浅析当前药品说明书存在的问题及建议

Problems and Suggestions of Current Package Inserts of Drugs

目的:促进药品说明书的规范,为合理用药提供依据。方法:根据《中华人民共和国药品管理法》和《药品说明书规范细则》对我院常用药品说明书存在的问题进行统计分析。结果与结论:部分药品说明书存在基本项目不齐、安全性信息缺失、服用时间不明确等问题,应采取增加警示标志、明确服药时间、列出变质提示等相应措施对当前药品说明书进行规范。

OBJECTIVE： To facilitate development of the current package inserts of drugs and provide basis for the rational use of drugs. METHODS： The problems existing in the package inserts of the commonly used drugs in our hospital were analyzed statistically based on ＂The Drug Administration Law of the PRC＂ and ＂Detailed Regulations of Drug Package Inserts＂. RESULTS ＆ CONCLUSIONS： There are many problems existing in drug package inserts such as incompletion of basic items, absence of safety information, unclear medication time. It＇s advisable to take effective coping measures such as to add warning mark to package inserts, clarify the medication time and list information about quality deterioration etc to standardize the current drug package inserts.