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A Potential Use of the National Death Index for Postmarketing Drug Surveillance
Stanley A. Edlavitch, PhD;
Manning Feinleib, MD, DrPH;
Charles Anello, ScD
JAMA. 1985;253(9):1292-1295.
Abstract
A particularly difficult problem for both the Food and Drug Administration and the pharmaceutical manufacturer is evaluation of the importance of spontaneous reports of suspected drug-associated fatalities. These reports are rare, and usually no accurate denominator data on drug use exist. This article proposes that the National Death Index be used to calculate mortality rates for selected drugs as part of the postmarketing surveillance efforts of the government and manufacturers. When hypotheses are generated from spontaneous reports and/or the mortality data, additional studies can be conducted on the cohorts that were identified for mortality follow-up.
(JAMA 1985;253:1292-1295)
Author Affiliations
From the Epidemiology Development Branch, Division of Drug and Biologic Product Experience (Dr Edlavitch), and the Division of Biometrics (Dr Anello), National Center for Drugs and Biologics, Food and Drug Administration, Rockville, Md; and the National Center for Health Statistics, Hyattsville, Md (Dr Feinleib).
Footnotes
This article represents the personal opinion of the authors. No official support or endorsement by the Food and Drug Administration is intended or should be inferred.
Reprint requests to Division of Epidemiology, School of Public Health, 611 Beacon St SE, Minneapolis, MN 55455 (Dr Edlavitch).
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