Vice President, Pharmacoepidemiology and Risk Management.
Article first published online: 18 SEP 2006
Copyright © 2006 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Volume 15, Issue 12, pages 839–849, December 2006
How to Cite
Hirst, C., Cook, S., Dai, W., Perez-Gutthann, S. and Andrews, E. (2006), A call for international harmonization in therapeutic risk management. Pharmacoepidem. Drug Safe., 15: 839–849. doi: 10.1002/pds.1319
The intent of the article is to raise awareness of issues relating to worldwide pharmaceutical risk management, in general, and not to promote the adoption or use of any particular product mentioned in the article.
Disclosure: Dr Andrews is an employee of RTI Health Solutions and conducts research and consulting services for the pharmaceutical industry, including some of the manufacturers of products mentioned in this article. Dr Andrews is also a special government employee of the FDA. Dr Hirst is an employee of RTI Health Solutions, which as mentioned above, conducts research and consulting for the pharmaceutical industry. Dr Cook is an employee of GlaxoSmithKline. Dr Perez-Gutthann is an employee of Pfizer. Dr Dai is an employee of sanofi-aventis. The authors declare no other conflicts of interest or financial interest in any product or service mentioned in this article.
- Issue published online: 24 NOV 2006
- Article first published online: 18 SEP 2006
- Manuscript Accepted: 28 JUL 2006
- Manuscript Revised: 26 JUL 2006
- Manuscript Received: 17 NOV 2005
- risk management;
- international drug safety
Therapeutic risk management is required to ensure that the benefits of a particular drug outweigh the risks in general practice. Current risk management strategies and handling of risk management and pharmacovigilance issues differ across borders. Differences in key regulatory decisions on the same product around the world, including the handling of safety issues with cisapride, dofetilide, and isotretinoin, bring into question the robustness of these decisions and the procedures currently in place to manage the risks to the public of products with potentially unfavorable risk-benefit balances. These differences may be partly due to differences in health care systems, regulatory requirements and procedures, and cultures. Greater international harmonization in approaches to risk management potentially would improve safety of medicines around the world by developing a greater uniformity in acquiring and interpreting risk-benefit evidence. The appropriateness and effectiveness of risk management interventions in different regions should be examined, and international strategies should be ‘fine-tuned’ for each regional health care setting. Recently issued international guidance on risk management and pharmacovigilance may help to improve consistency of decision-making around the world and promote better international communication and collaboration. Copyright © 2006 John Wiley & Sons, Ltd.