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National/International Systems for Post-Marketing Surveillance

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Book cover Drug Development, Regulatory Assessment, and Postmarketing Surveillance

Part of the book series: NATO Advanced Study Institutes 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?

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References

  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.

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  2. FDA’s Adverse Reactions. A Summary 1969–1979. National Technical Information Service #PB-80-227788 (Hard Copy #E20; Microfiche #E06).

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  3. Fraunfelder FT. Drug-Induced Ocular Side Effects and Drug Interactions, Lea and Febiger, Philadelphia, 1976.

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  4. Zimmerman, HJ. Hepatotoxicity. The Adverse Effects of Drugs and Other Chemicals on the Liver. Appleton Century Crofts, New York, 1978.

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  5. Finney D. Statistical logic in the monitoring of reactions to therapeutic drugs. Methods Inform. Med. 1971; 10: 237–245.

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  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.

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Author information

Authors and Affiliations

  1. Division of Drug Experience Office of Biometrics and Epidemiology, Bureau of Drugs, Food and Drug Administration, 5600 Fishers Lane, Rockville, Maryland, 20857, USA

    Judith K. Jones M.D., Ph.D. (Director)

Authors
  1. Judith K. Jones M.D., Ph.D.
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Editor information

Editors and Affiliations

  1. The University of Rochester School of Medicine and Dentistry, Rochester, New York, USA

    William M. Wardell

  2. University of Padua, Verona, Italy

    Giampaolo Velo

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© 1981 Springer Science+Business Media New York

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Jones, J.K. (1981). National/International Systems for Post-Marketing Surveillance. In: Wardell, W.M., Velo, G. (eds) Drug Development, Regulatory Assessment, and Postmarketing Surveillance. NATO Advanced Study Institutes Series, vol 39. Springer, Boston, MA. https://doi.org/10.1007/978-1-4684-4055-3_29

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  • DOI: https://doi.org/10.1007/978-1-4684-4055-3_29

  • Publisher Name: Springer, Boston, MA

  • Print ISBN: 978-1-4684-4057-7

  • Online ISBN: 978-1-4684-4055-3

  • eBook Packages: Springer Book Archive

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