美国药品风险评估与减轻策略的简介及启示

Introduction of the Risk Evaluation and Mitigation Strategies in the United States and its Enlightenment

目的:借鉴美国药品风险评估与减轻策略,为我国探索建立良好的药品风险控制体系提供参考。方法:概述美国药品风险评估与减轻策略,分析风险评估与减轻策略的实施现状,学习其实践经验REMS药房门户网站,为我国相应机制的建立提供借鉴。结果与结论:美国药品风险评估与减轻策略的实践始终坚持“保证药品效益大于风险”的原则,将患者使用药品的风险降至最小化,提高药品信息的透明度,减少和预防药品上市后不良反应事件的发生和危害,完善对药品的全生命周期监管。我国可以借鉴美国经验,立足中国医疗卫生体制现状,探索建立符合发展要求的医疗联动网络。

Objective:To learn from the risk evaluation and mitigation strategy in the United States,and to provide reference for establishing a good drug risk control system in China.Methods:the risk evaluation and mitigation strategy in the United States was summarized,its implementation status was analyzed and learned the practical experience of the REMS pharmacy portal to provide enlightenment of relevant mechanism in China.Results&Conclusion:The practice of US risk assessment and corrective strategies always adheres to the principle of“ensuring that a drug′s benefits outweigh its risks”,which minimizes the risk of patients using drugs,improve the transparency of drug information,and reduce and prevent the occurrence of adverse drug reactions after marketing,and improve the life cycle monitoring of drugs.Through the experience of the United States,based on the status of China′s medical and health system,we can explore the establishment of a medical linkage network that meets the development requirements.