超药品说明书用药的法律责任研究

Study on the legal liability of off-label uses of drug

目的:为医务人员超药品说明书用药提供法律上的参考,希望为规范超药品说明书用药起到一定的借鉴作用。方法:通过文献研究的方法,分析超药品说明书用药的现状、责任性质、责任主体、免责事由等。结果与结论:超药品说明书用药并非一定会导致法律责任,若操作规范也可以得到法律的保护。

Objective： In order to provide legal reference of off—label uses for medical staff to regulate the off—label uses. Method： The status quo, responsibility, subject of liability, exemption excuses.and etc. of off—label uses were analyzed by literature research. Result and Conclusion： The off—label uses are not certainly lead legal liability, and the right operation can also get the protection of the law.