Medication in the Elderly Assignment Paper

Medication in the Elderly Assignment Paper

B. Discuss alterations in the absorption, distribution, metabolism and excretion of medication in the elderly? How does this impact on dose and frequency of medications prescribed for this population

The crucial role played by medication use in the elderly is common knowledge in the worlds of health services research, clinical epidemiology, and geriatrics. It is now widely known that although persons over age sixty-five represent only about 13 percent of the population, they consume nearly one-third of all medications in the United States; that medications probably are the single most important health care technology in preventing illness, disability, and death in the geriatric population; that drugs represent one of the largest and fastest-rising out-of-pocket health care expenditures for the elderly; and that the old, because of their high drug usage rate, greater frequency of coexisting illnesses, and diminished physiological reserves, are at greater risk of experiencing adverse drug effects. Medication in the Elderly Assignment Paper. Yet despite this knowledge, the use of drugs by the elderly and their clinical outcomes have not been prominent research or programmatic priorities for federal government, philanthropic, or corporate grantmakers. Beginning in the mid-1980s, The John A. Hartford Foundation began a grant-making program in the area of medication use and aging, out of an interest in enhancing the therapeutic effect of drugs used by this age group and in reducing the frequency and consequences of adverse drug events.

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After a number of years of active support in this area, the foundation convened its Expert Panel on Medications and Aging. This panel brought together authorities in the disciplines of geriatrics, gerontology, epidemiology, health services research, public policy, and pharmacology. Its mandate was to provide a consensus report that would critically define the further work needed to make the use of medications by the elderly more effective. This essay represents a synthesis of the work of that panel. The positions and opinions expressed below are extracted from transcripts of the expert panel’s deliberations, a structured survey administered to panel members, reviews of the relevant clinical and policy research, as well as supplementary statements by panel members. These recommendations are designed to define the current issues relating to medication use by the elderly; to guide future activities of health care policymakers, grantmakers, providers, and payers; and to inform researchers, clinicians, and patients themselves.

Current Status Of The Field
In beginning its work, the panel identified six aspects of the health care system relevant to medications and the elderly: ( 1 ) health of elderly patients; (2) professional training of physicians, nurses, and pharmacists; (3) continuing professional education; (4) health policy planning; (5) quality of life among older Americans; and (6) iatrogenic complications in the elderly. Medications were seen as being vitally relevant to each of these areas, yet the panel felt that such points of intersection have not received adequate research or policy attention.

The group considered the current level of activity in this area conducted in several key sectors in the United States. Both the pharmaceutical industry and the National Institutes of Health (NIH) support important basic or developmental research leading to the production of new drugs that benefit the elderly. However, the panel’s concern was not the development of new agents, but rather research or programs designed to improve the use of available drugs. In this regard, the panel found only minimal activity in this field by the governmental, philanthropic, or corporate groups evaluated. Medication in the Elderly Assignment Paper.

Panel members noted that throughout NIH in the past decade there has been only a single request for applications issued on the topic of medications and aging: a small program on geriatric pharmacology conducted on a one-time basis by the National Institute on Aging in 1989, which resulted in the funding of about ten modest-size research projects. A one-time request for applications issued by the Agency for Health Care Policy and Research (AHCPR) in 1992 dealt with the effectiveness of pharmaceutical therapy in general but did not specifically address medication use in the elderly. AHCPR planned to launch a follow-up grants program to focus on medication use in long-term care facilities. However, this program was removed from the agency’s agenda.

The Department of Veterans Affairs (VA), which provides nearly a billion dollars annually in drug benefits to a patient population that is increasingly elderly, has acknowledged the growing importance of geriatric pharmacotherapy to its mission and could become an increasingly active participant in this arena in the coming years. By contrast, NIH appears less committed to allocating resources to the study of therapeutic decision making and outcomes in the elderly at the population level. This problem appears to be at least as acute at the National Institute on Aging.

As for the corporate sector, nearly all research funded by the pharmaceutical industry understandably is driven by the need to discover or promote specific products of a given company. However, support available from industry drops off sharply for the study of adverse effects of drugs in the elderly. If a proposed research project or intervention is unlikely to improve the marketability of a patented drug, chances of the work being funded are reduced further. One important exception has been Merck and Company, which has supported fellowship training in geriatric clinical pharmacology since 1988.

In the philanthropic sector, only the Hartford foundation has identified medication use by the elderly as a priority area for grant making. To our knowledge, no other foundation plans to move in this direction. 1

The panel spent considerable time examining areas where future activity could yield promising results in improving use of medications by the elderly. The group identified eleven priority areas, discussed below.

Drug Testing, Development, And Labeling
Gaps in the science base.
Most panel members agreed with the conventional wisdom that the elderly are more susceptible to adverse drug effects than are the young and may respond differently in terms of drug efficacy as well. However, it was noted that little information is available to define the separate effect of old age itself versus the comorbidity that often accompanies it. The panel believed that there is a dearth of solid pharmacological and epidemiologic data on these issues. This results in part from a perverse circularity: The very old (particularly the frail elderly) still are not well represented in premarketing studies of drugs, so that inadequate amounts of data are generated about such populations in clinical trials. Skepticism still exists at the Food and Drug Administration (FDA) concerning the magnitude and importance of differences in drug efficacy or toxicity that result from chronological age alone; this skepticism seems to result mostly from the absence of clear data demonstrating such age-related changes. In 1983 the FDA issued a Discussion Paper designed to focus attention on this area; the paper’s contents were issued as nonbinding recommendations in 1989. 2

FDA and pharmaceutical industry representatives on the panel reported that the number of older patients being included in premarketing studies of drugs is growing. Medication in the Elderly Assignment Paper. However, data indicated that often these patients are in their late sixties and early seventies and in good health, but that there are still relatively few patients over age seventy-five or with significant comorbidity. Thus, the relevance of study findings to patients in their eighties or to those with multiple medical problems may be limited.

Proposed action steps.
(1) Commission a small series of projects followed by a conference to better define the pharmacologic basis of age-related differences in pharmacokinetics, pharmacodynamics, efficacy, and adverse effects. This would help to distinguish those aspects of “conventional wisdom” that have clear clinical and policy relevance from those that are plausible but unfounded. (2) Collect more precise information on the actual rate of inclusion of patients in all older age groups (not simply “over age sixty-five”) in new drug applications brought before the FDA in the past decade. Particular attention should be paid to the rate of inclusion of patients over age seventy-five, as well as patients with typical comorbidity and concurrent drug therapies. (3) Based on the above, prepare updated guidelines for including elderly subjects in premarketing drug trials.

Enhanced recruitment of appropriate elderly subjects.
Enrolling adequate numbers of older patients in new drug testing is difficult in part because of researchers’ lack of experience with inclusion of such patients. Thus, even when there is willingness to recruit older subjects, they are often underrepresented because of the perceived difficulty in their recruitment and its attendant higher cost per subject. 3 In reviewing this area, the panel saw that while there were members firmly holding positions on both sides of the issue of involving more elderly patients in premarketing drug trials, data were insufficient to support either position. One area of uncertainty was the actual demographic composition of participants in premarketing drug studies and how this has changed in the past decade. A second area of controversy was the actual incremental cost of including more older patients in such trials. Some believed that including large numbers of older subjects would impose considerable additional economic burden on companies attempting to bring products to market, and that the additional knowledge so gained would need to be weighed carefully in relation to the increased regulatory and economic burden that would be imposed. Conversely, others argued that older patients may in many respects be easier and less costly to recruit into studies because of easier availability of retirees and ready access to older patients living in congregate settings. There was, however, consensus on the fact that no clear data exist to inform the development of rational policy in this difficult area.

Proposed action steps.
(1) Calculate the incremental cost of recruiting an elderly subject compared with a nonelderly one for typical drug trials, and estimate the cost/benefit implications of including older subjects. (2) Convene a working group of representatives of the clinical research departments of pharmaceutical manufacturers, geriatricians, biostatisticians, and regulators to address the following issues: the most cost-effective means of identifying, recruiting, and retaining elderly subjects for phase III clinical drug trials; statistical issues associated with analyzing data on subjects with life expectancies that are shorter and confounding characteristics more complex than those of younger subjects; and quantitative and regulatory approaches to address these problems. (3) Support the development of consortia of elderly subjects (to be drawn from academically affiliated long-term care facilities, the nursing home industry, or primary care practices) to work with pharmaceutical manufacturers to recruit more typical elderly patients to participate in drug trials. (4) Identify current clinical, organizational, legal, and ethical barriers to enrolling adequate numbers of typical elderly patients, and propose methods to overcome them. Medication in the Elderly Assignment Paper.

Better identification of outcomes.
Trials of new drugs often focus on careful measurement of a target therapeutic outcome (for example, blood pressure) but may pay inadequate attention to other outcomes that can be particularly relevant to the elderly (for example, effects on cognition, mood, or gait stability). This is particularly problematic for older patients in whom a drug’s adverse effects in organ systems other than those targeted may be more prominent than its therapeutic effect.

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Proposed action steps.
(1) Initiate a series of consensus-development activities (including conferences and literature reviews) to define geriatrically relevant outcomes that should be studied in trials of drugs in several common therapeutic categories. Prominent among these outcomes would be functional status measurements, such as effects on mood, memory, attention, mobility, and “quality of life.” (2) Pay particular attention to defining age-related changes in the relationship between intermediary outcomes (for example, blood pressure, serum lipids, or intraocular pressure) and actual clinical outcomes of concern in the elderly (for example, stroke, cardiovascular disease, and visual loss due to glaucoma). Even when reduction of such intermediary risk factors by drugs has resulted in improved clinical outcomes in younger subjects, the effectiveness of such therapy has often not been convincingly demonstrated in the elderly.

Labeling of prescription medications.
Labeling refers to the federally required specification of indications, instructions for use, efficacy, dosing, and adverse reactions that must be published for all prescription drugs. Despite the high proportion of drug usage accounted for by the elderly, the approved labeling for many commonly used drugs does not adequately address this population. Paradoxically, the official instructions for using many drugs common in geriatric practice often contain more information on the use of a given drug in pregnant women, nursing mothers, and children than in geriatric practice. A set of proposed regulations on geriatric-specific labeling was circulated by the FDA in 1990 but was never made into a regulatory requirement. Controversy surrounding this issue relates to the dearth of pharmacologic data described above under the first priority area. Some have argued that there is no need to identify special aspects of the use of a given drug “in the elderly” if separate sections of the instructions already have addressed use of that drug in such situations as renal failure, hepatic insufficiency, or drug interactions with other drugs. However, most panel members believed that proper prescribing for the elderly would be best served by a single section integrating these concepts under the heading “Use in the Elderly” whenever the availability of adequate data made it possible. It was acknowledged that generating and synthesizing such age-specific information would entail costs of their own. However, such costs likely would be small in relation to the total development and promotional expenditures for most drugs and would be warranted in view of the potential for improving medication use in the elderly.

Proposed action steps.
( 1 ) Mandate universal inclusion in drug labeling of specific considerations for prescribing an agent in older patients, if the drug is regularly used by older age groups. Initially, given the current limited state of knowledge and experience concerning drug effects in older patients, for many drugs this section would have to state, “Inadequate information is available concerning use of this drug in patients over age seventy.” However, within five years such information could be required of manufacturers by the FDA as a condition for continued registration of a drug. Particular attention also should be paid to the labeling of over-the-counter drugs commonly used by the elderly. (2) Transform the FDA’s nonbinding guidelines on inclusion of elderly persons in clinical trials into formal policy.  Medication in the Elderly Assignment Paper.