2. Geriatric Patients and Medications: When Less is More Susan W. Miller, Pharm.D. Mercer University College of Pharmacy 678-547-6217 miller_sw@mercer.edu

3. Geriatric Patients and Medications: When Less is More Susan W. Miller, Pharm.D. No affiliations or relationships to disclose.

4. Geriatric Patients and Medications: When Less is More OBJECTIVES: At the conclusion of the presentation and learning activities, the pharmacist should be able to: Classify the issues of polypharmacy in the geriatric patient population. Contrast the advantages and disadvantages when using clinical practice guidelines to prescribe medications for senior patients. Examine the evolving practice of medication discontinuation in senior patients. Given case scenarios, appropriately revise medication regimens for senior patients with chronic disease, including Alzheimer’s Dementia.

5. Goals of Pharmacotherapy All Patients Cure disease Eliminate or reduce symptoms of disease Arrest or slow disease progression Prevent disease or symptoms Geriatric Patients Maintain independence Prevent disability Prevent morbidity and mortality Avoid adverse effects Kane Rl, Ouslander JG, Abrass IB. Clinical implications of the aging process. In: Essentials of Clinical Geriatrics, 6th ed. New York: McGraw-Hill, 2009:3–22.

6. “Frailty” or “Frail Elderly” Seniors that are vulnerable and at highest risk for adverse health outcomes Associated with inflammation which may down-regulate drug metabolism and transport The frail are those at high risk for: Dependency Institutionalization, Hospitalization Falls, Injuries Acute Illness, Slow Recovery from Illness Mortality McLachlan AJ, Pont LG. Drug metabolism in older people—A key consideration in achieving optimal outcomes with medicines. J Gerontol A Biol Sci Med Sci 2012;67A:175–180.

7. Clinical Practice Guidelines Recommended by IOM to improve health care quality CPGs synthesize best evidence and expert opinion to support decision making about treating specific (single) diseases Measures of quality of care used to assess clinical performance for: Accountability purposes Pay-for-performance initiatives The National Guideline Clearinghouse http://www.guideline.gov/ http://www.guideline.gov/ – AHRQ >3000 active CPGs in June 2015 CPGs include: Medication therapy recommendations Suggested monitoring parameters (labs, diagnostics) Suggested ancillary HC services Recommendations for follow up care Boyd CM, Darer J, Boult C, et al. Clinical practice guidelines and quality of care for older patients with multiple comorbid diseases: implications for pay for performance. JAMA 294(6):2005; 716-24

8. Challenges of CPGs in Geriatrics Managing older adults with multiple conditions and consuming multiple medications Management of one condition may worsen others Older adults prioritize competing health outcome priorities: – Cardiovascular – Fall injury – Medication related symptoms Consideration of Patient Preferences – Clinical decision should involve both: Evidence based medicine Patient centered medicine – Ex: Preferences for intensity of treatment for diabetes in older adults Goals of care should be individualized to the clinical context, healthcare goals, and treatment preferences of the patient Larson EB. Evidence, guidelines, performance incentives, complexity, and old people: a clinician’s dilemma. JAGS 57(2):2009:353-4. Brown SES, Meltzer DO, Chin MH, et al. Perceptions of quality-of-life effects of treatments for diabetes mellitus in vulnerable and nonvulnerable older patients. JAGS 56:2008; 1183-90. Tinetti ME et al. Health outcome priorities among competing cardiovascular, fall injury, and medication related symptom outcomes. JAGS 56:2008;1409-14.

9. Polypharmacy Concomitant use of multiple medications OR Administration of more medications than are clinically indicated – Prescription, OTC, and Dietary Supplements A principle medication safety issue Associated risks and syndromes of polypharmacy – Falls, cognitive impairment, nonadherence, diminished functional status, increased HC costs Shah BM, Hajjar ER. Polypharmacy, adverse drug reactions, and geriatric syndromes. Clin Geriatri Med. 2012;28: 173–186.. Qato DM, Alexander GC, Conti RM, et al. Use of prescription and over-the-counter medications and dietary supplements among older adults in the United States. JAMA 2008;300:2867–2878.

10. Medication Nonadherence Not having prescription filled – Primary nonadherence Discontinuation before supply is consumed Taking more or less than the prescribed dose Reported to occur 40% - 86% of seniors Reasons include – ADEs, complex regimens, lack of understanding, cost, third party issues Elliott RA, Shinogle JA, Peele P, et al. Understanding medication compliance and persistence from an economics perspective. Value Health 2008;11:600–610. Butler RJ, Davis TK, Johnson WG, et al. Effects of nonadherence with prescription drugs among older adults. Am J Manag Care. 2011;17:153–160. Marcum ZA, Gellad WF. Medication adherence to multidrug regimens. Clin Geriatr Med 2012;28:287–300. Polinski JM, Donohue JM, Kilabuk E, Shrank WH. Medicare Part D’s effect on the under- and overuse of medications: a systematic review. J Am Geriatr Soc 2011;59:1922–1933.

11. Medication Nonadherence Associated with – Clinical decompensation – Increased HC services – 8% of ED visits – Increased hospitalizations – 4% - 11% of admissions – Potential or actual ADRs Sokol MC, McGuigan KA, Verbrugge, Epstein RS. Impact of medication adherence on hospitalization and health care cost. Med Care 2005;43:521–530. Roebuck MC, Liberman JN, Gemmill-Toyama M, et al. Medication adherence leads to lower health care use and costs despite increased drug spending. Health Aff (Millwood) 2011;30:91–99.

12. Adverse Drug Reaction Reaction that is noxious and unintended and occurs at the dosage normally used in humans for prophylaxis, diagnosis, or therapy – In 30,000 Medicare outpatients, 5% experienced at least one ADR in a one year period – 33% of frail elderly male outpatients experienced at least one ADR in a one year period – Most common type of MRP in elderly SNF patients Handler SM, Wright RM, Ruby CM, Hanlon JT. Epidemiology of medication-related adverse events in nursing homes. Am J Geriatr Pharmacother 2006;4:264–272. Institute of Medicine. Committee on Identifying and Preventing Medication Errors: Preventing Medication Errors: Quality Chasm Series. Washington, DC: National Academy Press, 2006. Gurwitz JH, Field TS, Harrold LR, et al. Incidence and preventability of adverse drug events among older persons in the ambulatory setting. JAMA 2003;289:1 107–1116. Hanlon JT, Pieper CF, Hajjar ER, et al. Incidence and predictors of all and preventable adverse drug reactions in frail elderly post hospital stay. J Gerontol Med Sci 2006;61A:511–515.

13. Geriatric Patients at High Risk for ADRs Use of NTI medications – lithium – digoxin – warfarin – anticonvulsants History of prior ADRs Presence of > 6 illnesses Polypharmacy – 9 or more meds – 12 or more doses per day – >3 cardiac meds Consumption of high-risk medications – Medications on the AGS Beers List, STOPP List and START List Patient characteristics – low body weight – > 85 yrs old – decreased renal function – “frail”

14. Suboptimal Drug Use and Adverse Drug Event in Geriatric Inpatient Case Study and Active Learning

15. Medication Appropriateness in Later Life Medication Appropriateness Tools available to evaluate medication appropriateness in seniors – AGS Beers Criteria, STOPP Criteria, START Criteria Little information available regarding “how to” & “effect of” discontinuation of medications in seniors Medication Discontinuation Consider at care transitions To guide the process of discontinuation consider: – Patients’ remaining life expectancy – Time until clinical benefit of the medication – Goals of care – Treatment targets – Taper based on PK Holmes HH. Rational prescribing for patients with a reduced life expectancy. Clin Pharm Ther 85(1): 2009; 103-7.

16. Medication Discontinuation Benefits of Discontinuation Minimize ADRs Minimize medication errors Minimize medication non- adherence Reduce medication burden Reduce costs Potentially improve QOL Barriers to Discontinuation Adverse Drug Withdrawal Events (ADWEs) Lack of data on process Patient interpretation that death is imminent Potentially viewed as substandard care What about algorithms and CPGs? Garfinkel D, Mangin D. Feasibility study of a systematic approach for discontinuation of multiple medications in older adults. Arch Itern Med 170(18): 2010;1648-54. Graves T, Hanlon JT, Schmader KE, et al. Adverse events after discontinuing medications in elderly outpatients. Arch Intern Med 1997;157:2205–2210.

17. Medication Discontinuation Consider Potential Risks and Benefits Statins Reduce risk of vascular events after 2 to 5 years AE: increased liver enzymes, myalgia Aspirin Reduce risk of MI after 5 years AE: GI bleed Antihypertensives and Antidiabetics Show benefit on average after 10 years Prevent renal damage AE: Orthostatic hypotension, hypoglycemia Bisphosphonates Reduce fracture risk in women with OP within 1 year AE: GI bleed

18. Adverse Drug Withdrawal Events Clinically significant sets of symptoms or signs caused by the removal of a drug – May be delayed based on PK Prevention: Avoid abrupt withdrawal; consider tapering Discontinue medications one-at-a-time, so ADWEs can be easily identified Examples: – Beta-blockers  angina, anxiety, hypertension, MI, tachycardia – Benzodiazepines  agitation, anxiety, confusion, delirium, insomnia, seizures – Antidepressants  depression symptoms – Antidiabetics  hyperglycemia Marcum ZA, Pugh MJV, Amuan ME, et al. Prevalence of potentially preventable unplanned hospitalizations caused by therapeutic failures and adverse drug withdrawal events among older veterans. J Gerontol 2012; 67(8):867-74.

19. Clinically Complex Ambulatory Geriatric Patient Case Study and Active Learning

20. Geriatric Patients and Medications: When Less is More Medication use by seniors can lead to improvements in QOL, yet negative outcomes caused by MRPs are considerable. MRPs in seniors are common, costly, and clinically important. Regular review of medications, with the intent to streamline medications, can lead to improvements in QOL while avoiding MRPs.

21. Observations on Drug Therapy “Any symptom in an elderly patient should be considered a drug side effect until proved otherwise.” J Gurwitz, et al. Brown University Long-Term Care Quality Letter, 1995.

22. References Avorn J. Polypharmacy: a new paradigm for quality drug therapy in the elderly. Arch Intern Med 164(18): 2004; 1957-9. Boyd CM, Darer J, Boult C, et al. Clinical practice guidelines and quality of care for older patients with multiple comorbid diseases: implications for pay for performance. JAMA 294(6):2005; 716-24. Brown SES, Meltzer DO, Chin MH, et al. Perceptions of quality-of-life effects of treatments for diabetes mellitus in vulnerable and nonvulnerable older patients. JAGS 2008;56:1183-90. Butler RJ, Davis TK, Johnson WG, et al. Effects of nonadherence with prescription drugs among older adults. Am J Manag Care. 2011;17:153–160. Elliott RA, Shinogle JA, Peele P, et al. Understanding medication compliance and persistence from an economics perspective. Value Health 2008;11:600–610. Garfinkel D, Mangin D. Feasibility study of a systematic approach for discontinuation of multiple medications in older adults. Arch Itern Med 170(18): 2010;1648-54.

23. References Graves T, Hanlon JT, Schmader KE, et al. Adverse events after discontinuing medications in elderly outpatients. Arch Intern Med 1997;157:2205–10. Gurwitz JH, Field TS, Harrold LR, et al. Incidence and preventability of adverse drug events among older persons in the ambulatory setting. JAMA 2003;289:1107– 1116. Hajjar ER, Hanlon JT, Sloane RJ, et al. Unnecessary drug use in frail older people at hospital discharge. J Am Geriatr Soc 2005;53:1518–1523. Hajjar ER, Cafiero AC, Hanlon JT. Polypharmacy in elderly patients. Am J Geriatr Pharmacother 2007;5:345–351. Handler SM, Wright RM, Ruby CM, Hanlon JT. Epidemiology of medication-related adverse events in nursing homes. Am J Geriatr Pharmacother 2006;4:264–272. Hanlon JT, Pieper CF, Hajjar ER, et al. Incidence and predictors of all and preventable adverse drug reactions in frail elderly post hospital stay. J Gerontol Med Sci 2006;61A:511–515. Holmes HH. Rational prescribing for patients with a reduced life expectancy. Clin Pharm Ther 85(1): 2009; 103-7.

24. References Hubbard RE, O’Mahony MS, Calver BL, Woodhouse KW. Plasma esterases and inflammation in ageing and frailty. Eur J Clin Pharmacol 2008;64:895–900. Institute of Medicine. Committee on Identifying and Preventing Medication Errors: Preventing Medication Errors: Quality Chasm Series. Washington, DC: National Academy Press, 2006. Kane Rl, Ouslander JG, Abrass IB. Clinical implications of the aging process. In: Essentials of Clinical Geriatrics, 6th ed. New York: McGraw-Hill, 2009:3–22. Larson EB. Evidence, guidelines, performance incentives, complexity, and old people: a clinician’s dilemma. JAGS 57(2):2009:353-4. Marcum ZA, Gellad WF. Medication adherence to multidrug regimens. Clin Geriatr Med 2012;28:287–300. Marcum ZA, Pugh MJV, Amuan ME, et al. Prevalence of potentially preventable unplanned hospitalizations caused by therapeutic failures and adverse drug withdrawal events among older veterans. J Gerontol 2012; 67(8):867-74.

25. References McLachlan AJ, Pont LG. Drug metabolism in older people—A key consideration in achieving optimal outcomes with medicines. J Gerontol A Biol Sci Med Sci 2012;67A:175–180. Polinski JM, Donohue JM, Kilabuk E, Shrank WH. Medicare Part D’s effect on the under- and overuse of medications: a systematic review. J Am Geriatr Soc 2011;59:1922–1933. Qato DM, Alexander GC, Conti RM, et al. Use of prescription and over-the-counter medications and dietary supplements among older adults in the United States. JAMA 2008;300:2867–2878. Roebuck MC, Liberman JN, Gemmill-Toyama M, et al. Medication adherence leads to lower health care use and costs despite increased drug spending. Health Aff (Millwood) 2011;30:91–99. Shah BM, Hajjar ER. Polypharmacy, adverse drug reactions, and geriatric syndromes. Clin Geriatr Med 2012;28: 173–186.

26. References Sokol MC, McGuigan KA, Verbrugge, Epstein RS. Impact of medication adherence on hospitalization and health care cost. Med Care 2005;43:521–530. Steinman MA, Hanlon JT. Managing medications in clinically complex elders. JAMA 304(14):2010;1592-1601. Tinetti ME et al. Health outcome priorities among competing cardiovascular, fall injury, and medication related symptom outcomes. JAGS 56:2008;1409-14. Tobias DE, Sey M. General and psychotherapeutic medication use in 328 nursing facilities: A year 2000 national survey. Consult Pharm 2001;16:54–64.