Social policy and drug safety.
Drug safety policy for the elderly says more by its relative silence and ambiguity than it could by any single affirmative set of rules and principles. The difficulties in developing such social policies embody the interaction of the complexities of each of three dimensions: social policy, which requires consensus on roles, responsibilities, and the sharing of costs; drug safety monitoring, which requires a maturing and evolving body of science, technology, and practice to converge; and geriatric pharmacology, about which the answers are only now beginning to materialize. The social forces of incomplete consensus, incomplete science, and incomplete technology beg for a solid public policy. However in the next breath they beg, yet more urgently, for the first step in such public policy, a step that remains to be taken and is of great urgency. All of those concerned with the goal of minimizing the morbidity and disability, regardless of the state of disease, in the elderly must collaborate to chart the course for each of these three forces to reach the level in which responsible social policy can be made. This will require a good faith collaboration among government, the pharmaceutical industry, the health professions, the university community, and patients or their advocates. Although the recommendations of the Melmon Commission for the creation of a "Center for Drug Safety," jointly funded by government, the industry, and the universities, may never be fulfilled and may not, in fact, be needed in bricks and mortar, certainly the spirit of such a center must be the essential first step. The ground rules--for collaboration, capacity building, nurturance, support, and professional development and technology, particularly linkage-extension--must similarly be discussed broadly in open forum. Otherwise, multiple empires, separate mutually incompatible systems, and epidemiologic squabbling will surely carry the day. Finally, research must be done better to define, understand, and address special problems of the elderly. In the end, it is this special population who must receive the unique attention of drug safety policies and their implementing systems. Just as the processes of health and of ill health need better understanding, so too must the processes of aging and their impacts upon drug risk be better understood. This research must go beyond the high-tech spheres of pharmacology and pharmacokinetics. The addition of epidemiologic analysis of risk factors for therapeutic misadventure (iatrogenic and self-induced) and for health status specific long- and short-term adverse drug experience will contribute substantially to drug safety in the elderly.
D000368:Aged; D000375:Aging; D002986:Clinical Trials as Topic; D004347:Drug Interactions; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D007880:Legislation, Drug; D004364:Pharmaceutical Preparations / Q000378:metabolism; D011640:Public Policy; D012306:Risk; D014481:United States; D014486:United States Food and Drug Administration
D004364:Pharmaceutical Preparations