Leng B N, Wang X
Key Laboratory of Evidence Science, Ministry of Education, China University of Political Science and Law, Beijing 100088, China.
Research Center of Forensic Science Standards, China University of Political Science and Law, Beijing 100088, China.
Fa Yi Xue Za Zhi. 2018 Apr;34(2):171-174. doi: 10.3969/j.issn.1004-5619.2018.02.014. Epub 2018 Apr 25.
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.
药品的超说明书使用在医疗实践中广泛存在。但目前，对于超说明书使用行为尚无明确的法律界定。即使在医学和法律领域，也未达成共识。一旦超说明书使用行为导致医疗损害，鉴定行业很难给出明确的界定。本文综述了国内外临床超说明书使用的现状、法律法规领域的研究现状以及国内超说明书使用的基本共识，以供同行参考。
