處方藥說明書是重要的溝通工具, 關(guān)系到藥品的正確使用與患者的用藥安全。介紹我國、美國食品藥品管理局和歐盟藥品管理局對處方藥說明書[藥物過量]項目撰寫要點的有關(guān)要求, 并從報送到國家食品藥品監(jiān)督管理總局藥審中心的說明書樣稿中選取11個典型案例, 分析目前我國藥品注冊過程中該項目存在的問題。結(jié)果發(fā)現(xiàn)基本內(nèi)容缺失是該項目存在的主要問題, 以此為鑒并且避免這些問題的出現(xiàn)對規(guī)范藥品說明書撰寫和有效監(jiān)管大有裨益。

The labeling for Prescription drug is an important communication tool, that is related to the correct use and drug safety of patients. The writing highlights of overdosage section of labeling for prescription drug required by CFDA, FDA and EMA are described. 11 typical cases are selected from the labeling drafts submitted to CFDA CDE for registration, and current problems of the section in process of drug registration of our country are analyzed. That lack of basic content is the main problem is found. Taking this as a lesson and avoiding these problems is of greater advantage to standardization of drug labeling and itseffective supervision.