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

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.