevention applicable to the solo practitioner

Recommendations

Recommendation no 1

Widespread adoption of the IOM patient safety paradigm and nomenclature in mental health and substance abuse treatment settings is recommended

Advantages of its use include

Consistency with the nomenclature used by other medical specialties

Increased leverage in advocating for needed services and resources when the absence of essential treatments are quantified as errors of omission causing near misses or preventable adverse events

Increased likelihood that medication errors in mental health and substance abuse will be researched and a determination made whether such errors are causing preventable adverse events and

Increased awareness among mental health and substance abuse clinicians that patient harm can come from a broader array of errors in diagnosis and treatment than has been studied to date

Widespread adoption will require systematic educational efforts for trainees and current practitioners in mental health and substance abuse including systematic introduction to the IOMs existence mission and safety and quality efforts such as the Quality Chasm Series (Many mental health and substance abuse clinicians and administrators seem unaware of the IOM at all)

Recommendation no 2

Further studies of medical error in mental health and substance disorders are needed

Some areas of potential harm in this field remain largely unexamined For example we found only 2 studies of medication errors in mental health settings and none in substance abuse detoxification and stabilization settings despite multiple risk factors for errors and preventable adverse events The impact of variable education -- in pharmacology physiology and general medicine -- on the safety of prescribing practices has not been studied nor has the clinical consequences of formulary restrictions on clinical outcome and potential patient harm The current acceptance of self-reported hospital error rates must be challenged through a process of independently validating self-reported errors

Recommendation no 3

Integration of mental health and substance abuse services is recommended

High rates of co-occurrence and associated higher rates of morbidity and mortality among those with mental health and substance abuse disorders requires integration of mental health and substance abuse treatment paradigms This has not occurred to date

Recommendation no 4

The IOMs 10 rules for change in healthcare should be adopted

The 10 IOM rules for change in healthcare are as follows[173]

1 Care based on continuous healing relationships

2 Customization based on patient needs and values

3 The patient as the source of control

4 Shared knowledge and the free-flow of information

5 Evidence-based decision-making

6 Safety as a system property

7 The need for transparency

8 Anticipation of needs

9 Continuous decrease in waste

10 Cooperation among clinicians

As an example of adoption of these rules seclusion and restraint remain high risk treatments yet current reporting systems do not permit transparency regarding the rate and types of injuries incurred including mortality rates Such transparency requires a non-punitive work culture yet there is little evidence to suggest its adoption in high-risk environments such as state psychiatric hospitals or inpatient detoxification and stabilization substance abuse treatment settings

Recommendation no 5

Reporting systems in outpatient mental health and substance abuse treatment settings must be adopted

Reliance upon unsubstantiated self-reporting of medication errors in inpatient mental health and substance abuse settings remains a significant flaw when attempting accurate assessment of near misses and preventable adverse events and must be changed A key necessity is anonymous yet authenticated medication error reporting for all staff using available web-based error reporting systems Such systems are cost-savers and make reported error data immediately and continuously available Web-based reporting systems providing anonymity with authentication could be used for further seclusion and restraint data collection and as a means of establishing an outpatient error reporting system of safety and quality data by recipients and providers of outpatient treatment

Recommendation no 6

Resources should be allocated to study and develop practical interventions to improve patient safety

Much current research in mental health and substance abuse and resource appropriation is focused on efficacy of pharmacotherapy and psychotherapy and on establishing neurobiologic evidence to support causal theories of known clinical disorders At a policy level we recommend more consideration be given to funding practical interventions predicted to immediately improve patient safety

References

[ CLOSE WINDOW ]

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Authors and Disclosures

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Medscape LLC encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration at first mention and where appropriate in the content

Author

Benjamin C Grasso MD

Staff Psychiatrist VA Clinic Saco Maine Disclosure Benjamin C Grasso MD has disclosed no relevant financial relationships

Cathryn M Clary MD MBA

Vice President US External Medical Affairs Pfizer Inc New York NY Disclosure Cathryn M Clary MD MBA has disclosed that she is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Benjamin Eng MD MA

Senior Medical Director Group Leader Pfizer Inc New York NY Disclosure Benjamin Eng MD MA has disclosed that he is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Stanley J Evans MD FASAM PA

Assistant Professor of Clinical Medicine St Matthews University Windham Maine

Medical Director Renaissance Institute of Palm Beach Boca Raton Florida Disclosure Stanley J Evans MD has disclosed no relevant financial relationships

Terry J Golash MD

Clinical Instructor Psychiatry Columbia University New York NY Assistant Attending St Lukersquos Roosevelt Hospital Center New York NY Disclosure Terry J Golash MD has disclosed no relevant financial relationships

Kevin Ann Huckshorn RN MSN CAP ICADC

Director Office of Technical Assistance National Association of State mental Health Program Directors Inc Alexandria Virginia Disclosure Kevin Ann Huckshorn RN MSN CAP ICADC has disclosed no relevant financial relationships

Kenneth Minkoff MD

Clinical Assistant Professor Department of Psychiatry Cambridge Hospital Harvard University Acton Massachusetts Consultant ZiaLogic Acton Massachusetts Disclosure Kenneth Minkoff MD has disclosed no relevant financial relationships

Joseph J Parks MD

Assistant Associate Professor Department of Psychiatry University of Missouri Columbia Missouri Disclosure Joseph J Parks MD has disclosed that he has received grants for educational activities from Letters amp Science and Physician Postgraduate Press Dr Parks has also disclosed that he has served as a consultant to the National Association of State Mental Health Program Directors and Bristol-Myers Squibb Dr Parks has also disclosed that he has received funds for services provided to the state of Missouri from Eli Lilly and Abbott

Miles F Shore MD

Bullard Distinguished Professor of Psychiatry Harvard Medical School Needham Massachusetts Junior Consultant Harvard Medical International Boston Massachusetts Disclosure Miles F Shore MD has disclosed no relevant financial relationships

Editor

Jacqueline A Hart MD

Freelance Clinical Editor Medscape LLC New York New York Disclosure Jacqueline A Hart MD has disclosed no relevant financial relationships

Elizabeth Saenger PhD

Editorial Director Medscape LLC New York NY Disclosure Elizabeth Saenger PhD has disclosed no relevant financial relationships

Registration for CME credit the post test and the evaluation must be completed online To access the activity Post Test and Evaluation link please go to httpwwwmedscapecomviewprogram7809_index

Page 21: Medication Errors and Patient Safety in Mental Health CME/CE · 2019. 6. 27. · Medication Errors and Patient Safety in Mental Health CME/CE Complete author affiliations and disclosures

Systems for reliably reporting outpatient psychotherapy medical errors particularly among the large numbers of solo practitioners do not exist The prevailing paradigm for reducing harm arises from risk reduction in order to diminish medical liability exposure Studies that shed light on potential medical errors have arisen from risk management claims medical liability lawsuits and reports of death by suicide not from research intended to examine patient safety per se

Error reporting systems applicable to outpatient mental health settings including incentives for their use need to be developed Professional risk management programs primarily used to diminish medical liability exposure from the following could also be used to promulgate the relevance and value of the patient safety paradigm

Boundary violations

Suicide and

Treatment errors

Most particularly thought needs to be given to developing systems of error prevention applicable to the solo practitioner

Recommendations

Recommendation no 1

Widespread adoption of the IOM patient safety paradigm and nomenclature in mental health and substance abuse treatment settings is recommended

Advantages of its use include

Consistency with the nomenclature used by other medical specialties

Increased leverage in advocating for needed services and resources when the absence of essential treatments are quantified as errors of omission causing near misses or preventable adverse events

Increased likelihood that medication errors in mental health and substance abuse will be researched and a determination made whether such errors are causing preventable adverse events and

Increased awareness among mental health and substance abuse clinicians that patient harm can come from a broader array of errors in diagnosis and treatment than has been studied to date

Widespread adoption will require systematic educational efforts for trainees and current practitioners in mental health and substance abuse including systematic introduction to the IOMs existence mission and safety and quality efforts such as the Quality Chasm Series (Many mental health and substance abuse clinicians and administrators seem unaware of the IOM at all)

Recommendation no 2

Further studies of medical error in mental health and substance disorders are needed

Some areas of potential harm in this field remain largely unexamined For example we found only 2 studies of medication errors in mental health settings and none in substance abuse detoxification and stabilization settings despite multiple risk factors for errors and preventable adverse events The impact of variable education -- in pharmacology physiology and general medicine -- on the safety of prescribing practices has not been studied nor has the clinical consequences of formulary restrictions on clinical outcome and potential patient harm The current acceptance of self-reported hospital error rates must be challenged through a process of independently validating self-reported errors

Recommendation no 3

Integration of mental health and substance abuse services is recommended

High rates of co-occurrence and associated higher rates of morbidity and mortality among those with mental health and substance abuse disorders requires integration of mental health and substance abuse treatment paradigms This has not occurred to date

Recommendation no 4

The IOMs 10 rules for change in healthcare should be adopted

The 10 IOM rules for change in healthcare are as follows[173]

1 Care based on continuous healing relationships

2 Customization based on patient needs and values

3 The patient as the source of control

4 Shared knowledge and the free-flow of information

5 Evidence-based decision-making

6 Safety as a system property

7 The need for transparency

8 Anticipation of needs

9 Continuous decrease in waste

10 Cooperation among clinicians

As an example of adoption of these rules seclusion and restraint remain high risk treatments yet current reporting systems do not permit transparency regarding the rate and types of injuries incurred including mortality rates Such transparency requires a non-punitive work culture yet there is little evidence to suggest its adoption in high-risk environments such as state psychiatric hospitals or inpatient detoxification and stabilization substance abuse treatment settings

Recommendation no 5

Reporting systems in outpatient mental health and substance abuse treatment settings must be adopted

Reliance upon unsubstantiated self-reporting of medication errors in inpatient mental health and substance abuse settings remains a significant flaw when attempting accurate assessment of near misses and preventable adverse events and must be changed A key necessity is anonymous yet authenticated medication error reporting for all staff using available web-based error reporting systems Such systems are cost-savers and make reported error data immediately and continuously available Web-based reporting systems providing anonymity with authentication could be used for further seclusion and restraint data collection and as a means of establishing an outpatient error reporting system of safety and quality data by recipients and providers of outpatient treatment

Recommendation no 6

Resources should be allocated to study and develop practical interventions to improve patient safety

Much current research in mental health and substance abuse and resource appropriation is focused on efficacy of pharmacotherapy and psychotherapy and on establishing neurobiologic evidence to support causal theories of known clinical disorders At a policy level we recommend more consideration be given to funding practical interventions predicted to immediately improve patient safety

References

[ CLOSE WINDOW ]

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Authors and Disclosures

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Medscape LLC encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration at first mention and where appropriate in the content

Author

Benjamin C Grasso MD

Staff Psychiatrist VA Clinic Saco Maine Disclosure Benjamin C Grasso MD has disclosed no relevant financial relationships

Cathryn M Clary MD MBA

Vice President US External Medical Affairs Pfizer Inc New York NY Disclosure Cathryn M Clary MD MBA has disclosed that she is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Benjamin Eng MD MA

Senior Medical Director Group Leader Pfizer Inc New York NY Disclosure Benjamin Eng MD MA has disclosed that he is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Stanley J Evans MD FASAM PA

Assistant Professor of Clinical Medicine St Matthews University Windham Maine

Medical Director Renaissance Institute of Palm Beach Boca Raton Florida Disclosure Stanley J Evans MD has disclosed no relevant financial relationships

Terry J Golash MD

Clinical Instructor Psychiatry Columbia University New York NY Assistant Attending St Lukersquos Roosevelt Hospital Center New York NY Disclosure Terry J Golash MD has disclosed no relevant financial relationships

Kevin Ann Huckshorn RN MSN CAP ICADC

Director Office of Technical Assistance National Association of State mental Health Program Directors Inc Alexandria Virginia Disclosure Kevin Ann Huckshorn RN MSN CAP ICADC has disclosed no relevant financial relationships

Kenneth Minkoff MD

Clinical Assistant Professor Department of Psychiatry Cambridge Hospital Harvard University Acton Massachusetts Consultant ZiaLogic Acton Massachusetts Disclosure Kenneth Minkoff MD has disclosed no relevant financial relationships

Joseph J Parks MD

Assistant Associate Professor Department of Psychiatry University of Missouri Columbia Missouri Disclosure Joseph J Parks MD has disclosed that he has received grants for educational activities from Letters amp Science and Physician Postgraduate Press Dr Parks has also disclosed that he has served as a consultant to the National Association of State Mental Health Program Directors and Bristol-Myers Squibb Dr Parks has also disclosed that he has received funds for services provided to the state of Missouri from Eli Lilly and Abbott

Miles F Shore MD

Bullard Distinguished Professor of Psychiatry Harvard Medical School Needham Massachusetts Junior Consultant Harvard Medical International Boston Massachusetts Disclosure Miles F Shore MD has disclosed no relevant financial relationships

Editor

Jacqueline A Hart MD

Freelance Clinical Editor Medscape LLC New York New York Disclosure Jacqueline A Hart MD has disclosed no relevant financial relationships

Elizabeth Saenger PhD

Editorial Director Medscape LLC New York NY Disclosure Elizabeth Saenger PhD has disclosed no relevant financial relationships

Registration for CME credit the post test and the evaluation must be completed online To access the activity Post Test and Evaluation link please go to httpwwwmedscapecomviewprogram7809_index

Page 22: Medication Errors and Patient Safety in Mental Health CME/CE · 2019. 6. 27. · Medication Errors and Patient Safety in Mental Health CME/CE Complete author affiliations and disclosures

Further studies of medical error in mental health and substance disorders are needed

Some areas of potential harm in this field remain largely unexamined For example we found only 2 studies of medication errors in mental health settings and none in substance abuse detoxification and stabilization settings despite multiple risk factors for errors and preventable adverse events The impact of variable education -- in pharmacology physiology and general medicine -- on the safety of prescribing practices has not been studied nor has the clinical consequences of formulary restrictions on clinical outcome and potential patient harm The current acceptance of self-reported hospital error rates must be challenged through a process of independently validating self-reported errors

Recommendation no 3

Integration of mental health and substance abuse services is recommended

High rates of co-occurrence and associated higher rates of morbidity and mortality among those with mental health and substance abuse disorders requires integration of mental health and substance abuse treatment paradigms This has not occurred to date

Recommendation no 4

The IOMs 10 rules for change in healthcare should be adopted

The 10 IOM rules for change in healthcare are as follows[173]

1 Care based on continuous healing relationships

2 Customization based on patient needs and values

3 The patient as the source of control

4 Shared knowledge and the free-flow of information

5 Evidence-based decision-making

6 Safety as a system property

7 The need for transparency

8 Anticipation of needs

9 Continuous decrease in waste

10 Cooperation among clinicians

As an example of adoption of these rules seclusion and restraint remain high risk treatments yet current reporting systems do not permit transparency regarding the rate and types of injuries incurred including mortality rates Such transparency requires a non-punitive work culture yet there is little evidence to suggest its adoption in high-risk environments such as state psychiatric hospitals or inpatient detoxification and stabilization substance abuse treatment settings

Recommendation no 5

Reporting systems in outpatient mental health and substance abuse treatment settings must be adopted

Reliance upon unsubstantiated self-reporting of medication errors in inpatient mental health and substance abuse settings remains a significant flaw when attempting accurate assessment of near misses and preventable adverse events and must be changed A key necessity is anonymous yet authenticated medication error reporting for all staff using available web-based error reporting systems Such systems are cost-savers and make reported error data immediately and continuously available Web-based reporting systems providing anonymity with authentication could be used for further seclusion and restraint data collection and as a means of establishing an outpatient error reporting system of safety and quality data by recipients and providers of outpatient treatment

Recommendation no 6

Resources should be allocated to study and develop practical interventions to improve patient safety

Much current research in mental health and substance abuse and resource appropriation is focused on efficacy of pharmacotherapy and psychotherapy and on establishing neurobiologic evidence to support causal theories of known clinical disorders At a policy level we recommend more consideration be given to funding practical interventions predicted to immediately improve patient safety

References

[ CLOSE WINDOW ]

References

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Authors and Disclosures

As an organization accredited by the ACCME Medscape LLC requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest The ACCME defines relevant financial relationships as financial relationships in any amount occurring within the past 12 months including financial relationships of a spouse or life partner that could create a conflict of interest

Medscape LLC encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration at first mention and where appropriate in the content

Author

Benjamin C Grasso MD

Staff Psychiatrist VA Clinic Saco Maine Disclosure Benjamin C Grasso MD has disclosed no relevant financial relationships

Cathryn M Clary MD MBA

Vice President US External Medical Affairs Pfizer Inc New York NY Disclosure Cathryn M Clary MD MBA has disclosed that she is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Benjamin Eng MD MA

Senior Medical Director Group Leader Pfizer Inc New York NY Disclosure Benjamin Eng MD MA has disclosed that he is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Stanley J Evans MD FASAM PA

Assistant Professor of Clinical Medicine St Matthews University Windham Maine

Medical Director Renaissance Institute of Palm Beach Boca Raton Florida Disclosure Stanley J Evans MD has disclosed no relevant financial relationships

Terry J Golash MD

Clinical Instructor Psychiatry Columbia University New York NY Assistant Attending St Lukersquos Roosevelt Hospital Center New York NY Disclosure Terry J Golash MD has disclosed no relevant financial relationships

Kevin Ann Huckshorn RN MSN CAP ICADC

Director Office of Technical Assistance National Association of State mental Health Program Directors Inc Alexandria Virginia Disclosure Kevin Ann Huckshorn RN MSN CAP ICADC has disclosed no relevant financial relationships

Kenneth Minkoff MD

Clinical Assistant Professor Department of Psychiatry Cambridge Hospital Harvard University Acton Massachusetts Consultant ZiaLogic Acton Massachusetts Disclosure Kenneth Minkoff MD has disclosed no relevant financial relationships

Joseph J Parks MD

Assistant Associate Professor Department of Psychiatry University of Missouri Columbia Missouri Disclosure Joseph J Parks MD has disclosed that he has received grants for educational activities from Letters amp Science and Physician Postgraduate Press Dr Parks has also disclosed that he has served as a consultant to the National Association of State Mental Health Program Directors and Bristol-Myers Squibb Dr Parks has also disclosed that he has received funds for services provided to the state of Missouri from Eli Lilly and Abbott

Miles F Shore MD

Bullard Distinguished Professor of Psychiatry Harvard Medical School Needham Massachusetts Junior Consultant Harvard Medical International Boston Massachusetts Disclosure Miles F Shore MD has disclosed no relevant financial relationships

Editor

Jacqueline A Hart MD

Freelance Clinical Editor Medscape LLC New York New York Disclosure Jacqueline A Hart MD has disclosed no relevant financial relationships

Elizabeth Saenger PhD

Editorial Director Medscape LLC New York NY Disclosure Elizabeth Saenger PhD has disclosed no relevant financial relationships

Registration for CME credit the post test and the evaluation must be completed online To access the activity Post Test and Evaluation link please go to httpwwwmedscapecomviewprogram7809_index

Page 23: Medication Errors and Patient Safety in Mental Health CME/CE · 2019. 6. 27. · Medication Errors and Patient Safety in Mental Health CME/CE Complete author affiliations and disclosures

Reporting systems in outpatient mental health and substance abuse treatment settings must be adopted

Reliance upon unsubstantiated self-reporting of medication errors in inpatient mental health and substance abuse settings remains a significant flaw when attempting accurate assessment of near misses and preventable adverse events and must be changed A key necessity is anonymous yet authenticated medication error reporting for all staff using available web-based error reporting systems Such systems are cost-savers and make reported error data immediately and continuously available Web-based reporting systems providing anonymity with authentication could be used for further seclusion and restraint data collection and as a means of establishing an outpatient error reporting system of safety and quality data by recipients and providers of outpatient treatment

Recommendation no 6

Resources should be allocated to study and develop practical interventions to improve patient safety

Much current research in mental health and substance abuse and resource appropriation is focused on efficacy of pharmacotherapy and psychotherapy and on establishing neurobiologic evidence to support causal theories of known clinical disorders At a policy level we recommend more consideration be given to funding practical interventions predicted to immediately improve patient safety

References

[ CLOSE WINDOW ]

References

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Authors and Disclosures

As an organization accredited by the ACCME Medscape LLC requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest The ACCME defines relevant financial relationships as financial relationships in any amount occurring within the past 12 months including financial relationships of a spouse or life partner that could create a conflict of interest

Medscape LLC encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration at first mention and where appropriate in the content

Author

Benjamin C Grasso MD

Staff Psychiatrist VA Clinic Saco Maine Disclosure Benjamin C Grasso MD has disclosed no relevant financial relationships

Cathryn M Clary MD MBA

Vice President US External Medical Affairs Pfizer Inc New York NY Disclosure Cathryn M Clary MD MBA has disclosed that she is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Benjamin Eng MD MA

Senior Medical Director Group Leader Pfizer Inc New York NY Disclosure Benjamin Eng MD MA has disclosed that he is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Stanley J Evans MD FASAM PA

Assistant Professor of Clinical Medicine St Matthews University Windham Maine

Medical Director Renaissance Institute of Palm Beach Boca Raton Florida Disclosure Stanley J Evans MD has disclosed no relevant financial relationships

Terry J Golash MD

Clinical Instructor Psychiatry Columbia University New York NY Assistant Attending St Lukersquos Roosevelt Hospital Center New York NY Disclosure Terry J Golash MD has disclosed no relevant financial relationships

Kevin Ann Huckshorn RN MSN CAP ICADC

Director Office of Technical Assistance National Association of State mental Health Program Directors Inc Alexandria Virginia Disclosure Kevin Ann Huckshorn RN MSN CAP ICADC has disclosed no relevant financial relationships

Kenneth Minkoff MD

Clinical Assistant Professor Department of Psychiatry Cambridge Hospital Harvard University Acton Massachusetts Consultant ZiaLogic Acton Massachusetts Disclosure Kenneth Minkoff MD has disclosed no relevant financial relationships

Joseph J Parks MD

Assistant Associate Professor Department of Psychiatry University of Missouri Columbia Missouri Disclosure Joseph J Parks MD has disclosed that he has received grants for educational activities from Letters amp Science and Physician Postgraduate Press Dr Parks has also disclosed that he has served as a consultant to the National Association of State Mental Health Program Directors and Bristol-Myers Squibb Dr Parks has also disclosed that he has received funds for services provided to the state of Missouri from Eli Lilly and Abbott

Miles F Shore MD

Bullard Distinguished Professor of Psychiatry Harvard Medical School Needham Massachusetts Junior Consultant Harvard Medical International Boston Massachusetts Disclosure Miles F Shore MD has disclosed no relevant financial relationships

Editor

Jacqueline A Hart MD

Freelance Clinical Editor Medscape LLC New York New York Disclosure Jacqueline A Hart MD has disclosed no relevant financial relationships

Elizabeth Saenger PhD

Editorial Director Medscape LLC New York NY Disclosure Elizabeth Saenger PhD has disclosed no relevant financial relationships

Registration for CME credit the post test and the evaluation must be completed online To access the activity Post Test and Evaluation link please go to httpwwwmedscapecomviewprogram7809_index

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2003337 Available at httpwwwcdcgovnchsdataadad337pdf Accessed August 29 2007

11 Grasso BC Rothschild J Genest R Bates DW Medication errors in psychiatry are patients being harmed Psychiatr Serv 20034599

12 Grasso BC Clary CM Evans SJ et al Medication errors in psychiatric care Incidence and reduction strategies Medscape June 29 2007 Available at httpwwwmedscapecomviewprogram7319 Accessed August 28 2007

13 Grasso BC Genest R Jordan CW Bates DW Use of chart and record reviews to detect medication errors in a state psychiatric hospital Psychiatr Serv 200354677-681 Abstract

14 Grasso BC Rothschild J Genest R Bates DW What do we know about medication errors in inpatient psychiatry Jt Comm J Qual Patient Saf 2003298391-401

15 Guadagnino C Improving anesthesia safety Physicians News Digest February 2000 Available at httpwwwphysiciansnewscomspotlight200wphtml Accessed August 28 2007

16 Classen DC Pestotnik SL Evans RS Burke JP Computerized surveillance of adverse drug events in hospital patients JAMA 19912662847-2851 Abstract

17 Brennan TA Leape LL Laird NM et al Incidence of adverse events and negligence in hospitalized patients results of the Harvard Medical Practice Study I N Engl J Med 1991324370-376 Abstract

18 Leape LL Brennan TA Laird N et al The nature of adverse events in hospitalized patients results of the Harvard Medical Practice Study II N Engl J Med 1991324377-384 Abstract

19 Fourth Decennial International Conference on Nosocomial and Healthcare-Associated Infections MMWR 200049138 Available at wwwcdcgovmmwrpreviewmmwrhtmlmm4907a4htm Accessed August 28 2007

20 Herzog A Shore MF Beale RR et al Recommendation to the Board of Trustees of the American Psychiatric Association from the APA Task Force on Patient Safety January 24 2003 Available at httpwwwpsychorgpsych_practpract_mgmtapa_patientsafety_toc21003pdf Accessed August 28 2007

21 Lazarou J Pomeranz BH Corey PN Incidence of adverse drug reactions in hospitalized patients a meta-analysis of prospective studies JAMA 19982791200-1205 Abstract

22 National Coordinating Council for Medication Error Reporting and Prevention What Is a Medication Error Available at wwwnccmerporg Accessed May 16 2003

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32 Coyne JC Schwenk TL Fechner-Bates S Non-detection of depression by primary care physicians reconsidered Gen Hosp Psychiatry 1995173-12 Abstract

33 Gerber PD Barrett J Barrett J Manheimer E Whiting R Smith R Recognition of depression by internists in primary care a comparison of internist and gold standard psychiatric assessments J Gen Intern Med 198947-13 Abstract

34 Simon GE Goldberg D Tiemens BG Ustun TB Outcomes of recognized and unrecognized depression in an international primary care study Gen Hosp Psychiatry 19992197-105 Abstract

35 Perez-Stable EJ Miranda J Munoz RF Ying YW Depression in medical out-patients Underrecognition and misdiagnosis Arch Intern Med 19901501083-1088 Abstract

36 Wittchen HU Pittrow D Prevalence recognition and management of depression in primary care in Germany the depression 2000 study Human Psychopharmacol 200217S1-S11

37 Tiemens BG VonKorff M Lin EH Diagnosis of depression by primary care physicians versus a structured diagnostic interview Understanding discordance Gen Hosp Psychiatry 19992187-96 Abstract

38 Klinkman MS Coyne JC Gallo S Schwenk TL False positives false negatives and the validity of the diagnosis of major depression in primary care Arch Fam Med 19987451-461 Abstract

39 Nisenson LG Pepper CM Schwenk TL Coyne JC The nature and prevalence of anxiety disorders in primary care Gen Hosp Psychiatry 19982021-28 Abstract

40 Fifer SK Mathias SD Patrick DL Mazaonson PD Lubeck DP Buesching DP Untreated anxiety among adult primary care patients in a health maintenance organization Arch Gen Psychiatry 199451740-750 Abstract

41 Kirmayar LJ Robbins JM Dworkind M Yaffe MJ Somatization and the recognition of depression and anxiety in primary care Am J Psychiatry 1993150723-741

42 Harman JS Rollman BL Hanusa BH Lenze EJ Shear MK Physician office visits of adults for anxiety disorders in the United States 1985-1998 J Gen Intern Med 200217165-172 Abstract

43 Tauman-Ben-Ari O Rabinowitz J Feldman D et al Posttraumatic stress disorder in primary care settings prevalence and physicians detection Psychol Med 200131555-560 Abstract

44 Beesdo K Krause P Hofler M Wittchen HU Do primary care physicians know generalized anxiety disorders Estimates of prevalence attitudes and interventions Fortschritte Med 200111913-16

45 Linden M Lecrubier Y Bellantuono C Benkert O Kisely S Simon G The prescribing of psychotropic drugs by primary care physicians an international collaborative study J Clin Psychopharmacol 199919132-140 Abstract

46 Ornstein S Stuart G Jenkins R Depression diagnoses and antidepressant use in primary care practices a study from the Practice Partner Research Network (PPRNet) J Fam Pract 20004968-72 Abstract

47 Katon W Von Korff M Lin E Bush T Ormel J Adequacy and duration of antidepressant treatment in primary care Med Care 19923067-76 Abstract

48 Weisberg RB Haisley E Culpepper L Keller MB Psychiatric treatment in primary care patients with anxiety disorders Posters and abstracts presented at the annual meeting of the North American Primary Care Research Group October 13-16 2001 Nova Scotia Canada

49 Roy-Byrne PP Stein MB Russo J et al Panic disorder in the primary care setting comorbidity disability service utilization and treatment J Clin Psychiatry 199960492-499 Abstract

50 Hays R Wells K Sherbourne C et al Functioning and well-being outcomes of patients with depression compared with chronic general medical illness Arch Gen Psychiatry 19955211-19 Abstract

51 Wells KB Stewart A Hays RD et al The functioning and well-being of depressed patients results from the medical outcomes study JAMA 1989262914-919 Abstract

52 Katon W Sullivan MD Depression and chronic medical illness J Clin Psychiatry 1990 513-11

53 Frasure-Smith N Lesperance F Gravel G et al Depression and health-care costs during the first year following myocardial infarction J Psychosomatic Res 200048471-478

54 Ariyo AA Haan M Tangen CM et al for the Cardiovascular Health Study Collaborative Research Group Depressive symptoms and risks of coronary heart disease and mortality in elderly Americans Circulation 2000 1021773-1779 Abstract

55 Schulz R Beach SR Ives DG et al Association between depression and mortality in older adults the Cardiovascular Health Study Arch Intern Med 20001601761-1768 Abstract

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57 Foster T Gillespie K McClelland R Patterson C Risk factors for suicide independent of DSM-III-R Axis I disorder Br J Psychiatry 1999175175-179 Abstract

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Authors and Disclosures

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Medscape LLC encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration at first mention and where appropriate in the content

Author

Benjamin C Grasso MD

Staff Psychiatrist VA Clinic Saco Maine Disclosure Benjamin C Grasso MD has disclosed no relevant financial relationships

Cathryn M Clary MD MBA

Vice President US External Medical Affairs Pfizer Inc New York NY Disclosure Cathryn M Clary MD MBA has disclosed that she is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Benjamin Eng MD MA

Senior Medical Director Group Leader Pfizer Inc New York NY Disclosure Benjamin Eng MD MA has disclosed that he is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Stanley J Evans MD FASAM PA

Assistant Professor of Clinical Medicine St Matthews University Windham Maine

Medical Director Renaissance Institute of Palm Beach Boca Raton Florida Disclosure Stanley J Evans MD has disclosed no relevant financial relationships

Terry J Golash MD

Clinical Instructor Psychiatry Columbia University New York NY Assistant Attending St Lukersquos Roosevelt Hospital Center New York NY Disclosure Terry J Golash MD has disclosed no relevant financial relationships

Kevin Ann Huckshorn RN MSN CAP ICADC

Director Office of Technical Assistance National Association of State mental Health Program Directors Inc Alexandria Virginia Disclosure Kevin Ann Huckshorn RN MSN CAP ICADC has disclosed no relevant financial relationships

Kenneth Minkoff MD

Clinical Assistant Professor Department of Psychiatry Cambridge Hospital Harvard University Acton Massachusetts Consultant ZiaLogic Acton Massachusetts Disclosure Kenneth Minkoff MD has disclosed no relevant financial relationships

Joseph J Parks MD

Assistant Associate Professor Department of Psychiatry University of Missouri Columbia Missouri Disclosure Joseph J Parks MD has disclosed that he has received grants for educational activities from Letters amp Science and Physician Postgraduate Press Dr Parks has also disclosed that he has served as a consultant to the National Association of State Mental Health Program Directors and Bristol-Myers Squibb Dr Parks has also disclosed that he has received funds for services provided to the state of Missouri from Eli Lilly and Abbott

Miles F Shore MD

Bullard Distinguished Professor of Psychiatry Harvard Medical School Needham Massachusetts Junior Consultant Harvard Medical International Boston Massachusetts Disclosure Miles F Shore MD has disclosed no relevant financial relationships

Editor

Jacqueline A Hart MD

Freelance Clinical Editor Medscape LLC New York New York Disclosure Jacqueline A Hart MD has disclosed no relevant financial relationships

Elizabeth Saenger PhD

Editorial Director Medscape LLC New York NY Disclosure Elizabeth Saenger PhD has disclosed no relevant financial relationships

Registration for CME credit the post test and the evaluation must be completed online To access the activity Post Test and Evaluation link please go to httpwwwmedscapecomviewprogram7809_index

Page 25: Medication Errors and Patient Safety in Mental Health CME/CE · 2019. 6. 27. · Medication Errors and Patient Safety in Mental Health CME/CE Complete author affiliations and disclosures

31 Borus JF Howes MJ Devins NP Rosenberg R Livingston WW Primary healthcare providers recognition and diagnosis of mental disorders in their patients Gen Hosp Psychiatry 198810317-321 Abstract

32 Coyne JC Schwenk TL Fechner-Bates S Non-detection of depression by primary care physicians reconsidered Gen Hosp Psychiatry 1995173-12 Abstract

33 Gerber PD Barrett J Barrett J Manheimer E Whiting R Smith R Recognition of depression by internists in primary care a comparison of internist and gold standard psychiatric assessments J Gen Intern Med 198947-13 Abstract

34 Simon GE Goldberg D Tiemens BG Ustun TB Outcomes of recognized and unrecognized depression in an international primary care study Gen Hosp Psychiatry 19992197-105 Abstract

35 Perez-Stable EJ Miranda J Munoz RF Ying YW Depression in medical out-patients Underrecognition and misdiagnosis Arch Intern Med 19901501083-1088 Abstract

36 Wittchen HU Pittrow D Prevalence recognition and management of depression in primary care in Germany the depression 2000 study Human Psychopharmacol 200217S1-S11

37 Tiemens BG VonKorff M Lin EH Diagnosis of depression by primary care physicians versus a structured diagnostic interview Understanding discordance Gen Hosp Psychiatry 19992187-96 Abstract

38 Klinkman MS Coyne JC Gallo S Schwenk TL False positives false negatives and the validity of the diagnosis of major depression in primary care Arch Fam Med 19987451-461 Abstract

39 Nisenson LG Pepper CM Schwenk TL Coyne JC The nature and prevalence of anxiety disorders in primary care Gen Hosp Psychiatry 19982021-28 Abstract

40 Fifer SK Mathias SD Patrick DL Mazaonson PD Lubeck DP Buesching DP Untreated anxiety among adult primary care patients in a health maintenance organization Arch Gen Psychiatry 199451740-750 Abstract

41 Kirmayar LJ Robbins JM Dworkind M Yaffe MJ Somatization and the recognition of depression and anxiety in primary care Am J Psychiatry 1993150723-741

42 Harman JS Rollman BL Hanusa BH Lenze EJ Shear MK Physician office visits of adults for anxiety disorders in the United States 1985-1998 J Gen Intern Med 200217165-172 Abstract

43 Tauman-Ben-Ari O Rabinowitz J Feldman D et al Posttraumatic stress disorder in primary care settings prevalence and physicians detection Psychol Med 200131555-560 Abstract

44 Beesdo K Krause P Hofler M Wittchen HU Do primary care physicians know generalized anxiety disorders Estimates of prevalence attitudes and interventions Fortschritte Med 200111913-16

45 Linden M Lecrubier Y Bellantuono C Benkert O Kisely S Simon G The prescribing of psychotropic drugs by primary care physicians an international collaborative study J Clin Psychopharmacol 199919132-140 Abstract

46 Ornstein S Stuart G Jenkins R Depression diagnoses and antidepressant use in primary care practices a study from the Practice Partner Research Network (PPRNet) J Fam Pract 20004968-72 Abstract

47 Katon W Von Korff M Lin E Bush T Ormel J Adequacy and duration of antidepressant treatment in primary care Med Care 19923067-76 Abstract

48 Weisberg RB Haisley E Culpepper L Keller MB Psychiatric treatment in primary care patients with anxiety disorders Posters and abstracts presented at the annual meeting of the North American Primary Care Research Group October 13-16 2001 Nova Scotia Canada

49 Roy-Byrne PP Stein MB Russo J et al Panic disorder in the primary care setting comorbidity disability service utilization and treatment J Clin Psychiatry 199960492-499 Abstract

50 Hays R Wells K Sherbourne C et al Functioning and well-being outcomes of patients with depression compared with chronic general medical illness Arch Gen Psychiatry 19955211-19 Abstract

51 Wells KB Stewart A Hays RD et al The functioning and well-being of depressed patients results from the medical outcomes study JAMA 1989262914-919 Abstract

52 Katon W Sullivan MD Depression and chronic medical illness J Clin Psychiatry 1990 513-11

53 Frasure-Smith N Lesperance F Gravel G et al Depression and health-care costs during the first year following myocardial infarction J Psychosomatic Res 200048471-478

54 Ariyo AA Haan M Tangen CM et al for the Cardiovascular Health Study Collaborative Research Group Depressive symptoms and risks of coronary heart disease and mortality in elderly Americans Circulation 2000 1021773-1779 Abstract

55 Schulz R Beach SR Ives DG et al Association between depression and mortality in older adults the Cardiovascular Health Study Arch Intern Med 20001601761-1768 Abstract

56 Lin EH von Korff M Wagner EH Identifying suicide potential in primary care J Gen Intern Med 198941-6 Abstract

57 Foster T Gillespie K McClelland R Patterson C Risk factors for suicide independent of DSM-III-R Axis I disorder Br J Psychiatry 1999175175-179 Abstract

58 Henriksson MM Aro HM Marttunen MJ et al Mental disorders and comorbidity in suicide Am J Psychiatry 1993150935-940 Abstract

59 Greenberg PE Kessler RC Birnbaum HG Leong SA Lowe SW Berglund PA Corey-Lisle PK The economic burden of depression in the United States how did it change between 1990 and 2000 J Clin Psychiatry 2003541465-1475

60 Murray CJL Lopez AD Ed The Global Burden of Disease A Comprehensive Assessment of Mortality and Disability From Diseases Injuries and Risk Factors in 1990 and Projected To 2020 Cambridge Massachusetts Harvard School of Public Health on behalf of the World Health Organization and the World Bank 1996

61 Zatzick DF Marmar CR Weiss DS et al Posttraumatic stress disorder and functioning and quality of life outcomes in a nationally representative sample of male Vietnam veterans Am J Psychiatry 19971541690-1695 Abstract

62 Stein MB Walker JR Hazen AL Forde DR Full and partial posttraumatic stress disorder findings from a community survey Am J Psychiatry 19971541114-1119 Abstract

63 Klerman GL Weissman MM Ouellette R Johnson J Greenwald S Panic attacks in the community Social morbidity and healthcare utilization JAMA 1991265742-746 Abstract

64 Katerndahl DA Realini JP Quality of life and panic-related work disability in subjects with infrequent panic and panic disorder J Clin Psychiatry 199758153-158 Abstract

65 Wittchen HU Zhao S Kessler RC Eaton WW DSM-III-R generalized anxiety disorder in the National Comorbidity Survey Arch Gen Psychiatry 199451355-364 Abstract

66 Schneier FR Johnson J Hornig CD Liebowitz MR Weissman MM Social phobia Comorbidity and morbidity in an epidemiologic sample Arch Gen Psychiatry 199249282-288 Abstract

67 Wittchen HU Beloch E The impact of social phobia on quality of life Int Clin Psychopharmacol 199611(suppl 3)15-23 Abstract

68 Sherbourne CD Wells KB Judd LL Functioning and wellbeing of patients with panic disorder Am J Psychiatry 1996 153213-218 Abstract

69 Weiller E Bisserbe JC Maier W Lecrubier Y Prevalence and recognition of anxiety syndromes in five European primary care settings Br J Psychiatry 1998173(suppl 34)18-23

70 Simon GE VonKorff M Recognition management and outcomes of depression in primary care Arch Fam Med 1995499-105 Abstract

71 Greenberg PE Sisitsky T Kessler RC et al The economic burden of anxiety disorders in the 1990s J Clin Psychiatry 199960427-435 Abstract

72 Ormel J van den Brink W Koeter MW et al Recognition management and outcome of psychological disorders in primary care a naturalistic follow-up study Psychol Med 199020909-923 Abstract

73 Brown TA Di Nardo PA Lehman CL Campbell LA Reliability of DSM-IV mood and anxiety disorders implications for the classification of emotional disorders J Abnorm Psychol 200111049-58 Abstract

74 Dowrick C Buchan I Twelve month outcome of depression in general practice does detection or disclosure make a difference BMJ 19953111274-1276 Abstract

75 Regier DA Farmer ME Rae DS et al Comorbidity of mental disorders with alcohol and other drug abuse results from the epidemiologic catchment area (ECA) study JAMA 19902642511-2518 Abstract

76 Gilbody S Whitty P Grimshaw J Thomas R Educational and organizational interventions to improve the management of depression in primary care a systematic review JAMA 20032893145-3151 Abstract

77 Spitzer RL Kroenke K Williams JB Validation and utility of a self-report version of PRIME-MD the PHQ primary care study Primary Care Evalation of Mental Disorders Patient Health Questionnaire JAMA 19992821737-1744 Abstract

78 Bridges to Excellence Rewarding Quality Across The Healthcare System Available at httpwwwbridgestoexcellenceorg Accessed August 28 2007

79 The Integrated Healthcare Association Available at httpwwwihaorg Accessed February 28 2007

80 National Committee on Quality Assurance Healthy Communities Access Program Evaluation Report 2004 Available at httpwwwncqaorgProgramsHEDISHEDIS20200520Summarypdf Accessed June 3 2004

81 Weiss EM Altimari D Blint DF et al Deadly restraints A nationwide pattern of death The Hartford Courant October 1998

82 US General Accounting Office (USGAO) Mental health Improper restraint or seclusion use places people at risk GAOHES-99-176 Washington DC United States General Accounting Office 1999

83 Success Stories and Ideas for Reducing RestraintSeclusion (2003) A compendium of strategies created by the American Psychiatric Association (APA) the American Psychiatric Nurses Association (APNA) the National Association of Psychiatric Health Systems (NAPHS) and the American Hospital Association Section for Psychiatric and Substance Abuse Services (AHA) Available at httpwwwpsychorgpsych_practtreatgpglearningfromeachothercfm Accessed August 28 2007

84 National Technical Assistance Center for State Mental Health Planning (NTAC) Violence and coercion in mental health settings Eliminating the use of seclusion and restraint Alexandria Va National Association of State Mental Health Program Directors (NASMHPD) National Technical Assistance Center for State Mental Health Planning (NTAC) 2002

85 Bullard L Fulmore D Johnson K Reducing the use of seclusion and restraint Promising practices and successful strategies Childrens Welfare League of America 2003 Washington DC CWLA Press 2003

86 NASMHPDNASADAD The new conceptual framework for co-occurring mental health and substance use disorders Washington DC NASMHPD 1998

87 HCFA Interim Rules Medicare and Medicaid programs Hospital conditions of participation Patients Rights 42 CFR Part 482 1999 Baltimore Md Department of Health and Human Services

88 National Executive Training Institute (NETI) Training Curriculum for Reduction of Seclusion and Restraint Draft Curriculum Manual 2003 Alexandria Va National Association of State Mental Health Program Directors (NASMHPD) National Technical Assistance Center for State Mental Health Planning (NTAC)

89 Mohr WK Anderson JA Faulty assumptions associated with the use of restraints with children J Child Adolesc Psychiatr Nurs200114141-151 Abstract

90 Finke LM The use of seclusion is not evidence-based practice J Child Adolesc Psychiatry 200114186-188

91 Center for Medicare and Medicaid Services (CMS) Testimony from the public hearing on the one hour rule 2002 Baltimore Md CMS

92 Joint Commission on Accreditation of Healthcare Organization Standards for Behavioral Healthcare 2004-2005 Oakbrook Terrace Ill Joint Commission Resources 2005

93 Gross G Restraint and seclusion overview of federal laws and policies Washington DC National Association of Protection and Advocacy Systems (NAPAS) 2003

94 American Association of Community Psychiatry (AACP) (2003) AACP guidelines for recovery oriented services Available at httpwwwcommpsychpittedufindsROSMenuhtml Accessed June 2 2004

95 Schnaars C Tape called strong evidence in boys death Daily Press April 13 2003 Available at httpgroupsmsncomHumanRightsUSAnewhopeiimsnw Accessed August 28 2007

96 Erikson J 5 pinned woman prone on Kino floor Report describes patients death struggle at hospital Arizona Daily Star July 29 2003 July 29 Available at httpwwwfox11azcomnewslocalstoriesKMSB_local_kino_072903d8c78db2html Accessed August 28 2007

97 Masters KJ Bellonci C the Work Group on Quality Issues Practice parameters for the prevention and management of aggressive behavior in child and adolescent psychiatric institutions with special reference to seclusion and restraint Available to American Academy of Childhood and Adolescent Psychiatry (AACAP) members at httpwwwaacaporg Washington DC AACAP 2001 Accessed August 28 2007

98 Fisher W Restraint and seclusion A review of the literature Am J Psychiatry 19941511584-1591 Abstract

99 US Department of Health and Human Services (USDHHS) Mental health of the nation report of the Surgeon General (SMA01-3613) Office of the Surgeon General Public Health Service Washington DC US Government Printing Office 1999

100 Onken S Dumont J Ridgeway P Dornan D Ralph R Mental health recovery What helps and what hinders A national research project for the development of recovery facilitating system performance indicators Alexandria Va National Association of State Mental Health Program Directors (NASMHPD) National Technical Assistance Center for State Mental Health Planning (NTAC) 2002

101 American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Washington DC American Psychiatric Association 1994

102 Cusack KJ Frueh BC Brady KT Trauma history screening in a community mental health center Psychiatr Serv 200455157-162 Abstract

103 Cusack KJ Frueh BC Hiers TG Keane TM Mueser KT (2003) The impact of trauma and posttraumatic stress disorder upon American society Report to the Presidents New Freedom Commission on Mental Health Unpublished subcommittee report Washington DC 2003

104 Frueh BC Dalton ME Johnson MR et al Trauma within the psychiatric setting conceptual framework research directions and policy implications Admin Policy Ment Health 200028147-154

105 Rosenberg SD Mueser KT Friedman MJ et al Developing effective treatments for posttraumatic disorders among people with severe mental illness Psychiatr Serv 2001521453-1461 Abstract

106 Mueser KT Goodman LB Trumbetta SL et al Trauma and posttraumatic stress disorder in severe mental illness J Consult Clin Psychol 199866493-499 Abstract

107 Nemeroff CB Neurobiological consequences of childhood trauma J Clin Psychiatry 200465(suppl 1)18-28 Abstract

108 Saxe G Johansson R A trauma informed approach to extreme behaviors in intensive child mental health programs 2003 National Child Traumatic Stress Network Boston Mass Boston University School of Medicine2003

109 Huckshorn KA Reducing seclusion and restraint in mental health use settings J Psychosoc Nurs Ment Health Serv 20044222-33

110 Hardenstine B Leading the way toward a seclusion and restraint-free environment Pennsylvanias success story Philadelphia Pa Office of Mental Health and Substance Abuse Services Pennsylvania Department of Public Welfare 2001

111 Detmer D Information technology for quality healthcare A summary of United Kingdom and United States experiences Background paper for the Ditchley Park Conference Co-sponsored by the Commonwealth Fund and the Nuffield Trust 2000 Oxfordshire England 2000

112 Work Group on Computerization of Patient Records (2000) Toward a national health information infrastructure Report of the Work Group on Computerization of Patient Records Washington DC US Department of Health and Human Services 2000

113 Kessler RC Nelson CB McGonagle KA Edlund MJ Frank RG Leaf PJ The epidemiology of co-occurring addictive and mental disorders implications for prevention and service utilization Am J Orthopsychiatry 19966617-31 Abstract

114 Li G Keyl PM Rothman R Chanmugam A Kelen GD Epidemiology of alcohol-related emergency department visits Acad Emerg Med 19996666-668 Abstract

115 Dickey B Normand SL Weiss RD Drake RE Azeni H Medical morbidity mental illness and substance use disorders Psychiatr Serv 200253861-867 Abstract

116 Dickey B Dembling B Azeni H Normand SL Externally caused deaths for adults with substance use and mental disorders J Behav Health Serv Res 20043175-85 Abstract

117 Cline C Minkoff K Substance Abuse and Mental Health Services Administration A Strength Based Systems Approach to Creating Integrated Services for Individuals with Co-occurring Psychiatric and Substance Abuse Disorders -- A Technical Assistance Document New Mexico Department of Health (NMDOH)BHSD Dec 2002

118 American Society of Addiction Medicine Patient Placement Criteria 2R Washington DC ASAM 2001

119 Dalton EJ Cate-Carter TD Mundo E Parikh SV Kennedy JL Suicide risk in bipolar patients the role of co-morbid substance use disorders Bipolar Disord 2003558-61 Abstract

120 Tondo L Baldessarini RJ Hennen J et al Suicide attempts in major affective disorder patients with comorbid substance use disorders J Clin Psychiatry 19996063-69 discussion 75-76 113-116

121 Baldessarini RJ Jamison KR Effects of medical interventions on suicidal behavior Summary and conclusions J Clin Psychiatry 199960117-122 Abstract

122 Aharonovich E Liu X Nunes E Hasin DS Suicide attempts in substance abusers effects of major depression in relation to substance use disorders Am J Psychiatry 20021591600-1602 Abstract

123 Pages KP Russo JE Roy-Byrne PP Ries RK Cowley DS Determinants of suicidal ideation the role of substance use disorders J Clin Psychiatry 199758510-515 Abstract

124 Anderson RN Minintildeo AM Fingerhut LA Warner M Heinen MA Deaths Injuries 2001 National Vital Statistics Reports June 2 2004 Available at httpwwwcdcgovnchsdatanvsrnvsr52nvsr52_21accpdf Accessed August 28 2007

125 Centers for disease Control Alcohol-Related Traffic Fatalities Involving Children -- United States 1985-1996 MMWR Weekly 1997461130-1133 Available at httpwwwcdcgovmmwrpreviewmmwrhtml00050119htm Accessed August 28 2007

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131 NIH Diagnosis and treatment of attention deficit hyperactivity disorder NIH Consensus Statement 1998161-37 Available at httpconsensusnihgov19981998AttentionDeficitHyperactivityDisorder110htmlhtm Accessed August 28 2007

132 Jensen P Bhatara VS Vitiello B Hoagwood K Feil M Burke LB Psychoactive medication prescribing practices for US children gaps between research and clinical practice J Am Acad Child Adolesc Psychiatry 199938557-565 Abstract

133 Popper CW Disorders usually first evident in infancy childhood or adolescence In Talbott JA Hales RE Yudofsky SC eds Textbook of Psychiatry Washington DC American Psychiatric Press 1988649-735

134 Shaffer D Fisher P Dulcan MK et al The NIMH Diagnostic Interview Schedule for Children Version 23 (DISC-23) description acceptability prevalence rates and performance in the MECA Study Methods for the Epidemiology of Child and Adolescent Mental Disorders Study J Am Acad Child Adolesc Psychiatry 199635865-877 Abstract

135 Lahey BB Applegate B McBurnett K et al DSM-IV field trials for attention-deficit hyperactivity disorder in children and adolescents Am J Psychiatry 19941511673-1685 Abstract

136 Biederman J Comorbidity of attention deficit hyperactivity disorder with conduct depressive anxiety and other disorders Am J Psychiatry 1991148564-577 Abstract

137 Mannuzza S Klein RG Bessler A et al Adult outcome of hyperactive boys Arch Gen Psychiatry Educational achievement occupational rank and psychiatric status 199350565-576

138 Mackey P Kipras A Medication for attention deficithyperactivity disorder (ADHD) An analysis by federal electorate Available at httpwwwaphgovaulibrarypubscib2000-0101cib11html Accessed July 23 2001

139 Marshall E Epidemiology Duke study faults overuse of stimulants for children Science 2000289721

140 Morrow RC Morrow AL Haislip G Methylphenidate in the United States 1990 through 1995 Am J Pub Health 1998881121

141 Eaton S Marchak E Ritalin prescription rates vary widely across the country Staten Island New York Staten Island Sunday Advance A23 June 10 2001

142 Jensen P Current concepts and controversies in the diagnosis and treatment of attention deficit hyperactivity disorder Current Psychiatry Rep 20002102-109

143 Multimodal Treatment Study of Children with ADHD Cooperative Group 14-month randomized clinical trial of treatment strategies for attention deficit hyperactivity disorder Arch Gen Psychiatry 1999561073-1086 Abstract

144 American Academy of Pediatrics Clinical practice guideline Treatment of the school-aged child with attention-deficithyperactivity disorder Pediatrics 20011081033-1044 Abstract

145 National Institutes of Health Electroconvulsive Therapy Consensus Development Conference Statement 1985 Available at httpconsensusnihgov19851985ElectroconvulsiveTherapy051htmlhtm Accessed August 28 2007

146 Thompson JW Weiner RD Myers CP Use of ECT in the United States in 1975 1980 and 1986 Am J Psychiatry 19941511657-1661 Abstract

147 Hermann RC Dorwart RA Hoover CW Brody J Variation in ECT use in the United States Am J Psychiatry 1995152869-875 Abstract

148 Rose D Fleishmann P Wykes T Leese M Bindman J Patients perspectives on electroconvulsive therapy systematic review BMJ 20033261363

149 Lisanby SH Maddox JH Prudic J Devanand DP Sackeim HA The effects of electroconvulsive therapy on memory of autobiographical and public events Arch Gen Psychiatry 200057591-592 Abstract

150 Abrams R The mortality rate with ECT Convuls Ther 199713125-127 Abstract

151 Shiwach RS Reid WH Carmody TJ An analysis of reported deaths following electroconvulsive therapy in Texas 1993-1998 Psychiatr Serv 2001 521095-1097 Abstract

152 Breggin PR Electroshock scientific ethical and political issues Int J Risk Safety Med 1998115-40

153 Melonas JM Split treatment does managed care change the risk in psychiatry Psychiatric Practice Managed Care Newsletter 19995

154 Kessler RC Berglund P Demler O et al The epidemiology of major depressive disorder results from the National Comorbidity Survey Replication (NCS-R) JAMA 20032893095-3105 Abstract

155 Pulier ML Ciccone DS Castellano C Marcus K Schleifer SJ Medical versus non-medical mental health referral clinical decision-making by telephone access center staff J Behav Health Serv Res 200330444-451 Abstract

156 Simon GE Katon WJ VonKorff M et al Cost-effectiveness of a collaborative care program for primary care patients with persistent depression Am J Psychiatry 20011581638-1644 Abstract

157 Lazarus J Macbeth J Wheeler N Divided treatment in managed care Psychiatr Pract Managed Care 1997

158 Olfson M Pincus HA Outpatient mental healthcare in non hospital settings distribution of patients across provider groups Am J Psychiatry 19961531353-1356 Abstract

159 Levinson W Physician-patient communication -- a key to malpractice prevention JAMA 1994201619-1620

160 Smith D 10 ways practitioners can avoid frequent ethical pitfalls Monitor on Psychology 20033450 Available at httpapaorgmonitorjan0310wayshtml Accessed on August 28 2007

161 Fishalow SE The tort liability of the psychiatrist Bull Am Acad Psychiatric Law 19753191-230

162 American Psychiatric Association The principles of medical ethics with annotations especially applicable to psychiatry 2001 Available at httpwwwpsychorgpsych_practethicsmedicalethics2001_42001cfm Accessed August 28 2007

163 American Psychological Association Ethical Principles and Code of Conduct June 1 2003 Available at httpwwwapaorgethicscode2002html Accessed August 28 2007

164 Gutheil TG Gabbard GO The concept of boundaries in clinical practice theoretical and risk management dimensions Am J Psychiatry 1993150188-196 Abstract

165 Gutheil TG Gabbard GO Misuses and misunderstandings of boundary theory in clinical and regulatory settings Am J Psychiatry 1998155409-414

166 Malmquist CP Notman MT Psychiatrist and patient boundary issues following treatment termination Am J Psychiatry 20011581010-1018 Abstract

167 Herman JL Gartell N Olarte S Feldstein M Localio R Psychiatrist-patient sexual contact results of a national survey II Psychiatrists attitudes Am J Psychiatry 1987144164-169 Abstract

168 Risk Management in Cyberspace Rx for Risk 20019 169 Miller RH Hillman JM Given RS Physician use of IT Results from the Deloitte

research survey J Healthc Inf Manag 20041872-80 Abstract 170 Applebaum PS Privacy in psychiatric treatment threats and responses Focus

20031396-406 171 Godolphin W The role of risk communication in shared decision making BMJ

2003327692-693 Abstract 172 Oregon Medical Association Lets talk disclosures after an adverse medical

event(video) Portland OR 2002 Available at httpwwwPatientSafetyStorecom Accessed August 28 2007

173 Institute of Medicine (IOM) Crossing the Quality of Chasm Adaptation to Mental Health and Addictive Disorders April 26 2004 Available at httpwwwiomeduCMS380919405aspx Accessed September 6 2007

Authors and Disclosures

As an organization accredited by the ACCME Medscape LLC requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest The ACCME defines relevant financial relationships as financial relationships in any amount occurring within the past 12 months including financial relationships of a spouse or life partner that could create a conflict of interest

Medscape LLC encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration at first mention and where appropriate in the content

Author

Benjamin C Grasso MD

Staff Psychiatrist VA Clinic Saco Maine Disclosure Benjamin C Grasso MD has disclosed no relevant financial relationships

Cathryn M Clary MD MBA

Vice President US External Medical Affairs Pfizer Inc New York NY Disclosure Cathryn M Clary MD MBA has disclosed that she is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Benjamin Eng MD MA

Senior Medical Director Group Leader Pfizer Inc New York NY Disclosure Benjamin Eng MD MA has disclosed that he is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Stanley J Evans MD FASAM PA

Assistant Professor of Clinical Medicine St Matthews University Windham Maine

Medical Director Renaissance Institute of Palm Beach Boca Raton Florida Disclosure Stanley J Evans MD has disclosed no relevant financial relationships

Terry J Golash MD

Clinical Instructor Psychiatry Columbia University New York NY Assistant Attending St Lukersquos Roosevelt Hospital Center New York NY Disclosure Terry J Golash MD has disclosed no relevant financial relationships

Kevin Ann Huckshorn RN MSN CAP ICADC

Director Office of Technical Assistance National Association of State mental Health Program Directors Inc Alexandria Virginia Disclosure Kevin Ann Huckshorn RN MSN CAP ICADC has disclosed no relevant financial relationships

Kenneth Minkoff MD

Clinical Assistant Professor Department of Psychiatry Cambridge Hospital Harvard University Acton Massachusetts Consultant ZiaLogic Acton Massachusetts Disclosure Kenneth Minkoff MD has disclosed no relevant financial relationships

Joseph J Parks MD

Assistant Associate Professor Department of Psychiatry University of Missouri Columbia Missouri Disclosure Joseph J Parks MD has disclosed that he has received grants for educational activities from Letters amp Science and Physician Postgraduate Press Dr Parks has also disclosed that he has served as a consultant to the National Association of State Mental Health Program Directors and Bristol-Myers Squibb Dr Parks has also disclosed that he has received funds for services provided to the state of Missouri from Eli Lilly and Abbott

Miles F Shore MD

Bullard Distinguished Professor of Psychiatry Harvard Medical School Needham Massachusetts Junior Consultant Harvard Medical International Boston Massachusetts Disclosure Miles F Shore MD has disclosed no relevant financial relationships

Editor

Jacqueline A Hart MD

Freelance Clinical Editor Medscape LLC New York New York Disclosure Jacqueline A Hart MD has disclosed no relevant financial relationships

Elizabeth Saenger PhD

Editorial Director Medscape LLC New York NY Disclosure Elizabeth Saenger PhD has disclosed no relevant financial relationships

Registration for CME credit the post test and the evaluation must be completed online To access the activity Post Test and Evaluation link please go to httpwwwmedscapecomviewprogram7809_index

Page 26: Medication Errors and Patient Safety in Mental Health CME/CE · 2019. 6. 27. · Medication Errors and Patient Safety in Mental Health CME/CE Complete author affiliations and disclosures

51 Wells KB Stewart A Hays RD et al The functioning and well-being of depressed patients results from the medical outcomes study JAMA 1989262914-919 Abstract

52 Katon W Sullivan MD Depression and chronic medical illness J Clin Psychiatry 1990 513-11

53 Frasure-Smith N Lesperance F Gravel G et al Depression and health-care costs during the first year following myocardial infarction J Psychosomatic Res 200048471-478

54 Ariyo AA Haan M Tangen CM et al for the Cardiovascular Health Study Collaborative Research Group Depressive symptoms and risks of coronary heart disease and mortality in elderly Americans Circulation 2000 1021773-1779 Abstract

55 Schulz R Beach SR Ives DG et al Association between depression and mortality in older adults the Cardiovascular Health Study Arch Intern Med 20001601761-1768 Abstract

56 Lin EH von Korff M Wagner EH Identifying suicide potential in primary care J Gen Intern Med 198941-6 Abstract

57 Foster T Gillespie K McClelland R Patterson C Risk factors for suicide independent of DSM-III-R Axis I disorder Br J Psychiatry 1999175175-179 Abstract

58 Henriksson MM Aro HM Marttunen MJ et al Mental disorders and comorbidity in suicide Am J Psychiatry 1993150935-940 Abstract

59 Greenberg PE Kessler RC Birnbaum HG Leong SA Lowe SW Berglund PA Corey-Lisle PK The economic burden of depression in the United States how did it change between 1990 and 2000 J Clin Psychiatry 2003541465-1475

60 Murray CJL Lopez AD Ed The Global Burden of Disease A Comprehensive Assessment of Mortality and Disability From Diseases Injuries and Risk Factors in 1990 and Projected To 2020 Cambridge Massachusetts Harvard School of Public Health on behalf of the World Health Organization and the World Bank 1996

61 Zatzick DF Marmar CR Weiss DS et al Posttraumatic stress disorder and functioning and quality of life outcomes in a nationally representative sample of male Vietnam veterans Am J Psychiatry 19971541690-1695 Abstract

62 Stein MB Walker JR Hazen AL Forde DR Full and partial posttraumatic stress disorder findings from a community survey Am J Psychiatry 19971541114-1119 Abstract

63 Klerman GL Weissman MM Ouellette R Johnson J Greenwald S Panic attacks in the community Social morbidity and healthcare utilization JAMA 1991265742-746 Abstract

64 Katerndahl DA Realini JP Quality of life and panic-related work disability in subjects with infrequent panic and panic disorder J Clin Psychiatry 199758153-158 Abstract

65 Wittchen HU Zhao S Kessler RC Eaton WW DSM-III-R generalized anxiety disorder in the National Comorbidity Survey Arch Gen Psychiatry 199451355-364 Abstract

66 Schneier FR Johnson J Hornig CD Liebowitz MR Weissman MM Social phobia Comorbidity and morbidity in an epidemiologic sample Arch Gen Psychiatry 199249282-288 Abstract

67 Wittchen HU Beloch E The impact of social phobia on quality of life Int Clin Psychopharmacol 199611(suppl 3)15-23 Abstract

68 Sherbourne CD Wells KB Judd LL Functioning and wellbeing of patients with panic disorder Am J Psychiatry 1996 153213-218 Abstract

69 Weiller E Bisserbe JC Maier W Lecrubier Y Prevalence and recognition of anxiety syndromes in five European primary care settings Br J Psychiatry 1998173(suppl 34)18-23

70 Simon GE VonKorff M Recognition management and outcomes of depression in primary care Arch Fam Med 1995499-105 Abstract

71 Greenberg PE Sisitsky T Kessler RC et al The economic burden of anxiety disorders in the 1990s J Clin Psychiatry 199960427-435 Abstract

72 Ormel J van den Brink W Koeter MW et al Recognition management and outcome of psychological disorders in primary care a naturalistic follow-up study Psychol Med 199020909-923 Abstract

73 Brown TA Di Nardo PA Lehman CL Campbell LA Reliability of DSM-IV mood and anxiety disorders implications for the classification of emotional disorders J Abnorm Psychol 200111049-58 Abstract

74 Dowrick C Buchan I Twelve month outcome of depression in general practice does detection or disclosure make a difference BMJ 19953111274-1276 Abstract

75 Regier DA Farmer ME Rae DS et al Comorbidity of mental disorders with alcohol and other drug abuse results from the epidemiologic catchment area (ECA) study JAMA 19902642511-2518 Abstract

76 Gilbody S Whitty P Grimshaw J Thomas R Educational and organizational interventions to improve the management of depression in primary care a systematic review JAMA 20032893145-3151 Abstract

77 Spitzer RL Kroenke K Williams JB Validation and utility of a self-report version of PRIME-MD the PHQ primary care study Primary Care Evalation of Mental Disorders Patient Health Questionnaire JAMA 19992821737-1744 Abstract

78 Bridges to Excellence Rewarding Quality Across The Healthcare System Available at httpwwwbridgestoexcellenceorg Accessed August 28 2007

79 The Integrated Healthcare Association Available at httpwwwihaorg Accessed February 28 2007

80 National Committee on Quality Assurance Healthy Communities Access Program Evaluation Report 2004 Available at httpwwwncqaorgProgramsHEDISHEDIS20200520Summarypdf Accessed June 3 2004

81 Weiss EM Altimari D Blint DF et al Deadly restraints A nationwide pattern of death The Hartford Courant October 1998

82 US General Accounting Office (USGAO) Mental health Improper restraint or seclusion use places people at risk GAOHES-99-176 Washington DC United States General Accounting Office 1999

83 Success Stories and Ideas for Reducing RestraintSeclusion (2003) A compendium of strategies created by the American Psychiatric Association (APA) the American Psychiatric Nurses Association (APNA) the National Association of Psychiatric Health Systems (NAPHS) and the American Hospital Association Section for Psychiatric and Substance Abuse Services (AHA) Available at httpwwwpsychorgpsych_practtreatgpglearningfromeachothercfm Accessed August 28 2007

84 National Technical Assistance Center for State Mental Health Planning (NTAC) Violence and coercion in mental health settings Eliminating the use of seclusion and restraint Alexandria Va National Association of State Mental Health Program Directors (NASMHPD) National Technical Assistance Center for State Mental Health Planning (NTAC) 2002

85 Bullard L Fulmore D Johnson K Reducing the use of seclusion and restraint Promising practices and successful strategies Childrens Welfare League of America 2003 Washington DC CWLA Press 2003

86 NASMHPDNASADAD The new conceptual framework for co-occurring mental health and substance use disorders Washington DC NASMHPD 1998

87 HCFA Interim Rules Medicare and Medicaid programs Hospital conditions of participation Patients Rights 42 CFR Part 482 1999 Baltimore Md Department of Health and Human Services

88 National Executive Training Institute (NETI) Training Curriculum for Reduction of Seclusion and Restraint Draft Curriculum Manual 2003 Alexandria Va National Association of State Mental Health Program Directors (NASMHPD) National Technical Assistance Center for State Mental Health Planning (NTAC)

89 Mohr WK Anderson JA Faulty assumptions associated with the use of restraints with children J Child Adolesc Psychiatr Nurs200114141-151 Abstract

90 Finke LM The use of seclusion is not evidence-based practice J Child Adolesc Psychiatry 200114186-188

91 Center for Medicare and Medicaid Services (CMS) Testimony from the public hearing on the one hour rule 2002 Baltimore Md CMS

92 Joint Commission on Accreditation of Healthcare Organization Standards for Behavioral Healthcare 2004-2005 Oakbrook Terrace Ill Joint Commission Resources 2005

93 Gross G Restraint and seclusion overview of federal laws and policies Washington DC National Association of Protection and Advocacy Systems (NAPAS) 2003

94 American Association of Community Psychiatry (AACP) (2003) AACP guidelines for recovery oriented services Available at httpwwwcommpsychpittedufindsROSMenuhtml Accessed June 2 2004

95 Schnaars C Tape called strong evidence in boys death Daily Press April 13 2003 Available at httpgroupsmsncomHumanRightsUSAnewhopeiimsnw Accessed August 28 2007

96 Erikson J 5 pinned woman prone on Kino floor Report describes patients death struggle at hospital Arizona Daily Star July 29 2003 July 29 Available at httpwwwfox11azcomnewslocalstoriesKMSB_local_kino_072903d8c78db2html Accessed August 28 2007

97 Masters KJ Bellonci C the Work Group on Quality Issues Practice parameters for the prevention and management of aggressive behavior in child and adolescent psychiatric institutions with special reference to seclusion and restraint Available to American Academy of Childhood and Adolescent Psychiatry (AACAP) members at httpwwwaacaporg Washington DC AACAP 2001 Accessed August 28 2007

98 Fisher W Restraint and seclusion A review of the literature Am J Psychiatry 19941511584-1591 Abstract

99 US Department of Health and Human Services (USDHHS) Mental health of the nation report of the Surgeon General (SMA01-3613) Office of the Surgeon General Public Health Service Washington DC US Government Printing Office 1999

100 Onken S Dumont J Ridgeway P Dornan D Ralph R Mental health recovery What helps and what hinders A national research project for the development of recovery facilitating system performance indicators Alexandria Va National Association of State Mental Health Program Directors (NASMHPD) National Technical Assistance Center for State Mental Health Planning (NTAC) 2002

101 American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Washington DC American Psychiatric Association 1994

102 Cusack KJ Frueh BC Brady KT Trauma history screening in a community mental health center Psychiatr Serv 200455157-162 Abstract

103 Cusack KJ Frueh BC Hiers TG Keane TM Mueser KT (2003) The impact of trauma and posttraumatic stress disorder upon American society Report to the Presidents New Freedom Commission on Mental Health Unpublished subcommittee report Washington DC 2003

104 Frueh BC Dalton ME Johnson MR et al Trauma within the psychiatric setting conceptual framework research directions and policy implications Admin Policy Ment Health 200028147-154

105 Rosenberg SD Mueser KT Friedman MJ et al Developing effective treatments for posttraumatic disorders among people with severe mental illness Psychiatr Serv 2001521453-1461 Abstract

106 Mueser KT Goodman LB Trumbetta SL et al Trauma and posttraumatic stress disorder in severe mental illness J Consult Clin Psychol 199866493-499 Abstract

107 Nemeroff CB Neurobiological consequences of childhood trauma J Clin Psychiatry 200465(suppl 1)18-28 Abstract

108 Saxe G Johansson R A trauma informed approach to extreme behaviors in intensive child mental health programs 2003 National Child Traumatic Stress Network Boston Mass Boston University School of Medicine2003

109 Huckshorn KA Reducing seclusion and restraint in mental health use settings J Psychosoc Nurs Ment Health Serv 20044222-33

110 Hardenstine B Leading the way toward a seclusion and restraint-free environment Pennsylvanias success story Philadelphia Pa Office of Mental Health and Substance Abuse Services Pennsylvania Department of Public Welfare 2001

111 Detmer D Information technology for quality healthcare A summary of United Kingdom and United States experiences Background paper for the Ditchley Park Conference Co-sponsored by the Commonwealth Fund and the Nuffield Trust 2000 Oxfordshire England 2000

112 Work Group on Computerization of Patient Records (2000) Toward a national health information infrastructure Report of the Work Group on Computerization of Patient Records Washington DC US Department of Health and Human Services 2000

113 Kessler RC Nelson CB McGonagle KA Edlund MJ Frank RG Leaf PJ The epidemiology of co-occurring addictive and mental disorders implications for prevention and service utilization Am J Orthopsychiatry 19966617-31 Abstract

114 Li G Keyl PM Rothman R Chanmugam A Kelen GD Epidemiology of alcohol-related emergency department visits Acad Emerg Med 19996666-668 Abstract

115 Dickey B Normand SL Weiss RD Drake RE Azeni H Medical morbidity mental illness and substance use disorders Psychiatr Serv 200253861-867 Abstract

116 Dickey B Dembling B Azeni H Normand SL Externally caused deaths for adults with substance use and mental disorders J Behav Health Serv Res 20043175-85 Abstract

117 Cline C Minkoff K Substance Abuse and Mental Health Services Administration A Strength Based Systems Approach to Creating Integrated Services for Individuals with Co-occurring Psychiatric and Substance Abuse Disorders -- A Technical Assistance Document New Mexico Department of Health (NMDOH)BHSD Dec 2002

118 American Society of Addiction Medicine Patient Placement Criteria 2R Washington DC ASAM 2001

119 Dalton EJ Cate-Carter TD Mundo E Parikh SV Kennedy JL Suicide risk in bipolar patients the role of co-morbid substance use disorders Bipolar Disord 2003558-61 Abstract

120 Tondo L Baldessarini RJ Hennen J et al Suicide attempts in major affective disorder patients with comorbid substance use disorders J Clin Psychiatry 19996063-69 discussion 75-76 113-116

121 Baldessarini RJ Jamison KR Effects of medical interventions on suicidal behavior Summary and conclusions J Clin Psychiatry 199960117-122 Abstract

122 Aharonovich E Liu X Nunes E Hasin DS Suicide attempts in substance abusers effects of major depression in relation to substance use disorders Am J Psychiatry 20021591600-1602 Abstract

123 Pages KP Russo JE Roy-Byrne PP Ries RK Cowley DS Determinants of suicidal ideation the role of substance use disorders J Clin Psychiatry 199758510-515 Abstract

124 Anderson RN Minintildeo AM Fingerhut LA Warner M Heinen MA Deaths Injuries 2001 National Vital Statistics Reports June 2 2004 Available at httpwwwcdcgovnchsdatanvsrnvsr52nvsr52_21accpdf Accessed August 28 2007

125 Centers for disease Control Alcohol-Related Traffic Fatalities Involving Children -- United States 1985-1996 MMWR Weekly 1997461130-1133 Available at httpwwwcdcgovmmwrpreviewmmwrhtml00050119htm Accessed August 28 2007

126 Wender P Bierman J French F et al Minimal Brain Dysfunction in Children New York John Wiley and Sons 1971

127 Barkley R Reflections on the NIHNIMH Consensus Conference on ADHD ADHD Report 199971-4

128 Sinha G New evidence about Ritalin What every parent should know Popular Science 200148-52

129 Conners CK Forty years of methylphenidate treatment in Attention-Deficit Hyperactivity Disorder J Atten Disord 20026S17-S30 Abstract

130 LeFever GB Arcona AP Antonuccio DO ADHD among American schoolchildren evidence of overdiagnosis and overuse of medication Sci Rev Ment

Health Pract 20032 Available at httpwwwsrmhporg0201adhdhtml Accessed August 28 2007

131 NIH Diagnosis and treatment of attention deficit hyperactivity disorder NIH Consensus Statement 1998161-37 Available at httpconsensusnihgov19981998AttentionDeficitHyperactivityDisorder110htmlhtm Accessed August 28 2007

132 Jensen P Bhatara VS Vitiello B Hoagwood K Feil M Burke LB Psychoactive medication prescribing practices for US children gaps between research and clinical practice J Am Acad Child Adolesc Psychiatry 199938557-565 Abstract

133 Popper CW Disorders usually first evident in infancy childhood or adolescence In Talbott JA Hales RE Yudofsky SC eds Textbook of Psychiatry Washington DC American Psychiatric Press 1988649-735

134 Shaffer D Fisher P Dulcan MK et al The NIMH Diagnostic Interview Schedule for Children Version 23 (DISC-23) description acceptability prevalence rates and performance in the MECA Study Methods for the Epidemiology of Child and Adolescent Mental Disorders Study J Am Acad Child Adolesc Psychiatry 199635865-877 Abstract

135 Lahey BB Applegate B McBurnett K et al DSM-IV field trials for attention-deficit hyperactivity disorder in children and adolescents Am J Psychiatry 19941511673-1685 Abstract

136 Biederman J Comorbidity of attention deficit hyperactivity disorder with conduct depressive anxiety and other disorders Am J Psychiatry 1991148564-577 Abstract

137 Mannuzza S Klein RG Bessler A et al Adult outcome of hyperactive boys Arch Gen Psychiatry Educational achievement occupational rank and psychiatric status 199350565-576

138 Mackey P Kipras A Medication for attention deficithyperactivity disorder (ADHD) An analysis by federal electorate Available at httpwwwaphgovaulibrarypubscib2000-0101cib11html Accessed July 23 2001

139 Marshall E Epidemiology Duke study faults overuse of stimulants for children Science 2000289721

140 Morrow RC Morrow AL Haislip G Methylphenidate in the United States 1990 through 1995 Am J Pub Health 1998881121

141 Eaton S Marchak E Ritalin prescription rates vary widely across the country Staten Island New York Staten Island Sunday Advance A23 June 10 2001

142 Jensen P Current concepts and controversies in the diagnosis and treatment of attention deficit hyperactivity disorder Current Psychiatry Rep 20002102-109

143 Multimodal Treatment Study of Children with ADHD Cooperative Group 14-month randomized clinical trial of treatment strategies for attention deficit hyperactivity disorder Arch Gen Psychiatry 1999561073-1086 Abstract

144 American Academy of Pediatrics Clinical practice guideline Treatment of the school-aged child with attention-deficithyperactivity disorder Pediatrics 20011081033-1044 Abstract

145 National Institutes of Health Electroconvulsive Therapy Consensus Development Conference Statement 1985 Available at httpconsensusnihgov19851985ElectroconvulsiveTherapy051htmlhtm Accessed August 28 2007

146 Thompson JW Weiner RD Myers CP Use of ECT in the United States in 1975 1980 and 1986 Am J Psychiatry 19941511657-1661 Abstract

147 Hermann RC Dorwart RA Hoover CW Brody J Variation in ECT use in the United States Am J Psychiatry 1995152869-875 Abstract

148 Rose D Fleishmann P Wykes T Leese M Bindman J Patients perspectives on electroconvulsive therapy systematic review BMJ 20033261363

149 Lisanby SH Maddox JH Prudic J Devanand DP Sackeim HA The effects of electroconvulsive therapy on memory of autobiographical and public events Arch Gen Psychiatry 200057591-592 Abstract

150 Abrams R The mortality rate with ECT Convuls Ther 199713125-127 Abstract

151 Shiwach RS Reid WH Carmody TJ An analysis of reported deaths following electroconvulsive therapy in Texas 1993-1998 Psychiatr Serv 2001 521095-1097 Abstract

152 Breggin PR Electroshock scientific ethical and political issues Int J Risk Safety Med 1998115-40

153 Melonas JM Split treatment does managed care change the risk in psychiatry Psychiatric Practice Managed Care Newsletter 19995

154 Kessler RC Berglund P Demler O et al The epidemiology of major depressive disorder results from the National Comorbidity Survey Replication (NCS-R) JAMA 20032893095-3105 Abstract

155 Pulier ML Ciccone DS Castellano C Marcus K Schleifer SJ Medical versus non-medical mental health referral clinical decision-making by telephone access center staff J Behav Health Serv Res 200330444-451 Abstract

156 Simon GE Katon WJ VonKorff M et al Cost-effectiveness of a collaborative care program for primary care patients with persistent depression Am J Psychiatry 20011581638-1644 Abstract

157 Lazarus J Macbeth J Wheeler N Divided treatment in managed care Psychiatr Pract Managed Care 1997

158 Olfson M Pincus HA Outpatient mental healthcare in non hospital settings distribution of patients across provider groups Am J Psychiatry 19961531353-1356 Abstract

159 Levinson W Physician-patient communication -- a key to malpractice prevention JAMA 1994201619-1620

160 Smith D 10 ways practitioners can avoid frequent ethical pitfalls Monitor on Psychology 20033450 Available at httpapaorgmonitorjan0310wayshtml Accessed on August 28 2007

161 Fishalow SE The tort liability of the psychiatrist Bull Am Acad Psychiatric Law 19753191-230

162 American Psychiatric Association The principles of medical ethics with annotations especially applicable to psychiatry 2001 Available at httpwwwpsychorgpsych_practethicsmedicalethics2001_42001cfm Accessed August 28 2007

163 American Psychological Association Ethical Principles and Code of Conduct June 1 2003 Available at httpwwwapaorgethicscode2002html Accessed August 28 2007

164 Gutheil TG Gabbard GO The concept of boundaries in clinical practice theoretical and risk management dimensions Am J Psychiatry 1993150188-196 Abstract

165 Gutheil TG Gabbard GO Misuses and misunderstandings of boundary theory in clinical and regulatory settings Am J Psychiatry 1998155409-414

166 Malmquist CP Notman MT Psychiatrist and patient boundary issues following treatment termination Am J Psychiatry 20011581010-1018 Abstract

167 Herman JL Gartell N Olarte S Feldstein M Localio R Psychiatrist-patient sexual contact results of a national survey II Psychiatrists attitudes Am J Psychiatry 1987144164-169 Abstract

168 Risk Management in Cyberspace Rx for Risk 20019 169 Miller RH Hillman JM Given RS Physician use of IT Results from the Deloitte

research survey J Healthc Inf Manag 20041872-80 Abstract 170 Applebaum PS Privacy in psychiatric treatment threats and responses Focus

20031396-406 171 Godolphin W The role of risk communication in shared decision making BMJ

2003327692-693 Abstract 172 Oregon Medical Association Lets talk disclosures after an adverse medical

event(video) Portland OR 2002 Available at httpwwwPatientSafetyStorecom Accessed August 28 2007

173 Institute of Medicine (IOM) Crossing the Quality of Chasm Adaptation to Mental Health and Addictive Disorders April 26 2004 Available at httpwwwiomeduCMS380919405aspx Accessed September 6 2007

Authors and Disclosures

As an organization accredited by the ACCME Medscape LLC requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest The ACCME defines relevant financial relationships as financial relationships in any amount occurring within the past 12 months including financial relationships of a spouse or life partner that could create a conflict of interest

Medscape LLC encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration at first mention and where appropriate in the content

Author

Benjamin C Grasso MD

Staff Psychiatrist VA Clinic Saco Maine Disclosure Benjamin C Grasso MD has disclosed no relevant financial relationships

Cathryn M Clary MD MBA

Vice President US External Medical Affairs Pfizer Inc New York NY Disclosure Cathryn M Clary MD MBA has disclosed that she is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Benjamin Eng MD MA

Senior Medical Director Group Leader Pfizer Inc New York NY Disclosure Benjamin Eng MD MA has disclosed that he is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Stanley J Evans MD FASAM PA

Assistant Professor of Clinical Medicine St Matthews University Windham Maine

Medical Director Renaissance Institute of Palm Beach Boca Raton Florida Disclosure Stanley J Evans MD has disclosed no relevant financial relationships

Terry J Golash MD

Clinical Instructor Psychiatry Columbia University New York NY Assistant Attending St Lukersquos Roosevelt Hospital Center New York NY Disclosure Terry J Golash MD has disclosed no relevant financial relationships

Kevin Ann Huckshorn RN MSN CAP ICADC

Director Office of Technical Assistance National Association of State mental Health Program Directors Inc Alexandria Virginia Disclosure Kevin Ann Huckshorn RN MSN CAP ICADC has disclosed no relevant financial relationships

Kenneth Minkoff MD

Clinical Assistant Professor Department of Psychiatry Cambridge Hospital Harvard University Acton Massachusetts Consultant ZiaLogic Acton Massachusetts Disclosure Kenneth Minkoff MD has disclosed no relevant financial relationships

Joseph J Parks MD

Assistant Associate Professor Department of Psychiatry University of Missouri Columbia Missouri Disclosure Joseph J Parks MD has disclosed that he has received grants for educational activities from Letters amp Science and Physician Postgraduate Press Dr Parks has also disclosed that he has served as a consultant to the National Association of State Mental Health Program Directors and Bristol-Myers Squibb Dr Parks has also disclosed that he has received funds for services provided to the state of Missouri from Eli Lilly and Abbott

Miles F Shore MD

Bullard Distinguished Professor of Psychiatry Harvard Medical School Needham Massachusetts Junior Consultant Harvard Medical International Boston Massachusetts Disclosure Miles F Shore MD has disclosed no relevant financial relationships

Editor

Jacqueline A Hart MD

Freelance Clinical Editor Medscape LLC New York New York Disclosure Jacqueline A Hart MD has disclosed no relevant financial relationships

Elizabeth Saenger PhD

Editorial Director Medscape LLC New York NY Disclosure Elizabeth Saenger PhD has disclosed no relevant financial relationships

Registration for CME credit the post test and the evaluation must be completed online To access the activity Post Test and Evaluation link please go to httpwwwmedscapecomviewprogram7809_index

Page 27: Medication Errors and Patient Safety in Mental Health CME/CE · 2019. 6. 27. · Medication Errors and Patient Safety in Mental Health CME/CE Complete author affiliations and disclosures

73 Brown TA Di Nardo PA Lehman CL Campbell LA Reliability of DSM-IV mood and anxiety disorders implications for the classification of emotional disorders J Abnorm Psychol 200111049-58 Abstract

74 Dowrick C Buchan I Twelve month outcome of depression in general practice does detection or disclosure make a difference BMJ 19953111274-1276 Abstract

75 Regier DA Farmer ME Rae DS et al Comorbidity of mental disorders with alcohol and other drug abuse results from the epidemiologic catchment area (ECA) study JAMA 19902642511-2518 Abstract

76 Gilbody S Whitty P Grimshaw J Thomas R Educational and organizational interventions to improve the management of depression in primary care a systematic review JAMA 20032893145-3151 Abstract

77 Spitzer RL Kroenke K Williams JB Validation and utility of a self-report version of PRIME-MD the PHQ primary care study Primary Care Evalation of Mental Disorders Patient Health Questionnaire JAMA 19992821737-1744 Abstract

78 Bridges to Excellence Rewarding Quality Across The Healthcare System Available at httpwwwbridgestoexcellenceorg Accessed August 28 2007

79 The Integrated Healthcare Association Available at httpwwwihaorg Accessed February 28 2007

80 National Committee on Quality Assurance Healthy Communities Access Program Evaluation Report 2004 Available at httpwwwncqaorgProgramsHEDISHEDIS20200520Summarypdf Accessed June 3 2004

81 Weiss EM Altimari D Blint DF et al Deadly restraints A nationwide pattern of death The Hartford Courant October 1998

82 US General Accounting Office (USGAO) Mental health Improper restraint or seclusion use places people at risk GAOHES-99-176 Washington DC United States General Accounting Office 1999

83 Success Stories and Ideas for Reducing RestraintSeclusion (2003) A compendium of strategies created by the American Psychiatric Association (APA) the American Psychiatric Nurses Association (APNA) the National Association of Psychiatric Health Systems (NAPHS) and the American Hospital Association Section for Psychiatric and Substance Abuse Services (AHA) Available at httpwwwpsychorgpsych_practtreatgpglearningfromeachothercfm Accessed August 28 2007

84 National Technical Assistance Center for State Mental Health Planning (NTAC) Violence and coercion in mental health settings Eliminating the use of seclusion and restraint Alexandria Va National Association of State Mental Health Program Directors (NASMHPD) National Technical Assistance Center for State Mental Health Planning (NTAC) 2002

85 Bullard L Fulmore D Johnson K Reducing the use of seclusion and restraint Promising practices and successful strategies Childrens Welfare League of America 2003 Washington DC CWLA Press 2003

86 NASMHPDNASADAD The new conceptual framework for co-occurring mental health and substance use disorders Washington DC NASMHPD 1998

87 HCFA Interim Rules Medicare and Medicaid programs Hospital conditions of participation Patients Rights 42 CFR Part 482 1999 Baltimore Md Department of Health and Human Services

88 National Executive Training Institute (NETI) Training Curriculum for Reduction of Seclusion and Restraint Draft Curriculum Manual 2003 Alexandria Va National Association of State Mental Health Program Directors (NASMHPD) National Technical Assistance Center for State Mental Health Planning (NTAC)

89 Mohr WK Anderson JA Faulty assumptions associated with the use of restraints with children J Child Adolesc Psychiatr Nurs200114141-151 Abstract

90 Finke LM The use of seclusion is not evidence-based practice J Child Adolesc Psychiatry 200114186-188

91 Center for Medicare and Medicaid Services (CMS) Testimony from the public hearing on the one hour rule 2002 Baltimore Md CMS

92 Joint Commission on Accreditation of Healthcare Organization Standards for Behavioral Healthcare 2004-2005 Oakbrook Terrace Ill Joint Commission Resources 2005

93 Gross G Restraint and seclusion overview of federal laws and policies Washington DC National Association of Protection and Advocacy Systems (NAPAS) 2003

94 American Association of Community Psychiatry (AACP) (2003) AACP guidelines for recovery oriented services Available at httpwwwcommpsychpittedufindsROSMenuhtml Accessed June 2 2004

95 Schnaars C Tape called strong evidence in boys death Daily Press April 13 2003 Available at httpgroupsmsncomHumanRightsUSAnewhopeiimsnw Accessed August 28 2007

96 Erikson J 5 pinned woman prone on Kino floor Report describes patients death struggle at hospital Arizona Daily Star July 29 2003 July 29 Available at httpwwwfox11azcomnewslocalstoriesKMSB_local_kino_072903d8c78db2html Accessed August 28 2007

97 Masters KJ Bellonci C the Work Group on Quality Issues Practice parameters for the prevention and management of aggressive behavior in child and adolescent psychiatric institutions with special reference to seclusion and restraint Available to American Academy of Childhood and Adolescent Psychiatry (AACAP) members at httpwwwaacaporg Washington DC AACAP 2001 Accessed August 28 2007

98 Fisher W Restraint and seclusion A review of the literature Am J Psychiatry 19941511584-1591 Abstract

99 US Department of Health and Human Services (USDHHS) Mental health of the nation report of the Surgeon General (SMA01-3613) Office of the Surgeon General Public Health Service Washington DC US Government Printing Office 1999

100 Onken S Dumont J Ridgeway P Dornan D Ralph R Mental health recovery What helps and what hinders A national research project for the development of recovery facilitating system performance indicators Alexandria Va National Association of State Mental Health Program Directors (NASMHPD) National Technical Assistance Center for State Mental Health Planning (NTAC) 2002

101 American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Washington DC American Psychiatric Association 1994

102 Cusack KJ Frueh BC Brady KT Trauma history screening in a community mental health center Psychiatr Serv 200455157-162 Abstract

103 Cusack KJ Frueh BC Hiers TG Keane TM Mueser KT (2003) The impact of trauma and posttraumatic stress disorder upon American society Report to the Presidents New Freedom Commission on Mental Health Unpublished subcommittee report Washington DC 2003

104 Frueh BC Dalton ME Johnson MR et al Trauma within the psychiatric setting conceptual framework research directions and policy implications Admin Policy Ment Health 200028147-154

105 Rosenberg SD Mueser KT Friedman MJ et al Developing effective treatments for posttraumatic disorders among people with severe mental illness Psychiatr Serv 2001521453-1461 Abstract

106 Mueser KT Goodman LB Trumbetta SL et al Trauma and posttraumatic stress disorder in severe mental illness J Consult Clin Psychol 199866493-499 Abstract

107 Nemeroff CB Neurobiological consequences of childhood trauma J Clin Psychiatry 200465(suppl 1)18-28 Abstract

108 Saxe G Johansson R A trauma informed approach to extreme behaviors in intensive child mental health programs 2003 National Child Traumatic Stress Network Boston Mass Boston University School of Medicine2003

109 Huckshorn KA Reducing seclusion and restraint in mental health use settings J Psychosoc Nurs Ment Health Serv 20044222-33

110 Hardenstine B Leading the way toward a seclusion and restraint-free environment Pennsylvanias success story Philadelphia Pa Office of Mental Health and Substance Abuse Services Pennsylvania Department of Public Welfare 2001

111 Detmer D Information technology for quality healthcare A summary of United Kingdom and United States experiences Background paper for the Ditchley Park Conference Co-sponsored by the Commonwealth Fund and the Nuffield Trust 2000 Oxfordshire England 2000

112 Work Group on Computerization of Patient Records (2000) Toward a national health information infrastructure Report of the Work Group on Computerization of Patient Records Washington DC US Department of Health and Human Services 2000

113 Kessler RC Nelson CB McGonagle KA Edlund MJ Frank RG Leaf PJ The epidemiology of co-occurring addictive and mental disorders implications for prevention and service utilization Am J Orthopsychiatry 19966617-31 Abstract

114 Li G Keyl PM Rothman R Chanmugam A Kelen GD Epidemiology of alcohol-related emergency department visits Acad Emerg Med 19996666-668 Abstract

115 Dickey B Normand SL Weiss RD Drake RE Azeni H Medical morbidity mental illness and substance use disorders Psychiatr Serv 200253861-867 Abstract

116 Dickey B Dembling B Azeni H Normand SL Externally caused deaths for adults with substance use and mental disorders J Behav Health Serv Res 20043175-85 Abstract

117 Cline C Minkoff K Substance Abuse and Mental Health Services Administration A Strength Based Systems Approach to Creating Integrated Services for Individuals with Co-occurring Psychiatric and Substance Abuse Disorders -- A Technical Assistance Document New Mexico Department of Health (NMDOH)BHSD Dec 2002

118 American Society of Addiction Medicine Patient Placement Criteria 2R Washington DC ASAM 2001

119 Dalton EJ Cate-Carter TD Mundo E Parikh SV Kennedy JL Suicide risk in bipolar patients the role of co-morbid substance use disorders Bipolar Disord 2003558-61 Abstract

120 Tondo L Baldessarini RJ Hennen J et al Suicide attempts in major affective disorder patients with comorbid substance use disorders J Clin Psychiatry 19996063-69 discussion 75-76 113-116

121 Baldessarini RJ Jamison KR Effects of medical interventions on suicidal behavior Summary and conclusions J Clin Psychiatry 199960117-122 Abstract

122 Aharonovich E Liu X Nunes E Hasin DS Suicide attempts in substance abusers effects of major depression in relation to substance use disorders Am J Psychiatry 20021591600-1602 Abstract

123 Pages KP Russo JE Roy-Byrne PP Ries RK Cowley DS Determinants of suicidal ideation the role of substance use disorders J Clin Psychiatry 199758510-515 Abstract

124 Anderson RN Minintildeo AM Fingerhut LA Warner M Heinen MA Deaths Injuries 2001 National Vital Statistics Reports June 2 2004 Available at httpwwwcdcgovnchsdatanvsrnvsr52nvsr52_21accpdf Accessed August 28 2007

125 Centers for disease Control Alcohol-Related Traffic Fatalities Involving Children -- United States 1985-1996 MMWR Weekly 1997461130-1133 Available at httpwwwcdcgovmmwrpreviewmmwrhtml00050119htm Accessed August 28 2007

126 Wender P Bierman J French F et al Minimal Brain Dysfunction in Children New York John Wiley and Sons 1971

127 Barkley R Reflections on the NIHNIMH Consensus Conference on ADHD ADHD Report 199971-4

128 Sinha G New evidence about Ritalin What every parent should know Popular Science 200148-52

129 Conners CK Forty years of methylphenidate treatment in Attention-Deficit Hyperactivity Disorder J Atten Disord 20026S17-S30 Abstract

130 LeFever GB Arcona AP Antonuccio DO ADHD among American schoolchildren evidence of overdiagnosis and overuse of medication Sci Rev Ment

Health Pract 20032 Available at httpwwwsrmhporg0201adhdhtml Accessed August 28 2007

131 NIH Diagnosis and treatment of attention deficit hyperactivity disorder NIH Consensus Statement 1998161-37 Available at httpconsensusnihgov19981998AttentionDeficitHyperactivityDisorder110htmlhtm Accessed August 28 2007

132 Jensen P Bhatara VS Vitiello B Hoagwood K Feil M Burke LB Psychoactive medication prescribing practices for US children gaps between research and clinical practice J Am Acad Child Adolesc Psychiatry 199938557-565 Abstract

133 Popper CW Disorders usually first evident in infancy childhood or adolescence In Talbott JA Hales RE Yudofsky SC eds Textbook of Psychiatry Washington DC American Psychiatric Press 1988649-735

134 Shaffer D Fisher P Dulcan MK et al The NIMH Diagnostic Interview Schedule for Children Version 23 (DISC-23) description acceptability prevalence rates and performance in the MECA Study Methods for the Epidemiology of Child and Adolescent Mental Disorders Study J Am Acad Child Adolesc Psychiatry 199635865-877 Abstract

135 Lahey BB Applegate B McBurnett K et al DSM-IV field trials for attention-deficit hyperactivity disorder in children and adolescents Am J Psychiatry 19941511673-1685 Abstract

136 Biederman J Comorbidity of attention deficit hyperactivity disorder with conduct depressive anxiety and other disorders Am J Psychiatry 1991148564-577 Abstract

137 Mannuzza S Klein RG Bessler A et al Adult outcome of hyperactive boys Arch Gen Psychiatry Educational achievement occupational rank and psychiatric status 199350565-576

138 Mackey P Kipras A Medication for attention deficithyperactivity disorder (ADHD) An analysis by federal electorate Available at httpwwwaphgovaulibrarypubscib2000-0101cib11html Accessed July 23 2001

139 Marshall E Epidemiology Duke study faults overuse of stimulants for children Science 2000289721

140 Morrow RC Morrow AL Haislip G Methylphenidate in the United States 1990 through 1995 Am J Pub Health 1998881121

141 Eaton S Marchak E Ritalin prescription rates vary widely across the country Staten Island New York Staten Island Sunday Advance A23 June 10 2001

142 Jensen P Current concepts and controversies in the diagnosis and treatment of attention deficit hyperactivity disorder Current Psychiatry Rep 20002102-109

143 Multimodal Treatment Study of Children with ADHD Cooperative Group 14-month randomized clinical trial of treatment strategies for attention deficit hyperactivity disorder Arch Gen Psychiatry 1999561073-1086 Abstract

144 American Academy of Pediatrics Clinical practice guideline Treatment of the school-aged child with attention-deficithyperactivity disorder Pediatrics 20011081033-1044 Abstract

145 National Institutes of Health Electroconvulsive Therapy Consensus Development Conference Statement 1985 Available at httpconsensusnihgov19851985ElectroconvulsiveTherapy051htmlhtm Accessed August 28 2007

146 Thompson JW Weiner RD Myers CP Use of ECT in the United States in 1975 1980 and 1986 Am J Psychiatry 19941511657-1661 Abstract

147 Hermann RC Dorwart RA Hoover CW Brody J Variation in ECT use in the United States Am J Psychiatry 1995152869-875 Abstract

148 Rose D Fleishmann P Wykes T Leese M Bindman J Patients perspectives on electroconvulsive therapy systematic review BMJ 20033261363

149 Lisanby SH Maddox JH Prudic J Devanand DP Sackeim HA The effects of electroconvulsive therapy on memory of autobiographical and public events Arch Gen Psychiatry 200057591-592 Abstract

150 Abrams R The mortality rate with ECT Convuls Ther 199713125-127 Abstract

151 Shiwach RS Reid WH Carmody TJ An analysis of reported deaths following electroconvulsive therapy in Texas 1993-1998 Psychiatr Serv 2001 521095-1097 Abstract

152 Breggin PR Electroshock scientific ethical and political issues Int J Risk Safety Med 1998115-40

153 Melonas JM Split treatment does managed care change the risk in psychiatry Psychiatric Practice Managed Care Newsletter 19995

154 Kessler RC Berglund P Demler O et al The epidemiology of major depressive disorder results from the National Comorbidity Survey Replication (NCS-R) JAMA 20032893095-3105 Abstract

155 Pulier ML Ciccone DS Castellano C Marcus K Schleifer SJ Medical versus non-medical mental health referral clinical decision-making by telephone access center staff J Behav Health Serv Res 200330444-451 Abstract

156 Simon GE Katon WJ VonKorff M et al Cost-effectiveness of a collaborative care program for primary care patients with persistent depression Am J Psychiatry 20011581638-1644 Abstract

157 Lazarus J Macbeth J Wheeler N Divided treatment in managed care Psychiatr Pract Managed Care 1997

158 Olfson M Pincus HA Outpatient mental healthcare in non hospital settings distribution of patients across provider groups Am J Psychiatry 19961531353-1356 Abstract

159 Levinson W Physician-patient communication -- a key to malpractice prevention JAMA 1994201619-1620

160 Smith D 10 ways practitioners can avoid frequent ethical pitfalls Monitor on Psychology 20033450 Available at httpapaorgmonitorjan0310wayshtml Accessed on August 28 2007

161 Fishalow SE The tort liability of the psychiatrist Bull Am Acad Psychiatric Law 19753191-230

162 American Psychiatric Association The principles of medical ethics with annotations especially applicable to psychiatry 2001 Available at httpwwwpsychorgpsych_practethicsmedicalethics2001_42001cfm Accessed August 28 2007

163 American Psychological Association Ethical Principles and Code of Conduct June 1 2003 Available at httpwwwapaorgethicscode2002html Accessed August 28 2007

164 Gutheil TG Gabbard GO The concept of boundaries in clinical practice theoretical and risk management dimensions Am J Psychiatry 1993150188-196 Abstract

165 Gutheil TG Gabbard GO Misuses and misunderstandings of boundary theory in clinical and regulatory settings Am J Psychiatry 1998155409-414

166 Malmquist CP Notman MT Psychiatrist and patient boundary issues following treatment termination Am J Psychiatry 20011581010-1018 Abstract

167 Herman JL Gartell N Olarte S Feldstein M Localio R Psychiatrist-patient sexual contact results of a national survey II Psychiatrists attitudes Am J Psychiatry 1987144164-169 Abstract

168 Risk Management in Cyberspace Rx for Risk 20019 169 Miller RH Hillman JM Given RS Physician use of IT Results from the Deloitte

research survey J Healthc Inf Manag 20041872-80 Abstract 170 Applebaum PS Privacy in psychiatric treatment threats and responses Focus

20031396-406 171 Godolphin W The role of risk communication in shared decision making BMJ

2003327692-693 Abstract 172 Oregon Medical Association Lets talk disclosures after an adverse medical

event(video) Portland OR 2002 Available at httpwwwPatientSafetyStorecom Accessed August 28 2007

173 Institute of Medicine (IOM) Crossing the Quality of Chasm Adaptation to Mental Health and Addictive Disorders April 26 2004 Available at httpwwwiomeduCMS380919405aspx Accessed September 6 2007

Authors and Disclosures

As an organization accredited by the ACCME Medscape LLC requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest The ACCME defines relevant financial relationships as financial relationships in any amount occurring within the past 12 months including financial relationships of a spouse or life partner that could create a conflict of interest

Medscape LLC encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration at first mention and where appropriate in the content

Author

Benjamin C Grasso MD

Staff Psychiatrist VA Clinic Saco Maine Disclosure Benjamin C Grasso MD has disclosed no relevant financial relationships

Cathryn M Clary MD MBA

Vice President US External Medical Affairs Pfizer Inc New York NY Disclosure Cathryn M Clary MD MBA has disclosed that she is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Benjamin Eng MD MA

Senior Medical Director Group Leader Pfizer Inc New York NY Disclosure Benjamin Eng MD MA has disclosed that he is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Stanley J Evans MD FASAM PA

Assistant Professor of Clinical Medicine St Matthews University Windham Maine

Medical Director Renaissance Institute of Palm Beach Boca Raton Florida Disclosure Stanley J Evans MD has disclosed no relevant financial relationships

Terry J Golash MD

Clinical Instructor Psychiatry Columbia University New York NY Assistant Attending St Lukersquos Roosevelt Hospital Center New York NY Disclosure Terry J Golash MD has disclosed no relevant financial relationships

Kevin Ann Huckshorn RN MSN CAP ICADC

Director Office of Technical Assistance National Association of State mental Health Program Directors Inc Alexandria Virginia Disclosure Kevin Ann Huckshorn RN MSN CAP ICADC has disclosed no relevant financial relationships

Kenneth Minkoff MD

Clinical Assistant Professor Department of Psychiatry Cambridge Hospital Harvard University Acton Massachusetts Consultant ZiaLogic Acton Massachusetts Disclosure Kenneth Minkoff MD has disclosed no relevant financial relationships

Joseph J Parks MD

Assistant Associate Professor Department of Psychiatry University of Missouri Columbia Missouri Disclosure Joseph J Parks MD has disclosed that he has received grants for educational activities from Letters amp Science and Physician Postgraduate Press Dr Parks has also disclosed that he has served as a consultant to the National Association of State Mental Health Program Directors and Bristol-Myers Squibb Dr Parks has also disclosed that he has received funds for services provided to the state of Missouri from Eli Lilly and Abbott

Miles F Shore MD

Bullard Distinguished Professor of Psychiatry Harvard Medical School Needham Massachusetts Junior Consultant Harvard Medical International Boston Massachusetts Disclosure Miles F Shore MD has disclosed no relevant financial relationships

Editor

Jacqueline A Hart MD

Freelance Clinical Editor Medscape LLC New York New York Disclosure Jacqueline A Hart MD has disclosed no relevant financial relationships

Elizabeth Saenger PhD

Editorial Director Medscape LLC New York NY Disclosure Elizabeth Saenger PhD has disclosed no relevant financial relationships

Registration for CME credit the post test and the evaluation must be completed online To access the activity Post Test and Evaluation link please go to httpwwwmedscapecomviewprogram7809_index

Page 28: Medication Errors and Patient Safety in Mental Health CME/CE · 2019. 6. 27. · Medication Errors and Patient Safety in Mental Health CME/CE Complete author affiliations and disclosures

91 Center for Medicare and Medicaid Services (CMS) Testimony from the public hearing on the one hour rule 2002 Baltimore Md CMS

92 Joint Commission on Accreditation of Healthcare Organization Standards for Behavioral Healthcare 2004-2005 Oakbrook Terrace Ill Joint Commission Resources 2005

93 Gross G Restraint and seclusion overview of federal laws and policies Washington DC National Association of Protection and Advocacy Systems (NAPAS) 2003

94 American Association of Community Psychiatry (AACP) (2003) AACP guidelines for recovery oriented services Available at httpwwwcommpsychpittedufindsROSMenuhtml Accessed June 2 2004

95 Schnaars C Tape called strong evidence in boys death Daily Press April 13 2003 Available at httpgroupsmsncomHumanRightsUSAnewhopeiimsnw Accessed August 28 2007

96 Erikson J 5 pinned woman prone on Kino floor Report describes patients death struggle at hospital Arizona Daily Star July 29 2003 July 29 Available at httpwwwfox11azcomnewslocalstoriesKMSB_local_kino_072903d8c78db2html Accessed August 28 2007

97 Masters KJ Bellonci C the Work Group on Quality Issues Practice parameters for the prevention and management of aggressive behavior in child and adolescent psychiatric institutions with special reference to seclusion and restraint Available to American Academy of Childhood and Adolescent Psychiatry (AACAP) members at httpwwwaacaporg Washington DC AACAP 2001 Accessed August 28 2007

98 Fisher W Restraint and seclusion A review of the literature Am J Psychiatry 19941511584-1591 Abstract

99 US Department of Health and Human Services (USDHHS) Mental health of the nation report of the Surgeon General (SMA01-3613) Office of the Surgeon General Public Health Service Washington DC US Government Printing Office 1999

100 Onken S Dumont J Ridgeway P Dornan D Ralph R Mental health recovery What helps and what hinders A national research project for the development of recovery facilitating system performance indicators Alexandria Va National Association of State Mental Health Program Directors (NASMHPD) National Technical Assistance Center for State Mental Health Planning (NTAC) 2002

101 American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Washington DC American Psychiatric Association 1994

102 Cusack KJ Frueh BC Brady KT Trauma history screening in a community mental health center Psychiatr Serv 200455157-162 Abstract

103 Cusack KJ Frueh BC Hiers TG Keane TM Mueser KT (2003) The impact of trauma and posttraumatic stress disorder upon American society Report to the Presidents New Freedom Commission on Mental Health Unpublished subcommittee report Washington DC 2003

104 Frueh BC Dalton ME Johnson MR et al Trauma within the psychiatric setting conceptual framework research directions and policy implications Admin Policy Ment Health 200028147-154

105 Rosenberg SD Mueser KT Friedman MJ et al Developing effective treatments for posttraumatic disorders among people with severe mental illness Psychiatr Serv 2001521453-1461 Abstract

106 Mueser KT Goodman LB Trumbetta SL et al Trauma and posttraumatic stress disorder in severe mental illness J Consult Clin Psychol 199866493-499 Abstract

107 Nemeroff CB Neurobiological consequences of childhood trauma J Clin Psychiatry 200465(suppl 1)18-28 Abstract

108 Saxe G Johansson R A trauma informed approach to extreme behaviors in intensive child mental health programs 2003 National Child Traumatic Stress Network Boston Mass Boston University School of Medicine2003

109 Huckshorn KA Reducing seclusion and restraint in mental health use settings J Psychosoc Nurs Ment Health Serv 20044222-33

110 Hardenstine B Leading the way toward a seclusion and restraint-free environment Pennsylvanias success story Philadelphia Pa Office of Mental Health and Substance Abuse Services Pennsylvania Department of Public Welfare 2001

111 Detmer D Information technology for quality healthcare A summary of United Kingdom and United States experiences Background paper for the Ditchley Park Conference Co-sponsored by the Commonwealth Fund and the Nuffield Trust 2000 Oxfordshire England 2000

112 Work Group on Computerization of Patient Records (2000) Toward a national health information infrastructure Report of the Work Group on Computerization of Patient Records Washington DC US Department of Health and Human Services 2000

113 Kessler RC Nelson CB McGonagle KA Edlund MJ Frank RG Leaf PJ The epidemiology of co-occurring addictive and mental disorders implications for prevention and service utilization Am J Orthopsychiatry 19966617-31 Abstract

114 Li G Keyl PM Rothman R Chanmugam A Kelen GD Epidemiology of alcohol-related emergency department visits Acad Emerg Med 19996666-668 Abstract

115 Dickey B Normand SL Weiss RD Drake RE Azeni H Medical morbidity mental illness and substance use disorders Psychiatr Serv 200253861-867 Abstract

116 Dickey B Dembling B Azeni H Normand SL Externally caused deaths for adults with substance use and mental disorders J Behav Health Serv Res 20043175-85 Abstract

117 Cline C Minkoff K Substance Abuse and Mental Health Services Administration A Strength Based Systems Approach to Creating Integrated Services for Individuals with Co-occurring Psychiatric and Substance Abuse Disorders -- A Technical Assistance Document New Mexico Department of Health (NMDOH)BHSD Dec 2002

118 American Society of Addiction Medicine Patient Placement Criteria 2R Washington DC ASAM 2001

119 Dalton EJ Cate-Carter TD Mundo E Parikh SV Kennedy JL Suicide risk in bipolar patients the role of co-morbid substance use disorders Bipolar Disord 2003558-61 Abstract

120 Tondo L Baldessarini RJ Hennen J et al Suicide attempts in major affective disorder patients with comorbid substance use disorders J Clin Psychiatry 19996063-69 discussion 75-76 113-116

121 Baldessarini RJ Jamison KR Effects of medical interventions on suicidal behavior Summary and conclusions J Clin Psychiatry 199960117-122 Abstract

122 Aharonovich E Liu X Nunes E Hasin DS Suicide attempts in substance abusers effects of major depression in relation to substance use disorders Am J Psychiatry 20021591600-1602 Abstract

123 Pages KP Russo JE Roy-Byrne PP Ries RK Cowley DS Determinants of suicidal ideation the role of substance use disorders J Clin Psychiatry 199758510-515 Abstract

124 Anderson RN Minintildeo AM Fingerhut LA Warner M Heinen MA Deaths Injuries 2001 National Vital Statistics Reports June 2 2004 Available at httpwwwcdcgovnchsdatanvsrnvsr52nvsr52_21accpdf Accessed August 28 2007

125 Centers for disease Control Alcohol-Related Traffic Fatalities Involving Children -- United States 1985-1996 MMWR Weekly 1997461130-1133 Available at httpwwwcdcgovmmwrpreviewmmwrhtml00050119htm Accessed August 28 2007

126 Wender P Bierman J French F et al Minimal Brain Dysfunction in Children New York John Wiley and Sons 1971

127 Barkley R Reflections on the NIHNIMH Consensus Conference on ADHD ADHD Report 199971-4

128 Sinha G New evidence about Ritalin What every parent should know Popular Science 200148-52

129 Conners CK Forty years of methylphenidate treatment in Attention-Deficit Hyperactivity Disorder J Atten Disord 20026S17-S30 Abstract

130 LeFever GB Arcona AP Antonuccio DO ADHD among American schoolchildren evidence of overdiagnosis and overuse of medication Sci Rev Ment

Health Pract 20032 Available at httpwwwsrmhporg0201adhdhtml Accessed August 28 2007

131 NIH Diagnosis and treatment of attention deficit hyperactivity disorder NIH Consensus Statement 1998161-37 Available at httpconsensusnihgov19981998AttentionDeficitHyperactivityDisorder110htmlhtm Accessed August 28 2007

132 Jensen P Bhatara VS Vitiello B Hoagwood K Feil M Burke LB Psychoactive medication prescribing practices for US children gaps between research and clinical practice J Am Acad Child Adolesc Psychiatry 199938557-565 Abstract

133 Popper CW Disorders usually first evident in infancy childhood or adolescence In Talbott JA Hales RE Yudofsky SC eds Textbook of Psychiatry Washington DC American Psychiatric Press 1988649-735

134 Shaffer D Fisher P Dulcan MK et al The NIMH Diagnostic Interview Schedule for Children Version 23 (DISC-23) description acceptability prevalence rates and performance in the MECA Study Methods for the Epidemiology of Child and Adolescent Mental Disorders Study J Am Acad Child Adolesc Psychiatry 199635865-877 Abstract

135 Lahey BB Applegate B McBurnett K et al DSM-IV field trials for attention-deficit hyperactivity disorder in children and adolescents Am J Psychiatry 19941511673-1685 Abstract

136 Biederman J Comorbidity of attention deficit hyperactivity disorder with conduct depressive anxiety and other disorders Am J Psychiatry 1991148564-577 Abstract

137 Mannuzza S Klein RG Bessler A et al Adult outcome of hyperactive boys Arch Gen Psychiatry Educational achievement occupational rank and psychiatric status 199350565-576

138 Mackey P Kipras A Medication for attention deficithyperactivity disorder (ADHD) An analysis by federal electorate Available at httpwwwaphgovaulibrarypubscib2000-0101cib11html Accessed July 23 2001

139 Marshall E Epidemiology Duke study faults overuse of stimulants for children Science 2000289721

140 Morrow RC Morrow AL Haislip G Methylphenidate in the United States 1990 through 1995 Am J Pub Health 1998881121

141 Eaton S Marchak E Ritalin prescription rates vary widely across the country Staten Island New York Staten Island Sunday Advance A23 June 10 2001

142 Jensen P Current concepts and controversies in the diagnosis and treatment of attention deficit hyperactivity disorder Current Psychiatry Rep 20002102-109

143 Multimodal Treatment Study of Children with ADHD Cooperative Group 14-month randomized clinical trial of treatment strategies for attention deficit hyperactivity disorder Arch Gen Psychiatry 1999561073-1086 Abstract

144 American Academy of Pediatrics Clinical practice guideline Treatment of the school-aged child with attention-deficithyperactivity disorder Pediatrics 20011081033-1044 Abstract

145 National Institutes of Health Electroconvulsive Therapy Consensus Development Conference Statement 1985 Available at httpconsensusnihgov19851985ElectroconvulsiveTherapy051htmlhtm Accessed August 28 2007

146 Thompson JW Weiner RD Myers CP Use of ECT in the United States in 1975 1980 and 1986 Am J Psychiatry 19941511657-1661 Abstract

147 Hermann RC Dorwart RA Hoover CW Brody J Variation in ECT use in the United States Am J Psychiatry 1995152869-875 Abstract

148 Rose D Fleishmann P Wykes T Leese M Bindman J Patients perspectives on electroconvulsive therapy systematic review BMJ 20033261363

149 Lisanby SH Maddox JH Prudic J Devanand DP Sackeim HA The effects of electroconvulsive therapy on memory of autobiographical and public events Arch Gen Psychiatry 200057591-592 Abstract

150 Abrams R The mortality rate with ECT Convuls Ther 199713125-127 Abstract

151 Shiwach RS Reid WH Carmody TJ An analysis of reported deaths following electroconvulsive therapy in Texas 1993-1998 Psychiatr Serv 2001 521095-1097 Abstract

152 Breggin PR Electroshock scientific ethical and political issues Int J Risk Safety Med 1998115-40

153 Melonas JM Split treatment does managed care change the risk in psychiatry Psychiatric Practice Managed Care Newsletter 19995

154 Kessler RC Berglund P Demler O et al The epidemiology of major depressive disorder results from the National Comorbidity Survey Replication (NCS-R) JAMA 20032893095-3105 Abstract

155 Pulier ML Ciccone DS Castellano C Marcus K Schleifer SJ Medical versus non-medical mental health referral clinical decision-making by telephone access center staff J Behav Health Serv Res 200330444-451 Abstract

156 Simon GE Katon WJ VonKorff M et al Cost-effectiveness of a collaborative care program for primary care patients with persistent depression Am J Psychiatry 20011581638-1644 Abstract

157 Lazarus J Macbeth J Wheeler N Divided treatment in managed care Psychiatr Pract Managed Care 1997

158 Olfson M Pincus HA Outpatient mental healthcare in non hospital settings distribution of patients across provider groups Am J Psychiatry 19961531353-1356 Abstract

159 Levinson W Physician-patient communication -- a key to malpractice prevention JAMA 1994201619-1620

160 Smith D 10 ways practitioners can avoid frequent ethical pitfalls Monitor on Psychology 20033450 Available at httpapaorgmonitorjan0310wayshtml Accessed on August 28 2007

161 Fishalow SE The tort liability of the psychiatrist Bull Am Acad Psychiatric Law 19753191-230

162 American Psychiatric Association The principles of medical ethics with annotations especially applicable to psychiatry 2001 Available at httpwwwpsychorgpsych_practethicsmedicalethics2001_42001cfm Accessed August 28 2007

163 American Psychological Association Ethical Principles and Code of Conduct June 1 2003 Available at httpwwwapaorgethicscode2002html Accessed August 28 2007

164 Gutheil TG Gabbard GO The concept of boundaries in clinical practice theoretical and risk management dimensions Am J Psychiatry 1993150188-196 Abstract

165 Gutheil TG Gabbard GO Misuses and misunderstandings of boundary theory in clinical and regulatory settings Am J Psychiatry 1998155409-414

166 Malmquist CP Notman MT Psychiatrist and patient boundary issues following treatment termination Am J Psychiatry 20011581010-1018 Abstract

167 Herman JL Gartell N Olarte S Feldstein M Localio R Psychiatrist-patient sexual contact results of a national survey II Psychiatrists attitudes Am J Psychiatry 1987144164-169 Abstract

168 Risk Management in Cyberspace Rx for Risk 20019 169 Miller RH Hillman JM Given RS Physician use of IT Results from the Deloitte

research survey J Healthc Inf Manag 20041872-80 Abstract 170 Applebaum PS Privacy in psychiatric treatment threats and responses Focus

20031396-406 171 Godolphin W The role of risk communication in shared decision making BMJ

2003327692-693 Abstract 172 Oregon Medical Association Lets talk disclosures after an adverse medical

event(video) Portland OR 2002 Available at httpwwwPatientSafetyStorecom Accessed August 28 2007

173 Institute of Medicine (IOM) Crossing the Quality of Chasm Adaptation to Mental Health and Addictive Disorders April 26 2004 Available at httpwwwiomeduCMS380919405aspx Accessed September 6 2007

Authors and Disclosures

As an organization accredited by the ACCME Medscape LLC requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest The ACCME defines relevant financial relationships as financial relationships in any amount occurring within the past 12 months including financial relationships of a spouse or life partner that could create a conflict of interest

Medscape LLC encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration at first mention and where appropriate in the content

Author

Benjamin C Grasso MD

Staff Psychiatrist VA Clinic Saco Maine Disclosure Benjamin C Grasso MD has disclosed no relevant financial relationships

Cathryn M Clary MD MBA

Vice President US External Medical Affairs Pfizer Inc New York NY Disclosure Cathryn M Clary MD MBA has disclosed that she is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Benjamin Eng MD MA

Senior Medical Director Group Leader Pfizer Inc New York NY Disclosure Benjamin Eng MD MA has disclosed that he is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Stanley J Evans MD FASAM PA

Assistant Professor of Clinical Medicine St Matthews University Windham Maine

Medical Director Renaissance Institute of Palm Beach Boca Raton Florida Disclosure Stanley J Evans MD has disclosed no relevant financial relationships

Terry J Golash MD

Clinical Instructor Psychiatry Columbia University New York NY Assistant Attending St Lukersquos Roosevelt Hospital Center New York NY Disclosure Terry J Golash MD has disclosed no relevant financial relationships

Kevin Ann Huckshorn RN MSN CAP ICADC

Director Office of Technical Assistance National Association of State mental Health Program Directors Inc Alexandria Virginia Disclosure Kevin Ann Huckshorn RN MSN CAP ICADC has disclosed no relevant financial relationships

Kenneth Minkoff MD

Clinical Assistant Professor Department of Psychiatry Cambridge Hospital Harvard University Acton Massachusetts Consultant ZiaLogic Acton Massachusetts Disclosure Kenneth Minkoff MD has disclosed no relevant financial relationships

Joseph J Parks MD

Assistant Associate Professor Department of Psychiatry University of Missouri Columbia Missouri Disclosure Joseph J Parks MD has disclosed that he has received grants for educational activities from Letters amp Science and Physician Postgraduate Press Dr Parks has also disclosed that he has served as a consultant to the National Association of State Mental Health Program Directors and Bristol-Myers Squibb Dr Parks has also disclosed that he has received funds for services provided to the state of Missouri from Eli Lilly and Abbott

Miles F Shore MD

Bullard Distinguished Professor of Psychiatry Harvard Medical School Needham Massachusetts Junior Consultant Harvard Medical International Boston Massachusetts Disclosure Miles F Shore MD has disclosed no relevant financial relationships

Editor

Jacqueline A Hart MD

Freelance Clinical Editor Medscape LLC New York New York Disclosure Jacqueline A Hart MD has disclosed no relevant financial relationships

Elizabeth Saenger PhD

Editorial Director Medscape LLC New York NY Disclosure Elizabeth Saenger PhD has disclosed no relevant financial relationships

Registration for CME credit the post test and the evaluation must be completed online To access the activity Post Test and Evaluation link please go to httpwwwmedscapecomviewprogram7809_index

Page 29: Medication Errors and Patient Safety in Mental Health CME/CE · 2019. 6. 27. · Medication Errors and Patient Safety in Mental Health CME/CE Complete author affiliations and disclosures

110 Hardenstine B Leading the way toward a seclusion and restraint-free environment Pennsylvanias success story Philadelphia Pa Office of Mental Health and Substance Abuse Services Pennsylvania Department of Public Welfare 2001

111 Detmer D Information technology for quality healthcare A summary of United Kingdom and United States experiences Background paper for the Ditchley Park Conference Co-sponsored by the Commonwealth Fund and the Nuffield Trust 2000 Oxfordshire England 2000

112 Work Group on Computerization of Patient Records (2000) Toward a national health information infrastructure Report of the Work Group on Computerization of Patient Records Washington DC US Department of Health and Human Services 2000

113 Kessler RC Nelson CB McGonagle KA Edlund MJ Frank RG Leaf PJ The epidemiology of co-occurring addictive and mental disorders implications for prevention and service utilization Am J Orthopsychiatry 19966617-31 Abstract

114 Li G Keyl PM Rothman R Chanmugam A Kelen GD Epidemiology of alcohol-related emergency department visits Acad Emerg Med 19996666-668 Abstract

115 Dickey B Normand SL Weiss RD Drake RE Azeni H Medical morbidity mental illness and substance use disorders Psychiatr Serv 200253861-867 Abstract

116 Dickey B Dembling B Azeni H Normand SL Externally caused deaths for adults with substance use and mental disorders J Behav Health Serv Res 20043175-85 Abstract

117 Cline C Minkoff K Substance Abuse and Mental Health Services Administration A Strength Based Systems Approach to Creating Integrated Services for Individuals with Co-occurring Psychiatric and Substance Abuse Disorders -- A Technical Assistance Document New Mexico Department of Health (NMDOH)BHSD Dec 2002

118 American Society of Addiction Medicine Patient Placement Criteria 2R Washington DC ASAM 2001

119 Dalton EJ Cate-Carter TD Mundo E Parikh SV Kennedy JL Suicide risk in bipolar patients the role of co-morbid substance use disorders Bipolar Disord 2003558-61 Abstract

120 Tondo L Baldessarini RJ Hennen J et al Suicide attempts in major affective disorder patients with comorbid substance use disorders J Clin Psychiatry 19996063-69 discussion 75-76 113-116

121 Baldessarini RJ Jamison KR Effects of medical interventions on suicidal behavior Summary and conclusions J Clin Psychiatry 199960117-122 Abstract

122 Aharonovich E Liu X Nunes E Hasin DS Suicide attempts in substance abusers effects of major depression in relation to substance use disorders Am J Psychiatry 20021591600-1602 Abstract

123 Pages KP Russo JE Roy-Byrne PP Ries RK Cowley DS Determinants of suicidal ideation the role of substance use disorders J Clin Psychiatry 199758510-515 Abstract

124 Anderson RN Minintildeo AM Fingerhut LA Warner M Heinen MA Deaths Injuries 2001 National Vital Statistics Reports June 2 2004 Available at httpwwwcdcgovnchsdatanvsrnvsr52nvsr52_21accpdf Accessed August 28 2007

125 Centers for disease Control Alcohol-Related Traffic Fatalities Involving Children -- United States 1985-1996 MMWR Weekly 1997461130-1133 Available at httpwwwcdcgovmmwrpreviewmmwrhtml00050119htm Accessed August 28 2007

126 Wender P Bierman J French F et al Minimal Brain Dysfunction in Children New York John Wiley and Sons 1971

127 Barkley R Reflections on the NIHNIMH Consensus Conference on ADHD ADHD Report 199971-4

128 Sinha G New evidence about Ritalin What every parent should know Popular Science 200148-52

129 Conners CK Forty years of methylphenidate treatment in Attention-Deficit Hyperactivity Disorder J Atten Disord 20026S17-S30 Abstract

130 LeFever GB Arcona AP Antonuccio DO ADHD among American schoolchildren evidence of overdiagnosis and overuse of medication Sci Rev Ment

Health Pract 20032 Available at httpwwwsrmhporg0201adhdhtml Accessed August 28 2007

131 NIH Diagnosis and treatment of attention deficit hyperactivity disorder NIH Consensus Statement 1998161-37 Available at httpconsensusnihgov19981998AttentionDeficitHyperactivityDisorder110htmlhtm Accessed August 28 2007

132 Jensen P Bhatara VS Vitiello B Hoagwood K Feil M Burke LB Psychoactive medication prescribing practices for US children gaps between research and clinical practice J Am Acad Child Adolesc Psychiatry 199938557-565 Abstract

133 Popper CW Disorders usually first evident in infancy childhood or adolescence In Talbott JA Hales RE Yudofsky SC eds Textbook of Psychiatry Washington DC American Psychiatric Press 1988649-735

134 Shaffer D Fisher P Dulcan MK et al The NIMH Diagnostic Interview Schedule for Children Version 23 (DISC-23) description acceptability prevalence rates and performance in the MECA Study Methods for the Epidemiology of Child and Adolescent Mental Disorders Study J Am Acad Child Adolesc Psychiatry 199635865-877 Abstract

135 Lahey BB Applegate B McBurnett K et al DSM-IV field trials for attention-deficit hyperactivity disorder in children and adolescents Am J Psychiatry 19941511673-1685 Abstract

136 Biederman J Comorbidity of attention deficit hyperactivity disorder with conduct depressive anxiety and other disorders Am J Psychiatry 1991148564-577 Abstract

137 Mannuzza S Klein RG Bessler A et al Adult outcome of hyperactive boys Arch Gen Psychiatry Educational achievement occupational rank and psychiatric status 199350565-576

138 Mackey P Kipras A Medication for attention deficithyperactivity disorder (ADHD) An analysis by federal electorate Available at httpwwwaphgovaulibrarypubscib2000-0101cib11html Accessed July 23 2001

139 Marshall E Epidemiology Duke study faults overuse of stimulants for children Science 2000289721

140 Morrow RC Morrow AL Haislip G Methylphenidate in the United States 1990 through 1995 Am J Pub Health 1998881121

141 Eaton S Marchak E Ritalin prescription rates vary widely across the country Staten Island New York Staten Island Sunday Advance A23 June 10 2001

142 Jensen P Current concepts and controversies in the diagnosis and treatment of attention deficit hyperactivity disorder Current Psychiatry Rep 20002102-109

143 Multimodal Treatment Study of Children with ADHD Cooperative Group 14-month randomized clinical trial of treatment strategies for attention deficit hyperactivity disorder Arch Gen Psychiatry 1999561073-1086 Abstract

144 American Academy of Pediatrics Clinical practice guideline Treatment of the school-aged child with attention-deficithyperactivity disorder Pediatrics 20011081033-1044 Abstract

145 National Institutes of Health Electroconvulsive Therapy Consensus Development Conference Statement 1985 Available at httpconsensusnihgov19851985ElectroconvulsiveTherapy051htmlhtm Accessed August 28 2007

146 Thompson JW Weiner RD Myers CP Use of ECT in the United States in 1975 1980 and 1986 Am J Psychiatry 19941511657-1661 Abstract

147 Hermann RC Dorwart RA Hoover CW Brody J Variation in ECT use in the United States Am J Psychiatry 1995152869-875 Abstract

148 Rose D Fleishmann P Wykes T Leese M Bindman J Patients perspectives on electroconvulsive therapy systematic review BMJ 20033261363

149 Lisanby SH Maddox JH Prudic J Devanand DP Sackeim HA The effects of electroconvulsive therapy on memory of autobiographical and public events Arch Gen Psychiatry 200057591-592 Abstract

150 Abrams R The mortality rate with ECT Convuls Ther 199713125-127 Abstract

151 Shiwach RS Reid WH Carmody TJ An analysis of reported deaths following electroconvulsive therapy in Texas 1993-1998 Psychiatr Serv 2001 521095-1097 Abstract

152 Breggin PR Electroshock scientific ethical and political issues Int J Risk Safety Med 1998115-40

153 Melonas JM Split treatment does managed care change the risk in psychiatry Psychiatric Practice Managed Care Newsletter 19995

154 Kessler RC Berglund P Demler O et al The epidemiology of major depressive disorder results from the National Comorbidity Survey Replication (NCS-R) JAMA 20032893095-3105 Abstract

155 Pulier ML Ciccone DS Castellano C Marcus K Schleifer SJ Medical versus non-medical mental health referral clinical decision-making by telephone access center staff J Behav Health Serv Res 200330444-451 Abstract

156 Simon GE Katon WJ VonKorff M et al Cost-effectiveness of a collaborative care program for primary care patients with persistent depression Am J Psychiatry 20011581638-1644 Abstract

157 Lazarus J Macbeth J Wheeler N Divided treatment in managed care Psychiatr Pract Managed Care 1997

158 Olfson M Pincus HA Outpatient mental healthcare in non hospital settings distribution of patients across provider groups Am J Psychiatry 19961531353-1356 Abstract

159 Levinson W Physician-patient communication -- a key to malpractice prevention JAMA 1994201619-1620

160 Smith D 10 ways practitioners can avoid frequent ethical pitfalls Monitor on Psychology 20033450 Available at httpapaorgmonitorjan0310wayshtml Accessed on August 28 2007

161 Fishalow SE The tort liability of the psychiatrist Bull Am Acad Psychiatric Law 19753191-230

162 American Psychiatric Association The principles of medical ethics with annotations especially applicable to psychiatry 2001 Available at httpwwwpsychorgpsych_practethicsmedicalethics2001_42001cfm Accessed August 28 2007

163 American Psychological Association Ethical Principles and Code of Conduct June 1 2003 Available at httpwwwapaorgethicscode2002html Accessed August 28 2007

164 Gutheil TG Gabbard GO The concept of boundaries in clinical practice theoretical and risk management dimensions Am J Psychiatry 1993150188-196 Abstract

165 Gutheil TG Gabbard GO Misuses and misunderstandings of boundary theory in clinical and regulatory settings Am J Psychiatry 1998155409-414

166 Malmquist CP Notman MT Psychiatrist and patient boundary issues following treatment termination Am J Psychiatry 20011581010-1018 Abstract

167 Herman JL Gartell N Olarte S Feldstein M Localio R Psychiatrist-patient sexual contact results of a national survey II Psychiatrists attitudes Am J Psychiatry 1987144164-169 Abstract

168 Risk Management in Cyberspace Rx for Risk 20019 169 Miller RH Hillman JM Given RS Physician use of IT Results from the Deloitte

research survey J Healthc Inf Manag 20041872-80 Abstract 170 Applebaum PS Privacy in psychiatric treatment threats and responses Focus

20031396-406 171 Godolphin W The role of risk communication in shared decision making BMJ

2003327692-693 Abstract 172 Oregon Medical Association Lets talk disclosures after an adverse medical

event(video) Portland OR 2002 Available at httpwwwPatientSafetyStorecom Accessed August 28 2007

173 Institute of Medicine (IOM) Crossing the Quality of Chasm Adaptation to Mental Health and Addictive Disorders April 26 2004 Available at httpwwwiomeduCMS380919405aspx Accessed September 6 2007

Authors and Disclosures

As an organization accredited by the ACCME Medscape LLC requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest The ACCME defines relevant financial relationships as financial relationships in any amount occurring within the past 12 months including financial relationships of a spouse or life partner that could create a conflict of interest

Medscape LLC encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration at first mention and where appropriate in the content

Author

Benjamin C Grasso MD

Staff Psychiatrist VA Clinic Saco Maine Disclosure Benjamin C Grasso MD has disclosed no relevant financial relationships

Cathryn M Clary MD MBA

Vice President US External Medical Affairs Pfizer Inc New York NY Disclosure Cathryn M Clary MD MBA has disclosed that she is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Benjamin Eng MD MA

Senior Medical Director Group Leader Pfizer Inc New York NY Disclosure Benjamin Eng MD MA has disclosed that he is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Stanley J Evans MD FASAM PA

Assistant Professor of Clinical Medicine St Matthews University Windham Maine

Medical Director Renaissance Institute of Palm Beach Boca Raton Florida Disclosure Stanley J Evans MD has disclosed no relevant financial relationships

Terry J Golash MD

Clinical Instructor Psychiatry Columbia University New York NY Assistant Attending St Lukersquos Roosevelt Hospital Center New York NY Disclosure Terry J Golash MD has disclosed no relevant financial relationships

Kevin Ann Huckshorn RN MSN CAP ICADC

Director Office of Technical Assistance National Association of State mental Health Program Directors Inc Alexandria Virginia Disclosure Kevin Ann Huckshorn RN MSN CAP ICADC has disclosed no relevant financial relationships

Kenneth Minkoff MD

Clinical Assistant Professor Department of Psychiatry Cambridge Hospital Harvard University Acton Massachusetts Consultant ZiaLogic Acton Massachusetts Disclosure Kenneth Minkoff MD has disclosed no relevant financial relationships

Joseph J Parks MD

Assistant Associate Professor Department of Psychiatry University of Missouri Columbia Missouri Disclosure Joseph J Parks MD has disclosed that he has received grants for educational activities from Letters amp Science and Physician Postgraduate Press Dr Parks has also disclosed that he has served as a consultant to the National Association of State Mental Health Program Directors and Bristol-Myers Squibb Dr Parks has also disclosed that he has received funds for services provided to the state of Missouri from Eli Lilly and Abbott

Miles F Shore MD

Bullard Distinguished Professor of Psychiatry Harvard Medical School Needham Massachusetts Junior Consultant Harvard Medical International Boston Massachusetts Disclosure Miles F Shore MD has disclosed no relevant financial relationships

Editor

Jacqueline A Hart MD

Freelance Clinical Editor Medscape LLC New York New York Disclosure Jacqueline A Hart MD has disclosed no relevant financial relationships

Elizabeth Saenger PhD

Editorial Director Medscape LLC New York NY Disclosure Elizabeth Saenger PhD has disclosed no relevant financial relationships

Registration for CME credit the post test and the evaluation must be completed online To access the activity Post Test and Evaluation link please go to httpwwwmedscapecomviewprogram7809_index

Page 30: Medication Errors and Patient Safety in Mental Health CME/CE · 2019. 6. 27. · Medication Errors and Patient Safety in Mental Health CME/CE Complete author affiliations and disclosures

Health Pract 20032 Available at httpwwwsrmhporg0201adhdhtml Accessed August 28 2007

131 NIH Diagnosis and treatment of attention deficit hyperactivity disorder NIH Consensus Statement 1998161-37 Available at httpconsensusnihgov19981998AttentionDeficitHyperactivityDisorder110htmlhtm Accessed August 28 2007

132 Jensen P Bhatara VS Vitiello B Hoagwood K Feil M Burke LB Psychoactive medication prescribing practices for US children gaps between research and clinical practice J Am Acad Child Adolesc Psychiatry 199938557-565 Abstract

133 Popper CW Disorders usually first evident in infancy childhood or adolescence In Talbott JA Hales RE Yudofsky SC eds Textbook of Psychiatry Washington DC American Psychiatric Press 1988649-735

134 Shaffer D Fisher P Dulcan MK et al The NIMH Diagnostic Interview Schedule for Children Version 23 (DISC-23) description acceptability prevalence rates and performance in the MECA Study Methods for the Epidemiology of Child and Adolescent Mental Disorders Study J Am Acad Child Adolesc Psychiatry 199635865-877 Abstract

135 Lahey BB Applegate B McBurnett K et al DSM-IV field trials for attention-deficit hyperactivity disorder in children and adolescents Am J Psychiatry 19941511673-1685 Abstract

136 Biederman J Comorbidity of attention deficit hyperactivity disorder with conduct depressive anxiety and other disorders Am J Psychiatry 1991148564-577 Abstract

137 Mannuzza S Klein RG Bessler A et al Adult outcome of hyperactive boys Arch Gen Psychiatry Educational achievement occupational rank and psychiatric status 199350565-576

138 Mackey P Kipras A Medication for attention deficithyperactivity disorder (ADHD) An analysis by federal electorate Available at httpwwwaphgovaulibrarypubscib2000-0101cib11html Accessed July 23 2001

139 Marshall E Epidemiology Duke study faults overuse of stimulants for children Science 2000289721

140 Morrow RC Morrow AL Haislip G Methylphenidate in the United States 1990 through 1995 Am J Pub Health 1998881121

141 Eaton S Marchak E Ritalin prescription rates vary widely across the country Staten Island New York Staten Island Sunday Advance A23 June 10 2001

142 Jensen P Current concepts and controversies in the diagnosis and treatment of attention deficit hyperactivity disorder Current Psychiatry Rep 20002102-109

143 Multimodal Treatment Study of Children with ADHD Cooperative Group 14-month randomized clinical trial of treatment strategies for attention deficit hyperactivity disorder Arch Gen Psychiatry 1999561073-1086 Abstract

144 American Academy of Pediatrics Clinical practice guideline Treatment of the school-aged child with attention-deficithyperactivity disorder Pediatrics 20011081033-1044 Abstract

145 National Institutes of Health Electroconvulsive Therapy Consensus Development Conference Statement 1985 Available at httpconsensusnihgov19851985ElectroconvulsiveTherapy051htmlhtm Accessed August 28 2007

146 Thompson JW Weiner RD Myers CP Use of ECT in the United States in 1975 1980 and 1986 Am J Psychiatry 19941511657-1661 Abstract

147 Hermann RC Dorwart RA Hoover CW Brody J Variation in ECT use in the United States Am J Psychiatry 1995152869-875 Abstract

148 Rose D Fleishmann P Wykes T Leese M Bindman J Patients perspectives on electroconvulsive therapy systematic review BMJ 20033261363

149 Lisanby SH Maddox JH Prudic J Devanand DP Sackeim HA The effects of electroconvulsive therapy on memory of autobiographical and public events Arch Gen Psychiatry 200057591-592 Abstract

150 Abrams R The mortality rate with ECT Convuls Ther 199713125-127 Abstract

151 Shiwach RS Reid WH Carmody TJ An analysis of reported deaths following electroconvulsive therapy in Texas 1993-1998 Psychiatr Serv 2001 521095-1097 Abstract

152 Breggin PR Electroshock scientific ethical and political issues Int J Risk Safety Med 1998115-40

153 Melonas JM Split treatment does managed care change the risk in psychiatry Psychiatric Practice Managed Care Newsletter 19995

154 Kessler RC Berglund P Demler O et al The epidemiology of major depressive disorder results from the National Comorbidity Survey Replication (NCS-R) JAMA 20032893095-3105 Abstract

155 Pulier ML Ciccone DS Castellano C Marcus K Schleifer SJ Medical versus non-medical mental health referral clinical decision-making by telephone access center staff J Behav Health Serv Res 200330444-451 Abstract

156 Simon GE Katon WJ VonKorff M et al Cost-effectiveness of a collaborative care program for primary care patients with persistent depression Am J Psychiatry 20011581638-1644 Abstract

157 Lazarus J Macbeth J Wheeler N Divided treatment in managed care Psychiatr Pract Managed Care 1997

158 Olfson M Pincus HA Outpatient mental healthcare in non hospital settings distribution of patients across provider groups Am J Psychiatry 19961531353-1356 Abstract

159 Levinson W Physician-patient communication -- a key to malpractice prevention JAMA 1994201619-1620

160 Smith D 10 ways practitioners can avoid frequent ethical pitfalls Monitor on Psychology 20033450 Available at httpapaorgmonitorjan0310wayshtml Accessed on August 28 2007

161 Fishalow SE The tort liability of the psychiatrist Bull Am Acad Psychiatric Law 19753191-230

162 American Psychiatric Association The principles of medical ethics with annotations especially applicable to psychiatry 2001 Available at httpwwwpsychorgpsych_practethicsmedicalethics2001_42001cfm Accessed August 28 2007

163 American Psychological Association Ethical Principles and Code of Conduct June 1 2003 Available at httpwwwapaorgethicscode2002html Accessed August 28 2007

164 Gutheil TG Gabbard GO The concept of boundaries in clinical practice theoretical and risk management dimensions Am J Psychiatry 1993150188-196 Abstract

165 Gutheil TG Gabbard GO Misuses and misunderstandings of boundary theory in clinical and regulatory settings Am J Psychiatry 1998155409-414

166 Malmquist CP Notman MT Psychiatrist and patient boundary issues following treatment termination Am J Psychiatry 20011581010-1018 Abstract

167 Herman JL Gartell N Olarte S Feldstein M Localio R Psychiatrist-patient sexual contact results of a national survey II Psychiatrists attitudes Am J Psychiatry 1987144164-169 Abstract

168 Risk Management in Cyberspace Rx for Risk 20019 169 Miller RH Hillman JM Given RS Physician use of IT Results from the Deloitte

research survey J Healthc Inf Manag 20041872-80 Abstract 170 Applebaum PS Privacy in psychiatric treatment threats and responses Focus

20031396-406 171 Godolphin W The role of risk communication in shared decision making BMJ

2003327692-693 Abstract 172 Oregon Medical Association Lets talk disclosures after an adverse medical

event(video) Portland OR 2002 Available at httpwwwPatientSafetyStorecom Accessed August 28 2007

173 Institute of Medicine (IOM) Crossing the Quality of Chasm Adaptation to Mental Health and Addictive Disorders April 26 2004 Available at httpwwwiomeduCMS380919405aspx Accessed September 6 2007

Authors and Disclosures

As an organization accredited by the ACCME Medscape LLC requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest The ACCME defines relevant financial relationships as financial relationships in any amount occurring within the past 12 months including financial relationships of a spouse or life partner that could create a conflict of interest

Medscape LLC encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration at first mention and where appropriate in the content

Author

Benjamin C Grasso MD

Staff Psychiatrist VA Clinic Saco Maine Disclosure Benjamin C Grasso MD has disclosed no relevant financial relationships

Cathryn M Clary MD MBA

Vice President US External Medical Affairs Pfizer Inc New York NY Disclosure Cathryn M Clary MD MBA has disclosed that she is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Benjamin Eng MD MA

Senior Medical Director Group Leader Pfizer Inc New York NY Disclosure Benjamin Eng MD MA has disclosed that he is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Stanley J Evans MD FASAM PA

Assistant Professor of Clinical Medicine St Matthews University Windham Maine

Medical Director Renaissance Institute of Palm Beach Boca Raton Florida Disclosure Stanley J Evans MD has disclosed no relevant financial relationships

Terry J Golash MD

Clinical Instructor Psychiatry Columbia University New York NY Assistant Attending St Lukersquos Roosevelt Hospital Center New York NY Disclosure Terry J Golash MD has disclosed no relevant financial relationships

Kevin Ann Huckshorn RN MSN CAP ICADC

Director Office of Technical Assistance National Association of State mental Health Program Directors Inc Alexandria Virginia Disclosure Kevin Ann Huckshorn RN MSN CAP ICADC has disclosed no relevant financial relationships

Kenneth Minkoff MD

Clinical Assistant Professor Department of Psychiatry Cambridge Hospital Harvard University Acton Massachusetts Consultant ZiaLogic Acton Massachusetts Disclosure Kenneth Minkoff MD has disclosed no relevant financial relationships

Joseph J Parks MD

Assistant Associate Professor Department of Psychiatry University of Missouri Columbia Missouri Disclosure Joseph J Parks MD has disclosed that he has received grants for educational activities from Letters amp Science and Physician Postgraduate Press Dr Parks has also disclosed that he has served as a consultant to the National Association of State Mental Health Program Directors and Bristol-Myers Squibb Dr Parks has also disclosed that he has received funds for services provided to the state of Missouri from Eli Lilly and Abbott

Miles F Shore MD

Bullard Distinguished Professor of Psychiatry Harvard Medical School Needham Massachusetts Junior Consultant Harvard Medical International Boston Massachusetts Disclosure Miles F Shore MD has disclosed no relevant financial relationships

Editor

Jacqueline A Hart MD

Freelance Clinical Editor Medscape LLC New York New York Disclosure Jacqueline A Hart MD has disclosed no relevant financial relationships

Elizabeth Saenger PhD

Editorial Director Medscape LLC New York NY Disclosure Elizabeth Saenger PhD has disclosed no relevant financial relationships

Registration for CME credit the post test and the evaluation must be completed online To access the activity Post Test and Evaluation link please go to httpwwwmedscapecomviewprogram7809_index

Page 31: Medication Errors and Patient Safety in Mental Health CME/CE · 2019. 6. 27. · Medication Errors and Patient Safety in Mental Health CME/CE Complete author affiliations and disclosures

151 Shiwach RS Reid WH Carmody TJ An analysis of reported deaths following electroconvulsive therapy in Texas 1993-1998 Psychiatr Serv 2001 521095-1097 Abstract

152 Breggin PR Electroshock scientific ethical and political issues Int J Risk Safety Med 1998115-40

153 Melonas JM Split treatment does managed care change the risk in psychiatry Psychiatric Practice Managed Care Newsletter 19995

154 Kessler RC Berglund P Demler O et al The epidemiology of major depressive disorder results from the National Comorbidity Survey Replication (NCS-R) JAMA 20032893095-3105 Abstract

155 Pulier ML Ciccone DS Castellano C Marcus K Schleifer SJ Medical versus non-medical mental health referral clinical decision-making by telephone access center staff J Behav Health Serv Res 200330444-451 Abstract

156 Simon GE Katon WJ VonKorff M et al Cost-effectiveness of a collaborative care program for primary care patients with persistent depression Am J Psychiatry 20011581638-1644 Abstract

157 Lazarus J Macbeth J Wheeler N Divided treatment in managed care Psychiatr Pract Managed Care 1997

158 Olfson M Pincus HA Outpatient mental healthcare in non hospital settings distribution of patients across provider groups Am J Psychiatry 19961531353-1356 Abstract

159 Levinson W Physician-patient communication -- a key to malpractice prevention JAMA 1994201619-1620

160 Smith D 10 ways practitioners can avoid frequent ethical pitfalls Monitor on Psychology 20033450 Available at httpapaorgmonitorjan0310wayshtml Accessed on August 28 2007

161 Fishalow SE The tort liability of the psychiatrist Bull Am Acad Psychiatric Law 19753191-230

162 American Psychiatric Association The principles of medical ethics with annotations especially applicable to psychiatry 2001 Available at httpwwwpsychorgpsych_practethicsmedicalethics2001_42001cfm Accessed August 28 2007

163 American Psychological Association Ethical Principles and Code of Conduct June 1 2003 Available at httpwwwapaorgethicscode2002html Accessed August 28 2007

164 Gutheil TG Gabbard GO The concept of boundaries in clinical practice theoretical and risk management dimensions Am J Psychiatry 1993150188-196 Abstract

165 Gutheil TG Gabbard GO Misuses and misunderstandings of boundary theory in clinical and regulatory settings Am J Psychiatry 1998155409-414

166 Malmquist CP Notman MT Psychiatrist and patient boundary issues following treatment termination Am J Psychiatry 20011581010-1018 Abstract

167 Herman JL Gartell N Olarte S Feldstein M Localio R Psychiatrist-patient sexual contact results of a national survey II Psychiatrists attitudes Am J Psychiatry 1987144164-169 Abstract

168 Risk Management in Cyberspace Rx for Risk 20019 169 Miller RH Hillman JM Given RS Physician use of IT Results from the Deloitte

research survey J Healthc Inf Manag 20041872-80 Abstract 170 Applebaum PS Privacy in psychiatric treatment threats and responses Focus

20031396-406 171 Godolphin W The role of risk communication in shared decision making BMJ

2003327692-693 Abstract 172 Oregon Medical Association Lets talk disclosures after an adverse medical

event(video) Portland OR 2002 Available at httpwwwPatientSafetyStorecom Accessed August 28 2007

173 Institute of Medicine (IOM) Crossing the Quality of Chasm Adaptation to Mental Health and Addictive Disorders April 26 2004 Available at httpwwwiomeduCMS380919405aspx Accessed September 6 2007

Authors and Disclosures

As an organization accredited by the ACCME Medscape LLC requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest The ACCME defines relevant financial relationships as financial relationships in any amount occurring within the past 12 months including financial relationships of a spouse or life partner that could create a conflict of interest

Medscape LLC encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration at first mention and where appropriate in the content

Author

Benjamin C Grasso MD

Staff Psychiatrist VA Clinic Saco Maine Disclosure Benjamin C Grasso MD has disclosed no relevant financial relationships

Cathryn M Clary MD MBA

Vice President US External Medical Affairs Pfizer Inc New York NY Disclosure Cathryn M Clary MD MBA has disclosed that she is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Benjamin Eng MD MA

Senior Medical Director Group Leader Pfizer Inc New York NY Disclosure Benjamin Eng MD MA has disclosed that he is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Stanley J Evans MD FASAM PA

Assistant Professor of Clinical Medicine St Matthews University Windham Maine

Medical Director Renaissance Institute of Palm Beach Boca Raton Florida Disclosure Stanley J Evans MD has disclosed no relevant financial relationships

Terry J Golash MD

Clinical Instructor Psychiatry Columbia University New York NY Assistant Attending St Lukersquos Roosevelt Hospital Center New York NY Disclosure Terry J Golash MD has disclosed no relevant financial relationships

Kevin Ann Huckshorn RN MSN CAP ICADC

Director Office of Technical Assistance National Association of State mental Health Program Directors Inc Alexandria Virginia Disclosure Kevin Ann Huckshorn RN MSN CAP ICADC has disclosed no relevant financial relationships

Kenneth Minkoff MD

Clinical Assistant Professor Department of Psychiatry Cambridge Hospital Harvard University Acton Massachusetts Consultant ZiaLogic Acton Massachusetts Disclosure Kenneth Minkoff MD has disclosed no relevant financial relationships

Joseph J Parks MD

Assistant Associate Professor Department of Psychiatry University of Missouri Columbia Missouri Disclosure Joseph J Parks MD has disclosed that he has received grants for educational activities from Letters amp Science and Physician Postgraduate Press Dr Parks has also disclosed that he has served as a consultant to the National Association of State Mental Health Program Directors and Bristol-Myers Squibb Dr Parks has also disclosed that he has received funds for services provided to the state of Missouri from Eli Lilly and Abbott

Miles F Shore MD

Bullard Distinguished Professor of Psychiatry Harvard Medical School Needham Massachusetts Junior Consultant Harvard Medical International Boston Massachusetts Disclosure Miles F Shore MD has disclosed no relevant financial relationships

Editor

Jacqueline A Hart MD

Freelance Clinical Editor Medscape LLC New York New York Disclosure Jacqueline A Hart MD has disclosed no relevant financial relationships

Elizabeth Saenger PhD

Editorial Director Medscape LLC New York NY Disclosure Elizabeth Saenger PhD has disclosed no relevant financial relationships

Registration for CME credit the post test and the evaluation must be completed online To access the activity Post Test and Evaluation link please go to httpwwwmedscapecomviewprogram7809_index

Page 32: Medication Errors and Patient Safety in Mental Health CME/CE · 2019. 6. 27. · Medication Errors and Patient Safety in Mental Health CME/CE Complete author affiliations and disclosures

173 Institute of Medicine (IOM) Crossing the Quality of Chasm Adaptation to Mental Health and Addictive Disorders April 26 2004 Available at httpwwwiomeduCMS380919405aspx Accessed September 6 2007

Authors and Disclosures

As an organization accredited by the ACCME Medscape LLC requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest The ACCME defines relevant financial relationships as financial relationships in any amount occurring within the past 12 months including financial relationships of a spouse or life partner that could create a conflict of interest

Medscape LLC encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration at first mention and where appropriate in the content

Author

Benjamin C Grasso MD

Staff Psychiatrist VA Clinic Saco Maine Disclosure Benjamin C Grasso MD has disclosed no relevant financial relationships

Cathryn M Clary MD MBA

Vice President US External Medical Affairs Pfizer Inc New York NY Disclosure Cathryn M Clary MD MBA has disclosed that she is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Benjamin Eng MD MA

Senior Medical Director Group Leader Pfizer Inc New York NY Disclosure Benjamin Eng MD MA has disclosed that he is employed by a commercial interest in and owns stock stock options or bonds in Pfizer Inc

Stanley J Evans MD FASAM PA

Assistant Professor of Clinical Medicine St Matthews University Windham Maine

Medical Director Renaissance Institute of Palm Beach Boca Raton Florida Disclosure Stanley J Evans MD has disclosed no relevant financial relationships

Terry J Golash MD

Clinical Instructor Psychiatry Columbia University New York NY Assistant Attending St Lukersquos Roosevelt Hospital Center New York NY Disclosure Terry J Golash MD has disclosed no relevant financial relationships

Kevin Ann Huckshorn RN MSN CAP ICADC

Director Office of Technical Assistance National Association of State mental Health Program Directors Inc Alexandria Virginia Disclosure Kevin Ann Huckshorn RN MSN CAP ICADC has disclosed no relevant financial relationships

Kenneth Minkoff MD

Clinical Assistant Professor Department of Psychiatry Cambridge Hospital Harvard University Acton Massachusetts Consultant ZiaLogic Acton Massachusetts Disclosure Kenneth Minkoff MD has disclosed no relevant financial relationships

Joseph J Parks MD

Assistant Associate Professor Department of Psychiatry University of Missouri Columbia Missouri Disclosure Joseph J Parks MD has disclosed that he has received grants for educational activities from Letters amp Science and Physician Postgraduate Press Dr Parks has also disclosed that he has served as a consultant to the National Association of State Mental Health Program Directors and Bristol-Myers Squibb Dr Parks has also disclosed that he has received funds for services provided to the state of Missouri from Eli Lilly and Abbott

Miles F Shore MD

Bullard Distinguished Professor of Psychiatry Harvard Medical School Needham Massachusetts Junior Consultant Harvard Medical International Boston Massachusetts Disclosure Miles F Shore MD has disclosed no relevant financial relationships

Editor

Jacqueline A Hart MD

Freelance Clinical Editor Medscape LLC New York New York Disclosure Jacqueline A Hart MD has disclosed no relevant financial relationships

Elizabeth Saenger PhD

Editorial Director Medscape LLC New York NY Disclosure Elizabeth Saenger PhD has disclosed no relevant financial relationships

Registration for CME credit the post test and the evaluation must be completed online To access the activity Post Test and Evaluation link please go to httpwwwmedscapecomviewprogram7809_index

Page 33: Medication Errors and Patient Safety in Mental Health CME/CE · 2019. 6. 27. · Medication Errors and Patient Safety in Mental Health CME/CE Complete author affiliations and disclosures

Medical Director Renaissance Institute of Palm Beach Boca Raton Florida Disclosure Stanley J Evans MD has disclosed no relevant financial relationships

Terry J Golash MD

Clinical Instructor Psychiatry Columbia University New York NY Assistant Attending St Lukersquos Roosevelt Hospital Center New York NY Disclosure Terry J Golash MD has disclosed no relevant financial relationships

Kevin Ann Huckshorn RN MSN CAP ICADC

Director Office of Technical Assistance National Association of State mental Health Program Directors Inc Alexandria Virginia Disclosure Kevin Ann Huckshorn RN MSN CAP ICADC has disclosed no relevant financial relationships

Kenneth Minkoff MD

Clinical Assistant Professor Department of Psychiatry Cambridge Hospital Harvard University Acton Massachusetts Consultant ZiaLogic Acton Massachusetts Disclosure Kenneth Minkoff MD has disclosed no relevant financial relationships

Joseph J Parks MD

Assistant Associate Professor Department of Psychiatry University of Missouri Columbia Missouri Disclosure Joseph J Parks MD has disclosed that he has received grants for educational activities from Letters amp Science and Physician Postgraduate Press Dr Parks has also disclosed that he has served as a consultant to the National Association of State Mental Health Program Directors and Bristol-Myers Squibb Dr Parks has also disclosed that he has received funds for services provided to the state of Missouri from Eli Lilly and Abbott

Miles F Shore MD

Bullard Distinguished Professor of Psychiatry Harvard Medical School Needham Massachusetts Junior Consultant Harvard Medical International Boston Massachusetts Disclosure Miles F Shore MD has disclosed no relevant financial relationships

Editor

Jacqueline A Hart MD

Freelance Clinical Editor Medscape LLC New York New York Disclosure Jacqueline A Hart MD has disclosed no relevant financial relationships

Elizabeth Saenger PhD

Editorial Director Medscape LLC New York NY Disclosure Elizabeth Saenger PhD has disclosed no relevant financial relationships

Registration for CME credit the post test and the evaluation must be completed online To access the activity Post Test and Evaluation link please go to httpwwwmedscapecomviewprogram7809_index

Page 34: Medication Errors and Patient Safety in Mental Health CME/CE · 2019. 6. 27. · Medication Errors and Patient Safety in Mental Health CME/CE Complete author affiliations and disclosures

Freelance Clinical Editor Medscape LLC New York New York Disclosure Jacqueline A Hart MD has disclosed no relevant financial relationships

Elizabeth Saenger PhD

Editorial Director Medscape LLC New York NY Disclosure Elizabeth Saenger PhD has disclosed no relevant financial relationships

Registration for CME credit the post test and the evaluation must be completed online To access the activity Post Test and Evaluation link please go to httpwwwmedscapecomviewprogram7809_index