药物警戒中致医务人员的函的欧美对比研究与启示  

Characteristics of dear health care provider letters in Europe and America

作　　者：梁佳琪 邵蓉[1] 柳鹏程[1] 李明[2] 任经天 汤韧 王越 LIANG Jiaqi;SHAO Rong;LIU Pengcheng;LI Ming;RENG Jingtian;TANG Ren;WANG Yue(Institute of Regulatory Science for Medical Products,China Pharmaceutical University,Nanjing Jiangsu 211198,China;Jiangsu Center for ADR Monitoring,Nanjing Jiangsu 210002,China;Center for Drug Reevaluation,NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance,Beijing 100022,China;Jiangsu Provincial Administration for Market Regulation,Jiangsu Nanjing 210036,China)

机构地区：[1]中国药科大学药品监管科学研究院,江苏南京211198 [2]江苏省药品不良反应监测中心,江苏南京210002 [3]国家药品监督管理局药品评价中心/国家药品监督管理局药物警戒研究与评价重点实验室,北京100022 [4]江苏省市场监督管理局,江苏南京210036

出　　处：《中国药物警戒》2022年第3期275-278,286,共5页Chinese Journal of Pharmacovigilance

基　　金：2021年中国药科大学大学生创新创业训练计划项目(202110316134);国家药品监督管理局药品评价中心课题(CDRW20204007)。

摘　　要：目的为我国进行“致医务人员的函”风险沟通方式提供思路。方法通过查阅欧美国家药品监督管理部门“致医务人员的函”实施的相关指南及法规,比较研究其药物警戒中“致医务人员的函”的发起、实施流程等方面的不同。结果欧美国家在“致医务人员的函”工作中,分类、发起情况、目标受众的选择及有效性评估等方面有所不同,可以为我国开展此项工作提供参考。结论建议我国尽快开展“致医务人员的函”工作,出台相关指南,并详细规定“致医务人员的函”实施流程及有效性评估等细节。Objective To give advice on risk communication methods related to Dear Health Care Provider Letters in China.Methods The difference in the initiation,implementation process,and effectiveness evaluation of Dear Health Care Provider Letters was analyzed by reviewing the related guidelines and regulations for the implementation of Dear Health Care Provider Letters in Europe and the United States.Results There was difference in specific classification,initiation,and details of Dear Health Care Provider Letters in Europe and the United States,which could serve as reference for China.Conclusion It is recommended that China start Dear Health Care Provider Letters,issue relevant guidelines and specify the details.

关 键 词：欧盟 美国 致医务人员的函 风险沟通 药物警戒 

分 类 号：R951[医药卫生—药学]