医院药品质量控制与现有药品质量监管体系不足的探讨  

Discussions of the Deficiency in the Drug Quality Control in Hospital and Present Drug Quality Supervisory System

作　　者：黄源[1] 沈烽[1] 张健[1] 吴颖坤[1] 金梁[1] 梁斌[1] 

机构地区：[1]上海交通大学医学院附属新华医院,上海200092

出　　处：《中国药房》2013年第1期54-56,共3页China Pharmacy

摘　　要：目的:促进药品质量的不断提高。方法:对我院3年来登记的药品质量数据从入库拒收原因、质量问题分类、质量登记综合情况等进行统计分析,从各角度阐述药品质量变化趋势,并结合质量数据对现有药品质量监管体系中存在的不足进行剖析。结果与结论:出厂前即已存在的药品质量问题发生比例在逐年下降,药品在运输中出现的破损率在逐年上升;药品检验所抽样药品检验样本存在被动性和偶然性且检验报告时间过长。建议监管层纳入药品身份编码和外包装等的图片信息为管理范围,建立药品质量信息平台,确保监管部门、生产企业、经销企业和医院担当各自在药品安全中的职责。OBJECTIVE：To improve the drug quality continuously.METHODS：The data of drug quality in our hospital in recent 3 years were analyzed statistically in respect of reasons for rejection,classification and statistics of quality problems,comprehensive information of drug quality.The trends of drug quality were interpreted from different sides,and the deficiencies of present drug quality supervisory system were analyzed on the basis of quality information.RESULTS CONCLUSIONS：The percentage of drug quality problems already existed before leave-factory dropped annually.The rate of drug breakage increased year by year.The sample inspections have passivity and fortuity,passing a relatively long duration.Supervisory department should concern about pictorial information of drug code and external packing,establish drug quality information platform to guarantee the responsibility of supervisory department,pharmaceutical production enterprise,drug supplier and hospital.

关 键 词：关键字药品质量 监督管理 数据 统计分析 

分 类 号：R95[医药卫生—药学]