School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, NSW, Australia.
Program on Regulation, Therapeutics, and Law (PORTAL) Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Clin Pharmacol Ther. 2021 Jun;109(6):1424-1442. doi: 10.1002/cpt.2010. Epub 2020 Oct 11.
In the wake of the withdrawal of the nonsteroidal anti-inflammatory drug rofecoxib, regulators worldwide reconsidered their approach to postmarket safety. Many have since adopted a "life cycle" approach to regulation of medicines, facilitating faster approval of new medicines while planning for potential postmarket safety issues. A crucial aspect of postmarket safety is the effective and timely communication of emerging risk information using postmarket safety advisories, commonly issued as letters to healthcare professionals, drug safety bulletins, media alerts, and website announcements. Yet regulators differ in their use of postmarket safety advisories. We examined the capacity of regulators in the United States, Europe, Canada, and Australia to warn about postmarket safety issues through safety advisories by assessing their governance, legislative authority, risk communication capabilities, and transparency.
在非甾体抗炎药罗非昔布撤回后，全球监管机构重新考虑了他们对上市后安全性的方法。此后，许多机构都采用了“生命周期”方法来管理药品，在规划潜在的上市后安全问题的同时，促进新药的快速批准。上市后安全性的一个关键方面是使用上市后安全性咨询有效地、及时地传递新出现的风险信息，这些咨询通常以致医疗保健专业人员的信、药物安全通报、媒体警报和网站公告的形式发布。然而，监管机构在使用上市后安全性咨询方面存在差异。我们通过评估美国、欧洲、加拿大和澳大利亚监管机构的治理、立法权、风险沟通能力和透明度，考察了它们通过安全咨询来警告上市后安全性问题的能力。
