عنوان

Improving Drug Safety - A Joint Responsibility

3642612504

9783642612503

b571742

Improving Drug Safety - A Joint Responsibility

[Book]

edited by Rolf Dinkel, Bruno Horisberger, Kenneth W. Tolo.

Berlin, Heidelberg

Springer Berlin Heidelberg

1991

(xxi, 338 pages 35 illustrations)

Health systems research.

I: The Wolfsberg Dialogue --; 1. From Questions to Missions and Actions --; 2. The RAD-AR Agenda --; II: Welcoming Addresses --; 3. Council for International Organizations of Medical Sciences --; 4. International Federation of Pharmaceutical Manufacturers Associations --; 5. Intercantonal Office for the Control of Medicines --; 6. RAD-AR Consortium --; III: Ethical Perspectives --; 7. The Discipline of Ethics --; 8. Ethics and Health --; 9. A Biomedical Ethical Perspective --; 10. Corporate Ethics --; 11. Discussion --; IV: Generating Knowledge About Drug Risks --; 12. Categories of Risk and Worldwide Resources --; 13. International Risk Assessment --; 14. Resources Needed for Risk Assessment --; V: Generating Knowledge About Drug Benefits --; 15. Quality of Life and Health Status: Innovative Outcome Variables for Research in Population Health --; 16. The Socioeconomic Evaluation of Medicines: A New Dimension --; 17. Expanding Measures of Benefit in Socioeconomic Studies --; VI: Assessing the Risk/Benefit Relationship --; 18. Challenges in Benefit/Risk Appraisal --; 19. Analysis and Synthesis of Adverse Drug Reaction Evidence --; 20. The Complexities of Assessment --; 21. A Review of the Regulatory Process in Japan --; 22. Postmarketing Surveillance in Japan: An Industry View --; 23. Distortions in Risk Assessment --; 24. Weighing Risk/Benefit Assessment: Views of a Swedish 'Regulator' --; 25. Scientific Evaluations and Personal Judgments --; 26. Discussion --; VII: Expections in Drug Safety Communication --; 27. The Challenge of Communicating Drug Safety Information --; 28. The Media Perspective --; 29. The Culture of Weighing --; 30. Patient Package Inserts: Carriers of Consensus Information --; 31. The Patients' View --; 32. Patient Motivation --; 33. Japans's Other Drug Market: Exports via Tourists --; 34. Controlling Drug Safety: Making Cautious Changes --; 35. Discussion --; VIII: Experiences in Drug Safety Communication Through Traditional Channels --; 36. Principles, Experiences, and Desired Actions --; 37. Physician-Patient Communication and Decision Making --; 38. Problem-Oriented Drug Information Services --; IX: Responses Beyond Traditional Communication Channels --; 39. Manufacturer Standards for Communicating Risks and Benefits --; 40. Health Behavior Change via Community Education --; 41. Risk Perception: Analyzing Images and Fears --; 42. New Channels for the Patients --; 43. The Patients-in-the-Know Program --; 44. Information for the Public: A Swedish Example --; 45. Discussion --; X: RAD-AR Activities --; 46. International Overview --; 47. RAD-AR Council Japan --; XI: Reports and Recommendations from the Working Groups --; 48. Generating and Assessing Knowledge --; 49. Dialogue and Communication --; XII: Ethical Perspectives Revisited --; 50. Applying Ethics --; 51. Moral Common Sense --; 52. Guiding Principles --; XIII: An Agenda for Action --; 53. Future Directions --; 54. Wolfsberg Think Pieces --; 55. Bibliography --; 56. RAD-AR Bibliography --; 57. Curriculum Vitae of Authors and Editors --; 58. International Life Sciences Institute --; 59. International Medical Benefit/Risk Foundation --; RAD-AR --; 60. Subject Index.

The subject of drug risks and benefits has moved from doctors' offices and pharmaceutical company research laboratories to the front pages of daily newspapers and international conferences. There is a growing body of knowledge about drug risk/benefit appraisal, pharmacoepidemiology, patient behavior and corporate and regulatory trends. This book documents the papers presented and discussions held at an international dialogue conference in April, 1990, at Wolfsberg, Switzerland, which took the topic of risk 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 communications. 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. Future directions are described by the Wolfsberg Thinkpieces, which were set out at the conclusion of the conference and which show how the leaders from various countries and fields of work viewed specific drug safety issues and how they thought responsibility for improving the situation could be shared.

Drug Evaluation.

Medicine.

Toxicology.

edited by Rolf Dinkel, Bruno Horisberger, Kenneth W. Tolo.

Bruno Horisberger

Kenneth W Tolo

Rolf Dinkel

[Book]

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