Considerations on Unlicensed and Off-Label Drug Uses
- VernacularTitle:关于没有经过许可或药品说明书以外用药问题的探讨
- Author:
Liping LIU
;
Yuling CHEN
;
Jin XIE
;
Yiwen WANG
;
Jin HAN
- Publication Type:Journal Article
- Keywords:
Unlicensed;
Drug package insert;
Indication;
Medication
- From:
China Pharmacy
2007;0(25):-
- CountryChina
- Language:Chinese
-
Abstract:
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.