《中国超药品说明书用药管理指南(2021)》推荐意见及要点解读

Interpretation on Management Guideline for the Off-label Use of Drugs in China(2021 Edition)

超药品说明书用药在某些情况下是诊疗的合理需求,但其面临潜在的用药安全和法律风险。对于如何指导中国的超药品说明书用药管理,至今尚无相关指南,故北京协和医院牵头,与兰州大学循证医学中心共同组织临床、药学、循证医学、法律和医院管理等多学科领域专家,根据《中华人民共和国医师法》关于超药品说明书用药的规定以及《世界卫生组织指南制定手册》相关指南制订方法,制定了《中国超药品说明书用药管理指南(2021)》。这是我国第一部关于超药品说明书用药的管理指南,共确定9个问题,并形成了23条推荐意见。指南的英文版本Management guideline for the off-label use of medicine in China(2021)已于2022年9月发表,本文对该指南要点进行全面解读,以期提高临床对该问题的认识,为建立标准化的超药品说明书用药管理程序提供参考和帮助。

Off-label drug use represents a reasonable need for diagnosis and treatment in some cases,but it faces potential risks with drug safety and legal challenges.However,there was no guideline on how to manage the off-label drug use in China.Therefore,Peking Union Medical College Hospital,in cooperation with Evidence-based Medicine Center of Lanzhou University,established a working group and an expert group consisting of multidisciplinary group of experts to develop the Management Guideline for the Off-label Use of Drugs in China(2021).The Guideline is guided by the Law on Doctors of the People's Republic of China and the World Health Organization Guideline Development Manual.This is the first management guideline on the off-label use of drugs,aiming to improve the stakeholders'understanding of this topic and establish a standardized management procedure in China.This guideline has determined nine questions and proposed a total of twenty-three recommendations.The English version of the guideline was published in September 2022.This paper offers a detailed interpretation of the key points of the guidelines in order to provide suggestions and references for the management of off-label drug use.