摘要
本研究分析、探讨我国目前已存在的解决超说明书用药问题的措施所存在的一些误区（寄希望于药品生产者申报修改药品说明书、要求医疗机构加强超说明书用药审批管理、通过知情同意规避法律风险），指出这些措施存在的缺陷，并基于此提出一些解决超说明书用药合理性、合法性问题的切实可行的思路及方法（包括厘清药品说明书的法律地位、鼓励超药品说明书的权威指导、确立超药品说明书行为合理性的评价主体等建议），以期进一步推动我国超说明书用药尽早摆脱目前的法律困境。
This paper identified misunderstandings of the measures taken in China to overcome the problems incurred by off-label uses （namely reliance on drug makers to modify their medicine specifications,on medical institutions to enhance their regulation and management of off-label uses,and on informed consent to avoid risks）.Based on such findings,the paper named defects found with such measures,and puts forward feasible ideas and methods to make such off-label uses legitimate and reasonable.These include clarification of the legal status of the medicine specifications,encouraging authoritative guidance for off-label uses,and determining the subject of evaluation to approve the off-label uses as reasonable.Such efforts aim at helping off-label uses out of the legal difficulties.
出处
《中华医院管理杂志》
北大核心
2014年第9期690-692,共3页
Chinese Journal of Hospital Administration
基金
北京协和医学院和美国乔治城大学奥尼尔国际卫生法研究中心合作的研究课题《关键医疗行为法律指引》
关键词
超说明书用药
药品说明书
法律地位
评价主体
Off-label uses
Medication specifications
Legal status
Subject of evaluation
