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Establishment of the Management Systems for Off-label Drug Use in Medical Institution
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摘要: 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。
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关键词:
- 超药品说明书用法 /
- 管理办法 /
- 《中华人民共和国医师法》 /
- 制度
Abstract: 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 College Hospital 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.作者贡献：左玮、刘容吉、牛子冉和都丽萍负责文献检索和数据汇总；左玮和刘容吉负责初稿撰写；张波指导研究设计；常青、彭华、潘慧和张波负责文章审阅和修订。利益冲突：所有作者均声明不存在利益冲突 -
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