Avoiding Hobson’s choice in older patients: Managing multi-morbidity and multiple medications in geriatrics Marilyn N. Bulloch, PharmD, BCPS Assistant Clinical Professor Harrison School of Pharmacy Auburn University The Hobson’s Choice in Geriatric Pharmacotherapy Don’t Prescribe It Prescribe It Objectives Discuss the impact of the aging population on healthcare utilization. Understand age-related pharmacokinetic and pharmacodynamics changes that may affect pharmacotherapy in older adults Describe complications of chronic medication therapy in the aging patient. Identify strategies to optimize benefit and minimize harm with chronic medication therapy in older adults. Our Patients Are Aging Population 65+ by Age: 1900-2050 Source: U.S. Bureau of the Census 100,000,000 90,000,000 80,000,000 Number of Persons 65+ 70,000,000 60,000,000 50,000,000 40,000,000 30,000,000 20,000,000 10,000,000 0 1900 1910 1920 1930 1940 1950 1960 Age 65-74 1970 Age 75-84 1980 1990 2000 2010 2020 2030 2040 2050 Age 85+ Available: http://www.aoa.gov/Aging_Statistics/future_growth/future_growth.aspx#age (Accessed April 2013) Patients Are Living Older Longer Available: http://www.aoa.gov/Aging_Statistics/future_growth/future_growth.aspx#age (Accessed April 2013) Chronic Conditions in Older Adults Available: http://www.aoa.gov/Aging_Statistics/future_growth/future_growth.aspx#age (Accessed April 2013) Multi-morbidity Co-occurrence of: Index disease Preexisting age-related health condition or diseases Impact Affect disease progression Decrease quality of life Increase risk and severity of disability Increase risk of mortality Shi et al. Eur J Clin Pharmacol 2008;64:183-199 Patients with Multi-morbidity 2009-2010 60.00% 50.00% 45.30% 2009-2010 60.00% 49.00% 42.50% 40.00% 30.00% 30.00% 20.00% 20.00% 10.00% 10.00% 0.00% 0.00% Men Women 45.10% 42.40% 50.00% 40.00% Total 51.60% Black White Hispanic Adapted from Figure 1. Fried et al. NCHS Data Brief 2012;100:1 Adapted from Figure 2. Fried et al. NCHS Data Brief 2012;100:2 Multiple Medications in Older Adults Exhibit 13. IMS Institute for Healthcare Informatics. Avoidable Costs in U.S. Healthcare: The $200 Billion Opportunity from Using Medicines More Responsibly. June 2013. Available http://www.imshealth.com (accessed 20 June 2013) Evidence-Based Geriatric Medicine Studies involving geriatrics 3% randomized, controlled studies 1% meta-analyses Make up 2-9% study subjects In 2000 3.45% of controlled trials 1.2% of meta-analysis Le Couteur et al. Aus Fam Phys 2004;33:777-781 Applying EBM to Older Adults Does your patient resemble the studied population? How many older adults with multi-morbidity were included? What are the intended outcomes – are these applicable to older patients? Are there clinically important variation in baseline factors that affect intended outcome? Are the risks of the intervention known in older adults with multi-morbidity? What is known about the comparator intervention in older adults? What is the time until benefit or harm? Adapted from Table 1. J Am Geriatr Soc 2012;60:1957-68 Age-Related Physiologic Changes Adapted from Figure 1. Huang A. 28th Annual Scientific Meeting of the Canadian Geriatric Society 2008;11(10):7 Absorption Changes ↓ saliva production ↓ gastric acid secretion ↓ gastrointestinal blood flow Delayed gastric emptying Intestinal atrophy Changes in body fat and lean muscle Pulmonary changes Skin changes Conjunctiva changes Hubbard et al. Eur J Clin Pharmacol 2013;69:319-326 McLean et al. Pharmacol Rev 2004;56:163-184 Corsonello et al. Cur Med Chem 2010;17:571-584 Distribution Changes ↑ body fat ↓ lean muscle ↓ total body water ↓ albumin ↑ CNS penetration Hubbard et al. Eur J Clin Pharmacol 2013;69:319-326 Sitar. Expert Rev Clin Pharmacol 2012;5:397-402 McLean et al. Pharmacol Rev 2004;56:163-184 Corsonello et al. Cur Med Chem 2010;17:571-584 Metabolism Changes ↓ hepatic blood flow ↓ liver volume ↓ plasma esterase quantity & activity Associated more with health status than age Phase I pathways more impacted than Phase II McLean et al. Pharmacol Rev 2004;56:163-184 Elimination Changes ↓ glomeruli causes ↓kidney mass ↓ GFR in 2/3 of patients ↑ drug elimination half-life McLean et al. Pharmacol Rev 2004;56:163-184 Pharmacokinetic Questions How readily absorbed is the medication? What is the onset and duration of desired therapeutic action? What is the patient’s body composition? Is the medication excreted unchanged? What is the major route of elimination? Does the medication have an metabolite? Is the metabolite active or toxic? How is the metabolite eliminated? Adapted from Table 2. Lamy. J Am Ger Soc 1982;11;s11- Pharmacodynamic Changes Receptor down regulation Change in receptor sensitivity Increased Decreased Impaired homeostatic mechanisms and/or physiologic reserves COMPLICATIONS OF GERIATRIC MEDICATION USE Polypharmacy Quantity ≥ X Medications Limiting - assumes > X is incorrect Quality More medications than is clinically indicated No indication Lack efficacy Duplications Requires more thorough review of medications DeSovo et al. Prim Care Clin Office Pract 2012;39:345-362 Reasons for Polypharmacy Age Ethnicity Rural residence Education level Insurance Multiple healthcare providers Poor health status Provider visits Chronic diseases Anemia Angina Asthma Depression Diabetes Diverticulosis Gout Hypertension Osteoarthritis DeSovo et al. Prim Care Clin Office Pract 2012;39:345-362 Avoidable Costs of Polypharmacy Exhibit 12. IMS Institute for Healthcare Informatics. Avoidable Costs in U.S. Healthcare: The $200 Billion Opportunity from Using Medicines More Responsibly. June 2013. Available http://www.imshealth.com (accessed 20 June 2013) Adverse Drug Reactions Unwanted and/or harmful effects that can occur at standard doses Gurwitz et al 50.1 ADRs per 1000 person years 13.8 preventable ADRs per 1000 person years VA GEM Study 33% of patients experienced an ADR within 12 months of hospital discharge 38% considered preventable Boparai MK et al. Mt Sinai J Med 2011;78:613-626 Gurwitz et al. JAMA 2003;289:1107-1116 Steinman et al. J Gerontol A Biol Sci Med Sci 2011;66:444-451 Risks for ADRs Prior ADR Polypharmacy Dementia/cognitive impairment Multi-morbidity Frailty CrCl < 50 mL/min Female Fragmented care Altered stimuli-induced adaptation capacity Recent hospital admission Age ≥ 85 years Low body weight ≥ 1 oz alcohol intake/ day Vision or hearing impairment Compliance Regimen complexity DeSovo et al. Prim Care Clin Office Pract 2012;39:345-362 Boparai MK et al. Mt Sinai J Med 2011;78:613-626 Medications Causing ADRs Preventable ADRs Total ADRs 40% 35% 30% 25% 20% 15% 10% 5% 0% Gurwitz JH, et al. JAMA 2003;289;107-116 Types of ADRs Occurring Figure 1. Percent patients suffering selected injuries commonly studied among patients who experienced adverse drug events: Reducing and Preventing Adverse Drug Events To Decrease Hospital Costs. March 2001. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/research/findings/factsheets/errors-safety/aderia/figure1.html (Accessed April 24, 2013) ADR Consequences Health care utilization 10% of emergency room visits 10-17% of hospitalizations $1.33 to manage medication-related morbidity and mortality for each $1 spent on older adults in nursing homes Can be fatal Symptoms should be considered ADRs until proven otherwise. Le Couteur et al. Aus Fam Phys 2004;33:777-781 Budnitz et al. N Eng J Med 2011;365”2002-2012 Boparai MK et al. Mt Sinai J Med 2011;78:613-626 Drug Interactions Many types 15-46% patients have ≥ 1 interaction 1 in 25 community patients at risk for severe interaction Over 26% cause ADRs that require hospitalization 25% serious or life-threatening Approximately 20% occur in the hospital Potential for drug-drug interaction in over 6% of medication orders McDonnell, et al. Ann Pharmacother 2002;36:1331-1336 Qato et al. JAMA 2008;300:2867-2878 Reimche et al. Clin Pharmacol 2011;51:1043-1050 Lindblad et al. Clin Therapeu 2006;28:1133-1143 Drug Interactions Age years – 24% ≥ 80 years – 36% 60-74 Risk increases with # medications ≥ 2 medications – 13% > 6 medications – 82% ≥ 8 medications – almost 100% Boparai MK et al. Mt Sinai J Med 2011;78:613-626 Stegemann et al. Age Research Rev 2010;9:284-298 Minimizing ADRs and Interactions Know allergies – including reactions Evaluate cognitive function Have a drug information source Use safest/most effective medication Match medications to indications Use fewest medications possible Use simple dosing Do not start 2 medications at the same time Screen for DDIs routinely Dose for renal & hepatic function Recognize a symptom as an ADR Give prophylaxis for known side effects when able Stop medications without benefit Stop PRN medications not used in past month Medication lists Involve caregivers Adapted from: Boparai MK et al. Mt Sinai J Med 2011;78:613-626 Non-Adherence Adherence in patients with chronic conditions only 50-60% Responsible for up to 70.4% of medication-related ER visits May account for 39-69% of drug-related hospitalizations each year Costs $100 billion/year Coleman et al. J Manag Care Pharm 2012;18:527-539 Orwig et al. Gerontologist 2006;46:66 Cost of Non-Adherence Exhibit 3. IMS Institute for Healthcare Informatics. Avoidable Costs in U.S. Healthcare: The $200 Billion Opportunity from Using Medicines More Responsibly. June 2013. Available http://www.imshealth.com (accessed 20 June 2013) Types of Non-adherence Forgetfulness Confusion over dosage schedule Intentional underuse Primary non-adherence Non-persistence Nonconforming non-adherence Intentional overuse Coleman et al. J Manag Care Pharm 2012;18:527-539 Risk Factors for Non-Adherence Communication Regimen complexity Patient-provider relationship Transition of care Health literacy Mental health disorders Cognition Smoking Asymptomatic chronic diseases Age Physical impairment Lack of social support Minority demographic Patient beliefs Sensory changes Product use Dysphagia Dosing Influence on Adherence Frequency of Daily Dosing Taking Adherence Regimen Adherence Timing Adherence Once daily 93% 81.8% 76.9% Twice daily 85.6% 74.2% 59.3% 3 times daily 80.1% 62.8% 35.9% 4 times daily 84.4% 68.2% 18.8% Coleman et al. J Manag Care Pharm 2012;18:527-539 Overcoming Adherence Barriers Barrier Solution Forgetfulness • • • • • Patient beliefs • Establish shared goals of care • Provide literacy appropriate materials • Simplify regimen/reduce pill burden Difficulty Taking • • • • • • Cost • Generics Pill organizers Medication Calendar/Cues Dispensing Devices Family/caregiver involvement Internet-linked or electronic adherence aid Change formulation Easy off caps Pill cutters Simplify regimen Syringe magnification Spacer Steinman et al. JAMA 2010;304:1592-1601 EVALUATING MEDICATION MANAGEMENT ABILITY Drug Regimen Unassisted Grading Scale (DRUGS) Medication List (container or chart) Medication List (patient-reported) Identification Total Medications: Total Doses: Maximum Score: Total Score: Access Dosage Timing Summary Score: (Total Score/Maximum Score) X 100 Time: Adapted from Edelberg et al. J Am Geriatr Soc 1999;47:592-596 MedTake Test Drug Name, dose, SIG Patient description of how to take drug Dose (25%) Indication (25%) Food/water coingestion (25%) Regimen (25%) Score per drug Comment (0-100%) 1. 2. 3. 4. 5. Scoring: 1 = correct, 0 = incorrect Composite (Mean) MedTake Score (0-100%): _____% Adapted from Appendix I. Raehl et al. Pharmacotherapy 2002;22:1239-1248 Perfectly correct Mostly correct Somewhat correct Somewhat incorrect Mostly incorrect Totally incorrect MedTake Test Dose +0 +5 +10 +15 +20 +25 Indication +0 +5 +10 +15 +20 +25 Co-ingestion with food or water +0 +5 +10 +15 +20 +25 Regimen and schedule +0 +5 +10 +15 +20 +25 Sum of points (0-100) Knowledge score for individual drug Adapted from Appendix I. Raehl et al. Pharmacotherapy 2002;22:1239-1248 Medication Regimen Complexity Index Checklist style tool to evaluate regimen Only for prescribed medications Medication Regimen Complexity = Total (A) + Total (B) + Total (C) Open index # medications and directions vary by patient George et al. Ann Pharmacother 2004;38:1369-1376 MRCI Section A: Dosage Forms Adapted from Appendix II. George et al. Ann Pharmacother 2004;38:1374-1375 MRCI Section B: Dose Frequency Adapted from Appendix II. George et al. Ann Pharmacother 2004;38:1374-1375 MRCI Section C: Directions Adapted from Appendix II. George et al. Ann Pharmacother 2004;38:1374-1375 Medication Management Instrument for Deficiencies in the Elderly What a Patient Knows About Their Medications Yes No 1. Name all daily medications – Rx and OTC 2. State time of day each prescription medication is taken 3. State how each medication is taken (po, with water, ect) 4. State indication for each medication 5. State amount of each medication to be taken at each dose 6. Identify if there are problems with medications (ADRs) 7. Does patient get help with medications By whom:_____________ Type:__________________ 8. Other medications on hand (outdated, unused, discontinued) “No” selection for 1-5 credited to Total Deficiency Score Adapted from Orwig et al. Gerontologist 2006;46:661-668 Medication Management Instrument for Deficiencies in the Elderly If a Patient Knows How to Take Their Medications Yes No Yes No 1. Can fill a glass with water 2. Can remove top from medication container 3. Can count out required number of pills into hand or cup 4. Can put hand with medication to open mouth; put hand to eye for eye drops; hand to mouth for inhaler; draw up insulin; place a transdermal patch 5. Can sip enough water to swallow medication 6. How are medications currently stored If a Patient Knows How to Get Their Medications 1. Identify a refill exists on a prescription 2. Identify who to contact to refill a prescription 3. Does patient have resources to obtain medications “No” selection for Part 1: 1-5 and Part 2: 1-3 credited to Total Deficiency Score Adapted from Orwig et al. Gerontologist 2006;46:661-668 Hopkins Medications Schedule Appendix. Carlson et al. J Gerontol A Biol Sci Med Sci 2005;60;223 AUXILIARY LABELS & THE IMPORTANCE OF VERBAL COUNSELING In Conclusion We have a lot of older patients Patients are staying older longer Older patients need medications They respond differently than younger patients There is not a lot of EBM to guide decisions or answer questions on geriatric medication use Try to optimize medication prescribing and use to minimize complications before taking the Hobson’s Choice Questions “All substances are poisons; there is none which is not. The right dose differentiates a poison from a remedy” -Paracelsus (1493-1541)