The Perception and Management of Drug Safety Risks

ISBN-13: 9783642742743 / Angielski / Miękka / 2011 / 216 str.

Bruno Horisberger; Rolf Dinkel

Opis

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."

Spis treści

Opening Address.- I: Society and the Benefit/Risk Relationship.- 1. Acceptable Risk in Society.- 2. A Broad Framework for Confronting Health Risks.- 3. Communicating the Risks and Benefits of Technology: The Case of Pharmaceuticals.- 4. Overview of the Drug Safety Issue and Ciba-Geigy’s Response: RAD-AR.- 5. Summary of Part I: Presentations and Discussions.- II: Benefit/Risk Analysis and Appraisal.- 6. Limitations of Available Sources of Data on Prescription Drug Safety.- 7. Strategies, Designs, Criteria, Tactics and Statistics to be Considered when Evaluating Scientific Evidence.- 8. Statistics in Drug Risk Research: The Background of Pharmacoepidemiology.- 9. Industry-Sponsored Risk Institutes.- 10. The Feldene Experience: A Case Study.- 11. Risk Perception of Prescription Drugs: Report on a Survey in Sweden.- 12. Risk Perception of Prescription Drugs: Report on Surveys in Japan.- 13. Scientific and Political Components of Regulatory Decision Making: General Considerations.- 14. Scientific and Political Components of Regulatory Decision Making: The United States Experience.- 15. Summary of Part II: Presentations and Discussions.- III: Current Challenges.- 16. Professional Drug Information: A Consumer Perspective.- 17. Going Patient, Going Public.- 18. Reporting Adverse Drug Reactions: The Media Approach.- 19. What Can Be Learned from Drug Safety Issues?.- 20. Summary of Part III: Presentations and Discussions.- IV: Responding to the Issues.- 21. Editor’s Note.- 22. Pharmacoepidemiology.- Comparative Data Base Analysis.- NSAIDs Data Base.- Management Training in Epidemiology.- 23. Risk Perception Analysis.- Public Perception.- Perception Research.- 24. Communicating the Benefit/Risk Relationship.- Communication Proposals.- Participating in the Public Debate: The United Kingdom as an Example.- Political Intelligence System.- 25. Risk Appraisal on an International Scale.- Council for International Organizations of Medical Sciences.- Pharmaceutical Risk Management Activities in Japan.- Establishment of Risk Institutes.- V: Outlook.- 26. The Wolfsberg Questions.- VI: Annex.- 27. Curriculum Vitae of Authors.- 28. Bibliography.- 29. Subject Index.- 30. A Handbook of International Data Sources for Drug Benefit/Risk Assessment.