基于中心化管理的药物临床试验药房信息化平台设计与实现  

Design and Implementation of Information System for Drug Clinical Trial Pharmacy Based on Centralized Management

作　　者：黄冰琳 方令平[1] 郭锦华[1] 林碧娟[1] 郑瀚森 郑佳冰[3] 郑斌[1] 陈新峰[1] 刘茂柏[1] HUANG Binglin;FANG Lingping;GUO Jinhua;LIN Bijuan;ZHENG Hansen;ZHENG Jiabing;ZHENG Bin;CHEN Xinfeng;LIU Maobai(Fujian Medical University Union Hospital,Department of Pharmacy,Fuzhou 350001,China;Fujian Medical University Union Hospital,Department of Information Management,Fuzhou 350001,China;Fujian Medical University Union Hospital,Department of Science and Education,Fuzhou 350001,China)

机构地区：[1]福建医科大学附属协和医院,药学部,福州350001 [2]福建医科大学附属协和医院,信息处,福州350001 [3]福建医科大学附属协和医院,科教处,福州350001

出　　处：《中国现代应用药学》2022年第21期2781-2786,共6页Chinese Journal of Modern Applied Pharmacy

基　　金：福建省科学技术厅创新战略研究项目(2020R0052);福建省科学技术厅科技创新联合资金项目(2021Y9051)。

摘　　要：目的构建药物临床试验药房信息化管理新模式,提高药房运行效率,为其他药物临床试验机构提供参考。方法梳理试验用药品管理工作流程,分析临床试验药房信息化需求,建立信息化平台,并对比信息化前后的试验用药品管理成效。结果利用信息化平台以临床试验项目为单位,在立项阶段建立项目信息档案,在项目启动后进行药品接收、入库、分发/回收、退回的全流程电子化记录,实现药房盘点、效期预警、处方审核等功能。信息化管理模式下药房各环节所需时间明显缩短,工作效率和服务能力有效提高,数据可溯源性增强,药品记录相关的差错事件发生频次明显下降。结论基于中心化管理设计的药房信息化平台能满足临床试验各阶段的试验用药品管理和监管需求,使试验用药品的应用更为规范,可保障受试者的用药安全,提高药物临床试验质量。OBJECTIVE To construct a new information management model for drug clinical trial pharmacy,improve the efficiency of pharmacy operation,and provide reference for other drug clinical trial institutions.METHODS The workflow of investigational products management was evaluated,the informatization needs of clinical trial pharmacy were analyzed,the informatization platform was established and the efficiency of investigational products management was compared before and after the informatization.RESULTS The project information file was established at the project approval stage on the information platform by taking each clinical trial project as individual unit.After the start of the project,the whole process of drug receipt,warehousing,distribution/recovery and return were recorded electronically to realize pharmacy inventory,expiration warning,prescription review and other functions.Under the information management model,the time required for each step of pharmacy workflow was significantly reduced,work efficiency and service ability had been effectively improved,data traceability was enhanced,and the frequency of error events associated with drug records were significantly decreased.CONCLUSION The pharmacy information platform designed based on centralized management can meet the management and supervision needs of investigational drugs at all stages of clinical trials,make the application of investigational drugs more standardized,ensure the drug use safety on subjects,and improve the quality of drug clinical trials.

关 键 词：临床试验用药品 药物临床试验药房 信息化管理 

分 类 号：R952[医药卫生—药学]