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The Perception and Management of Drug Safety Risks

  • Book
  • © 1989

Overview

Editors:
  1. Bruno Horisberger

    1. Interdisciplinary Research Centre for Public Health, St. Gallen, Switzerland

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    You can also search for this editor in PubMed   Google Scholar

  2. Rolf Dinkel

    1. HealthEcon Ltd., Basel, Switzerland

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    You can also search for this editor in PubMed   Google Scholar

Part of the book series: Health Systems Research (HEALTH)

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Table of contents (29 chapters)

  1. Front Matter

    Pages I-XXIII
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  2. Opening Address

    1. Opening Address

      • J. Orsinger
      Pages 1-2

  3. Society and the Benefit/Risk Relationship

    1. Front Matter

      Pages 1-1
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    2. Acceptable Risk in Society

      • A. Krauer
      Pages 5-8

    3. A Broad Framework for Confronting Health Risks

      • W. W. Lowrance
      Pages 9-18

    4. Communicating the Risks and Benefits of Technology: The Case of Pharmaceuticals

      • D. Nelkin
      Pages 19-36

    5. Overview of the Drag Safety Issue and Ciba-Geigy’s Response: RAD-AR

      • W. P. Von Wartburg
      Pages 37-44

    6. Summary of Part I: Presentations and Discussions

      • Bruno Horisberger, Rolf Dinkel
      Pages 45-47

  4. Benefit/Risk Analysis and Appraisal

    1. Front Matter

      Pages 49-49
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    2. Limitations of Available Sources of Data on Prescription Drag Safety

      • H. A. Guess
      Pages 51-56

    3. Strategies, Designs, Criteria, Tactics and Statistics to be Considered when Evaluating Scientific Evidence

      • Bruno Horisberger, Rolf Dinkel
      Pages 57-69

    4. Statistics in Drug Risk Research: The Background of Pharmacoepidemiology

      • H. Letzel
      Pages 70-76

    5. Industry-Sponsored Risk Institutes

      • W. W. Lowrance
      Pages 77-80

    6. The Feldene Experience: A Case Study

      • R. M. Sachs, G. S. Dieck
      Pages 81-89

    7. Risk Perception of Prescription Drugs: Report on a Survey in Sweden

      • P. Slovic, N. N. Kraus, H. Lappe, H. Letzel, T. Malmfors
      Pages 90-111

    8. Risk Perception of Prescription Drugs: Report on Surveys in Japan

      • S. Fujino
      Pages 112-116

    9. Scientific and Political Components of Regulatory Decision Making: General Considerations

      • G. Fülgraff
      Pages 117-120

    10. Scientific and Political Components of Regulatory Decision Making: The United States Experience

      • L. Lasagna
      Pages 121-127

    11. Summary of Part II: Presentations and Discussions

      • Bruno Horisberger, Rolf Dinkel
      Pages 128-131

  5. Current Challenges

    1. Front Matter

      Pages 133-133
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Keywords

About this book

In the past two decades public debate about the risks, benefits, and safety associated with drugs has intensified. Public disputes over risks are brought to court when individuals seek compensation for health problems attributed to a pharmaceutical product. The issue reaches legislatures and regulatory agencies when consumer advocates seek to influence the standards of drug usage. Front-page news tends to focus on accidents or other risk events with drugs. Drug risk and drug safety have become an important political issue. Drug regulat­ ory agencies have been instituted, and their responsibility has increased. The approval to market a drug is dependent on a set of sophisticated studies executed according to strict protocols and scientifically defined criteria. Drug surveillance activities have gained recognition, and reporting systems to identify drug safety problems have been strengthened. The understanding and management of drug safety is, nonetheless, beset by doubts, disagreements, and disputes. Conflict occurs over the significance of risk, the adequacy of evidence, the methodologies used to evaluate and measure risk, the standards that guide regulation, and the optimal means of communicating risk information to the public.

Editors and Affiliations

  • Interdisciplinary Research Centre for Public Health, St. Gallen, Switzerland

    Bruno Horisberger

  • HealthEcon Ltd., Basel, Switzerland

    Rolf Dinkel

Bibliographic Information

  • Book Title: The Perception and Management of Drug Safety Risks

  • Editors: Bruno Horisberger, Rolf Dinkel

  • Series Title: Health Systems Research

  • DOI: https://doi.org/10.1007/978-3-642-74272-9

  • Publisher: Springer Berlin, Heidelberg

  • eBook Packages: Springer Book Archive

  • Copyright Information: Springer-Verlag Berlin Heidelberg 1989

  • Softcover ISBN: 978-3-642-74274-3Published: 23 December 2011

  • eBook ISBN: 978-3-642-74272-9Published: 06 December 2012

  • Series ISSN: 1431-4002

  • Edition Number: 1

  • Number of Pages: XXIV, 216

  • Topics: Medicine/Public Health, general, Pharmacology/Toxicology

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