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FDA ADVERSE DRUG REACTION REPORTING REVISED GUIDELINES

Executive Summary

FDA ADVERSE DRUG REACTION REPORTING REVISED GUIDELINES will be available within a year, FDA Office of Epidemiology and Biometrics Director Gerald Faich, MD/MPH hold a Drug Information Assn. (DIA) workshop held in Bethesda, Md. Oct. 18-20. Noting that FDA has spent the last year "fixing the processing and the outputting" of its adverse drug reaction (ADR) reporting system, Faich said that over the next year the agency will "almost certainly change the 1639 form in a variety of ways, some big and some small." More importantly, he commented, FDA will change or recommend a change in guidelines for ADR reporting. Faich said the guidelines will "specify more clearly . . . which drugs we're really talking about, and for what period of time we are talking about, and which reactions we are talking about." He noted that the lack of standardized terms in ADR reporting is a problem. For example, he suggested that instead of using the term "serious" to describe an ADR, that "death" or "hospitalization" would more clearly describe the reaction. The DIA workshop on "International Adverse Drug Reaction Surveillance" involved approximately 350 registrants, one-third of which were from outside the U.S. The agenda included presentations on eight drug epidemiology systems, including those of Upjohn, Burroughs Wellcome, Kaiser Permanente, and a system developed in Saskatchewan, Canada. FDA Deputy Com. Novitch said that to help handle increasing ADRS, which could reach 100,000 reports in a year, FDA is "completing an arrangement with the American Medical Assn. that will allow us automatic access to their own physician reporting system."

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