基于FOCUS-PDCA管理工具提升试验用药品管理效率与质量的实践应用  

Practical Application of FOCUS-PDCA to Improve the Efficiency and Quality of Clinical Investigational Product Management

作　　者：段舟萍[1] 程晓华[1] 温金华[1] 朱艳 宋艳 余路易 DUAN Zhou-ping;CHENG Xiao-hua;WEN Jin-hua;ZHU Yan;SONG Yan;YU Lu-yi(Research Center of Clinical Trial,the First Affiliated Hospital of Nanchang University,Nanchang 330006,China)

机构地区：[1]南昌大学第一附属医院临床研究中心,江西南昌330006

出　　处：《海峡药学》2022年第12期168-172,共5页Strait Pharmaceutical Journal

基　　金：江西省卫生健康委科技计划项目202210450。

摘　　要：目的为促进试验用药品管理工作的高效、高质量的发展,保障受试者用药安全。方法调查临床试验药房的管理记录文件,采用FOCUS-PDCA作为管理工具,对改进前后的问题、各项指标进行评价分析。结果改进指标达到了预期目标,处方不合格率由6.02%降低至0.34%;回收数量差异率由1.89%降低到0%;通过整改措施,彻底解决了记录文件中的药名不规范、规格错误、患者姓名错误、年龄错误等问题。结论通过此次FOCUS-PDCA活动,我院试验用药品的管理工作从完全依赖人工管理,转变为信息化系统管理,有效提高了管理效率和质量。我院的探索实践经验具有一定的借鉴意义。OBJECTIVE In order to promote the efficient and quality of the administration of investigational product,and ensure the safety of the subjects.METHODS Investigating record files of clinical trial pharmacy,Using FOCUS-PDCA as a management tool,Evaluating the problems and Improvement indicators before and after the activities.RESULTS The improvement indicators reached the expected goal;The unqualified rate of prescription decreased from 6.02%to 0.34%;The difference rate of recycling quantity decreased from 1.89%to 0%;The problems such as non-standard drug name,wrong specification,wrong patient name,wrong age were completely solved.CONCLUSION Through the FOCUS-PDCA activity,The management-mode of investigational product in our hospital had changed from manual to information system management,so the change brought efficiency and quality to us.The exploration and practice experience of our hospital has certain reference significance.

关 键 词：药物临床试验 试验用药品 质量改进 FOCUS-PDCA 临床试验信息管理系统 

分 类 号：R95[医药卫生—药学]