Medication Risk in the Older Adult: Medication Risk in the Older Adult: A Hidden and Costly EpidemicA Hidden and Costly Epidemic

Penny Shelton, Pharm.D., CGP, FASCP

Director of Experiential Programs

Associate Professor, Dept of Pharmacy Practice

Campbell University

Claudia Schlosberg, J.D.

Director of Policy and Advocacy

American Society of Consultant Pharmacists

Agenda

Medication Use in Older AdultsMedication Related Problems (MRPS)Costs of MRPsPreventabilityInappropriate Prescribing and Non-AdherenceMTM and the Role of PharmacistsPolicy Implications and RecommendationsCase Studies

Medication Use in the ElderlyMedication Use in the Elderly

Seniors make-up approx. 12 % of U.S. population but account for 37.2% of total Rx spendMedicare Part D increased prescription utilization by almost 5% in 2006***40% OTC medications

Kaufman DW, et al. JAMA 2002;287:337-44; IMS 1997; Ketcham JK, Simon KI. Am J Managed Care 2008;14:SP14-21; U.S. Census Bureau

MRPs are Common among Older Adults

Older adults (65 +) are: 2.5 txs more likely to visit ERS due to an

MRPs than younger individuals. 7 txs more likely to be hospitalized for an

MRPs than younger individuals.

Budnitz DS, Pollock, DA, Weidenbach KN, et al, National Surveillance of ER Visits for Outpatient ADEs, JAMA, 2006; 296:1858-1866.

Outcomes of Medication Related Outcomes of Medication Related ProblemsProblems

10% of all hospital admissions28% of hospitalizations of the elderly

• ADRs (17%)

• Non-adherence (11%)

23% of all nursing home admissions

Vermiere E, Hearnshaw H, Van Royen P, Denekens J.  Patient adherence to treatment:  three decades of research:  a comprehensive review.  J Clin Pharm Ther 2001;26:331-342; Col N, Fanale JE, Kronholm P. The role of medication noncompliance and adverse drug reactions in hospitalizations of the elderly. Arch Intern Med 1990;150:841–5; Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients.  JAMA 1998;279(15):1200–5. Strandberg LR.  Drugs as a reasons for nursing home admissions.  J Am Health Care Assoc 1984;10:20-3

Example: Falls

Falls- “No risk factor for falls is as potentially preventable or reversible as medication use.”

Leipzig, Gumming and Tinetti, 1999)

• 1 in 3 seniors fall each year, 30% of falls result in injury

• Average non-fatal injury costs $7,300• $48 million: the annual cost of falls from a

populationof 100,000 seniors

Costs of MRPs in 2000Costs of MRPs in 2000

$ 13.8 billion – physician visits

$121.5 billion – hospitalizations

$ 5.8 billion – emergency room visits

$ 32.8 billion – nursing home care

$ 3.5 billion – new prescriptions

$177.4 billion – direct medical costs of

DRPs

Ernst FR, Grizzle AJ. J Am Pharm Assoc 2001;41:192-9

Prescription drug costs in 2006 = $217 billion

Annual Cost of Diseases Affecting People 65+ in the US

0

20

40

60

80

100

120

140

160

180

Billions of Dollars

cardiovascular

cancer

drug-related problemsAlzheimer's disease

diabetes

osteoarthritis

stroke

osteoporosis

Older Adults at Highest RiskOlder Adults at Highest RiskOlder adults are at the highest risk for medication related problems (MRPS) due to:

– age-related physiological changes

– high-prevalence of multiple chronic diseases

– large numbers of prescription and OTC medications

– visual and cognitive impairments that interfere with

proper use and adherence to medications

– poverty

– language, literacy, and cultural barriers

Potential Medication-Related Potential Medication-Related Problems (MRPs)Problems (MRPs)

Untreated indications

Improper drug selection

Subtherapeutic dose

Failure to receive drugs

Overdosage

Adverse drug reactions

Drug interactions

Drugs without an indicationStrand, et al. Drug Intell Clin Pharm 1990;24:1093-97

HCTZKCL

ZYLOPRIM

DIABETAMECLIZINE

The Domino EffectThe Domino Effect

Common Symptoms of the Elderly: Common Symptoms of the Elderly: Drug or Disease?Drug or Disease?

Fatigue

Altered mental status

Falling

Constipation

Blurred vision

Depression

Dizziness

Medication Problem or Aging?Medication Problem or Aging?

“Any symptom in an elderly patient should be considered a drug side effect until proven otherwise.”

Gurwitz J, Monane M, Monane S, Avorn J.Brown University Long-term Care Quarterly Letter 1995

Risk Factors for MRPs in Elderly Risk Factors for MRPs in Elderly OutpatientsOutpatients

PATIENT CHARACTERISTCSPolypharmacyDementiaMultiple chronic diseasesImpaired kidney functionRecent hospitalizationAge 85 yearsMultiple prescribersRegular use of alcohol (> 1 fl oz/d)Prior ADR

Hajjar ER, et al. Am J Geriatr Pharmacother 2003;1:82-9)

MRPs in Older Ambulatory PatientsMRPs in Older Ambulatory Patients

1523 ADE identified from records and MD reports27.6% preventable

Prescribing stage– wrong drug/wrong therapeutic choice (27.1%)– wrong dose (24%) – inadequate patient education (18%)– drug-drug interactions (13.3%)

Monitoring stage– Failure to respond to lab values or drug

toxicity(36.6%)– Inadequate lab monitoring (36.1%)

Gurwitz JH, et al. JAMA 2003;289:1107-16.

Preventability of MRPsPreventability of MRPs

Of fatal, life-threatening & serious events

Of significant events

Preventable42% Preventable

19%

Event Rate IssuesEvent Rate Issues

Rate found may be underestimate Based on chart review - limitations Classifiers required strong evidence

Extrapolation to total US Medicare population (n=38,000,000) 1,900,000 MRPs per year in ambulatory

setting 180,000 life threatening or fatal MRPs (50%

preventable)To Err is Human, IOM

Budnitz, D. S. et al. JAMA 2006;296:1858-1866.

Estimated Annual Incidence of MRPs Treated in US Emergency Departments

Red line - general population rate of ADEs; beginning at age 60, ADE rate begins to exceed general population

Factors Associated with Factors Associated with Medication ErrorsMedication Errors

The most common groups of factors associated The most common groups of factors associated with errors were those related to:with errors were those related to:

Knowledge and the application of knowledge Knowledge and the application of knowledge regarding drug therapy (30 percent);regarding drug therapy (30 percent);

Knowledge and use of knowledge regarding patient Knowledge and use of knowledge regarding patient factors that affect drug therapy (29.2); factors that affect drug therapy (29.2);

Use of calculations, decimal points, or unit and rate of Use of calculations, decimal points, or unit and rate of expression factors (17.5 percent); and expression factors (17.5 percent); and

Nomenclature (13.4 percent). Nomenclature (13.4 percent).

Lesar et al., Factors related to errors in medication prescribing, JAMA. 277(4):312-Lesar et al., Factors related to errors in medication prescribing, JAMA. 277(4):312-317, 1997, from “To Err is Human,” IOM 2000.317, 1997, from “To Err is Human,” IOM 2000.

Inappropriate Prescribing Inappropriate Prescribing 25 percent of prescriptions written for older people living 25 percent of prescriptions written for older people living the community are for potentially inappropriate medications the community are for potentially inappropriate medications Failure to routinely screen for potential drug interactions, Failure to routinely screen for potential drug interactions, even when medication history information is readily even when medication history information is readily available.available.Computerized alerts and clinical decision support tools Computerized alerts and clinical decision support tools while helpful, are limited:while helpful, are limited:

Alert burdenAlert burden Non-geriatric focusNon-geriatric focus Need to fully integrate clinical and lab informationNeed to fully integrate clinical and lab information Not a substitute for clinical judgmentNot a substitute for clinical judgment

Inappropriate Prescribing in Inappropriate Prescribing in Various Ambulatory SettingsVarious Ambulatory Settings

Setting ≥ 1 inappropriate Reference Community 28.7% ,Willcox 1994 Community 25.0% , Zhan 2001 Homebound 39.7% ,Golden 1999 ALF 16.0% ,Sloane 2002 Residential Care 22.0% . 2Gray 003 Community 21.2% , Curtis 2004 HMOs 28.8% ,Simon 2005

Homehealth 31.0% Cannon, 2006

NoncomplianceNoncomplianceLack of understandingBarriers to communicationsComplex regimenDiffering dosesInconvenient schedulingLack of perceived needAdverse eventsCostSocial isolation

Rx During 1 Year Following Fracture in Rx During 1 Year Following Fracture in Previously Untreated WomenPreviously Untreated Women

Andrade SE, et al. Arch Intern Med 2003;163:2052-7

State Example A: Utilization and Cost Summary for Uncoordinated Care

Patients

Percent Percent PatientsPatients

Percent Percent Prescription Prescription

CostsCosts

Percent Percent PrescriptionsPrescriptions

45% \\46%

10%

Uncoordinated Care Utilization and Cost PercentagesUncoordinated Care Utilization and Cost Percentages

32%

Percent Percent MedicalMedicalCostsCosts

36%

Percent Percent All Costs All Costs

(drug + medical)(drug + medical)

$1.8 B$1.8 B

State Example B: Utilization and Cost Summary for Uncoordinated Care

Patients

Percent Patients

Percent Prescription

Costs

Percent Prescriptions

39% 41% 7% 27%

Percent Medical

Costs

32%

Percent All Costs

(drug + medical)

$905M

Coordinated Care Patients Uncoordinated Care Patients

40,000 pts

$366M 4.3M rxs $539M

State Example C: Utilization and Cost Summary for Uncoordinated Care

Patients

Percent of Patients

Percent of Prescription

Costs

Percent ofTotal

Prescriptions

45% 48%

8% 30%

Percent of Medical Costs

34%

Percent of Medical Costs

plus Prescription Costs

$160.7 M$235.6 M

$75 M

Coordinated Care Patients Uncoordinated Care Patients

Comparison of Uncoordinated Care vs. Coordinated Care PatientsComparison of Uncoordinated Care vs. Coordinated Care Patients by Cost Groups (Percentage and Amount of Total Costs)by Cost Groups (Percentage and Amount of Total Costs)

State Example: Percent Total Dollars By Cost Groups

$500-$999

$1,000-$4,999

$5,000-$9,999

$10,000-$19,999

$20,000-$29,999

$30,000-$49,999

$50,000-$99,999

$100,000

Total Dollar Amount

$74 M

Total Cost Groups (Medical and Drug Costs)Total Cost Groups (Medical and Drug Costs)

$19 M

$130 M

$82 M

47%

53%

$61 M

$97 M $87 M

$123 M

58%

42%

59%

41%

57%

43%

58%

42%

69%

31% 10%

97%3%

90%

≥

Uncoordinated Care Patients

Coordinated Care Patients

Unpublished data, Southeastern ConsultantsMary Kay Owen, R.Ph., C.Ph., 2008

Improving the Quality of Medication Improving the Quality of Medication Use in Elderly PatientsUse in Elderly Patients

“Putting the pieces of the puzzle together to create a solution remains a formidable, but not insurmountable task….All the pieces of the puzzle lie before us; it remains for us to find a way to fit them together”

Jerry H. Gurwitz, M.D.

Gurwitz JH, Arch Intern Med 2002; 162:1670-3

Role of the Pharmacist

“Because of the immense variety and complexity of medications now available, it is impossible for nurses and doctors to keep up with all of the information required for safe medication use. The pharmacist has become an essential resource . . . And thus access to his/her expertise must be possible at all times.”

Institute of Medicine“To Err is Human: Building a Safer Health System” - 2000

What is MTM?What is MTM? Defined by the American Medical Association’s 2008 Current Procedural Terminology (CPT) as:

“Medication Therapy Management service(s) (MTMS) describe face-to-face patient assessment and intervention as appropriate, by a pharmacist.  MTMS is provided to optimize the response to medications or to manage treatment-related medication interactions or complications.”

What is MTM?What is MTM?

Distinct from dispensing and related activities, e.g., counseling

Patient-centered, not product-centered

Focus on the whole patient, not a drug product

Requires collaboration with treatment team

MTM GoalsMTM Goals

Promote appropriate, safe and effective medication use. Improve quality of life and quality of careEmpower patients/caregivers to be active participants in medication and health care managementBe cost effectiveDecrease overall health care costs

Others

Examples of MTM ServicesExamples of MTM Services

Patient assessment for MRPsFormulating a medication treatment planSelecting, initiating, modifying, administering medication within the scope of licenseMonitoring drug therapy outcomes – safety and effectivenessComprehensive medication review to identify and resolve drug-related problemsProviding patient education to enhance adherenceDocumenting and communicating recommendations to other providers

Settings for Delivering MTM Settings for Delivering MTM ServicesServices

All settings of patient care Community pharmacies Hospitals Nursing facilities Office practices Home visits Anywhere that involves patients and/or caregivers

and managing the patient’s medications

Empowerment model

Work collaboratively with other providers

Self-insured Employer: The Self-insured Employer: The Diabetes 10 City ChallengeDiabetes 10 City Challenge

Outcomes Decrease in A1C (5.2%), LDL (32%), SBP (15.7%),

DBP (9.2%) Increase in nutrition, exercise, and weight loss goals Employer savings of ~$918 per employee in total

health care costs ROI of at least 4:1 beginning in the second year 50% reduction in absenteeism and fewer workers’

compensation claims 97.5% of patients reported being satisfied or very

satisfied with their diabetes care

Private Sector: Minnesota CollaborativePrivate Sector: Minnesota Collaborative

BlueCross BlueShield of Minnesota, Fairview Health Services of Minneapolis, and the University of Minnesota one year prospective study 637 drug therapy problems resolved (285 patients) 78% without direct involvement with physician 22% through collaboration with a physician

Patients receiving MTM services demonstrated significant improvement inDrug problems resolvedDrug therapy goals achieved Improved HEDIS measures

Private Sector: Minnesota CollaborativePrivate Sector: Minnesota Collaborative

• Drug expenditures increased by 19.7%• Total health expenditures decreased from

$11,965 to $8,197 per person• Expenditures decreased by 57.9% for

facilities and 11% for professional claims• Return on Investment (ROI) was 12:1

(dollars saved for each dollar invested)• Now a benefit option to employer health

plans across the U.S. as ClearScript

Medicaid MTM Programs

Missouri - Pharmacists and primary care providers working collaboratively have reduced per capita annual program expenditures by $6,804 - total savings $2.4 million annually.Minnesota - Pharmacists identified 3.1 drug therapy problems per recipient. Inadequate therapy represented 73% of resolved problems.Other states with Medicaid MTM programs: Florida, Maryland, Mississippi, Ohio, Virginia, Vermont . . . .

Who Will Benefit from MTM?Who Will Benefit from MTM?

All patients, but most benefit will be realized by patients who are at highest risk Uses prescription or non-prescription medication Uses herbal products or dietary supplements Has an actual or potential drug-related problem

Physicians and other prescribers

Health care system

What the Research ShowsWhat the Research Shows

Pharmacists can: Help patients manage and monitor their drug

therapy Improve overall medication use Improve clinical outcomes Decrease adverse drug events Improve quality of life Reduce overall health care costs

Return on InvestmentReturn on Investment

Ashville Project - Pharmacist MTM program for diabetics saved $1200/pt/yr with improved outcomesMinnesota MTM program resolved 3.1 drug therapy problems per recipient generating average cost savings of approx. $403/pt/yrBussey, On average, $16.70 saved for every $1 invested in clinical pharmacy services (review of 104 studies)Schumock, benefit: cost ratio ranged from 1.7:1 - 17.0:1 (literature review).

Medicare Part D MTMMedicare Part D MTM- A misplaced opportunity- A misplaced opportunity

Inconsistent and overly restrictive inclusion criteria - focus on total drug spend, not risk factorsPoorly defined service criteria resulting in great variability and intensity of servicesIn PDPs, Poor integration with health care providersAntithetical business model

No outcomes criteria or monitoringLack of adequate payment mechanism for provider/pharmacists

Improving Drug Therapy Improving Drug Therapy OutcomesOutcomes

Patients must be educated about the medication, including potential ADRsRecords must contain all current medications, including OTC and herbals (HIT wil help!)Therapeutic end points and ADEs must be monitoredMedication therapy should be systematically review at least annually (or whenever there is a significant change)Improve care coordination between primary care and others treating the patient including pharmacistsIncrease access to pharmacist-provided MTM for patients at highest risk

Knight EL, Avorn J. Ann Intern Med 2001:135:703-10.

How?How?Create new payment models to enhance collaborations between physicians and pharmacists (i.e. patient-centered medical home; separate payment for clinical services from payment for product; Establish Part B benefit for high risk beneficiaries Revamp physician incentives and performance measures to promote effective medication assessment and managementIncrease number of pharmacists with training and expertise in geriatrics

Why is MTM a Policy Imperative?

The aging of the Baby Boom population, combined with an increase in life expectancy and a decrease in the relative number of younger persons, will create a surge in the elderly population that will severely strain the healthcare system.

Strain on the System

As the baby boomers come of age, more money will be spent on pharmaceutical care.

Controlling Drug Spending

The rapid growth of prescription drug expenditures is prompting consumers, policymakers and public and private payors to look for new ways to control drug spending.

• Drug Re-importation

• Promotion of restrictive formularies and formulary management tools

• Promoting generic and therapeutic substitution

• Mandating comparative effectiveness research

• Limiting DTC

• Registration of drug reps

• Academic detailing

Product Cost v. Appropriateness

Sound medication therapy management principles:

• Focus on more than the cost of the pill

• Require collaboration between prescriber and pharmacist

• Benefit from data exchange

– Appropriate prescribing

– Safety and effectiveness

– Persistence and adherence

CASE STUDIES

QUESTIONS?

CONTACT INFORMATION

Penny Shelton, Pharm.D., CGP, FASCP

Director of Experiential Programs

Associate Professor, Department of Pharmacy Practice

Campbell University

PO Box 1090

Buies Creek, NC 27506

800-760-9697 ext. 1716

sheltonp@campbell.edu

Claudia Schlosberg, J.D.American Society of Consultant

Pharmacists

1321 Duke Street

Alexandria, VA 22314

703-739-1316, ext 128

Cschlosberg@ascp.com