Scientific Obstacles to Overcome in Establishing Systematic Post-marketing Surveillance

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After three years of study, the Joint Commission on Prescription Drug Use unequivocally and unanimously supported the need for extending post-marketing surveillance beyond what presently exists in the United States. A Center for Drug Surveillance was requested. The Center was not to focus on regulatory implications or requirements of a post-marketing surveillance system rather it was to develop information that would encourage optimal medical decisions. The Center was to be a private, non-profit organization capable of generating support and research funds from industry, academia, and government It was charged with the responsability for the development and dissemination of therapeutic information that could be applied to the optimal use of drugs. The dominant functions of the Center would include education of physicians about drug related effects; the development of new methodology for post-marketing surveillance activities; and the training of physicians in epidemiology applicable to post-marketing surveillance requirements. The Commission stressed the need for the determination of rates of anticipated and unanticipated efficacy to be developed on the same patient population in whom incidences of adverse drug effects were determined. The feasibility for and approach to such studies of efficacy was stressed. The Commission found that even non- experimental techniques could be used for the estimation of anticipated efficacy in a large percentage of situations of actual practice use of the drugs. The Commission also indicated the requirement that data on the epidemiology of prescription drug use in the United States could be acquired and would be useful to practitioners and the public. The academic challenges that present themselves in developing an effective PMS will be discussed.