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May 22, 2002

Debra C. Nichols, M.D., M.P.H.
Department of Health and Human Services
Office of Disease Prevention and Health Promotion
Office of Public Health and Science
Room 738-G
200 Independence Avenue, S.W.
Washington, D.C. 20201

Dear Dr Nichols:

The American Geriatrics Society (AGS), an organization of over 6,000 geriatricians and other health care professionals who are specially trained in the management of care for frail, chronically ill older patients, appreciates the opportunity to provide comments to help develop a Department of Health and Human Services (HHS) national action plan to assure the appropriate use of therapeutic agents in elderly patients. Our answers to the questions posed by HHS are below.

What are the three to five most important priorities for assuring the appropriate use of therapeutic agents in elderly patients in the United States?


1. Improve elderly patient access to essential medications through increased funding for medication coverage under Medicare.
   
   
2. Improve the training of health professionals in principles of geriatric pharmacotherapy and non-pharmacologic treatments and methods of prevention and improve the knowledge and skills of health professionals in the principles of geriatric pharmacotherapy and drug prescribing for older adults.
   
   
3. Improve access to providers who can review the appropriateness of medications.
   
   
4. Educate elderly patients regarding appropriate use of medications, including non-pharmacologic treatments.
   
   
5. Develop systems/measures to identify elderly patients at risk for suboptimal drug use (over, under, inappropriate use) and implement appropriate interventions to modify/reduce associated drug-related problems (e.g. specialized geriatric care, clinical pharmacist activities). For instance, include the frail elderly, those persons with multiple chronic illnesses, and healthy persons over age 80 that may not meet these definitions in pre-marketing clinical drug trials and post-marketing surveillance so as to learn more about efficacy and safety in this population: especially for drugs aimed at treating conditions more common in older persons.
   
   
2. How should we, as a nation, pursue these strategies?
   
   
1. Provide coverage of medications for Medicare beneficiaries.
   
   
2. Provide Medicare reimbursement for a detailed medication regimen review for elderly outpatients with polypharmacy needs.
   
   
3. Implement guidelines for pharmaceutical companies requiring research in elderly adults regarding new molecular entities that are likely to have significant use in the elderly and fund geriatric specific Centers for Patient Safety Research and Practice, Centers for Education and Research on Therapeutics, and Evidence-based Practice Centers.
   
   
4. The Food and Drug Administration (FDA) should add specific requirements for drug approval that require testing of new agents in sufficient numbers of persons in the oldest-old age group, (80 and above) so that treatment recommendations for these persons can be made with adequate information.
   
   
5. Research is needed to address the effects of comorbidity on the efficacy, safety and benefits of single and multiple drug therapy. In this regard, the FDA should require that drug development include persons with multiple comorbidities in Phase III trials and in post marketing surveillance.
   
   
6. Increase general research funding for developing measures/systems to identify older patients at risk for suboptimal drug use, for interventions to reduce inappropriate prescribing of medications, and for studies to determine the association of clinical and functional outcomes with numbers of medications.
   
   
7. Mandate undergraduate and graduate training of appropriate health care professionals in principles of geriatric pharmacotherapy and drug prescribing.
   
   
8. Increase research funding into determining the efficacy and safety of herbal supplements and other alternative therapeutic products in the elderly population.
   
   
What are your views on the most effective ways to address disparities among different segments of the population?


1. Include adequate numbers of older minorities in pharmaceutical research trials to allow for racial/ethnic comparisons of drug adherence and efficacy.
   
   
2. Research should be supported to investigate disparities and to develop interventions to resolve identified disparities; research could focus upon cultural beliefs, attitudes and behaviors related to medication use.
   
   
3. To ensure adequate recruitment of minorities, research funding must be available for community outreach and follow-up. In this regard, patient education materials need to be developed for various languages and cultural contexts.
   
   
4. Minorities and low income individuals already have less access to care and, thus, are less likely to receive medication management services that are associated with prevention, screening and treatment.
5. Plans should make therapeutics (drugs and non-pharmacologic measures) affordable for the poor, particularly therapies for which evidence has demonstrated efficacy.
   
   
6. Traditional methods of looking at health disparities focus on culture, language and sociodemographic characteristics. It is important to realize that persons who are frail, chronically ill and/or of very advanced age are also disadvantaged by our current medical care and drug development system. Insufficient information exists to guide important aspects of the care of these persons. Specifically, little or no research addresses the important issue of comorbidity and its effects on treatment efficacy, safety or cost.
   
   
Below is a short summary of activities that the American Geriatrics Society is engaged in or plans to engage in to assure the appropriate use of therapeutic agents in the elderly.


1. AGS has been active in working toward the appropriate use of drugs in the elderly. We are the largest interdisciplinary organization of health care professional dedicated to this through clinical care, education of health care professionals and the public. We develop and disseminate guidelines about the appropriate use of drugs in the elderly (e.g. new persistent pain guidelines).
   
   
2. In addition, AGS develops and disseminates guidelines for curriculum in clinical geriatrics for physician trainees at all levels as well as advance practice nurses. Prescription drugs are a core content area.
   
   
3. Our journal regularly publishes state of the art research in the area of suboptimal drug use in the elderly as well as on the benefits of medication in the form of therapeutic trials and case reports.
   
   
4. The AGS has proposed Medicare reimbursement for Comprehensive Geriatric Assessment that includes a detailed medication review as an integral component of geriatric care.
   
   

If you should have comments or questions on this letter, please contact Susan Emmer in our Washington office at 301-320-3873.

Sincerely,   Jerry C. Johnson, MD President American Geriatrics Society