Postmarketing surveillance: curriculum for the clinical pharmacologist. Part I: Postmarketing surveillance within the continuum of the drug approval process.
This series of two articles on postmarketing safety surveillance has been developed for use in training clinical pharmacologists. It provides a basic overview useful to clinical pharmacologists in a range of occupational functions. These reports can be used as the basis for a lecture or as background reading material for establishing a unit on postmarketing surveillance. For teaching rounds, multiple illustrations and summary tables have been included. These can readily be made into 35-mm slides or transparencies. Table I outlines the curriculum on postmarketing surveillance for the clinical pharmacologist. The first article describes postmarketing surveillance within the continuum of the drug approval process. The relationship of clinical trials to safety surveillance after drug approval are reviewed. The importance of spontaneous adverse drug experience reporting also is discussed. The second article focuses on the regulatory aspects of postmarketing surveillance and discusses the FDA's (Food and Drug Administration) Spontaneous Reporting System. The two types of adverse experience reports in the Spontaneous Reporting System are described: reports voluntarily submitted by health care providers and others, and reports manufacturers are required by regulation to submit. The clinical pharmacologist's role in postmarketing surveillance is defined.
Johnson
J
J
Division of Epidemiology and Surveillance, Food and Drug Administration, Rockville, Maryland 20857.
Tanner
L A
LA
D002986:Clinical Trials as Topic; D003479:Curriculum; D017277:Drug Approval; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D010601:Pharmacology, Clinical / Q000193:education*; D011358:Product Surveillance, Postmarketing