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Abstract
US Food and Drug Administration (FDA) monitoring of the continued safety of marketed
medical products depends greatly on spontaneous reporting of serious adverse events
by health professionals. Despite its inherent limitations, the national postmarketing
surveillance system provides vital information of clinical importance.
Keywords
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References
- The ambiguity of adverse drug reactions.Eur J Clin Pharmacol. 1977; 11: 75-78
- Pre-existing conditions, placebo reactions, and “side effects”.Ann Intern Med. 1964; 60: 255-265
- Adverse nondrug reactions.NEJM. 1968; 279: 678-679
- Adverse drug reactions—a matter of opinion.Clin Pharmacol Ther. 1976; 19: 489-492
- The Vaccine Adverse Event Reporting System (VAERS).Vaccine. 1994; 12: 542-550
- Pharmacovigilance: Paradise lost, regained or postponed? The William Withering Lecture 1994.J R Coll Physicians Lond. 1995; 29: 41-49
- Pharmacoepidemiology: Current status, prospects, and problems.Ann Intern Med. 1990; 113: 179-181
- Rhode Island physicians' recognition and reporting of adverse drug reactions.R I Med J. 1987; 70: 311-316
- An evaluation of spontaneous adverse drug reaction monitoring systems.Am J Med. 1986; 81 (Suppl 5B): 49-55
- Epidemiology of adverse reactions to nonsteroidal antiinflammatory drugs.in: Rainsford KD Velo GP Advances in Inflammation Research. 6. Raven Press, New York1984: 1-7
- False-positives in spontaneous reporting: Should we worry about them?.Br J Clin Pharmacol. 1994; 38: 401-404
- Drug utilization study methodologies: National and international perspectives.Drug Intell Clin Pharm. 1987; 21: 994-1001
- Spontaneous adverse drug reaction reporting vs event monitoring: A comparison.J R Soc Med. 1991; 84: 341-344
- The detection of adverse reactions to therapeutic drugs.Stat Med. 1982; 1: 153-161
- Statistical aspects of monitoring for dangers in drug therapy.Methods Inf Med. 1971; 10: 1-8
- Standardization of definitions and criteria of causality assessment of adverse drug reactions: Drug-induced liver disorders: Report of an international consensus meeting.Int J Clin Pharmacol Ther Toxicol. 1990; 28: 317-322
- Does proof of causality ever exist in pharmacovigilance?.Drug Saf. 1993; 9: 230-235
- Adverse effects of newly marketed drugs.NEJM. 1979; 300: 1046-1047
- Discovery of new adverse drug reactions: A review of the Food and Drug Administration's Spontaneous Reporting System.JAMA. 1984; 252: 1030-1033
Article info
Footnotes
☆This manuscript is adapted from: Goldman SA. The clinical impact of adverse event reporting. MedWatch continuing education article. Rockville, Md: US Food and Drug Administration, October 1996. Available at www.fda.gov/medwatch/articles.htm, where it first appeared as a section of that publication.
Identification
Copyright
© 1998 Published by Elsevier Inc.
