说明书变更的超说明书用法所致医疗机构法律风险分析

Analysis of Medical Institutions Legal Risk Caused by Off-label Drug Use Due to Instruction Change

目的为应对因说明书变更而发生的超说明书用法所致医疗机构的法律风险提供建议。方法探讨超药品说明书用药的法律风险,分析相同成分、相同途径、不同厂家说明书间的差异以及说明书修改所致差异导致超药品说明书用法过程,提出超药品说明书用药的监控策略,望为应对相关问题提供思路。结果与结论设法杜绝说明书变更所致的超说明书用法,是医院药师责无旁贷的工作。

OBJECTIVE To provide advices in dealing with medical institutions legal risk caused by off-label drug use due to instruction change. METHODS To discuss the legal risk caused by off-label drug use due to instruction change. To analy the instructions differences in medicines of different manufactures. To analy the drug usage beyond the instructions result of the differences,due to modifying the instructions. Put forword the monitoring strategy to deal with the off-label drug use. RESULTS and CONCLUSION It is an unshirkable duty for hospital pharmacists to try to stop off-label drug use due to changes in instructions.