关于没有经过许可或药品说明书以外用药问题的探讨

Considerations on Unlicensed and Off-Label Drug Uses

目的:为解决临床药物治疗中使用没有经过许可或药品说明书以外用法问题提供参考。方法:分析没有经过许可或药品说明书以外用药存在的合理性以及可能引发的问题。结果:临床使用没有经过许可或药品说明书以外用法具有合理性,也符合国际惯例,但也可引发政策法规、用药安全等方面的一系列问题。结论:相关部门及行业协会应关注没有经过许可或药品说明书以外用药问题,确认公认的处理原则和对策。

OBJECTIVE： To provide reference for dealing with the problems arose from unlicensed and off- label drug uses. METHODS： The rationality of unlicensed and off- label drug uses and the possible problems induced by which were analyzed. RESULTS： The existence of unlicensed and off- label drug used has its rationality, and it also in line with the international practices, but it may cause some problems related to policy, laws and regulations and medication safety etc. CONCLUSION： The concerned department and trade association should attach great importance to unlicensed and off- label drug uses and establish a generally accepted principle and strategies to tackle the problems.