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

    • 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。

       

      Abstract: 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.

       

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