摘要
《外用中成药临床应用药物警戒指南》(T/CACM1563.5—2024)是我国首部针对外用中成药临床安全应用的专项指南,由中国中医科学院临床基础医学研究所牵头,联合全国30余家医疗科研机构共同研制。该指南旨在规范外用中成药临床应用的药物警戒活动,系统梳理潜在风险并提出防控措施,涵盖风险监测与报告、信号识别、评估与控制等11个核心板块,填补了国内外该领域标准化空白。该指南编制严格遵循国际规范与国内法规,通过多轮专家咨询、混合式访谈及证据整合(涵盖文献、医保、基药、药典数据及监管信息),明确其适用范围包括医疗机构、药品生产流通企业和监管部门,聚焦药品固有风险、质量风险、超说明书用药、联合用药风险及特殊人群安全性等关键问题。编制过程中处理了适用对象界定、质量风险控制等核心分歧,确保与《药品管理法》《药物警戒质量管理规范》等法规衔接,并完成国际指南注册(PREPARE—2022CN463)。未来将通过分层宣贯、动态修订和后效评价推动指南实施,促进临床合理用药,提升患者安全保障水平。
The Pharmacovigilance Guideline for Clinical Application of Chinese Patent Medicine for External Use(T/CACM 1563.5—2024),the first guideline in China specializing for the clinical safety of Chinese patent medicines for external use,was led by the Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,and jointly developed by more than 30 research institutions of medical sciences across the country.Aiming to standardize the pharmacovigilance activities in the clinical application of Chinese patent medicines for external use,the guideline systematically categorizes potential risks and proposes prevention and control measures that cover 11 core sections of risk monitoring and reporting,signal identification,as well as assessment and control,addressing the gap in domestic and international standardization of this field.The compilation of this guideline strictly adhered to international norms and domestic regulations,involving multiple rounds of expert consultations,hybrid interviews,and evidence integration(covering literature,medical insurance,essential medicine,pharmacopoeia data,and regulatory information).With the scope of application defined to include medical institutions,pharmaceutical manufacturers and distribution enterprises,as well as regulatory authorities,the guideline focuses on key issues such as inherent medicine risks,quality risks,off-label use,risks of combination therapy,and the safety in special populations.During the compilation,core discrepancies such as the definition of application scope and quality risk control were addressed to ensure alignment with regulations such as the Drug Administration Law of the People's Republic of China and the Good Pharmacovigilance Practice.The guideline is registered internationally(PREPARE—2022CN463).In the future,the implementation of the guideline will be promoted through hierarchical dissemination,dynamic revision,and post-effectiveness evaluation,contributing to rational clinical use and improved patient safety.
作者
崔鑫
杨顶权
谢振年
黎元元
王志飞
魏戌
高景华
王连心
谢雁鸣
CUI Xin;YANG Dingquan;XIE Zhennian;LI Yuanyuan;WANG Zhifei;WEI Xu;GAO Jinghua;WANG Lianxin;XIE Yanming(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;China-Japanese Friendship Hospital,Beijing 100029,China;Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China;Wangjing Hospital,China Academy of Chinese Medical Sciences,Beijing 100102,China)
出处
《中国实验方剂学杂志》
北大核心
2026年第8期252-259,共8页
Chinese Journal of Experimental Traditional Medical Formulae
基金
国家中医药管理局2021歧黄学者支持项目(国家中医药人教函[2022]6)
谢雁鸣全国名老中医药专家传承工作室建设项目(国家中医药人教函[2022]75)
国家重点研发计划项目(2022YFC3502004,2018YFC1707400)
中央级公益性科研院所基本科研业务费专项(Z0737)
中国中医科学院青年科研人员培养专项(ZZ18-XRZ-075)
中国中医科学院中药监管科学研究项目(ZYJGKX202408)。
关键词
外用中成药
药物警戒
编制说明
指南
临床应用
external Chinese patent medicines
pharmacovigilance
compilation instruction
guideline
clinical application
