超说明书用药司法判例中的药学分析

Pharmaceutical Analysis of Judicial Precedents Involving Off-label Drug Use

目的通过对13例涉及超说明书用药司法判例中的药学部分进行分析,探讨目前我国对超说明书用药的司法解释,以期为我国超说明书用药的制度建立及临床应用提供借鉴与参考。方法通过对中国裁判文书网、北大法宝、聚法案例、无讼案例4个法律数据库进行检索,对其中涉及超说明书用药的13个司法判例进行汇总,分析判例中不同判决结果与超说明书用药的关系。结果 13例判例中,具有合理性或不宜当然推定医方存在过错2例,欠合理但与结果无关2例,存在过错且与患者结局存在因果关系9例。判决存在过错且与患者结局存在因果关系的案例中,循证依据不足4例,知情同意特殊风险告知不足3例,用药后监护不足1例,特异质反应1例,符合同成分药物其他版本说明书,但由于未符合所用药物说明书用法1例。结论涉及超说明书用药的司法判例中,超说明书用药制度不完善、知情同意告知不清及无循证依据是判决不合理判例中存在的主要问题。建立更为完善的超说明书用药制度、规范超说明书用药知情同意交代及临床应用前进行反复循证分析论证是确保超说明书用药安全的重要手段。

OBJECTIVE To analyze 13 judicial precedents involving off-label drug use and explore the legal interpretation on off-label drug use in China in order to provide experience for establishment of off-label drug use and clinical application. METHODS Based on the law databases （China Judgements Online, Chinalawinfo, Jufaanli, Itslaw） , 13 cases were searched and screened involving legal off-label drug use. The relationship was investigated and discussed between different results and characteristics of the 13 cases. RESULTS In 13 eases, there are 2 cases probably reasonable for off-label use, 2 cases unreasonable but not correlated with patients＇ outcomes, 9 unreasonable and with a causal relationship with patients＇ outcomes. In the 9 unreasonable cases, there are 4 cases without sufficient evidence, 3 cases without informed consent, 1 case lack of monitoring after off-label use, 1 case with idiosyncratic reaction, and 1 ease not consistent with the label of the drug used. CONCLUSION Major deficiencies of off-label drug use in China are without sufficient evidence, lack of informed consent and with uncompleted system on off-label drug use. Establishing more completed and detailed system, investigating enough clinical evidence, better informed consent and monitoring after off-label use are important measurements to ensure safety on off-label drug use.