《医师法》视角下超说明书用药临床应用对策

Countermeasures for the clinical application of off-label drug use from the perspective of the Physicians Law

《医师法》于2022年3月正式实施,首次将循证医学下的超说明书用药写入法律,明确授权医师在符合一定条件下可以超说明书用药。为在《医师法》新规下临床超说明书用药能够依法开展,作者立足国内外现状,对临床中超说明书用药的条件、遵循原则进行了分析。在此基础上,提出区分高级别循证医学下、低级别循证医学下及临床试验性治疗中的超说明书用药应用对策,建立不同管理制度,保障患者权利,维护医疗安全。

The Physicians Law was officially implemented in March 2022,and for the first time,off-label drug use under evidence-based medicine was written into law,and physicians were clearly authorized to use drugs beyond the instructions under certain conditions.In order to carry out clinical off-label drug use under the new regulations of the Physicians Law,this paper is based on the current situation at home and abroad,the conditions and principles of clinical off-label drug use are analyzed;it proposes countermeasures to distinguish between high-level evidence-based medicine,low-level evidence-based medicine and clinical trial treatment,and establish different management systems to protect patient rights and maintain medical safety.