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

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.