Abstract: Drug risk management is the important measure to ensure drug use safety of patients, which can minimize the risks and maximize the benefits of drug use. Effective drug risk management can reduce the damage to patients induced by drugs. But there are still some problems in the implementation process as the domestic works of drug risk management lack experience and the system is not perfect. Based on the circulation, sale and use situation of the high-risk oral formulation of ketoconazole and combined with experience of working, the author identified some problems in current domestic drug risk management system and put forward some suggestions for improvement.

Key words: ketoconazole oral formulations, drug risk management, drug recall