Exploration of Off-label Drug Use in China

OBJECTIVE:To provide reference for the regulation of off-label drug use in China.METHODS:Based on the definition of off-label drug use in literatures and materials,the definition and classification of off-label drug use were introduced,and the reason,positive effects and risks of off-label drug use were analyzed to put forward relevant countermeasures.RESULTS CONCLUSIONS:Off-label drug use means indication,route of administration and dose beyond package insert issued by authority.Off-label drug use behaviors include expanding drug use for indication,over-dosage drug use,changing the method of drug use and route of administration,drug use beyond applicable people.The lack of clinical data of drugs for children and pregnant women,the violated promotion of pharmaceutical companies and the lack of benefit protection of new indication all lead to the popularity of off-label drug use.Thus,it is very important to formulate administrative regulations for off-label drug use,to severely punish the pharmaceutical companies that promote off-label drug use illegally and to standardize the physicians'behaviors in order to regulate off-label drug use.