Partnering in Medication Safety

Kevin L. Wallace, MD, FACMTAssoc. Professor, Dept. of Pharmacy

PracticeUNE College of Pharmacy

April 29, 2011

Perilous Polypharmacy

Presentation Objectives

Increase awareness of polypharmacy-related risk factors and impact on patient outcome.

Promote use of safe and cost-effective medication therapy management tools and strategies.

Support interprofessional collaboration and active patient involvement in care management.

Case 20 yo college student admitted for chief

complaint of several week-duration morning stiffness, unsteady gait, and dysphoria.

PMH: bipolar disorder; gastroesophageal reflux disorder (GERD)

Medications: Geodon 60 mg BID Wellbutrin SR 150 mg QAM Risperdal 2 mg QHS E-mycin 333 mg TID

Case (cont’d)

Failed GERD treatment with Reglan due to “muscle stiffness” innate susceptibility to D2 antagonist-

induced dystonia/movement disorder?

Started on promotility GERD therapy (oral erythromycin) about 2 months prior to this admission. ADE determinant?

Adverse Drug Events (ADE)

ADE = medication-related injury

Highly vulnerable groups include: Elderly (>65 yrs) Younger

adults/adolescents with psychobehavioral disorders

Infants/toddlers “Collateral Damage”

ADE Incidence & Impact

U.S. Population Approx. 500,000 Medicare patient

ADEs/yr in outpatient setting 5th leading cause of death Estimated cost: ~ $300

billion/yr Patient

quality of living cost of care

Gurwitz et al 2003; NEHI 2009

Major Risk Factor: Drug Provision

http://www.medscape.com/viewarticle/724186_print

ADE Risk Determinants

Drug-related Mechanism(s) of

action and potency Dose Formulation Route of

administration Frequency and

duration of use

Patient-related Age Genetic makeup Psychosocial factors Other underlying medical

disorders Exposure to other

substances (e.g., interacting nonpharmaceuticals) Number of drugs in treatment

regimen = most potent ADE risk factor!

Polypharmacy – Definition?

>4 drugs per regimen

May/may not include nonprescription (aka, “OTC”: over-the-counter) medications and other supplements

Common OTC ADEs

acetaminophen (APAP)

Elderly Polypharmacy

Seniors (13% total population) consume: 40% of all prescription drugs 35% of all OTC drugs

Average # Rx meds/yr (OTC NOT included) 65-69 yrs: >13 80-84 yrs: ~18

Am. Soc. Consultant Pharmacists 2004

Common Elderly Neurobehavioral Symptoms

Balance/gait problems

Dizziness Confusion

Insomnia Fatigue Irritability Depressed mood

Wolcott et al 2009

Medications & Fall Risk

Prescribing Cascade

Drug treatment of other drug-related side effects increases ADE risk!

(particularly when # meds exceeds 10)

Major ADE Determinants to Address in Patient Care

Inappropriate prescribing* (IP)

Drug regimen nonadherence*

Unexpected interactions (drug-drug, drug-disease, drug-diet, etc.)

*Overuse and/or underuse!

IP Occurrence by Type

Hanlon et al (2002)

(1989/90) →

(1992/93) →

Treatment indication?

Other ADE Factors to Consider

Critical transition point (e.g., hospital-to-home) provider and/or patient errors

Multiple prescribers per patient

Patient-related: ↓ functional status ↓ care support (family,

finance)

Case

20 yo college student admitted for morning stiffness, unsteady walk, and dysphoria.

PMH: bipolar disorder; gastroesophageal reflux disorder (GERD)

Medications: Geodon 60 mg BID Wellbutrin SR 150 mg qAM Risperdal 2 mg qHS E-mycin 333 mg TID

Case (cont’d)

Failed GERD Rx with Reglan due to “muscle stiffness” (parkinsonism?) Relatively high susceptibility to drug-

induced parkinsonism? Started on GERD therapy (oral

erythromycin) about 2 months prior to hospitalization.

Pharmacodynamic Determinants?

Agonist (+) or

Antagonist (- )

Drug D2

Wellbutrin (bupropion)

+

Geodon(ziprasidone)

- -

Risperdal(risperidone)

- -

Direct Adverse Drug Effects?

Drug Extrapyramidal Side Effects (EPS)*

Wellbutrin No

Geodon Maybe

Risperdal Maybe

Erythromycin No

*EPS: dystonia, parkisonism

Pharmacokinetic (PK) Factors?

Phase I Metabolism - CYP450:

Drug 2D6 3A4

bupropion ↓erythromycin ↓

PK Interactions of Concern

Geodon (ziprasidone) Level

Drug 2D6 3A4

bupropion

erythromycin

PK Interactions of Concern

Risperdal (risperidone) Level

Drug 2D6 3A4Wellbutrin

Erythromycin

Clinical Effects of Concern

Drug EPSWellbutrin

Geodon

Risperdal

Erythromycin

Direct

Indirect*

Direct

Indirect

*Straw that broke the camel’s back?

Other Effects of Concern?

Agonist (+) or

Antagonist (- )

Drug D2

Wellbutrin (bupropion)

+

Geodon(ziprasidone)

- -

Risperdal(risperidone)

- -

Orthostatic hypotension

ADE Primary Prevention

Reduce IP (overuse AND underuse)

Increase patient adherence Improve practice safety and

clinical outcome Collaborative interdisciplinary approach!!!

F.A.M.E.* Trial (2004-06)

>65yo army hospital pts on > 4 chronic disorder meds.

Intervention “combo”: Pharmacist review and

counseling Regular follow-up Use of BP- and lipid-lowering

medication blister packs Prospective trial:

consecutive ~6-mo. phases: “Observation” (n = 200) “Randomization” (n = 159)

Brookes 2007 (Lee et al 2006)* Federal Study of Adherence to Medications in the Elderly

Pr Patient Ph

Medication Therapy Management (MTM)

Pr = prescriber Ph = pharmacist

EPREMR

EMR = electronic medical records

EPR = electronicpharmacy records

Error Prevention

Pr Patient Ph

Medication Therapy Management (MTM)

Pr = prescriber Ph = pharmacist

EPREMR

EMR = electronic medical records

EPR = electronicpharmacy records

Pr Patient Ph

Medication Therapy Management (MTM)

Pr = prescriber Ph = pharmacist

EPREMR

EMR = electronic medical records

EPR = electronicpharmacy records

“The single most effective and necessary step to ensure appropriate prescribing is to assess all medications prescribed at every visit.”

Ballentine 2008

Medication Therapy Review

Missing in current practice?

SAFE Practice Search for ADE:

Symptoms/signs Risk factors (e.g., IP, nonadherence)

Address/Avoid: IP (e.g., inappropriate drug, dose,

frequency, duration) Automatic refills

SAFE Practice

Find and apply cost-effective treatment: Simpler/lower-cost regimen Close monitoring (adherence, outcome) Synchronized refills

Educate/inform: Patient/family Providers

Safe Practice “Rule of Thumb”

“Start low, go slow, listen and watch closely!”

Patient’s Role

More active care partner?

In Closing…

“As lay people and physicians increase their demands for coherent, evidence-based, unbiased drug information, we would all be well served by a comprehensive program to replace our current patchwork of bad communication and excessive promotion with a responsible national system of balanced, evidence-based, and user-friendly drug information.”

Avorn & Shrank 2009

Questions?

Comments?

References American Society of Consultant Pharmacists. Seniors at risk:

designing the system… Available at: http://www.ascp.com/publications/ seniorsatrisk/upload/AtRisk.pdf (accessed 06/21/09)

Avorn J, Shrank WH. Communication drug benefits and risks effectively: there must be a better way. Ann Int Med 2009;150(8):563-5.

Ballentine NH. Polypharmacy in the elderly: maximizing benefit, minimizing harm. Crit Care Nurs Q 2008;31(1):40-5.

Brookes L. Methods to improve adherence: The FAME Trial. 2007. Available at: http://cme.medscape.com/viewarticle/552105 (accessed 06/21/09)

Gurwitz JH, Field TS, Harrold LR, Rothschild J, et al. Incidence and Preventability of adverse drug events among older persons in the ambulatory setting. JAMA 2003;289:1107-1116.

Hanlon JT, Schmader KE, Koronnkowski MJ, Boult C, Artz MB, et al. Use of inappropriate prescription drugs by older people. J Am Geriatr Soc 2002;50:26-34.

References Lee JK, Grace KA, Taylor AJ. Effect of pharmacy care program on

medication adherence and persistence, blood pressure and low-density lipoprotein cholesterol: a randomized controlled trial. JAMA 2006;296(21)2563-2571.

Wolcott JC, Richardson KJ, Wiens MO, Patel B. Meta-analysis of the impact of 9 medication classes on falls in elderly persons. Arch Intern Med 2009;169(21):1952-60.