美国FDA药品上市后风险管理措施研究及对我国的启示——以沙利度胺为例

Research on post-marketing drug risk management measures of FDA and its implication for China: a case of thalidomide

通过研究美国FDA对沙利度胺上市后风险管理的实例,为我国药品风险管理制度的有效实施提供参考。主要采用文献研究法和案例分析法,通过查阅FDA药品上市后风险管理指南及法规,分析典型案例沙利度胺重新上市后实施的风险管理措施。针对已知毒性药物沙利度胺,美国FDA和药品生产厂商共同制定风险管理计划,采取一系列干预措施,包括登记注册项目、提供可获得性证明、知识测试等,直接作用于处方医师、药师、患者等多个环节,同时定期评估风险控制效果以不断完善,有效地控制沙利度胺严重风险,发挥其临床价值。美国药品上市后风险管理的理念和手段值得我国借鉴。

The aim of the article is to study the post-marketing risk management of thalidomide in the United States in order to provide the implication for the development of risk management system in China.The literature research and case analysis were mainly used to analyze the post-marketing risk management measures of thalidomide,and FDA’s post-marketing relevant guidelines and regulations were reviewed.For the known toxic drug thalidomide,FDA and drug manufacturers jointly formulated a risk management plan and adopted a series of interventions,including registration projects,provision of proof of availability,KAP testing and other tools,directly acting on physicians,pharmacists,patients,and relevant participants.And the evaluation of its effectiveness was regularly implemented,so as to effectively control the serious risks of thalidomide.The concept and methods of post-marketing risk management of FDA are worthy of being referred by our country.