医院药品质量控制与现有药品质量监管体系不足的探讨 - 中国药房.PDFVIP

医院药品质量控制与现有药品质量监管体系不足的探讨 ＊ 梁 黄 源 ，沈 烽，张 健，吴颖坤，金 ，梁 斌（上海交通大学医学院附属新华医院，上海 200092） 中图分类号 R95 文献标志码 A 文章编号 1001-0408（2013）01-0054-03 DOI 10.6039/j.issn. 1001-0408.2013.01.19 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。 关键字 药品质量；监督管理；数据；统计分析 Discussions of the Deficiency in the Drug Quality Control in Hospital and Present Drug Quality Supervisory System HUANG Yuan ，SHEN Feng ，ZHANG Jian ，WU Ying-kun ，JIN Liang ，LIANG Bin （Xinhua Hospital Affiliated to Shanghai Jiaotong University Medical College ，Shanghai 200092，China ） ABSTRACT OBJECTIVE ：To improve the drug quality continuously. METHODS ：The data of drug quality in our hospital in re- cent 3years were analyzed statistically in respect of reasons for rejection ，classification and statistics of quality problems ，compre- hensive 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. KEY WORDS Drug quality ；Supervision and management ；Data ；Statisti