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National/International Systems for Post-Marketing Surveillance

  • Judith K. Jones
Part of the NATO Advanced Study Institutes Series book series (NSSA, volume 39)

Abstract

This session will address the following questions:
  1. 1.

    Are national/international systems adequate?

     
  2. 2.

    What are the limits to these spontaneous reporting systems?

     
  3. 3.

    Could spontaneous reports alone account for a post-marketing surveillance system? If not, what else is needed?

     
  4. 4.

    What are the techniques for harmonizing post-marketing surveillance efforts at an international level?

     

Keywords

Spontaneous Reporting System Hepatic Reaction Adverse Reaction Reporting Erythromycin Estolate Highly Variable Quality 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

  1. 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. 2.
    FDA’s Adverse Reactions. A Summary 1969–1979. National Technical Information Service #PB-80-227788 (Hard Copy #E20; Microfiche #E06).Google Scholar
  3. 3.
    Fraunfelder FT. Drug-Induced Ocular Side Effects and Drug Interactions, Lea and Febiger, Philadelphia, 1976.Google Scholar
  4. 4.
    Zimmerman, HJ. Hepatotoxicity. The Adverse Effects of Drugs and Other Chemicals on the Liver. Appleton Century Crofts, New York, 1978.Google Scholar
  5. 5.
    Finney D. Statistical logic in the monitoring of reactions to therapeutic drugs. Methods Inform. Med. 1971; 10: 237–245.Google Scholar
  6. 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

Copyright information

© Springer Science+Business Media New York 1981

Authors and Affiliations

  • Judith K. Jones
    • 1
  1. 1.Division of Drug Experience Office of Biometrics and EpidemiologyBureau of Drugs, Food and Drug AdministrationRockvilleUSA

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