摘要
目的分析美国FDA风险评估与减低策略政策实施现状及运行方式,为我国《药品管理法》中药品风险管理计划条款落实提供参考。方法查阅中外文献以及FDA批准的风险评估与减低策略,对已经批准和撤销的独立风险评估与减低策略及单一共享系统风险评估与减低策略进行分析。结果风险评估与减低策略作为风险管理计划的一种类型,是动态的风险管理工具。并非所有药品都需要风险评估与减低策略,风险干预工具的优先使用原则应当由简入繁,由易到难。无论采取什么样的风险管理工具,风险管理计划必须直接干预到医生和患者。结论我国应探索《药品管理法》设定的风险管理计划执行路径,建立适应性的药品风险管理计划实施路径和配套文件,对药品风险进行动态控制。
Objective To analyze the current implementation and operation methods of the US FDA’s Risk Evaluation and Mitigation Strategies(REMS),and to provide reference for the implementation of the drug risk management plan specified in the Drug Administration Law of China.Methods Chinese and foreign literature and the FDA-approved REMS were reviewed,and the single system and shared system for implementation of REMS that had been approved and revoked were analyzed.Results As a risk management plan,REMS is a dynamic risk management tool.Not all drugs require REMS.The principle of prioritizing the use of risk minimization tools should be from simple to complex,from easy to difficult.Regardless of the risk management tool adopted,the risk management plan has to intervene with doctors and patients directly.Conclusion China should explore ways to execute the risk management plan specified by the Drug Administration Law,establish an adaptive method of implementing the drug risk management plan and formulate supporting documents in order to control drug risks dynamically.
作者
卫付茜
张威
杨悦
WEI Fuqian;ZHANG Wei;YANG Yue(School of Business Administration,Shenyang Pharmaceutical University,Shenyang Liaoning 110016,China;Academy of Drug Regulatory Sciences,Shenyang Pharmaceutical University,Shenyang Liaoning 110016,China)
出处
《中国药物警戒》
2020年第12期871-876,共6页
Chinese Journal of Pharmacovigilance
