法医学杂志

法医学杂志 ›› 2018, Vol. 34 ›› Issue (2): 171-174.DOI: 10.3969/j.issn.1004-5619.2018.02.014

• 综述 • 上一篇    下一篇

医疗损害鉴定中超说明书用药问题的研究现状

冷冰凝1，王  旭1，2   

  1. 1. 中国政法大学 证据科学教育部重点实验室，北京 100088； 2. 中国政法大学 法庭科学标准研究中心，北京 100088
  • 发布日期:2018-04-25 出版日期:2018-04-28
  • 通讯作者: 王旭，女，教授，主任法医师，主要从事法医临床学科研、鉴定和教学；E-mail：wangxu0409@126.com
  • 作者简介:冷冰凝（1991—），男，硕士研究生，主要从事法医临床学和医事法学研究；E-mail：lbnlawyer@163.com
  • 基金资助:
    国家自然科学基金应急管理资助项目（81450041）；国家自然科学基金面上资助项目（81172912）；上海市现场物证重点实验室开放课题资助项目（2017XCWZK19）

Research Status on Off-label Use in Appraisal for Medical Malpractice

LENG Bing-ning1, WANG Xu1,2   

  1. 1. Key Laboratory of Evidence Science, Ministry of Education, China University of Political Science and Law, Beijing 100088, China; 2. Research Center of Forensic Science Standards, China University of Political Science and Law, Beijing 100088, China
  • Online:2018-04-25 Published:2018-04-28

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摘要： 超说明书用药在医疗实践中广泛应用，现阶段对于超说明书用药的行为仍未有明确的法律性质界定，在医学界与法学界也未达成判断共识，一旦超说明书用药行为引起医疗损害，鉴定行业很难对其进行明确界定。本文综述了国内外临床上超说明书用药的现状、法律法规相关规定的研究现状以及国内对于超说明书用药问题的基本共识，供同行们参考。

关键词: 法医学, 说明书, 综述, 责任, 法律, 医疗损害

Abstract: Off-label use is widely happened in medical practice. But for now, there is no clear legalistic demarcation for the behaviour of off-label use. Even in medical and legal fields, the consensus has not been reached. Once the behaviour of off-label use caused medical damage, it is difficult for appraisal profession to provide a clear demarcation. This article reviews the status of clinical domestic and foreign off-label use, the research status in the fields of laws and regulations and the basic consensus of domestic off-label use, for peer reference.

Key words: forensic medicine, prospectuses, review, liability, legal, medical damage