我国药品说明书中已启用药品使用期限标示缺项问题分析  

Analysis on Validity Periods of Leftover Medicines in Medicine Instructions in China

作　　者：徐敢[1] 

机构地区：[1]国家食品药品监督管理总局执业药师资格认证中心,北京100098

出　　处：《中国药物警戒》2017年第2期95-98,共4页Chinese Journal of Pharmacovigilance

基　　金：国家社会科学基金项目(11CGL097):我国公立医院补偿机制系统建模与仿真研究

摘　　要：目的为规范我国药品说明书中已启用药品使用期限管理提供参考。方法通过检索相关文献,分析药品说明书管理相关法规和中国药典对已启用药品使用期限的规定,探讨我国药品说明书中已启用药品使用期限标示存在的问题,并提出相应的对策和建议。结果我国部分药品说明书存在已启用药品使用期限标示缺项问题,影响公众用药安全。结论已启用药品使用期限与公众安全用药息息相关,建议企业能不断完善已启用药品使用期限相关内容,有关部门能不断规范药品说明书管理,并对不同的已启用药品的使用期限给予科学解释和界定。Objective To provide reference to the management of validity periods of leftover medicines in medicine instructions in China. Methods Through searching the literatures, analyzing the regulations about medicine instructions and Chinese Pharmacopoeia, the problems of validity periods of leftover medicines were discussed, the solutions and recommendations were proposed. Results Most medicine instructions in our country do not provide the statements of validity periods of leftover medicines,which may influence public’s medication safety. Conclusion Validity periods of leftover medicines are closely associated with the public^ medication safety. It is necessary to strengthen the responsibility of drug manufacturers to improve the label contents of validity periods of remaining medicines further. It is suggested that drug regulatory authorities continue to improve the medicine instruction managements and provide scientific explanations and definitions on the validity periods of leftover medicines.

关 键 词：已启用药品 药品说明书 有效期 标示问题 

分 类 号：R951[医药卫生—药学]