今日药学

2021, v.31(12) 886-888

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广东省药学会超说明书用药规范管理工作成果写入《医师法》
Achievement of Off-label Drug Use Management by the Guangdong Pharmaceutical Association Written into the China Physicians Law

伍俊妍;邱凯锋;曾英彤;刘韬;王若伦;魏理;王勇;郑志华;
WU Junyan;Qiu Kaifeng;ZENG Yingtong;LIU Tao;WANG Ruolun;WEI Li;WANG Yong;ZHENG Zhihua;Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University;Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences);State Key Laboratory of Oncology in South China,Collaborative Innovation Center for Cancer Medicine,Sun Yat-sen University Cancer Center;Second Affiliated Hospital of Guangzhou Medical University;The First Affiliate Hospital of Guangzhou Medical University;Guangdong Pharmaceutical

摘要(Abstract):

广东省药学会2010年3月印发了我国第一个超说明书用药规范——《药品未注册用法专家共识》,提出了超说明书用药的5大原则,建立了国内公认的医疗机构超说明书用药管理标准流程;2011年发起并参与主编了我国第一本基于循证医学的超说明书用药专著——《超药品说明书用药参考》,2015年开始每年发布同样基于循证医学的《超药品说明书用药目录》;2021年5月发布《超说明书用药循证评价规范》团体标准(T/GDPA 1-2021)。有关工作成果被写入国家卫生和计划生育委员会规划教材,并在《英国医学杂志》(The BMJ)发表。2021年8月20日通过的《中华人民共和国医师法》首次将超说明书用药写入法条,与广东省药学会超说明书用药规范管理的基本原则是一致的。
In March 2010,the Guangdong Pharmaceutical Association(GDPA) issued the “Consensus on the use of medicines for unlabeled uses”,the first set of standards for off-label drug use in China, putting forward the five procedure protections that off-label drug use must meet, and then established the widely accepted standard procedure for off-label drug use management in medical institutions.In 2011,the GDPA initiated and co-edited the first book on off-label drug use based on evidence-based medicine in China, named Reference of off-label drug use.Since 2015,the GDPA issued the List of Off-label Drug Use every year, which was also based on evidence-based medicine.In May 2021,the GDPA issued the group standard The specification of evidence-based pharmaceutical evaluation method for off-label drug use(T/GDPA 1-2021).The achievement of the GDPA have been put into the clinical pharmacy textbook of the China National Health and Family Planning Commission and published in The BMJ.Now, in China, off-label drug use has for the first time been written into law, namely the new China Physicians Law, which was passed on 20 August 2021.The requirement in the law for off-label drug use is consistent with the management put forward by the GDPA.

关键词(KeyWords): 广东省药学会;超说明书用药;医师法
Guangdong Pharmaceutical Association;off-label drug use;Physicians Law

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作者(Authors): 伍俊妍;邱凯锋;曾英彤;刘韬;王若伦;魏理;王勇;郑志华;
WU Junyan;Qiu Kaifeng;ZENG Yingtong;LIU Tao;WANG Ruolun;WEI Li;WANG Yong;ZHENG Zhihua;Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University;Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences);State Key Laboratory of Oncology in South China,Collaborative Innovation Center for Cancer Medicine,Sun Yat-sen University Cancer Center;Second Affiliated Hospital of Guangzhou Medical University;The First Affiliate Hospital of Guangzhou Medical University;Guangdong Pharmaceutical

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