CAJ | 학술논문

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。
본연구분석、탐토아국목전이존재적해결초설명서용약문제적조시소존재적일사오구(기희망우약품생산자신보수개약품설명서、요구의료궤구가강초설명서용약심비관리、통과지정동의규피법률풍험)，지출저사조시존재적결함，병기우차제출일사해결초설명서용약합이성、합법성문제적절실가행적사로급방법(포괄전청약품설명서적법률지위、고려초약품설명서적권위지도、학립초약품설명서행위합이성적평개주체등건의)，이기진일보추동아국초설명서용약진조파탈목전적법률곤경。
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.