Food and Drug Administration's adverse drug reaction monitoring program.

The adverse drug reaction monitoring program of the Division of Drug Experience within the FDA is described. Historical information on the development and activities of the current drug reaction monitoring program, and goals and objectives of the current program are discussed. Also presented are a brief description of the Voluntary Reporting System, intensive drug monitoring studies and special epidemiologic studies, and a workable definition of alert reports and examples of their previous role within the FDA. Pharmacists should participate actively in adverse drug reaction monitoring.