The Clinical Impact of Adverse Event Reporting

Authors: Stephen A. Goldman, MD; Dianne L. Kennedy, RPh, MPH; David J. Graham, MD, MPH; Thomas P. Gross, MD, MPH; Richard M. Kapit, MD; Lori A. Love, MD, PhD; Gale G. White, MS, RN

Abstract: The Food and Drug Administration's (FDA's) monitoring of the continued safety of market medical products -- through MedWatch -- depends greatly upon reporting of adverse events by health professionals. An understanding of how FDA uses this information, and of the limitations/strengths of the national postmarketing surveillance system, underscores the importance of this professional responsibility to the public health. As part of its ongoing effort to encourage clinicians to report adverse events, the FDA , late last year, created and distributed the following continuing education article. Clinician Reviews, in cooperation with the FDA, is pleased to reprint the article. [Clinician Reviews 7(7):143-145, 149-150, 153-156, 158, 160, 166, 168-169, 171-172, 1997. © 1997 Clinicians Publishing Group and Williams & Wilkins.]

This paper in Medscape

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