Published January 21, 2015 GERIATRICS Questionable Medication Benefit in Advanced Dementia: Decision-Making Tools Mary Ann E. Zagaria, PharmD, MS, CGPIndependent Senior Care Consultant Pharmacist and President of MZ Associates, Inc.Norwich, New Yorkwww.mzassociatesinc.comChair 2014-2015, Board of Commissioners, Commission for Certification in Geriatric PharmacyRecipient of the Excellence in GeriatricPharmacy Practice Award from the Commission for Certification in Geriatric Pharmacy. US Pharm. 2015:40(1):21-23. The number of U.S. residents aged >65 years now reaches approximately 40 million; that number is expected to grow to an estimated 78.9 million in 2050.1 Included in those figures are most nursing home patients with advanced dementia who may be receiving medications with questionable benefit—medications that are also associated with adverse effects and substantial costs.2 Furthermore, the evidence base supporting the use of many common treatments and tests for older adults is inadequate; researchers suggest that this is partly because older adults are significantly underrepresented in clinical trials.3 Roughly half of those aged >65 years have multimorbidity; many geriatric patients, their families, and caregivers are dealing with complex medication regimens, thereby increasing the risk of medication-related problems and other adverse events.4-7 In addition, regardless of the availability of generic drug options, cost is still a very real concern for healthcare stakeholders, patients, and caregivers—and often one of the driving concerns presented when pharmacists’ expertise and guidance are sought regarding a pharmacotherapy plan and medication therapy management. Therefore, guidance for making appropriate medication choices for patients with advanced dementia is welcome. This article will review examples of medication and treatment issues in advanced dementia and highlight relevant guidance from Choosing Wisely, an initiative of the American Board of Internal Medicine (ABIM) Foundation. Medication Issues in Advanced Dementia Advanced dementia is characterized by severe cognitive impairment and complete functional dependence. Patients are unable to walk, feed themselves, or do any other activities of daily living; patients may also be incontinent. Memory, both recent and remote, is completely lost. Swallowing may be impaired; individuals are at risk of undernutrition, pneumonia (especially due to aspiration), and pressure ulcers.8 Placement in a long-term care facility often becomes necessary due to complete dependence on the care of others. Patients eventually become mute.8 Consideration of the use of medications having questionable benefit, especially in advanced dementia, has been a challenge for many clinicians. According to Tjia et al, patients’ goals of care should guide the prescribing of medication during a terminal illness such as advanced dementia.2 According to one prospective cohort study involving 22 Boston-area nursing homes, acetylcholinesterase inhibitors and lipid-lowering agents were the most common inappropriate drugs.9 Tjia et al found factors that were independently associated with a greater likelihood of taking inappropriate medications; these included being male, having better functional status, a diagnosis of diabetes mellitus, and a shorter nursing home stay; a do-not-hospitalize order was associated with a lower likelihood.9 A subsequent cross-sectional study of medication use by 5,406 nursing home residents with advanced dementia found that 53.9% of patients received at least one medication with questionable benefit; cholinesterase inhibitors, memantine hydrochloride, and lipid-lowering agents were the most commonly prescribed. Tjia et al concluded that most nursing home residents with advanced dementia receive medications with questionable benefit that incur substantial associated costs.2 Of note, Kiely et al found that a minority of nursing home residents with advanced dementia received hospice care; those receiving hospice care were more likely to have received scheduled opioids for pain and symptomatic treatment for dyspnea and had fewer unmet needs at the end of life.10 Overall, a philosophy of minimizing or eliminating medications that do not support the primary goal of care should be advocated by clinical healthcare providers.2 Conversations between clinician and patient are one necessary step to stay focused on a “less is more” approach. What tools can pharmacists use to educate healthcare providers and to assist in educating patients and caregivers so they are better informed to make goal-of-care decisions and advocate with regard to dementia care? How can clinician-patient conversations such as these be facilitated? According to Sachs, the work by Tjia and colleagues should stimulate clinical healthcare providers, not only in nursing homes but also in a variety of practice settings, to reconsider their prescribing and decision-making practices for a wide population of late-life patients.11 This work is also an integral part of a series called Less Is More, addressing the ABIM Foundation’s Choosing Wisely campaign.11 This initiative, among others, is focused on minimizing the use of questionably beneficial and potentially harmful medications, tests, and treatments and employing the most appropriate ones.3,12 The Choosing Wisely campaign is a multiyear effort engaging nearly 45 medical specialty societies to promote conversations between physicians and patients.13 Healthcare provider organizations in the United States—representing more than 1 million providers—developed lists of “things physicians and providers should question” for use in conversations to improve care and eliminate unnecessary tests and procedures. These lists are also appropriate for use by individuals, including pharmacists in their role as academic detailers. They have been highlighted by the National Resource Center for Academic Detailing (NaRCAD), which is supported by a grant from the Agency for Healthcare Research and Quality (AHRQ) with a mission to improve health outcomes and evidence-based medical practice by supporting programs of academic detailing.13,14 Choosing Wisely and the AGS The American Geriatrics Society (AGS) is partnering with the ABIM Foundation’s Choosing Wisely campaign, publishing “Ten Things Physicians and Patients Should Question,” to help physicians, patients, and other healthcare stakeholders think about and discuss the overuse of healthcare resources in the U.S.15 The first AGS list was published in 2013 and the second list was published in 2014.3,12 The national campaign aims to help patients take a more involved role in their healthcare by learning to choose medical tests and treatments that are supported by scientific evidence, are not duplicative of past tests or procedures, and are truly necessary for diagnosis or treatment. Choosing Wisely recommendations should not be used to establish coverage decisions or exclusions, but rather were developed to spark discussion and conversation about what treatments are appropriate and necessary. Since each patient situation is unique, tailored appropriate treatment plans should be developed by the healthcare provider in conjunction with the patient, using the recommendations as guidelines. Pharmacists are encouraged to view the complete sections and lists (www.choosingwisely.org) for guidance and materials for their patients in late life, specialty patient populations, and varied practice settings. Selected Recommendations Examples of Choosing Wisely guidance relevant to advanced dementia, two medication-related and one procedure-related, are outlined below (See Resources for more information). Don’t prescribe cholinesterase inhibitors for dementia without periodic assessment for perceived cognitive benefits and adverse gastrointestinal effects.15 This statement, sixth in the list “Ten Things Physicians and Patients Should Question” from the AGS, is supported by randomized controlled trials in which some patients with mild-to-moderate and moderate-to-severe Alzheimer’s disease achieved modest benefits in delaying cognitive and functional decline and decreasing neuropsychiatric symptoms. However, the impact of cholinesterase inhibitors on institutionalization, quality of life, and caregiver burden is less well established. The experts recommend that clinicians, caregivers, and patients discuss cognitive, functional and behavioral goals of treatment prior to beginning a trial of cholinesterase inhibitors. They also suggest that the following should be included in the treatment plan in addition to any consideration of a trial of cholinesterase inhibitors: advance care planning, patient and caregiver education about dementia, diet and exercise, and nonpharmacologic approaches to behavioral issues—all as an integral part of the care of patients with dementia. These experts recommend that if goals of treatment are not attained after a reasonable trial (e.g., 12 weeks), the clinician should consider discontinuing the medication. They indicate that the risks and benefits of long-term therapy have not been well-established and that the benefits of therapy beyond 1 year have not been investigated.15-19 Cholesterol drugs for people 75 and older: when you need them—and when you don’t.20 This section, produced by Consumer Reports and AMDA—The Society for Post-Acute and Long-Term Care Medicine, succinctly explains for the patient what cholesterol is and what it does. It addresses the following topics: 1) adults aged >75 and older may not need statins; 2) statins have risks; 3) weigh the risks and benefits; 4) statins can cost a lot; 5) when should older adults take statins? It discusses the fact that for older patients, there is no clear evidence that high cholesterol leads to heart disease and death, and that some studies indicate that older people with the lowest cholesterol levels actually have the highest risk of death. In addition, it outlines risks in older adults such as falls, memory loss, and confusion, and nausea, constipation, or diarrhea (in addition to muscular adverse effects and drug-drug interactions). Of note, older adults may experience an increase in the risk of diabetes, cataracts, and kidney and liver damage with statin use, further complicating a comorbidity, such as advanced dementia.20 Don’t recommend percutaneous feeding tubes in patients with advanced dementia; instead offer oral assisted feedings.21 This statement is the first in the list “Ten Things Physicians and Patients Should Question” from the AGS, and also addressed by AMDA—The Society for Post-Acute and Long-Term Care Medicine in the list “Five Things Physicians and Patients Should Question.” It is supported by strong evidence that artificial nutrition does not prolong life or improve quality of life in patients with advanced dementia. Percutaneous endoscopic gastrostomy, or PEG, is a procedure in which a flexible feeding tube is placed through the abdominal wall and into the stomach. PEG allows nutrition, fluids, and/or medications to be put directly into the stomach, bypassing the mouth and esophagus. Pharmacists are involved in this issue with regard to the appropriateness of medication administration considerations (e.g., with enteral nutrition [EN] formulations, dosage forms not appropriate for administration through a feeding tube, mixing medications with EN formulations, diluting liquid medications, medication administration timing, specific drug-nutrient interactions). The experts indicate that tube feeding does not ensure comfort or reduce suffering in advanced dementia and may cause fluid overload, diarrhea, abdominal pain, local complications, and less human interaction and may increase the risk of aspiration. It has been noted that a patient with advanced dementia who is not eating is unlikely to obtain any significant or long-term benefit from artificial nutrition. The experts underscore that assistance with oral feeding (i.e., careful hand-feeding) is an evidence-based approach and will provide nutrition (i.e., food as the preferred nutrient) for patients with advanced dementia and feeding problems.15,21 Conclusion Patients’ goals of care should guide the prescribing of medication in advanced dementia, a terminal condition characterized by severe cognitive impairment and complete functional dependence. When pharmacists address the use of unnecessary medications and focus on the patient’s goals of care to guide the prescribing of medication, the use of reliable, current, and evidence-based resource tools such as Choosing Wisely is encouraged as an integral part of pharmacotherapy planning and the comprehensive medication review process. REFERENCES 1. U.S. Department of Commerce Economics and Statistics Administration Bureau of the Census. Aging in the United States—past present and future. www.census.gov/population/international/files/97agewc.pdf. Accessed November 30, 2012. 2. Tjia J, Briesacher BA, Peterson D, et al. Use of medications of questionable benefit in advanced dementia. JAMA Intern Med. 2014;174:1763-1771. 3. American Geriatrics Society identifies five things that healthcare providers and patients should question. AGS Choosing Wisely Workgroup. J Am Geriatr Soc. 2013;61:622-631. 4. Boyd CM, Fortin M. Future of multimorbidity research: how should understanding of multimorbidity inform health system design? Public Health Rev. 2011;32:451-474. 5. Mercer SW, Smith SM, Wyke S, et al. Multimorbidity in primary care: developing the research agenda. Fam Pract. 2009;26:79-80. 6. 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. 2005;294:716-724. 7. 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American Geriatrics Society updated Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2012;60:616-631. 18. Kaduszkiewicz H, Zimmermann T, Beck-Bornholdt HP, van den Bussche H. Cholinesterase inhibitors for patients with Alzheimer’s disease: systematic review of randomized clinical trials. BMJ. 2005;331:321-327. 19. Birks J. Cholinesterase inhibitors for Alzheimer’s disease. Cochrane Database Syst Rev. 2006; 25;(1):CD005593. 20. ABIM Foundation. Choosing Wisely. Cholesterol drugs for people 75 and older: when you need them—and when you don’t. April 2014. www.choosingwisely.org/doctor-patient-lists/cholesterol-drugs-for-people-75-and-older. Accessed December 15, 2014. 21. ABIM Foundation. AMDA—The Society for Post-Acute and Long-Term Care Medicine. Choosing Wisely. Five things physicians and patients should question. Released September 4, 2013. www.choosingwisely.org/doctor-patient-lists/amda. Accessed December 15, 2014. 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