摘要
目的:探讨我国药品安全监管工作中存在的问题及发展方向。方法:通过查阅国内、外文献资料和全国药品不良反应数据库,分析丙氧氨酚复方片在英国撤市的原因及国内类似产品的安全性问题,进一步探讨其撤市事件给我国药品安全监管工作带来的启示。结果:药品过量引起的毒性反应是该产品撤市的主要原因;我国也存在类似的安全隐患,但不良事件的报告数量较少。结论:探索开展药物警戒工作和灵活多样的药品风险管理手段,是我国目前药品监管工作面临的新任务。
OBJECTIVE： To explore the problems and development directions of drug safety regulation in China. METHODS： Through referring to domestic and overseas literature and national ADR database, we analyzed the causes of the withdrawal of Co - proxamol in the UK and the potential safety problems of domestic Co - proxamol analog, and further discussed the implication of the withdrawal for our drug regulation system. RESULTS： The toxic reaction related to Co- proxamolin overdose is the main cause of its withdrawal in UK. Though few adverse events have been reported, there are also the similar potential risks in China. CONCLUSION： Currently it is urgently needed for us to conduct pharmacovigilance work and seek diversified and flexible approaches in risk management.
出处
《中国药房》
CAS
CSCD
北大核心
2007年第28期2207-2209,共3页
China Pharmacy
关键词
丙氧氨酚复方片
撤市
启示
Co - proxamol tablet
Withdrawal
Implication
