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Broader Uses of Post-Marketing Surveillance

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

Abstract

Since post-marketing surveillance has been functionally defined in many ways and can encompass a large number of activities, it is important to keep the output of any effort or system combining various efforts in mind. Various efforts of coordinating information on drug use go through a prolonged process and have various outcomes, but the overall goal is to optimize drug utilization and minimize preventable adverse effects.

Keywords

Spontaneous Report Preventable Adverse Effect Drug Abuse Warning Network Patient Package Insert Suspected Event 
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.
    The United States Code of Federal Regulations (CFR) 21:310.300–304.Google Scholar
  2. 2.
    Task, C., An Experiment in Early Post Marketing Surveillance. National Technical Information Service.Google Scholar
  3. 3.
    Slone, D., Shapiro, S., Miettinen, O.S. Case-control surveillance of serious illnesses attributable to ambulatory drug use, in Epidemiological Evaluation of Drugs edited by Colombo, F., Shapiro, S., Slone, D., Tagmoni, G. Littleton, Massachusetts Publishing Sciences Group, Inc. 1977; pp. 59–70.Google Scholar
  4. 4.
    Irey, N.S., Adverse Drug Reactions and Death, J Am Med Assoc. 1976; 236: 575–578.CrossRefGoogle Scholar
  5. 5.
    Karch, F.E. and Lasagna, L., Toward the Operational Identification of Adverse Drug Reaction. Clin Pharm Ther. 1977; 21: 247–254.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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