医疗机构中药药物警戒体系建设指南  

Guidelines for construction of traditional Chinese medicine pharmacovigilance system in medical institutions

作　　者：刘福梅 张力[2] 黎元元[1] 王志飞[1] 赵晓晓 崔鑫 魏瑞丽 杨硕[1] 王连心 谢雁鸣[1] LIU Fu-mei;ZHANG Li;LI Yuan-yuan;WANG Zhi-fei;ZHAO Xiao-xiao;CUI Xin;WEI Rui-li;YANG Shuo;WANG Lian-xin;XIE Yan-ming(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Dongfang Hospital of Beijing University of Chinese Medicine,Beijing 100700,China)

机构地区：[1]中国中医科学院、中医临床基础医学研究所,北京100700 [2]北京中医药大学、东方医院,北京100700

出　　处：《中国中药杂志》2024年第16期4266-4272,共7页China Journal of Chinese Materia Medica

基　　金：国家重点研发计划项目(2018YFC1707400,2022YFC3502004);中央级公益性科研院所基本科研业务费专项(Z0737)。

摘　　要：由中国中医科学院中医临床基础医学研究所与北京中医药大学东方医院牵头,中华中医药学会归口管理的《医疗机构中药药物警戒体系建设指南》团体标准于2024年1月16日于全国团体标准信息平台公布,标准号T/CACM 1563.2-2024。借鉴欧盟药物警戒法规以及国际人用药品注册技术协调会(ICH)的二级指导原则,在充分考虑中药自身特点基础上,明确医疗机构建设中药药物警戒体系的相关制度和流程,包括建设中药药物警戒信息平台、配备人员、制定各种规章制度、全链条监测中药(包括中药饮片、颗粒剂、中成药、院内制剂、上市前中成药等)药品不良反应等,形成符合中药特点的医疗机构中药药物警戒体系,在不同级别医疗机构中,可根据医疗机构职业范围和实际情况进行适当调整。从而更好地开展中药药物警戒工作,保障用药安全。该团体标准经组内外专家多轮征求意见,最终形成了适用于医疗机构以及医疗相关单位进行药物警戒活动的指南性文件。The group standard Guidelines for construction of traditional Chinese medicine(TCM)pharmacovigilance system in medical institutions,managed by Chinese Association of Chinese Medicine and led by the Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences and Dongfang Hospital of Beijing University of Chinese Medicine,was announced on National Group Standard Information Platform on January 16,2024,with the standard number T/CACM 1563.2-2024.According to EU pharmacovigilance regulations and the second-level guidance principles of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use(ICH),the unique characteristics of TCM were fully considered,and the relevant systems and procedures for constructing TCM pharmacovigilance systems in medical institutions were clearly defined.This included establishing TCM pharmacovigilance information platforms,arranging staff,formulating various regulations,and monitoring adverse reactions of TCM(including TCM decoction pieces,granules,Chinese patent medicines,in-hospital preparations,and pre-marketed Chinese patent medicines).It aimed to develop a TCM pharmacovigilance system in medical institutions that was tailored to the characteristics of TCM.The system could be appropriately adjusted according to the scope of practice and actual circumstances of medical institutions at different levels.This will enhance the implementation of TCM pharmacovigilance work and safeguard medication safety.The group standard underwent multiple rounds of consultations with internal and external experts and has ultimately evolved into a guiding document applicable to medical institutions and related entities engaged in pharmacovigilance activities.

关 键 词：医疗机构 药物警戒体系 中药 

分 类 号：R288[医药卫生—中药学]