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。
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.
作者
冷冰凝
王旭
LENG Bing-ning;WANG Xu(Key Laboratory of Evidence Science, Ministry of Education, China University of Political Science and Law, Beijing 100088, China;Research Center of Forensic Scie nce Standards, China University of Politi-cal Science and Law, Beijing 100088, China)
出处
《法医学杂志》
CAS
CSCD
2018年第2期171-174,共4页
Journal of Forensic Medicine
基金
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)
关键词
法医学
说明书
综述
责任
法律
医疗损害
forensic medicine
prospectuses
review
liability
legal
medical damage
