National/International Systems for Post-Marketing Surveillance
Are national/international systems adequate?
What are the limits to these spontaneous reporting systems?
Could spontaneous reports alone account for a post-marketing surveillance system? If not, what else is needed?
What are the techniques for harmonizing post-marketing surveillance efforts at an international level?
KeywordsSpontaneous Reporting System Hepatic Reaction Adverse Reaction Reporting Erythromycin Estolate Highly Variable Quality
Unable to display preview. Download preview PDF.
- 1.Inman WHW. “Post-Marketing Surveillance in the General Population: United Kingdom,” in, Inman WHW, ed. Monitoring for Drug Safety, JB Lippincott Co., Philadelphia, 1980.Google Scholar
- 2.FDA’s Adverse Reactions. A Summary 1969–1979. National Technical Information Service #PB-80-227788 (Hard Copy #E20; Microfiche #E06).Google Scholar
- 3.Fraunfelder FT. Drug-Induced Ocular Side Effects and Drug Interactions, Lea and Febiger, Philadelphia, 1976.Google Scholar
- 4.Zimmerman, HJ. Hepatotoxicity. The Adverse Effects of Drugs and Other Chemicals on the Liver. Appleton Century Crofts, New York, 1978.Google Scholar
- 5.Finney D. Statistical logic in the monitoring of reactions to therapeutic drugs. Methods Inform. Med. 1971; 10: 237–245.Google Scholar
- 6.Knapp DE, Zax BB, Rossi AC, et al. A method for postmarketing screening of adverse reactions to drugs (initial results). Drug Intell and Clin Pharm. 1980; 14: 23–27.Google Scholar