《医师法》施行背景下超说明书用药风险防控制度设计研究  

Design of Risk Prevention and Control System for Off-Label Drug Use under the Implementation of the Physician Law of the People's Republic of China

作　　者：耿曦 周泽新[1] GENG Xi;ZHOU Ze-xin(College of Humanities,Beijing University of Chinese Medicine)

机构地区：[1]北京中医药大学人文学院

出　　处：《中国食品药品监管》2024年第12期110-117,共8页China Food & Drug Administration Magazine

摘　　要：2022年我国《医师法》施行后,在法律规定的特定情形下实施超说明书用药成为合法的诊疗行为。有效的风险防控制度将成为推进超说明书用药相关立法的核心内容,超说明书用药风险防控应当以科学的医疗决策、执行、监督机制和患者参与机制为主线进行设计并展开。本文探讨通过合理的制度设计,有效防范和控制超说明书用药的医疗风险和法律风险,以期实现超说明书用药价值的最大化。Following the implementation of the Physician Law of the People's Republic of China in 2022,off-label drug use under specific circumstances stipulated by law has become a legal diagnostic and therapeutic practice.An effective risk prevention and control system will be a core component in advancing legislation related to off-label drug use.Risk prevention and control for off-label drug use should be designed and carried out based on a framework of scientific medical decision-making,enforcement mechanisms,supervisory systems,and patient participation.This paper explores how reasonable system design can effectively prevent and mitigate medical and legal risks associated with off-label drug use,aiming to maximize its value.

关 键 词：超说明书用药 风险防控 监管体系 患者 知情权 

分 类 号：R95[医药卫生—药学]