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Clinical Practice Tools for

Identifying Potential

Medication-Related

Problems in the Elderly

ASCP 45th Annual Meeting and ExhibitionOrlando,FLNovember 5,2014William Simonson,PharmD,CGP,FASCPIndependent Consultant PharmacistSenior Research Professor (Pharmacy Practice)Oregon State University

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+Learning Objectives

After attending this educational presentation the participant

will 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

! MAI- Medication Appropriateness Index

! IPET – Improved Prescribing in the

Elderly Tool

! Zhan – AHRQ

! ACOVE – Assessing Care of Vulnerable

Elderly

! MRCI – Medication Regimen Complexity

Index

! NCQA-HEDIS

! STOPP/START

! IMAP – Individual Medication Assessment

and Planning Tool

! Beers Criteria

! GPGPA – Good Palliative Geriatric

Practice Algorithm

! SMOG – Screening Medications in the

Older Drug User

! ARMOR – Assess, Review, Minimize,

Optimize, Reassess

! TIMER – Tool to Improve Medications in

the Elderly via Review

! AOU - Assessment of Underutilization

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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 t han 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 thecriteria.

! 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 elderlypopulation, 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.

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+ Assessing Care of Vulnerable Elderly (ACOVE):

Quality Indicators for Appropriate Medication Use in

Vulnerable Elders

! RAND Corporation, 2001, developed quality indicators to examine t he 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

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+ 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 f or 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

! ScreeningTool of Older PersonsPotentially InappropriatePrescriptions

! Identifies commission errors

! Comprehensive list of geriatric PIMs

! ScreeningTool to A lert Doctors to the Right Treatment! Identifies omission errors

! Recommends beneficial medications f or 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 ca re 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 “Criteria” – 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 Criteria – 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 theEvidence 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.

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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

! 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: observational (retrospective cohort study)

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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

! Measures: WHO-UMC ADE causality, 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

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! Pasina L et al. Clin Pharm Ther 2014;39:511-515.

! Sample: hospitalized 65 and over, PIM = Beers 2003/2012

! 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

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!Fick DM et al. Res Nursing Health 2008.!

Sample: MCO 65 and older; PIM: Beers 2003

! 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

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+PIMs, Pharmacist Intervention, andHospitalization

!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)

!

significant differences in comorbidities between groups

and small sample size (N=69)

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+Quick Review

! PIMs and hospitalization – not convincing

! PIMs and death – not convincing

! STOPP vs Beers – STOPP appears to be more

sensitive for harm

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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.

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+ Adverse Drug Events and the Elderly

Individuals > 65 yrs more likely than younger tosuffer an ADE; RR 2.4 (95% CI 1.8-3.0)

Budnitz DS et al. JAMA 2006:296:1858-66

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Budnitz et al. New Engl J Med 2011;365:2002-12.

Estimated Rates of Emergency

Hospitalizations for Adverse DrugEvents in Older Adults, 2007-2009

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+Independent Risk Factors forHaving 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

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+What has your experience been?

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+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

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