David Dosa MD, MPH

Assistant Professor of Medicine and Community Health

The Warren Alpert School of Medicine, Brown University

Director, Primary Care Geriatrics Clinic- Providence VAMC

VA Grand Rounds

Friday, December 4, 2009

Goals of the Lecture Definitions

Significance of Adverse Drug Events

Nationally

VA Specific

Common Errors Among the Elderly

Inappropriate Prescribing (PIPE drugs)

Errors related to Narcotic Prescribing

Monitoring

Developing Quality Indicators for Errors (Moving beyond Root Cause Analysis)

Definitions A medication error is defined as an error occuring in

the medication use process:

Prescribing

Order Communication

Dispensing

Administering

Monitoring

Only about 1-2% of all Medication Errors result in an Adverse Drug Event (ADE)

Definitions (2) Adverse Drug Event (ADE) is defined as “any injury

resulting from the medical use of a drug”

The term ADE:

includes harm caused by the drug (adverse drug reactions and overdoses)

and harm from the use of the drug (including dose reductions and discontinuations of drug therapy)

Definitions (3) Medication errors may result in medication-related

adverse events:

Adverse Drug Reactions (ADRs)—a response to a drug that is noxious and unintended and occurs at doses normally used in humans for prophylaxis, diagnosis, or therapy

Conversely, ¼ to ½ of all ADRs are caused by medication errors

ADRs defined as predictable (defined by the drugs properties) or unpredictable (idiosyncratic, allergic)

Definitions (4) Other forms of Medication Errors include:

Adverse Drug Withdrawal Event (ADWE)-a clinical set of symptoms or signs related to the removal of a drug

Therapeutic Failures (TFs)-- a failure to accomplish the goals of treatment resulting from inadequate drug therapy (as opposed to progression of disease)

An ADE is not a Medication Error

Medication Errors are much more common than ADEs but cause harm only 1% of the time

Conversely, about 25% of ADEs are caused by medication errors

Source: VA Center for Medication Safety

Source: Handler: American Journal of Geriatric Pharmacotherapy

What are the Effects of Medication Errors?

According to the Institute of Medicine Report: To Err is Human: Building a Safer Health System

Adverse Drug Events associated with:

Increased Mortality—

between 44,000 to 98,000 deaths annually (more than breast CA and AIDS)

Medication errors account for approximately one out of 131 outpatient deaths and one out of 854 inpatient deaths

Increased Morbidity

$17 billion to $29 billion per year in added hospital costs

Adverse Drug Events Studies have suggested:

530,000 ADEs per year among Medicare outpatient recipients

Total extra costs in the ambulatory setting estimated at 76.6 billion (mostly from subsequent hospital stays)

800,000 ADEs per year among Nursing Home residents

14.4 billion in extra long term care admissions

ADEs in Hospital Settings

400,000 ADEs per year

One ADE

$8750 per ADE

3.5 billion in extra health care costs

An analogy Average ICU patient

experiences 2 errors a day; 1 out of 5 is serious

~99% accuracy rate

If performance was the same at O’Hare airport

2 dangerous landings

per day

Epidemiology of ADEs Leape, Systems Analysis of Adverse Drug Events,

JAMA, 1995

Studied ADEs involving medications among 4031 adult admissions to a stratified random sample of 11 medical and surgical units in two tertiary care hospitals over a 6-month period

Using stimulated self report by nurses and pharmacists

Daily monitoring review by nurse investigators

Leape Study Over 6 months, 247 ADEs and 194 potential ADEs were

identified (6.5 and 5.5 ADEs/100 admissions:

Of all ADEs, 1% were fatal, 12% life-threatening, 30% serious, and 57% significant

Twenty-eight percent were judged preventable.

Of the life-threatening and serious ADEs, 42% were preventable

56% of ADEs related to prescribing errors

44% of ADEs involved administration

Gurwitz Study American Journal of Medicine, 2005

Cohort study of all patients admitted

Studied two academic nursing homes over 9 months

There were 815 adverse drug events, of which 42% were judged preventable.

The overall rate of adverse drug events was 9.8 per 100 resident-months, with a rate of 4.1 preventable adverse drug events per 100 resident-months.

Risk Factors for Preventable Errors included:

Gurwitz Study (2)

Gurwitz Study (3) Risk Factors for Preventable Errors included:

Psychotic Drug Use– Odds Ratio of 3.4(95% confidence interval [CI]: 2.0 to 5.9)

Anticoagulant Use– Odds Ratio of 2.8 (95% CI: 1.6 to 4.7)

Diuretic Use—Odds ratio of 2.2 (95% CI: 1.2 to 4.0)

Antiepileptic Use– Odds ratio of 2.0 (95% CI:1.1 to 3.7)

Why are the Elderly Most Affected

Simple Demographics By 2030, nearly 1 in 5 US Residents will be 65+

65 and older—38.7 million to 88.5 million by 2050

Oldest Old– age 85+ will go from 5.4 to 19 million

Chronic Disease Burden increases with age Diabetes

Congestive Heart Failure

COPD/Asthma

Hypertension

Glaucoma

Why are the Elderly Most Affected

Polypharmacy increases Disease Burden Ghandi et al---NEJM 2003 study determined that the

frequency of ADEs in the ambulatory setting increased by 10% (CI 6-15%) with each additional medication

Patient’s Physiological Reserve Decreases Liver Function

Renal Function

ADEs may be misrepresented and underestimated as new presentations of syncope, falls, delirium, and failure to thrive

Loss of Physiological Reserve

Disease Severity Compensatory Mechanisms

Symptomatic Asymptomatic

To Err is Human… Prescribing—39% (Physician)

Transcribing—12% (Pharmacy)

Compounding—11% (Pharmacy)

Administering---38% (Nursing/Point of Care)

What is Missing?

Studies have showen: Majority of Adverse Drug Events occur at the ordering

and monitoring stages (Gurwitz)

Ordering (59%)

Wrong Dose—48%

Wrong Drug—38%

Drug-Drug Interaction—12%

Dispensing (5%)

Administration (43%)

Monitoring (80%)

Evolution of the HEDIS list of avoidable medications

1991---Beers List is introduced Archives of Internal Medicine, 1991;151.1824-32.

Derived from consensus opinion of 13 experts

Highlighted medications that were inappropriate for use in nursing home residents

List consisted of 19 medications/classes to be avoided

1997—Beers list was revised by a panel of 6 experts to include 28 medications/classes to be avoided by all patients 65 and older

2003—Updated by Fick and Beers to include 48 drugs/classes and 20 drug-disease combination

Evolution of the HEDIS MEDs Though it serves as a good reference---many groups

have started to look past the Beers list:

Page and Ruscin conducted a retrospective review of 389 patients (Am J Geriatr Pharmacother; 2006)

107 patients (27%) received meds on the Beers list

124 patients experienced 131 ADEs

Only 12 (9.2%) of the 131 ADEs were linked to meds on the Beers list

Evolution of the HEDIS meds Jano and Aparasu (Ann Pharmacotherapy; 2007)

Conducted a systemic review of 18 health outcomes studies associated with the Beers criteria

In community setting--

the use of Beers meds were associated with increased hospitalization and ER use

No association with hard outcomes

In the Nursing Home Setting—

Underpowered to assess links to hospitalization

No associations noted with mortality

Evolution of the HEDIS meds 2005—the American Medical Directors Association

(AMDA) and American Society of Consultant Pharmacists (ASCP) published a joint statement suggesting that the Beers criteria should of not be used for the purpose of determining appropriateness.

In part—due to legal reasons

Evolution of the HEDIS meds 2006—National Committee on Quality Assurance

began a review of “high risk medications for the elderly as part of HEDIS

Using a Delphi process and expert panel they classified medications into 3 groups:

1) Always Avoid in the Elderly

2) Rarely Appropriate

3) Appropriate for Some Indications

Potentially Inappropriate Medications in the Elderly

Potentially Inappropriate Medications in the Elderly

Conditions Exacerbated by PIPE Medications

PIPE Use in Hospitalized Elders Rothberg et al; Society of Hospital Medicine; 2008

Studied the prescribing practices of PIPE Meds in the hospital setting

Retrospective Cohort Study from Sep. 1, 2002 to June 30,2005

Sample collected from 384 US Hospitals

Source: Rothberg

How does the VA Perform? Pugh MJ, Hanlon JT, et al. Journal of Managed Care

Pharmacy; 2006

Used HEDIS PIPE Medications and assessed Veterans with 2 or more ambulatory care visits during fiscal year 2000

All patients>65; N=1,096,361 patients

Multivariate regression utilized to stratify patient characteristics associated with increased PIPE use

Source: Pugh

Source: Pugh

Bottom Line of the Pugh Study 19.2% of men; 23.3% of women were on at least one

PIPE medication

Most commonly used meds were: Diphenhydramine (Benadryl): 9.0%; 10.7%

Hydroxyzine (Atarax): 3.5%; 4.7%

Propoxyphene (Darvocet): 4.5%; 5.7%

Diazepam (Valium): 1.5%; 1.7%

Predictors of Use Included: Serious Mental Illness (Odds Ratio; 1.7); Polypharmacy

(up to 8.2); Number of Visits (Up to 1.4)

Hospitalization and Death Associated with PIPE Use in the NH Lau DT, et al.; Archives of Internal Medicine,2005

Used the 1996 Medicare Expenditure Panel Survey Nursing Home Component

Studied 3372 NH residents aged 65 and up

Residents who received any PIPE meds

Greater Hospitalizations—(OR 1.27; p=0.02)

Increased Mortality—(OR 1.28;p=0.01)

Intermittent PIPE Use vs No PIPE use

Increased Mortality—(OR 1.89; p<0.001)

Affect of Geriatrics Care on PIPE Use Pugh MJ; PIPE Prescribing: Effects of Geriatric Care at

the Patient and Health Care System Level; Medical Care, 2008

Authors examined the association between geriatric care and PIPE use within the VA elderly population

Patients receiving geriatric care were less likely to have PIPE exposure (odds ratio, 0.64; 95% confidence interval, 0.59–0.73).

Weak effect for geriatric care penetration--patients in low geriatric care penetration facilities had higher rates of PIPE use regardless of care (odds ratio, 1.14; 95% confidence interval, 0.99 –1.30).

Common Medication Errors PD Mills; Effective interventions and implementation

strategies to reduce adverse drug events in the VA system. Quality Saf. Health Care,2008

Reviewed every medication related Root Cause Analysis reported to the VA National Center for Patient Safety in 2004

A Word about Root Cause Analysis National Center for Patient Safety (NCPS) instituted

an RCA policy to analyse adverse events

A Safety Manager is employed at each VA facility to investigate adverse events

All adverse events reported within the VA are rated against two criteria

harm (catastrophic, major, moderate, minor)

probability (frequent, occasional, uncommon, remote)

Safety Assessment Code (SAC) Coded from 1-3 with 1=low priority; 3=highest priority

All SAC 3s (either potential or actual) are to trigger RCA reports to the NCPS

In 2004, 143 single case RCAs were submitted to the VA

Mills et al also reviewed 111 aggregated reports

88% were potential harm

38% occurred in the outpatient setting

Distribution of ADEs

Actions 993 actions were taken by institutions to address RCAs

Actions that were positively correlated with improvement

Changes at Bedside

Improvement in Computers/Equipment

Leadership Involvement

Negatively correlated with improvement

Training without other action

Common Narcotics Errors Use of Inappropriate Narcotics

Meperidine

Propoxyphene

Renal Failure Considerations

Rapid Escalation of Narcotics

Particularly with Long Acting Opioids

Inappropriate Conversion

Short to Long Acting Agents

Common Narcotics Errors Errors occur from inappropriate initiation:

Example: Fentanyl patch use in naïve patients

Dosa et al- Journal of Pain and Symptom Management, 2009—Evaluated RI Nursing Homes using 2004-2005 Medicaid Data

Identified Long Acting Opioid (LAO) Initiators. Of the 591 Medicaid residents who initiated therapy with an LAO 232 (39.3%) were opiod naive.

Patients with advanced age, Alzheimer’s Disease were at the greatest risk for LAO initiation

Common Errors in Monitoring ACE Inhibitor Initiation

Mandated by the VA for patients with Congestive Heart Failure, Diabetes, etc.

No Cue for monitoring in the system

Multiple groups have determined that failure to monitor Potassium Post initiation is a serious error

Potassium Monitoring Hyperkalemia develops in 10% of all patients who are

initiated on ACEI within a year

Greatest risk in patients with advanced age, chronic renal insufficiency and diabetes

Over 1/3 of all hyperkalemia admissions attributed to failure to monitor

ACOVE and other groups now suggests monitoring within 1 month of initiation

Studies suggest monitoring occurs less than 1/3 time

VA performs similarly based on 2007 data we’ve looked at.

Common Errors with Monitoring Failure to monitor electrolytes after diuretic initiation

Recommendations are to monitor within 1 week of HCTZ/Lasix Initiation

Failure to monitor coumadin levels after antibiotic initiation

One of 5 most common malpractice lawsuits

Developing Quality Indicators Career Development Award

Aims:

To develop and test a series of medication quality indicators within VA Community Living Centers (Nursing Homes)

Will start with:

PIPE use in the nursing home

Monitoring of medications in the NH

Naïve initiation of Long acting opioids

Table 1: Highest and Lowest Performers for Potassium Monitoring Within

One Month of ACE Inhibitor initiation*

Lowest Performers (Most Errors)

Station ID Number of Patient’s Initiated on

ACEI Number of Errors (%)

1 36 36 (100%)

2 15 15 (100%)

3 13 13 (100%)

4 32 28(87.5%)

5 17 14 (82.4%)

Highest Performers (Least Errors)

Station ID Number of Patient’s Initiated on

ACEI Number of Errors (%)

6 21 0 (0%)

7 19 0 (0%)

8 15 0 (0%)

9 9 0 (0%)

10 9 0 (0%) *=Data censored for 3 or more ACE Inhibitor initiation events

Next Steps Develop benchmarks for Medication Errors in the

outpatient setting

Identify poor performers

Use Medicare D data to take it out of the VA environment

Questions?