336份药品说明书缺项统计分析  

Analysis of the Absent Items in 336 Package Inserts

作　　者：方顺干[1] 沈浓儿[1] 吴祖帅[1] 

机构地区：[1]浙江省人民医院药剂科,杭州310014

出　　处：《中国药房》2012年第45期4315-4316,共2页China Pharmacy

摘　　要：目的:为促进我国药品说明书规范化提供参考。方法:收集我院常用药品说明书336份,依据《化学药品使用说明书规范细则(暂行)》的要求,进行药品说明书的缺项份数和缺项比例的统计和分析,并提出建议。结果:本次调查中缺项比例最高的前3种项目为:老年患者用药(159份,47.32%)、药物过量(142份,42.26%)和儿童用药(140份,41.67%)。结论:我国药品说明书的规范性有待提高。建议国家食品药品监督管理部门在审批药品说明书的过程中严格把关,企业应进行严格的技术审核,医务人员应及时反馈出现的问题并提出合理化建议。OBJECTIVE：To provide reference for the standardization of package inserts in China.METHODS：336 package inserts were collected from our hospital.According to Regulations for the Usage of Chemical Drugs Instructions,the number and percentage of the absent items in package inserts were analyzed statistically to put forward suggestions.RESULTS：Top 3 items in the list of absent items proportion were medication of elderly patients（159 cases,47.32%）,overdose（142 cases,42.26%）and medication in children（140 cases,41.67%）.CONCLUSIONS：The standardization of package inserts needs to be improved in China.The departments of food and drug control should strictly check the package inserts,enterprises should strictly check the technology,and medical staff should feedback the problems timely and put forward reasonable suggestions.

关 键 词：药品说明书 缺项 统计 分析 

分 类 号：R969.3[医药卫生—药理学]