超说明书用药法律释读和应对策略分析.PDFVIP

·药事管理 · 超说明书用药法律释读及应对策略分析  * 羊波，孙云峰，郑造乾，辛传伟 (浙江省立同德医院，杭州 310000) 摘要：目的 解读超说明书用药的法律属性，促进超说明书用药的规范性和合法性使用。方法 通过分析药品注册流程， 明确药品说明书的法律地位。根据民法基本原则和相关法律规定，界定超说明书用药行为的合法性。对当前文献报道的 超说明书用药管理策略进行推荐等级和法律效力评价，进而提出建议。结果 药品说明书并非规范性法律文件，其法律 效力仅为医务人员临床用药的参考。超说明书用药行为本身并不违反我国相关法律法规，但其合法性在业内外仍缺乏共 识。为应对风险，部分学者建议并采取了一系列措施。考虑到临床实际和法律效应，部分措施的适用性有待商榷。结论 为 规避执业风险，结合我国国情，建议摸索建立高效的医患沟通机制、呼吁政府不断完善药品监管体系和提请最高人民法 院发布指导性案例，为合理合规的超说明书用药正名。 关键词：超说明书用药；合理用药；管理；医患沟通 中图分类号：R951 文献标志码：B 文章编号：1007-7693(2019)08-0993-04 DOI: 10.13748/ki.issn1007-7693.2019.08.019 引用本文：羊波, 孙云峰, 郑造乾, 等. 超说明书用药法律释读及应对策略分析[J]. 中国现代应用药学, 2019, 36(8): 993-996. Legal Interpretation and Coping Strategy Analysis on Off-label Use * YANG Bo, SUN Yunfeng, ZHENG Zaoqian, XIN Chuanwei (Tongde Hospital of Zhejiang Province, Hangzhou 310000, China) ABSTRACT: OBJECTIVE To interpret the legal attributes of off-label use, promote the standardization and legality of off-label use. METHODS By analyzing the drug registration process, the legal status of off-label use was clarified. According to the basic principles of civil law and relevant legal provisions, the legality of off-label use was defined. The recommendation level and legal effect evaluation of the off-label use management strategy reported in the current literature were made, and then suggestions were put forward. RESULTS The package insert was not a normative legal document, and its legal effect was only a reference for clinical use of medical personnel. The off-label use behavior didn’t violate Chinese laws, but its legitimacy still lack consensus of insides and outsides. In response to risks, some scholars had recommended and adopted a