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Discovery of New Adverse Drug Reactions

Discovery of New Adverse Drug Reactions 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) http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Discovery of New Adverse Drug Reactions

JAMA , Volume 252 (8) – Aug 24, 1984

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Publisher
American Medical Association
Copyright
Copyright © 1984 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.1984.03350080032022
Publisher site
See Article on Publisher Site

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)

Journal

JAMAAmerican Medical Association

Published: Aug 24, 1984

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