Medication Error Prevention M. Lisa Pagnucco, BS Pharm, PharmD, BCACP Assistant Professor, Pharmacy...

Medication Error Prevention

M. Lisa Pagnucco, BS Pharm, PharmD, BCACPAssistant Professor, Pharmacy Practice

University of New England, College of [email protected]

September 8th, 2013

mailto:[email protected]

Disclosure

I have no conflicts of interest to disclose.

Objectives

1) Discuss why a culture of safety is an important

element to improve the medication use process in

any practice setting.

3) Explain one or more strategies used to reduce or

eliminate errors identified at each stage in the

medication use process.

2) Describe one example of an error occurring at

each stage in the medication use process.

Patient Safety – Adverse Events

42%

36%

18%

4%

Medication Errors

Patient Care

Surgery or other procedures

Infection

DHHS. Office of Inspector General. (2010) Adverse Events in Hospitals: National Incidence Among Medicare Beneficiaries. Retrieved from http://oig.hhs.gov/oei/reports/oei-06-09-00090.pdf. Last accessed July 2012.

http://oig.hhs.gov/oei/reports/oei-06-09-00090.pdf

The Problem: Scope and Cost

Preventable Medication Errors:

• Occur in 3.8 million (inpatient admissions)• Occur in 3.3 million (outpatient visits)

NEHI. (2011) Preventing Medication Errors: A $21 Billion Opportunity. Retrieved from http://www.nehi.net/bendthecurve/sup/documents/Medication_Errors_#20Brief.pdf. Last accessed July 2012.

• $21 billion ($21,000,000,000) $16.4 billion (inpatient) $4.2 billion (outpatient)

http://www.nehi.net/bendthecurve/sup/documents/Medication_Errors_

Estimates that

30 - 50% of

$2.7 trillion annual

US healthcare spending

is……

wasteful.

http://thinkprogress.org/health/2013/01/11/1432291/surprising-root-wasteful-spending-health-care/?mobile=nc

What is a Medication Error?

…. “any error occurring in the medication use process.”

Bates DW, Boyle DL, Vander Vliet MB, Schneider J, Leape L. Relationship between medication errors and adverse drug events. J Gen Intern Med 1995;10(4): 100–205.

What is an Error?The failure of a planned action to be completed as intended (error of execution) or

the use of a wrong plan to achieve an aim (error of planning).

An error may be an act of commission or an act of omission.

Institute of Medicine, 2004

Error of Omission

• An act of failing to do

the right thing that

leads to an undesirable

outcome or significant

potential for such an

outcome.

Example:• Failing to prescribe VTE

prophylaxis for a patient after hip replacement surgery

Error of Commission

• An act of doing something

wrong that leads to an

undesirable outcome or

significant potential for such

an outcome.

Example:• Ordering a medication for a

patient with a documented

allergy to that medication.

AHRQ, Patient Safety Network (PSNet), Glossary

Where Do Medication Errors Occur (%)

39%

12%11%

38% Prescribing

Transcription

Dispensing

Administration

Leape LL, Bates DW, Cullen DJ, et al. Systems analysis of adverse drug events. JAMA. 1995;274:35-43.

Where are errors caught?

Stage of Medication Use Errors (%) Interception (%)

Prescribing 39% 48%

Transcription 12% 33%

Dispensing 11% 34%

Administration 38% 2%


• Established by National Academy of Sciences in 1970 to

examine policy issues related to the health of the public

• The Quality of Health Care in America project (1998) To develop a strategy for quality improvement in next ten years

• The first report from the project was released in 1999:

“To Err is Human: Building a Safer Health System”

“To Err is Human: Building a Safer Health System”

Landmark report, 1999• Examined impact of medical errors

• Identified errors are caused by faulty system

• Processes and conditions that lead people to

make mistakes or fail to prevent them

• Suggested national strategy for improvement

Estimated annually in US:

• 44,000 to 98,000 patient deaths from

patient care errors

• 7,000 deaths from medication errors

Institute of Medicine. To err is human: building a safer health system. Washington, DC: National Academy Press, 2000.

“To Err is Human: …1999”

Strategies for Improvement

1) Establish a national focus to create leadership, research,

tools and protocols to enhance the knowledge base about safety.

2) Identify and learn from errors by developing a nationwide

public mandatory reporting system and by encouraging health

care organizations and practitioners to develop and participate in voluntary

reporting systems.

3) Raise performance standards and expectations for improvements in safety through the actions of oversight organizations, professional groups, and group purchasers of health care.

4) Implement safety systems in health care organizations to ensure safe

practices at the delivery level.Institute of Medicine. To err is human: building a safer health system. Washington, DC: National Academy Press, 2000.

“Crossing the Quality Chasm: A New Health System for the 21st Century”

• Report released in 2001

• Health care harms patients frequently

• Chasm: The divide between the current health

care and what health care could be like

• Study how the health system can be

reinvented to foster innovation and

improve the delivery of careInstitute of Medicine. Crossing the quality chasm: a new health system for the 21st century. Washington, DC: National Academy Press, 2001.

“Crossing the Quality Chasm:…2001”


1) Safe

2) Effective

3) Patient-centered

4) Timely

5) Efficient

6) Equitable

Six Aims for Improvement:

Institute of Medicine. Crossing the quality chasm: a new health system for the 21st century. Washington, DC: National Academy Press, 2001.

“Preventing Medication Errors”

• Report released in 2006

• Adverse drug event (ADE):

Patient harm due to administration of a drug; may be

preventable (related to any error in the medication use

process) or non-preventable.

Hospitalized patients:• One medication error per patient per day

Estimated annually in US:• At least 1.5 million preventable ADEs

• At a cost of $3.5 billion Institute of Medicine. Preventing medication errors: quality chasm series. Washington, DC: National Academy Press, 2006.

“Preventing Medication Errors” 2006


1) Improving the Patient-Provider Partnership• Allow and encourage patients to take a more active role in their care

• Better communication with patients at all steps by all providers

2) New and Improved Drug Information Resources• Improve consumer access to information about medications

3) Electronic Prescribing and other IT Solutions• POC references, e-prescribing, EHR, HRO focus on medication safety

4) Drug Naming, Labeling and Packaging• Industry and agency collaboration to improve drug nomenclature, labeling and

information sheets

Institute of Medicine. Preventing medication errors: quality chasm series. Washington, DC: National Academy Press, 2006.

Recommendation 1:

To improve the quality and safety of the medication-

use process, specific measures should be instituted

to strengthen patients’ capacities for sound

medication self-management.

Preventing Medication Errors


Bates DW. Preventing medication errors: A summary. Am J Health-Syst Pharm 2007; 64;S3-S9.


Box S-3Patient Rights

Patients have the right to:• Be the source of control for all medication management decision that affect them

(that is, the right to self-determination).• Accept or reject medication therapy on the basis of their personal values.• Be adequately informed about their medication therapy and alternative treatments.• Ask questions to better understand their medication regimen.• Receive consultation about their medication regimen in all health settings and at all

points along the medication-use process.• Designate a surrogate to assist them with all aspects of their medication

management.• Expect providers to tell them when a clinical significant error has occurred, what the

effects of the event on their health (short- and long-term) will be, and what care they will receive to restore their health.

• Ask their provider to report an adverse event and give them information about how they can report the event themselves.


Box S-5Issues for Discussion with Patients by Providers

(Physicians, Nurses, and Pharmacists)

• Review the patient’s medication list routinely and during care transitions.

• Review different treatment options.

• Review the name and purpose of the selected medication.

• Discuss when and how to take the medication.

• Discuss important and likely side effects and what to do about them.

• Discuss drug-drug, drug-food, and drug-disease interactions.

• Review the patient’s or surrogate’s role in achieving appropriate medication use.

• Review the role of medications in the overall context of the patient’s health.

Recommendation 2:

Government agencies (AHRQ, CMS, FDA, NLM)

should enhance the resource base for consumer-

oriented drug information and medication self-

management support.




Recommendation 3:

All health care organizations should make available

to providers patient information and decision

support tools.


Institute of Medicine. Preventing medication errors: quality chasm series. Washington, DC: National Academy Press, 2006.Bates DW. Preventing medication errors: A summary. Am J Health-Syst Pharm 2007; 64;S3-S9.

Recommendation 4:

Better labeling is needed, as are better methods

for communicating medication information to

consumers.





Box S-6Drug Naming, Labeling, and Packaging Problems

• Brand names and generic names that look or sound alike

• Different formulations of the same brand and generic drug

• Multiple abbreviations to represent the same concept

• Confusing word derivatives, abbreviations, and symbols

• Unclear dose concentration/strength designations

• Cluttered labeling – small fonts, poor typefaces, no background

contrast, overemphasis on company logos

• Inadequate prominence of warnings and reminders

• Lack of standardized terminology

Recommendation 5:

Industry and government should collaborate to

establish standards affecting drug-related healthcare

information technology (HIT).




Recommendation 6:

Congress should fund AHRQ to work with other

agencies to develop a broad research agenda on safe

and appropriate medication use, especially testing of

error prevention strategies.



Bates DW. Preventing medication errors: A summary. Am J Health-Syst Pharm 2007; 64;S3-S9*.

Recommendation 7:

Oversight and regulatory organizations and payers

should use (tactics) to motivate the adoption of

practices that can reduce medication errors and

ensure that providers have needed competencies.




“We cannot change the human condition,

but we can change the conditions

under which humans work.”

Reason J. Human Error: models and management. BMJ 2000;320:768-770.

The Swiss Cheese model of how defences, barriers, and safeguards may be penetrated by an accident trajectory.

©2000 by British Medical Journal Publishing Group

Reason J. Human Error: models and management. BMJ 2000;320:768-770.

Swiss Cheese Model

Active failures Latent failures

• Unsafe acts by persons in direct contact with patient or system

• Slips, lapses, fumbles, mistakes, procedural violations

• ‘Sharp end’ of process

• RN, PharmD, MD, DO, RT

• Administrative level decisions

• Error provoking conditions

• Long lasting weaknesses

• ‘Accidents waiting to happen’

• Should review proactively

• ‘Blunt end’ of process

Traditional Approach to Errors

• Person approach

• Fault of the individualPhysician, nurse, pharmacistTrained for error-free practiceReinforced by “blame game”

• Trained to work without thinkingAutomatic

The Person Approach to Errors

• Focuses on unsafe acts by an individual

• Unsafe acts are result of aberrant mental processes

• Correction by reducing unwanted variability in human behavior

• ‘Bad things happen to bad people’

The Systems Approach

• Organizations operating in hazardous conditions that have fewer than their fair share of adverse events

• Preoccupied with possibility of failure

• Study Safety rather than just Failures

• Rehearse scenarios of failure

• Workforce trained to expect errors, recognize and recover from them

High Reliability Organizations (HROs)

US Air Flight 1549Hudson River January 2009

The Systems Approach - HROs

Design a system for safety:

• Assume things will fail • Anticipate what should be done• Non-punitive reporting system • Encouraged to report

HROs:Aviation, Nuclear Power, Space Travel

• Equally hazardous

• As complex as healthcare

Organizational Safety Cultures

• Fear of legal or criminal actions after an error Associated with hiding or not reporting errors Reduced likelihood of sharing ‘close calls’; missed opportunities

to learn and prepare

• ‘Just culture’: Address system issues that lead individuals to engage in

unsafe behaviors Maintains individual accountability by establishing zero

tolerance for reckless behavior Based on type of behavior associated with error, not the

severity of error

Safety Culture Project

• A safety culture enables trust and quality improvement.• A safety culture empowers staff to speak up about:

Risks to patients Report errors and near misses

• Summary of knowledge, attitudes, behaviors and beliefs that staff share about the importance of patient safety

• AHRQ survey 2010: 1,032 hospitals, 472,397 hospital staff 56% felt mistakes would be held against them 54% had not reported any events in the previous 12 months

Errors are……..Opportunities

• Root Cause Analysis (RCA)AFTER an error has occurred – ‘Reactive’What DID happen, why, why, why?Use results for system/process improvements

• Failure Mode and Effects Analysis (FMEA)BEFORE errors occur; anticipation – ‘Proactive’What COULD happen, how and why?Build safeguards into process before change

Patient Safety Organizations

• Patient Safety and Quality Improvement Act of 2005 Authorized creation of Patient Safety Organizations (PSOs) to

improve the quality and safety of U.S. health care delivery.

Encourages clinicians and health care organizations to

voluntarily report and share quality and patient safety

information without fear of legal discovery.

The Agency for Healthcare Research and Quality (AHRQ)

administers the Patient Safety Act and Rule for PSO operations.

Institute for Safe Medication Practices (ISMP)

• Non-profit, 501c (3) organization Devoted to medication error prevention

and safe medication use

• ISMP is a certified PSO• Expert analysis of errors

• Dissemination of medication error and safe medication use information for over 35 years; column in Hospital Pharmacy

• Newsletters, seminars, consultant services

Michael Cohen, President, ISMP

founder, Medication Safety Expert,

Pharmacist

Index of suspicion: • Awareness or concern for potentially serious underlying and unseen injuries

or illness

Suspicion: • “the act or an instance of suspecting something wrong without proof or on very

slight evidence, or a state of mental uneasiness and uncertainty.”

Mindfulness: • Defining characteristic of High Reliability Organizations (HROs)

• Sense of unease and preoccupation with failure that arises from admitting the

possibility of error, even with well-designed stable processes.

Where Do Medication Errors Occur (%)

39%

12%11%

38% Prescribing

Transcription

Dispensing

Administration


Prescribing

Challenges• Missing information

References, patient, history, labs, home meds

Medications unfamiliar• Distractions

Patient cases, missing charts Office hours and on- call Pagers

• Ordering process NCR, verbal orders,

telephone, hand written

Improvements• Improved information access

Remote computer system access Clinical decision support systems (CDSS) Electronic drug, disease information

• Electronic Health Record (EHR)• Use of checklists, care plans• Improved communication

Reduced phone time; less pager use, increased messaging and in person

Legibility, abbreviations strategies• Computerized Provider Order Entry

(CPOE), E-prescribing

TranscriptionChallenges

• Order appearance Legibility, abbreviations, decimals,

spaces

• Order clarifications Verification of calculations Incomplete orders, paging Pertinent labs, allergies, patient

history Wrong patient

• Order transmission Verbal, facsimile, NCR

Improvements

• Safety – written and printed “Do Not Use Abbreviations” Pre-printed order forms/sets QI/credentialing for legibility

• Improved information access Computer system interfaces CDSS and informatics Improved patient demographics

• Scanning or CPOE Minimize use of verbal orders E-prescribing

ISMP Error Prone Abbreviations

http://ismp.org/Tools/errorproneabbreviations.pdf

ISMP Error Prone Dose DesignationsError Prone Intended Consequences

‘Naked’ decimal

.5 mg 0.5 mgMissed decimal as 5 mg leading to 10-fold too high dose

Trailing zero

1.0 mcg 1 mcgMissed decimal as 10 mcg leading to 10-fold too high dose

Missing space

Tegretol300 mg Tegretol 300 mgMistaken ‘l’ as ‘1’ when medication name ends with ‘l’

Missing space

100mg 100 mg‘m’ mistaken for zero(s), leading to 10-100 fold error

Adapted from http://ismp.org/Tools/errorproneabbreviations.pdf

DispensingChallenges

• Environment Distractions, workload, stress,

workflow, storage, poor lighting

• Drug labels, drug names Look-alike, sound-alike Poor labels from Rx computer High-risk medications

• Rx system issues Problematic drug database Updates not timely

• Medication shortages

Improvements

• Process/system evaluations Ergonomics, lighting, reduce

distractions, redesign storage, work flow

Identify LASA, high-risk, use of tall-man lettering

Computer label format guidance Resources - system maintenance

• Staffing improvements Scheduling based on workload Technician support duties

• Technology Robotics, carousel, compounder, bar-

code verification, biometrics

AdministrationChallenges

• Information: patient, drug Missing age, ht/wt, allergies,

diagnoses, home medications Reference books outdated

• Dose admixtures and rates IV admixture, calculate IV rate Dose preparation from bulk

• Order verification Right order, med, patient Maintain manual MAR

• Distractions Phones, pagers, call buttons Missing or misplaced doses

Improvements

• Better Information Access Computer system interfaces Point-of-Care current drug info. CDSS pertinent lab verification Patient identification verification

• USP 797, unit dose and TJC• SMART pumps • Electronic MAR• Bar Code Medication Administration• Automated Dispensing Cabinets• Reduced interruptions/distractions• Patient engagement

Partnering with the Patient to Prevent Medication Errors

• Invite information sharing

• Use clear communication

• Assess and assist with

medication adherence

• Identify financial barriers

• Health literacy awareness

• Culturally competent care• Identify interpreter needs,

hearing, or visual aids• Engage care managers• Support health/wellness• Facilitate safe transition

IOM Report 2006

Preventing Medication

Errors

Patient Education

to Avoid

Medication Errors

National Patient Safety Foundation

Key Elements to Prevent Medication Errors

1) Create a culture of safety: Empower staff, patients, caregivers to speak up Report errors, near misses for process improvement Share information about problems and solutions Raise awareness of errors

3) Incorporate technology: Consider highest risk error stages early Engage expertise of end users before implementation Revisit process change often for continual quality improvement

2) Improve communication: Between all providers, providers and patients/caregivers Consider all communication forms for clarity and safety

Medication Error Prevention M. Lisa Pagnucco, BS Pharm, PharmD, BCACP Assistant Professor, Pharmacy...

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