David Dosa MD, MPH Assistant Professor of Medicine and Community Health The Warren Alpert School of Medicine, Brown University Director, Primary Care

Transcription

1 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

2 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)

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4 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)

5 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)

6 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)

7 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)

8 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

9 Source: Handler: American Journal of Geriatric Pharmacotherapy

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11 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

12 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

13 ADEs in Hospital Settings One ADE $8750 per ADE 400,000 ADEs per year 3.5 billion in extra health care costs

14 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

15 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

16 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

17 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:

18 Gurwitz Study (2)

19 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)

20 Why are the Elderly Most Affected Simple Demographics By 2030, nearly 1 in 5 US Residents will be 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

21 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

22 Loss of Physiological Reserve Disease Severity Compensatory Mechanisms Symptomatic Asymptomatic

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24 To Err is Human Prescribing 39% (Physician) Transcribing 12% (Pharmacy) Compounding 11% (Pharmacy) Administering---38% (Nursing/Point of Care) What is Missing?

25 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%)

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27 Evolution of the HEDIS list of avoidable medications Beers List is introduced Archives of Internal Medicine, 1991; 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

28 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

29 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

30 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

31 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

32 Potentially Inappropriate Medications in the Elderly

33 Potentially Inappropriate Medications in the Elderly

34 Conditions Exacerbated by PIPE Medications

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36 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

37 Source: Rothberg

38 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

39 Source: Pugh

40 Source: Pugh

41 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)

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43 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)

44 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, ). 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, ).

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46 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

47 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)

48 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

49 Distribution of ADEs

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51 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

52 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

53 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 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

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55 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

56 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.

57 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

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59 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

60 Table 1: Highest and Lowest Performers for Potassium Monitoring Within One Month of ACE Inhibitor initiation* Station ID Lowest Performers (Most Errors) Number of Patient s Initiated on ACEI Number of Errors (%) (100%) (100%) (100%) (87.5%) (82.4%) Station ID Highest Performers (Least Errors) Number of Patient s Initiated on ACEI Number of Errors (%) (0%) (0%) (0%) (0%) (0%) *=Data censored for 3 or more ACE Inhibitor initiation events

61 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

62 Questions?