This document summarizes a presentation on clinical practice tools for identifying potential medication-related problems in the elderly. The presentation discusses several tools including the Beers List, Medication Appropriateness Index, IPET, Zhan-AHRQ, Medication Regimen Appropriateness Index, STOPP/START, IMAP, and NCQA-HEDIS. It provides definitions of related terms and describes each tool, how it was developed, its strengths and limitations. The presentation aims to help clinicians incorporate these tools into practice to improve medication management for elderly patients.

1. +
Clinical Practice Tools for
Identifying Potential
Medication-Related
Problems in the Elderly
ASCP 45th Annual Meeting and Exhibition
Orlando, FL
November 5, 2014
William Simonson, PharmD, CGP, FASCP
Independent Consultant Pharmacist
Senior Research Professor (Pharmacy Practice)
Oregon State University

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Learning Objectives
After attending this educational presentation the participant
should be able to:
 List the names of at least three tools to identify ADEs, MRPs, or PIMs
 Identify the relative value of these tools in affecting patient outcomes
 Describe how these tools can be incorporated into day-to-day
practice

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Disclosures
 The speakers have no financial relationships to disclose

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PIMs and ADEs
What Tools are Available?
 Beers List
 Medication Appropriateness Index
 IPET
 Zhan-AHRQ
 Medication Regimen Appropriateness Index
 STOPP/START
 IMAP
 NCQA-HEDIS
 Beers Criteria

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Definitions and Terminology
 MRP- Medication Related Problem: An event or situation involving drug
therapy that negatively interferes with a patient’s health
 Polypharmacy – 5 or more medicines?, 6.1? 9 or more medicines?
 “Administration of more medicines than are clinically indicated, representing
unnecessary use”
 PIM – Potentially Inappropriate Medication
 DIM – Definitely Inappropriate Medication
 PIP – Potentially Inappropriate Prescription
 PIPE – Potentially Inappropriate Prescribing in the Elderly
 PPO – Potential Prescribing Omissions
 DAE – Drug to be avoided in the elderly
 DRP – Drug-Related Problem
 ADWE – Adverse Drug Withdrawal Events
 Suboptimal prescribing

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Potentially Inappropriate Medications
 Emphasis on “Potentially”
 PIM ≠ DIM
 Consider the individual patient
 Experts don’t always agree on “inappropriate”
 Delphi technique v. evidence-based methods
 Actual harm vs. predicted Harm – High “signal
to noise” ratio
 No harm no foul?
 PIM identification is only a starting point

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True or False?
 The STOPP criteria have been proven to identify
medications that are definitely inappropriate for use by
seniors in nursing facilities.

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Consequences of MRPs and PIMs
 Hospitalization
 ↑ length of stay
 ADR
 ADE
 Inefficient resource use
 Financial waste
 Polypharmacy
 Medication errors
 Therapeutic failure
 Poor QOL
 Morbidity and mortality
 ↑Illness duration
 NF placement
 Functional decline
 Social decline

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The Beers List
 In 1991, Dr Mark Beers published a paper with
explicit criteria to identify potentially inappropriate
medication (PIM) use in nursing home residents.
 Delphi technique (also referred to as GOBSAT)
 Update published in 1997 to apply to the elderly,
wherever they reside. Updated again in 2003.
 Most recent update - 2012 American Geriatrics
Society

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Medication Appropriateness Index
 Developed in 1992 by expert team based on clinical experience and background literature
 Serves as sensitive measure of potential improvement in prescribing quality secondary to
clinical pharmacist intervention
 May be applicable as quality of care outcome measure in health services research or in
institutional quality assurance programs
 Measures prescribing appropriateness according to ten criteria for each medication prescribed
 Appropriate
 Marginally appropriate
 Inappropriate
 It does not address under-prescribing. Clinical expertise is required to apply some of the
criteria.
 Requires at minimum, medical history, problem list, and medication list
 Barrier: 10 minutes/drug
Hanlon JT. J Clin Epidemiol 1992:45:1045-1051.

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Medication Appropriateness Index
1. Is there an indication for the drug?
2. Is the medication effective for the condition?
3. Is the dosage correct?
4. Are the directions correct?
5. Are the directions practical?
6. Are there clinically significant drug-drug interactions?
7. Are there clinically significant drug-disease interactions?
8. Is there unnecessary duplication with other drugs?
9. Is the duration of therapy acceptable?
10. Is this drug the least expensive alternative compared to
others of equal utility?
Min = 0 = Completely appropriate
Max = 18 = Completely inappropriate

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IPET
 Improved Prescribing in the Elderly Tool
 1997 consensus-based mail survey of 32 member panel
from Canadian medical centers (included 8 pharmacists)
 List of 38 high-risk prescribing situations in an elderly
population, primarily contraindicated drugs and drug-disease
interactions
McLeod PJ et al. Can Med Assoc J 1997;156:385-391.

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IPET Example
 Practice
 Long-term prescription of long t1/2 benzodiazepines to treat insomnia
 Mean clinical significance
 3.72
 Risk to patient
 May cause falls, fractures, confusion, dependence and withdrawal
 Alternative therapy
 Nondrug therapy or short t1/2 benzodiazepine
 % of panel members who agreed with alternative
 97%
McLeod PJ et al. Can Med Assoc J 1997;156:385-391.

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Zhan-AHRQ
 Looked at PIMs in community-dwelling elderly in 1996 using
Medical Expenditure Panel Survey representing 33.2 million lives
 Expert panel of 7 members (geriatricians,
pharmacoepidemiologist, pharmacist) classified 33 drugs from
1997 Beers drugs into three categories:
 Always avoid (used by 2.5% of study population)
 Rarely appropriate (used by 9.1% of study population)
 Some indications (used by 13.3 % of study population)
 Most use considered inappropriate
Zhan C et al. JAMA 2001;286:2823-29.

15. + Assessing Care of Vulnerable Elderly (ACOVE):
Quality Indicators for Appropriate Medication Use in
Vulnerable Elders
 RAND Corporation, 2001, developed quality indicators to examine the quality of
medical care for the vulnerable elderly in the US
 Vulnerable elderly – community-dwelling persons expected to die or become severely
disabled within next 2 years
 The most comprehensive examination to date
 Combination of clinical evidence and expert opinion
 ACOVE Phase 3 added new indicators for: COPD, colorectal cancer, breast cancer,
sleep disorders, BPH
Knight EL. Ann Int Med 2001;135:703-710

16. + Assessing Care of Vulnerable Elderly (ACOVE):
Quality Indicators for Appropriate Medication Use in
Vulnerable Elders
 ACOVE Quality Indicators
 Drug indication—clearly defined in record
 Patient education—purpose, how to take, expected side effects, important ADEs
 Medication list—up-to-date, in record
 Response to therapy—documented within six months
 Periodic drug regimen review—at least annually
 Monitoring warfarin therapy—INR w/in 4 days and at least every 6 weeks
 Monitoring of diuretic therapy—electrolytes w/in 1 week and yearly
 Avoid use of chlorpropamide as hypoglycemic agent, due to long half-life, serious
hypoglycemia
 Avoid drugs with strong anticholinergic properties when possible
 Avoid barbiturates—potent CNS depressants, low therapeutic index, highly
addictive, multiple drug interactions, increase risk for falls/fractures
 Avoid meperidine—increased risk for delirium
 Monitor renal function and potassium in patients prescribed ACE inhibitors w/in 1
week
Knight EL. Ann Int Med 2001;135:703-710

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Medication Regimen
Complexity Index (MRCI)
 Developed under the assumption that complexity of drug therapy involves more than number and types of
medications
 Developed by researchers and expert panel
 Tool consists of three sections
 Dosage form
 Dosing frequency
 Additional directions
 MRCI is a sum of the 3 sections -- higher scores, more complex regimen
 Drugs include Rx, OTC, nutritional supplements, health products, dermatologicals, short-term medications
(e.g. antibiotics)
 Requires 2-8 minutes per regimen, depending on complexity
 Possible use
 Risk assessment tool
 To predict health outcomes
 To identify patients who would benefit from additional services
 Reporting drug regimen data
 Research tool
George J. Ann Pharmacother 2004;38:1369-76.

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NCQA-HEDIS (2006)
 2002, Secretary of HHS called for national action plan to ensure appropriate use of therapeutic
agents in the elderly population
 NCQA convened expert consensus panel using modified delphi technique to identify rates of
inappropriate prescribing in the elderly
 Panel classified the 2003 beers drugs as follows
 Always avoid
 Rarely appropriate
 Some indications
 Drugs in the always avoid and rarely appropriate composed the 2006 Health Plan Employer
Data and Information set (HEDIS) measure to assess quality of care of older Americans
 Percent of persons receiving at least 1 HEDIS criteria drug
 Male 19.2%
 Female 23.3%
Pugh MH et al. J Manag Care Pharm. 2006;12:537-45.

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NCQA-HEDIS (2014)
 National Committee for Quality Assurance, Health Care
Effectiveness Data and Information Set (HEDIS)
 Continues to assess % of Medicare members ≥age 66 who receive
high-risk medications
 Based on 2012 Beers Criteria
 ↓ use of high-risk medications is an opportunity to reduce costs and
encourage clinicians to prescribe safer alternative medications
 Many other HEDIS measures are reported

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STOPP/START
 Screening Tool of Older Persons Potentially Inappropriate
Prescriptions
 Identifies commission errors
 Comprehensive list of geriatric PIMs
 Screening Tool to Alert Doctors to the Right Treatment
 Identifies omission errors
 Recommends beneficial medications for specific conditions
 Developed in 2008 by European geriatricians using Delphi consensus
technique and clinical evidence
 Inter-rater reliability: proportion of positive agreement
 STOPP 87%
 START 84%
Gallagher P et al. Int J Clin Pharmacol Ther 2008;46:72-83

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Selected STOPP Items
 Thiazide diuretic with diagnosis of gout
 Calcium channel blocker with constipation
 Tricyclic antidepressants with dementia
 PPI for PUD @ full dose for >8 weeks
 Regular opiates >2 weeks with chronic constipation without
laxative
 High risk drugs in fallers (psychoactive Rx, vasodilators,
diphenhydramine, etc.)

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Selected START Items
 Warfarin in chronic atrial fibrillation
 ACE inhibitor with chronic heart failure
 Antidepressants in severe depression >3 months
 Bisphosphonates when taking chronic corticosteriod Rx
 Ca++/Vit D in osteoporosis

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IMAP
 Individualized Medication Assessment and Planning tool.
 Developed in 2011 for use by ambulatory care pharmacists and for
research
 IMAP based on the best of existing tools
 Easy to use
 Applicable to ambulatory care
 Intuitive (easy identification of MRP category and recommendation)
 MRP clearly defined and distinctive
 Reliable and valid
Crisp GD et al. Am J Geriatr Pharmacotherapy 2011;9:451-460.

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IMAP
 Developed for ambulatory care pharmacists
 Guide RPhs’ comprehensive assessment of a pt’s medication use to
identify MRPs
 Provide RPh with mechanism for classifying:
 Clinically meaningful information to describe each MRP
 Their plan to address and resolve each MRP
Crisp GD et al. Am J Geriatr Pharmacotherapy 2011;9:451-460.

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The Beers “List” – What Is It?
 Beers Criteria, not Beers List
 Most recent update - 2012 American Geriatrics Society Updated
Beers Criteria published on-line (americangeriatrics.org)
 Evidence-based with recommendations, based on risk v benefit assessment
 Strength of evidence: strong, weak, insufficient
 Quality of evidence: high, moderate, low
 Well-known and respected, but not necessarily well-understood

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The Beer’s List – What Is It Not?
 A list
 A tool to identify “forbidden” drugs in the elderly
 A resource that everyone agrees on
 A resource that always improves clinical outcomes

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Take away Points
 Many different tools to identify MRPs, PIMs, etc. etc.
 Consider how they were developed
 Consider strengths v. weaknesses
 Consider what they are designed to do
 “Potential” problem vs. “actual”problem
 The tool doesn’t rule - never lose sight of the individual
patient

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PIMs and ADEs: What’s the
Evidence of Harm
ASCP 45th Annual Meeting and Exhibition
Orlando, FL
November 5, 2014
H. Edward Davidson, PharmD, MPH
Assistant Professor of Internal Medicine
Eastern Virginia Medical School
Partner, Insight Therapeutics, LLC
Norfolk, VA

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Are we looking in the right places?
Does the evidence build a strong case that
PIMs are contributing to increased
hospitalization or death in older individuals?
Or
Are there others areas that we should be focusing on
in order to reduce ADEs in older individuals?

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Hill’s Criteria of Causation (1965)
 Strength of Association: The larger the relative effect, the more likely
the causal role of the factor.
 Dose-response: If the risk increases with increasing dose of the risk
factor, the more likely the causal role of the factor.
 Consistency: If similar associations are found in different studies in
different populations, the more likely the causal role of the factor.
 Temporality: Risk factor exposure must precede the outcome.
 Intervention: Reduction or removal of the risk factor must reduce the
risk of the outcome.
 Biological Plausibility: The association agrees with currently accepted
understanding of pathological processes.
 Coherence: Associations between the risk factor and the outcome must
be consistent with existing knowledge.
31

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The Evidence
 Lau DT et al. Arch Intern Med 2005;165:68-74.
 Sample: nursing home 65 and over, MEPS NHC, PIM = Beers
2003
 Design: Retrospective cohort study, N=3,372
 Measures: use of PIM during 1 year period
 PIMs increased risk of hospitalization: OR 1.28 (1.10-1.50)
 PIMs increased risk of death: OR 1.21 (1.00-1.46)
 Most frequent PIMs: narcotics, antihistamines,
sedative/hypnotics, GI antispasmotics, antidepressants, platelet
inhibitors, iron supplements
 Limitations: did not find dose-response/duration effect, no
causality assessment
32

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The Evidence – cont.
 Hamilton H et al. Arch Intern Med 2011;171:1013-19.
 Sample: hospitalized 65 and over, PIM = STOPP/Beers 2003
 Design: Prospective cohort study, N=600
 Measures: WHO-UMC ADE causality and expert panel consensus
 STOPP PIMs contributed to hospitalization; OR 1.85 (1.51-2.26)
 Beers PIMS did not; OR 1.28 (0.95-1.72)
 Most common PIMs: benzodiazepines, antihypertensives, opiates
 Limitations: did not include OTC meds, duration of use not
determined
33

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The Evidence – cont.
 Pasina L et al. Clin Pharm Ther 2014;39:511-515.
 Sample: hospitalized 65 and over, PIM = Beers 2003/2012
 Design: Cross-sectional study, N=844
 Measures: use of PIM at hospital discharge, re-hospitalization or
death within 3 months
 No significant association with re-hospitalization: OR 0.77 (0.48-
1.19)
 No significant association with mortality: OR 0.84 (0.44-1.52)
 Most frequent PIMs (2012): ticlopidine, antiarrhythmic drugs,
alpha blockers, benzodiazepines
 Limitations: conducted in Italy, did not assess adherence, no
causality assessment
34

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The Evidence – cont.
Fick DM et al. Res Nursing Health 2008.;31:42-51.
 Sample: MCO 65 and older; PIM: Beers 2003
 Design: Retrospective cohort study, N=17,971
 Measure: health care utilization over 6 months, PIM use
 PIMs increased risk for hospitalization: OR 1.99 (1.76-2.26)
 Most frequent PIMs: estrogen only, propoxyphene,
benzodiazepines, digoxin, NSAIDs
 Limitations: did not consider diagnosis or condition criteria
35

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The Evidence – cont.
Dedhiya et al. Am J Geriatr Pharmacother 2010.
 Sample: Medicaid 65 and older; PIM: Beers 2003
 Design: Retrospective cohort study, N=7,594
 Measure: PIM use
 PIMs increased risk for hospitalization: OR 1.27 (1.10-1.46)
 PIMs increased risk of death: OR 1.46 (1.31-1.62)
 Most frequent PIMs: inappropriate drug choice category
 Limitations: retrospective, no causality assessment
36

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The Evidence – cont.
Reich O et al. PLos ONE 2014;9.
 Sample: Health Claims (Swiss) 65 and older; PIM: Beers
2012, PRISCUS (German)
 Design: Retrospective cohort study, N=49,668
 Measure: PIM use and hospitalization at 1 year
 PIMs increased risk for hospitalization: One PIM: OR 1.13
(1.07-1.19), 3 or more PIMs: 1.63 (1.40-1.90)
 Most frequent PIMs: not reported
 Limitations: did not consider diagnosis/condition criteria,
retrospective, no causality assessment
37

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PIMs, Pharmacist Intervention, and
Hospitalization
Cochrane Collaboration review – 2012
 4 studies addressed PIM use (Beers 2003, MAI), pharmacist
intervention, and hospitalization rate
 Overall, a significant reduction in MAI score post
intervention noted
 One of 4 studies …
 reported significant reduction in hospitalization rate in
intervention group (22% reduction)
 limitations: significant differences in comorbidities
between groups and small sample size (N=69)
38

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Quick Review
PIMs and hospitalization – low to moderate
level data suggest relationship, but….
PIMs and death – as above
STOPP vs Beers – STOPP appears to be more
sensitive for harm (one study)

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True or False?
When referring to causation, temporality describes
the increase in risk of an adverse drug event with
increasing dose of medication.

41. + Adverse Drug Events and the Elderly
Individuals > 65 yrs more likely than younger to
suffer an ADE; RR 2.4 (95% CI 1.8-3.0)
Budnitz DS et al. JAMA 2006:296:1858-66

42. Budnitz et al. New Engl J Med 2011;365:2002-12.
Estimated Rates of Emergency
Hospitalizations for Adverse Drug
Events in Older Adults, 2007-2009

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44. +
Executive Summary
653 Medicare beneficiaries discharged from hospitals
to SNF for post-acute care (35 days or less)
Assessed for adverse events (AE) (SNF Trigger Tool)
and temporary harm and if preventable
2 stage attribution process; screener, MD panel
22% experienced an AE during SNF stay
59% were deemed preventable
11% experienced harm (60% hospitalized)
44

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46. +
Independent Risk Factors for
Having a Preventable ADE in NFs
Risk Factor Odds Ratio 95% CI
Male 0.55 0.30 - 0.99
No. regularly scheduled meds
0-4
5-6
7-8
>=9
1.0
1.7
3.2
2.9
Referent
0.83 - 3.5
1.4 - 6.9
1.3 - 6.8
New resident+ 2.9 1.5 -5.7
+within 60 days of admission
Field TS, Gurwitz JH et al. Arch Intern Med 2001;161:1629-34.

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What about ….
Therapeutic failure
Adverse drug withdrawal events
Contribution of declining kidney function
Medication reconciliation

49. +
Take Away
PIM tools do . . .
 Educate health care team
 Raise awareness
 Make you think
PIM tools do not . . .
 Always prevent harm
 Work well to identify those at risk for harm