Todd P. Semla

Fighting against age discrimination in clinical trials.

At the American Geriatrics Society 2008 Annual Meeting, representatives of two geriatric societies, the European Union Geriatric Medicine Societies and the American Geriatrics Society, and two regulatory agencies, the U.S. Food and Drug Administration and the European Medicine Agency, conducted a roundtable discussion aimed at reviewing the participation of older people in clinical trials. This article summarizes the important issues discussed at the meeting. Historically, regulatory agencies started to promote the inclusion of older participants in clinical trials in the late 1980s. The identification of the causes of delay in including older participants in clinical trials, as well as of the ongoing bias against including older participants with multiple comorbidities, is important to help geriatricians fight against age discrimination in clinical trials. To overcome this problem, geriatrics societies and regulatory agencies must work together to propose new definitions, study designs, and technologies aimed at improving the evaluation of drugs in older people with multiple comorbidities and polypharmacy.

Assessment of Medication Management Skills in Older Outpatients

OBJECTIVE: To identify risk factors for poor medication management skills in community-dwelling older adults by using a performance-based medication management assessment instrument. DESIGN: A cross-sectional investigation. SETTING: A university outpatient geriatric assessment clinic. PARTICIPANTS: Fifty-nine community-dwelling older adults aged 62–102 years. MEASUREMENTS: Patients were assessed on their ability to perform medication management tasks, including reading prescription labels, interpreting medication instructions, opening safety-capped vials, removing tablets from vials, and differentiating tablet colors. The Mini-Mental State Examination (MMSE) was administered and the Katz index of activities of daily living was obtained during the same clinic visit. RESULTS: Cognitive impairment (MMSE <24) and physical dependency (Katz ≥1) were both found to be risk factors for the inability to perform individual tasks and independent risk factors for poor overall outcome on the medication management assessment, odds ratios (95% confidence interval) 9.39 (7.82 to 10.96) and 7.24 (5.60 to 8.88), respectively. Age, gender, education, or number of prescription medications were not associated with the ability to perform individual tasks or to overall outcome on the medication management assessment. CONCLUSIONS: Cognitive deficits and physical dependency appear to be strong predictors for the inability to perform tasks associated with medication management. Assessment of medication management skills in older adults living in the community may help identify specific problems, aid in planning patient care, and promote independence.OBJECTIVE:To identify risk factors for poor medication management skills in community-dwelling older adults by using a performance-based medication management assessment instrument.DESIGN:A cross-sectional investigation.SETTING:A university outpatient geriatric assessment clinic.PARTICIPANTS:Fifty-nine community-dwelling older adults aged 62–102 years.MEASUREMENTS:Patients were assessed on their ability to perform medication management tasks, including reading prescription labels, interpreting medication instructions, opening safety-capped vials, removing tablets from vials, and differentiating tablet colors. The Mini-Mental State Examination (MMSE) was administered and the Katz index of activities of daily living was obtained during the same clinic visit.RESULTS:Cognitive impairment (MMSE <24) and physical dependency (Katz ≥1) were both found to be risk factors for the inability to perform individual tasks and independent risk factors for poor overall outcome on the medication management assessment, odds...

2012 American Geriatrics Society Beers Criteria:: New Year, New Criteria, New Perspective

Mark Beers, MD, recognized more than 2 decades ago that the prevention of adverse drug events in older adults is crucial to the public health of this vulnerable population. The Beers Criteria remain simultaneously one of the most used and most controversial sets of medication criteria in the world. Although not without limitations, the Beers Criteria have done more than any other tool in the past decade to improve the awareness of and clinical outcomes for older adults with polypharmacy and for the most vulnerable older adults at risk of adverse drug events. They have accomplished this because of their explicit nature, simple application for nonpharmacy experts, and wide dissemination. The continued development of explicit lists of medications to avoid in older adults, such as the Beers Criteria, is a critical component, albeit not the only one, in the public health imperative to decrease drug-related problems and improve the health of older adults. Nevertheless, continuing challenges include evaluating and communicating a drug’s risks and benefits in older adults to individual clinicians across all settings of care and developing an explicit list of these medications as part of a concise document that meets the needs of patients, clinicians, educators, researchers, policy-makers, and regulators. This article provides a perspective from the co-chairs of the 2012 American Geriatrics Society (AGS) Beers Criteria by addressing these issues, exploring the major differences and intended use of the criteria in this AGS-sponsored update, and proposing an agenda for future work. The authors believe the 2012 criteria are vastly improved from previous iterations because they include important updates to the established method for developing the explicit list of medications to avoid in older adults and consider the challenges of guiding individual clinicians in avoiding certain drugs in older adults or using them with caution. Most importantly, the quality of the criteria has been improved by the application of an evidence-based approach and the support of AGS. The decision to follow the Institute of Medicine standards for evidence and transparency was an important benchmark—one that was clearly a transition for criteria that have been traditionally developed using a Delphi consensus process. Because of the nature of clinical drug trials in older adults, evidence was at times difficult to find and to apply cleanly. The literature search was complex because of the large number and diversity of search terms required, the extended time period searched, and the lack of clinical trial data in older adults often resulting in reliance on observational data. With AGS support, the development of databases to support more-frequent updates of the criteria and continual grading of the evidence as it emerges will continue to enhance this process. Past criticisms of the Beers Criteria correctly pointed out that many of the drugs were off the market or not in widespread use, lessening their relevance to clinicians and their association with health outcomes. The support of AGS has made this list more dynamic and relevant to the real-world practice of medicine. Still, caveats in their recommendation or rationale complicate some of the resulting criteria. These caveats offer additional guidance to clinicians about when to avoid a drug but at times cannot be used as a performance measure if extracted from a large database or by surveyors without sufficient clinical insight to discern these nuances. The Beers Criteria are situated within a larger perspective of strategies to improve medication safety in older adults. Previous studies have found that a small number of medications are responsible for most adverse drug events in older adults. In a recent study, four medications or medication classes (warfarin, insulin, oral antiplatelet agents, and oral hypoglycemic agents) were associated with most

Effect of the Omnibus Reconciliation Act 1987 on Antipsychotic Prescribing in Nursing Home Residents

Objective: To determine the impact of OBRA 87 on antipsychotic prescribing in a 485‐bed nursing home.

Consensus Guidelines for Oral Dosing of Primarily Renally Cleared Medications in Older Adults

OBJECTIVES: To establish consensus oral dosing guidelines for primarily renally cleared medications prescribed for older adults.

Recent Advances in Geriatrics: Drug-Related Problems in the Elderly

OBJECTIVE: To review recent articles examining drug-related problems in the elderly and comment on their potential impact on geriatric pharmacy practice. DATA SOURCES: Six articles published in 1997 and 1998. DATA SYNTHESIS: One study estimated that the cost of drug-related morbidity and mortality with the services of consultant pharmacists was

Drug Use Patterns of Persons with Alzheimer's Disease and Related Disorders Living in the Community

4 billion, compared with

Potential Underuse, Overuse, and Inappropriate Use of Antidepressants in Older Veteran Nursing Home Residents

7.6 billion without the services of consultant pharmacists. A study of ambulatory elderly patients with polypharmacy documented that 35% reported experiencing at least one adverse drug event within the previous year. Another study of ambulatory elderly found that in those with discontinued medications, adverse drug withdrawal events were uncommon. Two studies, one from Canada and one from the US, describe the development, by consensus, of explicit criteria for defining and identifying inappropriate drug use in the elderly (i.e., drugs to avoid, drugs with dose limits, drug–drug and drug–disease interactions). Finally, a modified Delphi survey of an expert panel reached consensus on 18 potential risk factors for drug-related factors in long-term care facility residents. CONCLUSIONS: Drug-related problems are considerable for elderly patients. Data from published studies should provide some guidance for todays practitioners as well as direction regarding future research.

Alternative Medications for Medications in the Use of High-Risk Medications in the Elderly and Potentially Harmful Drug-Disease Interactions in the Elderly Quality Measures.

Objective: To describe drug use patterns by persons with Alzheimers disease, multi‐infarct dementia, and mixed Alzheimers disease and multi‐infarct dementia.

Use of antipsychotics among older residents in VA nursing homes

OBJECTIVES: To examine prevalence and resident‐ and site‐level factors associated with potential underuse, overuse, and inappropriate use of antidepressants in older Veterans Affairs (VA) Community Living Center (CLC) residents.