《超说明书用药标准》制订与解析  

Formulation and Analysis on the Standard of Off-label Drug Use

作　　者：刘容吉[1,2] 左玮 甄健存[3,4] 张威 姜玲 卢晓阳 吕迁洲[7] 张志清[8] 陈英 张波[1,2] LIU Rongji;ZUO Wei;ZHEN Jiancun;ZHANG Wei;JIANG Ling;LU Xiaoyang;LYU Qianzhou;ZHANG Zhiqing;CHEN Ying;ZHANG Bo(Department of Pharmacy,Peking Union Medical College Hospital,Chinese Academy of Medical Science and Peking Union Medical College,Beijing 100730,China;State Key Laboratory of Complex Severe and Rare Diseases,Beijing 100730,China;Pharmaceutical Specialized Committee,Chinese Hospital Association,Beijing100035,China;Department of Pharmacy,Beijing Jishuitan Hospital of Capital Medical University,Beijing 100035,China;Department of Pharmacy,the First Affiliated Hospital of USTC(Anhui Provincial Hospital),Hefei 230031,China;Department of Pharmacy,the First Affiliated Hospital,Zhejiang University School of Medicine,Hangzhou 310003,China;Department of Pharmacy,Zhongshan Hospital,Fudan University,Shanghai 200032,China;Department of Pharmacy,the Second Hospital of Hebei Medical University,Shijiazhuang 050000,China;Department of Pharmacy,the People's Hospital of Guangxi Zhuang Autonomous Region,Nanning 530016,China)

机构地区：[1]中国医学科学院北京协和医学院北京协和医院药剂科,北京100730 [2]疑难重症及罕见病国家重点实验室,北京100730 [3]中国医院协会药事专业委员会,北京100035 [4]首都医科大学附属北京积水潭医院药学部,北京100035 [5]中国科学技术大学附属第一医院(安徽省立医院)药剂科,合肥230031 [6]浙江大学医学院附属第一医院药学部,杭州310003 [7]复旦大学附属中山医院药剂科,上海200032 [8]河北医科大学第二医院药学部,石家庄050000 [9]广西壮族自治区人民医院药学部,南宁530016

出　　处：《医药导报》2024年第7期1065-1069,共5页Herald of Medicine

基　　金：中央高水平医院临床科研业务费资助(2022-PUMCH-B-059)。

摘　　要：超说明书用药是指药品使用的适应证、剂量、疗程、途径或人群等未在国家药品监督管理部门批准的说明书记载范围内的用法。中国医院协会药事专业委员会基于国家相关法规、规范性文件,结合国内外相关指南文献、行业专家意见,遵循科学性、通用性、指导性和可操作性原则制订了《超说明书用药标准》。该标准对超说明书用药的制度与组织建设、流程管理、质量控制与评价改进的全过程进行了规范和标准化,是医疗机构开展超说明书用药管理的依据。该文介绍《超说明书用药标准》的制订过程,并解析该标准的重点内容,有助于医疗机构在超说明书用药管理实践中,更好地满足超说明书用药标准的各项要求。Off-label use means that the intended use of the drug is not included in the instructions approved by the National Medical Products Administration,including unapproved indication,dosage,the course of treatment,route of administration,or population.The formulation of Pharmaceutical Supply Services-Key Medications Management-Off-label Uses is based on relevant laws,regulations,normative documents,guidelines,literatures,and expert opinions,and follows the principles of scientificity,versatility,instructiveness,and operability.This standard regulates and standardizes the institutional and organizational construction,process management,and the whole process of quality management and evaluation improvement of off-label uses,which is the basis for medical institutions to carry out off-label uses management.This article introduced the formulation process of the off-label uses standard and analyzed the key contents of the standard,which would help medical institutions to better comply with and meet the requirements of this standard in the practice of off-label use management.

关 键 词：超说明书用药 标准制订 循证医学 

分 类 号：R95[医药卫生—药学]