Improving Drug Safety — A Joint Responsibility

1. Front Matter

   Pages I-XXI

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2. The Wolfsberg Dialogue

   1. Front Matter

      Pages 1-1

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   2. From Questions to Missions and Actions

      • Rolf Dinkel, Bruno Horisberger, Kenneth W. Tolo

      Pages 3-4

   3. The RAD-AR Agenda

      • W. P. von Wartburg

      Pages 5-9

3. Welcoming Addresses

   1. Front Matter

      Pages 11-11

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   2. Council for International Organizations of Medical Sciences

      • Z. Bankowski

      Pages 13-14

   3. International Federation of Pharmaceutical Manufacturers Associations

      • R. B. Arnold

      Pages 15-16

   4. Intercantonal Office for the Control of Medicines

      • J. Pfanner

      Pages 17-18

   5. RAD-AR Consortium

      • P. Simon

      Pages 19-20

4. Ethical Perspectives

   1. Front Matter

      Pages 21-21

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   2. The Discipline of Ethics

      • S. Gorovitz

      Pages 23-26

   3. Ethics and Health

      • Z. Bankowski

      Pages 27-35

   4. Biomedical Ethical Perspective

      • E. W. D. Young

      Pages 36-46

   5. Corporate Ethics

      • K. M. Leisinger

      Pages 47-57

   6. Discussion

      • Rolf Dinkel, Bruno Horisberger, Kenneth W. Tolo

      Pages 58-61

5. Generating Knowledge About Drug Risks

   1. Front Matter

      Pages 63-63

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   2. Categories of Risk and Worldwide Resources

      • J. K. Jones

      Pages 65-74

   3. International Risk Assessment

      • K. Strandberg

      Pages 75-79

   4. Resources Needed for Risk Assessment

      • G. A. Faich

      Pages 80-85

6. Generating Knowledge About Drug Benefits

   1. Front Matter

      Pages 87-87

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As the focus on pharmaceuticals has broadened from concern for their cost and effectiveness to their real and potential risks and benefits, a critical question has been raised: whose responsibility is it to improve drug safety? In April 1990, this question became the theme for a conference at Wolfsberg, Switzerland, near the shores of Lake Constance. Called an "international dialogue conference" by its organizers, the meeting brought together leaders from the pharmaceutical industry, regulatory authorities, academia, medicine, consumer organizations and the media. Opening addresses were given by representatives of the Council for International Organizations of Medical Sciences (CIOMS), the International Federation of Pharmaceutical Manufacturers Associations (IFPMA), the Swiss International Pharmaceutical Agency, and the RAD-AR Consortium. This book documents the papers presented and discussions held at this conference, which took the topic of risks and benefits of drug therapy one step further to responsibility. It includes a rich menu of issues for those who care about the evaluation of drug therapy, the ethics behind it, the expectations of the patient, and the role of traditional and nontraditional drug safety communica­ tions. The ideas expressed here come from different parts of the world but relate to common drug safety problems, observations, and scientific assessments; they provide insights into innovative approaches, cautious changes, and desired actions. The papers in this volume are broadly divided into conceptual perspectives (ethics, how the knowledge about drug risks and benefits is generated and appraised, the expectations in drug safety) and operational perspectives (communication, discussion, and action).

• Arzneimittel
• Arzneitherapie
• Bewertung der Therapie mit Arzneimitteln
• Drogenrisiko/Nutzen-Bewertung
• Suchttherapie
• addiction therapy
• assessment
• drug
• drug safety communications
• ethics
• regulatiory fo evaluation of drug therapy
• regulatorische Trends
• research
• therapy
• wissenschaftliche Bewertung

• HealthEcon Ltd., Basel, Switzerland

  Rolf Dinkel

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

  Bruno Horisberger

• The University of Texas at Austin, Austin, USA

  Kenneth W. Tolo

Policies and ethics