左玮;刘容吉;牛子冉;都丽萍;常青;彭华;潘慧;张波;
ZUO Wei;LIU Rongji;NIU Ziran;DU Liping;CHANG Qing;PENG Hua;PAN Hui;ZHANG Bo;Department of Pharmacy,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences & Peking Union Medical College;State Key Laboratory of Complex Severe and Rare Diseases,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences & Peking Union Medical College;Department of Medical Affairs,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences & Peking Union Medical College

• 1:中国医学科学院北京协和医院药剂科
• 2:中国医学科学院北京协和医院疑难重症及罕见病国家重点实验室
• 3:中国医学科学院北京协和医院医务处

摘要(Abstract)：

2022年3月1日，新版《中华人民共和国医师法》实施，为超药品说明书用法提供了法律依据，要求各医疗机构建立管理制度，对医师处方、用药医嘱的适宜性进行审核，严格规范医师用药行为。鉴于此，北京协和医院成立“超药品说明书用法”管理办法制订工作组，基于循证医学证据和专家意见，制订《医疗机构“超药品说明书用法”管理办法》。一方面保障医师的合法权益，为强化执业安全保障提供依据；另一方面充分权衡患者的治疗获益与潜在风险，尊重患者的知情同意权和自主决定权。对于高风险药物，制订风险防控及应急预案；同时，提出基于循证医学的分级管理办法，提高其在临床实践中的可操作性。
With the implementation of the Law on Doctors of the People's Republic of China on March 1,2022,off-label use of drugs has been included into the legislation for the first time. The Law on Doctors of the People's Republic of China stipulates: “In the absence of effective or better treatment approaches and other special circumstances, after obtaining the informed consent of the patient/guardian/entrusted agent, the clinician can undertake a usage not specified in the drug instruction if supported with evidence. Medical institutions are suggested to establish a management system to review the suitability of prescriptions and medications and strictly standardize the medication behavior of clinicians”. In view of this, Peking Union Medical CollegeHospital has established the management system for off-label drug use based on evidence-based methods, with the aim to strengthen its management and rational use in our hospital. The measures for off-label drug use have been formulated to safeguard the doctors' legitimate rights, as well as to strictly standardize practicing behavior. Contingency plans have been established for risk prevention and control to protect the patients' rights and escort the off-label use of drugs. Hierarchical management based on the patients' needs and the types of evidence sources for off-label medication use have been adopted to improve its feasibility.

关键词(KeyWords)： 超药品说明书用法;管理办法;《中华人民共和国医师法》;制度
off-label use of drugs;management;Law on Doctors of the People's Republic of China;regulation

Abstract:

Keywords:

基金项目(Foundation): 中央高水平医院临床科研业务费(2022-PUMCH-B-059,2022-PUMCH-B-060);; 中国医学科学院医学与健康科技创新工程2021年“揭榜挂帅”项目(2021-I2M-1-003)~~

作者(Authors): 左玮;刘容吉;牛子冉;都丽萍;常青;彭华;潘慧;张波;
ZUO Wei;LIU Rongji;NIU Ziran;DU Liping;CHANG Qing;PENG Hua;PAN Hui;ZHANG Bo;Department of Pharmacy,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences & Peking Union Medical College;State Key Laboratory of Complex Severe and Rare Diseases,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences & Peking Union Medical College;Department of Medical Affairs,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences & Peking Union Medical College

参考文献(References)：

• [1] 中华医学会儿科学分会临床药理学组，《中华儿科杂志》编辑委员会.中国儿科超说明书用药专家共识[J].中华儿科杂志，2016,54:101- 103.
• [2] 中华人民共和国中央人民政府.中华人民共和国医师法[EB/OL].(2021-08-20)[2022-03-17].http://www.npc.gov.cn/npc/c30834/202108/d954d9fa0af7458aa862182dc50 a0d63.shtml.
• [3] Radley DC,Finkelstein SN,Stafford RS.Off-label prescribing among office-based physicians[J].Arch Intern Med,2006,166:1021- 1026.
• [4] Atkins D,Best D,Briss PA,et al.Grading quality of evidence and strength of recommendations[J].BMJ,2004,328:1490.
• [5] Blanco-Reina E,Muňoz-García A,Cárdenas-Aranzana MJ,et al.Assessment of off-label prescribing:profile,evidence and evolution[J].Farm Hosp,2017,41:458- 469.
• [6] 张波，李大魁，杨晓.药品说明书之外的用法的若干问题及对策[J].中华风湿病学杂志，2004,8:451- 453.
• [7] 张波，刘容吉，左玮.细化医院规章，守好用药关口[EB/OL].(2021-09-03)[2022-03-17].http://health.yunnan.cn/system/2021/09/03/031647166.shtml.
• [8] 张波，郑志华，李大魁.超药品说明书用药参考[M].北京：人民卫生出版社，2013:5.
• [9] 侯宁.山东省超药品说明书用药专家共识(2021年版)[J].临床药物治疗杂志，2021,19:9- 40.
• [10] 陈敏英，刘紫锰.临床重症与药学超说明书用药专家共识[J].今日药学，2020,30:505- 515.
• [11] 广东省药学会.超药品说明书用药药物经济学评价专家共识[J].今日药学，2016,26:681- 683.
• [12] Vargas-Rivas JE,Sabater-Hernández D,Calleja-Hernández MA,et al.Role of the hospital pharmacy and therapeutics committee in detecting and regulating off-label drug use[J].Int J Clin Pharm,2011,33:719- 721.
• [13] Zheng Z,Zeng Y,Huang H.Pharmacists'role in off-label drug use in China[J].Eur J Hosp Pharm,2018,25:116.
• [14] Skledar SJ,Corman SL,Smitherman T.Addressing innovative off-label medication use at an academic medical center[J].Am J Health Syst Pharm,2015,72:469- 477.
• [15] 杨敏，劳海燕，曾英彤.医疗机构超药品说明书用药管理专家共识[J].中国现代应用药学，2017,34:436- 438.
• [16] General Medical Council.Good practice in prescribing good practice in prescribing and managing medicines and devices[EB/OL].(2013- 02- 25)[2022- 03- 17].https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-do-ctors/prescribing-and-managing-medicines-and-devices.
• [17] 劳海燕，王启仪，杨敏，等.广东省人民医院超说明书用药临床管理方法与流程研究[J].中国循证医学杂志，2014,14:1025- 1029.