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

1. Medication Risk in the Older Adult: A 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

2. Agenda Medication Use in Older Adults Medication Related Problems (MRPS) Costs of MRPs Preventability Inappropriate Prescribing and Non-Adherence MTM and the Role of Pharmacists Policy Implications and Recommendations Case Studies

3. Medication Use in the Elderly • Seniors make-up approx. 12 % of U.S. population but account for 37.2% of total Rx spend • Medicare 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

4. 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.

5. Outcomes of Medication Related Problems • 10% of all hospital admissions • 28% 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

6. 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

7. Costs 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 Prescription drug costs in 2006 = $217 billion Ernst FR, Grizzle AJ. J Am Pharm Assoc 2001;41:192-9

8. Annual Cost of Diseases Affecting People 65+ in the US

9. Older Adults at Highest Risk • Older 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

10. Potential Medication-Related Problems (MRPs) • Untreated indications • Improper drug selection • Subtherapeutic dose • Failure to receive drugs • Overdosage • Adverse drug reactions • Drug interactions • Drugs without an indication Strand, et al. Drug Intell Clin Pharm 1990;24:1093-97

11. The Domino Effect KCL HCTZ ZYLOPRIM DIABETA MECLIZINE

12. Common Symptoms of the Elderly: Drug or Disease? • Fatigue • Altered mental status • Falling • Constipation • Blurred vision • Depression • Dizziness

13. 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

14. Risk Factors for MRPs in Elderly Outpatients PATIENT CHARACTERISTCS • Polypharmacy • Dementia • Multiple chronic diseases • Impaired kidney function • Recent hospitalization • Age  85 years • Multiple prescribers • Regular use of alcohol (> 1 fl oz/d) • Prior ADR Hajjar ER, et al. Am J Geriatr Pharmacother 2003;1:82-9)

15. MRPs in Older Ambulatory Patients • 1523 ADE identified from records and MD reports • 27.6% 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.

16. Preventability of MRPs Of fatal, life-threatening & serious events Of significant events Preventable 42% Preventable 19%

17. Event 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

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

19. Factors Associated with Medication Errors • The most common groups of factors associated with errors were those related to: • Knowledge and the application of knowledge regarding drug therapy (30 percent); • Knowledge and use of knowledge regarding patient factors that affect drug therapy (29.2); • Use of calculations, decimal points, or unit and rate of expression factors (17.5 percent); and • Nomenclature (13.4 percent). Lesar et al., Factors related to errors in medication prescribing, JAMA. 277(4):312-317, 1997, from “To Err is Human,” IOM 2000.

20. Inappropriate Prescribing • 25 percent of prescriptions written for older people living the community are for potentially inappropriate medications • Failure to routinely screen for potential drug interactions, even when medication history information is readily available. • Computerized alerts and clinical decision support tools while helpful, are limited: • Alert burden • Non-geriatric focus • Need to fully integrate clinical and lab information • Not a substitute for clinical judgment

21. Inappropriate Prescribing in Various Ambulatory Settings

22. Noncompliance • Lack of understanding • Barriers to communications • Complex regimen • Differing doses • Inconvenient scheduling • Lack of perceived need • Adverse events • Cost • Social isolation

23. Rx During 1 Year Following Fracture in Previously Untreated Women Andrade SE, et al. Arch Intern Med 2003;163:2052-7

24. State Example A: Utilization and Cost Summary for Uncoordinated Care Patients Uncoordinated Care Utilization and Cost Percentages \\46% 45% 36% 32% $1.8 B 10% Percent Patients Percent Prescription Costs Percent Prescriptions Percent MedicalCosts Percent All Costs (drug + medical)

25. State Example B: Utilization and Cost Summary for Uncoordinated Care Patients Coordinated Care Patients Uncoordinated Care Patients $366M 4.3M rxs $539M 40,000 pts 41% 39% 27% 32% $905M 7% Percent Patients Percent Prescription Costs Percent Prescriptions Percent Medical Costs Percent All Costs (drug + medical)

26. State Example C: Utilization and Cost Summary for Uncoordinated Care Patients Coordinated Care Patients Uncoordinated Care Patients $75 M 48% 45% $160.7 M $235.6 M 34% 30% 8% Percent of Prescription Costs Percent ofTotal Prescriptions Percent of Medical Costs plus Prescription Costs Percent of Patients Percent of Medical Costs

27. Uncoordinated Care Patients Coordinated Care Patients State Example: Percent Total Dollars By Cost Groups Comparison of Uncoordinated Care vs. Coordinated Care Patientsby Cost Groups (Percentage and Amount of Total Costs) $130 M $123 M $97 M $87 M 58% $82 M $74 M 90% 58% $61 M 47% 69% 59% 57% $19 M 42% 53% 42% 41% 31% 43% 97% 3% 10% ≥ Total Cost Groups (Medical and Drug Costs) Unpublished data, Southeastern Consultants Mary Kay Owen, R.Ph., C.Ph., 2008

28. “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. Improving the Quality of Medication Use in Elderly Patients Gurwitz JH, Arch Intern Med 2002; 162:1670-3

29. 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

30. 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.”

31. 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

32. MTM Goals • Promote appropriate, safe and effective medication use. • Improve quality of life and quality of care • Empower patients/caregivers to be active participants in medication and health care management • Be cost effective • Decrease overall health care costs • Others

33. Examples of MTM Services • Patient assessment for MRPs • Formulating a medication treatment plan • Selecting, initiating, modifying, administering medication within the scope of license • Monitoring drug therapy outcomes – safety and effectiveness • Comprehensive medication review to identify and resolve drug-related problems • Providing patient education to enhance adherence • Documenting and communicating recommendations to other providers

34. Settings for Delivering MTM Services • 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

35. Self-insured Employer: The Diabetes 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

36. Private 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 in • Drug problems resolved • Drug therapy goals achieved • Improved HEDIS measures

37. Private 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

38. 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 . . . .

39. 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

40. What 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

41. Return on Investment • Ashville Project - Pharmacist MTM program for diabetics saved $1200/pt/yr with improved outcomes • Minnesota MTM program resolved 3.1 drug therapy problems per recipient generating average cost savings of approx. $403/pt/yr • Bussey, 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).

42. Medicare Part D MTM- A misplaced opportunity • Inconsistent and overly restrictive inclusion criteria - focus on total drug spend, not risk factors • Poorly defined service criteria resulting in great variability and intensity of services • In PDPs, • Poor integration with health care providers • Antithetical business model • No outcomes criteria or monitoring • Lack of adequate payment mechanism for provider/pharmacists

43. Improving Drug Therapy Outcomes • Patients must be educated about the medication, including potential ADRs • Records must contain all current medications, including OTC and herbals (HIT wil help!) • Therapeutic end points and ADEs must be monitored • Medication 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 pharmacists • Increase access to pharmacist-provided MTM for patients at highest risk Knight EL, Avorn J. Ann Intern Med 2001:135:703-10.

44. 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 management • Increase number of pharmacists with training and expertise in geriatrics

45. 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. Why is MTM a Policy Imperative?

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

47. 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 Controlling Drug Spending

48. 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 Product Cost v. Appropriateness

49. CASE STUDIES

50. QUESTIONS?