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Article
August 24, 1984

Discovery of New Adverse Drug Reactions: A Review of the Food and Drug Administration's Spontaneous Reporting System

Author Affiliations

From the Center for Drugs and Biologics, Food and Drug Administration, Rockville, Md.

JAMA. 1984;252(8):1030-1033. doi:10.1001/jama.1984.03350080032022
Abstract

Recently, several studies of spontaneous reporting systems (SRSs) have reported on the published literature's role in producing first reports of new adverse drug reactions. In order to provide further information on other components of SRS, the Food and Drug Administration's SRS was examined with regard to its effectiveness and efficiency in identifying new adverse drug reactions and the form, consistency, and timeliness of its communication of new adverse drug reactions to the medical community. While there was evidence that the literature was more effective in producing first reports of new adverse drug reactions for the years compared, there was reason to conclude that FDA's SRS was capable of making a contribution to the alerting process. Moreover, direct participation by practitioners in FDA's SRS was found to be the most efficiently obtained FDA source of new adverse drug reaction reports.

(JAMA 1984;252:1030-1033)

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