欧美与亚洲国家药品监管机构开展药品风险沟通的研究  

Drug Risk Communication among Drug Regulatory Agencies in the European Union,the United States and Asia

作　　者：张丹[1,2] 吕锦涛 宋海波 张冰 金勇男[4] 萨日娜 张晓朦 林志健 ZHANG Dan;LYU Jintao;SONG Haibo;ZHANG Bing;JIN Yongnan;SA Rina;ZHANG Xiaomeng;LIN Zhijian(School of Chinese Pharmacy,Beijing University of Chinese Medicine,Beijing 102488,China;Center for Pharmacovigilance and Rational Use of Chinese Medicine,Beijing University of Chinese Medicine,Beijing 102488,China;Center for Drug Reevaluation,Key Laboratory for Research and Evaluation of Pharmacovigilance,NMPA,Beijing 100022,China;Affiliated Hospital of Yanbian University,Yanji Jilin 133000,China;Department of Pharmacy,Gansu Provincial Hospital,Lanzhou Gansu 730000,China)

机构地区：[1]北京中医药大学中药学院,北京102488 [2]北京中医药大学中药药物警戒与合理用药研究中心,北京102488 [3]国家药品监督管理局药品评价中心,药物警戒研究与评价重点实验室,北京100022 [4]延边大学附属医院,吉林延吉133000 [5]甘肃省人民医院药剂科,甘肃兰州730000

出　　处：《中国药物警戒》2021年第9期845-849,854,共6页Chinese Journal of Pharmacovigilance

基　　金：中国毒理学会临床毒理专项课题(CST2020CT501);国家自然科学基金资助项目(81874349);国家中医药管理局-国家中医药领军人才支持计划“岐黄学者”项目(10400633210004);第三批国家高层次人才特殊支持计划(万人计划)教学名师项目。

摘　　要：目的分析亚洲国家药品监管机构开展药品风险沟通的现状,对比欧美国家相关内容与形式,为构建我国药品风险沟通模式提供参考。方法查阅国内外文献,检索亚洲各国药品风险沟通相关的法律法规及指南规范,浏览亚洲各国药品监管机构官方网站等,了解相关机构设置、沟通渠道、发布内容、开展形式等,同时对比欧美药品风险沟通情况。结果欧美国家及地区的药品风险沟通体系较为完善;东亚及东南亚一些国家已经意识到药品风险沟通的重要性,构建了较为及时、有效的风险沟通模式。结论建议我国进一步加强药品风险沟通体系构建,保障人民安全合理用药。Objective To provide reference for the establishment of modes of drug risk communication in China by analyzing the current ways of drug risk communication in Asian countries,and by comparing the related contents and forms in China with those of the European Union and the United States.Methods By reviewing domestic and foreign literature,retrieving the guidelines,specifications,laws and regulations related to drug risk communication in Asia,browsing the official websites of drug regulatory authorities and other websites in Asia,information on related institutions,laws and regulations,communication channels,information released,and ways of development was harvested.Results The system of drug risk communication in Europe and the United States was relatively perfect.Some countries in East Asia and Southeast Asia became aware of the importance of drug risk communication and constructed effective modes of drug risk communication.Conclusion The construction of drug risk communication systems Could be strengthened to guarantee safe and rational drug use.

关 键 词：药品安全 风险沟通 欧美 亚洲国家 

分 类 号：R951[医药卫生—药学]