首都医科大学附属北京潞河医院Ⅰ期临床试验药房试验用药品管理模式分析与探讨  

Analysis and Discussion on the Management Mode of Experimental Drugs in the Phase Ⅰ Clinical Trial Pharmacy of Beijing Luhe Hospital Affiliated to Capital Medical University

作　　者：郭俊荣 梁欣[1] 李江帆 庞宏贤 贺晓辉 王旭红[1] 邵鑫迪 Guo Junrong;Liang Xin;Li Jiangfan;Pang Hongxian;He Xiaohui;Wang Xuhong;Shao Xindi(Beijing Luhe Hospital Affi liated to Capital Medical University,Beijing 101149,China;Tianjin Medical University,Tianjin 300070,China)

机构地区：[1]首都医科大学附属北京潞河医院,北京101149 [2]天津医科大学,天津300070

出　　处：《中国药事》2023年第8期966-969,共4页Chinese Pharmaceutical Affairs

基　　金：2022年北京市通州区科委课题“利用智能化技术建立药物临床试验合并用药医嘱预警系统”(编号KJ2021CX008-01)。

摘　　要：目的:探讨首都医科大学附属北京潞河医院Ⅰ期临床试验药房试验用药品管理模式,总结经验和分析不足,为其他临床试验机构中心药房管理模式提供参考。方法:本文分析总结了Ⅰ期临床试验药房基本情况、试验用药品管理流程、智能冷链监控系统的使用、药物信息化管理等。结果与结论:首都医科大学附属北京潞河医院Ⅰ期临床试验药房不同存储区域可满足试验用药品不同温度存储要求。采用智能冷链温度监控系统监测24 h环境及仪器设备温度,可及时发现超温情况,能尽早采取措施,将试验风险降到最低。试验用药品的电子化管理可在线动态管理与实时记录,提高数据管理的安全性和可靠性,方便数据溯源,提高数据质量。Objective:To explore the management mode of experimental drugs in the Phase Ⅰ clinical trial pharmacy of Beijing Luhe Hospital affiliated to Capital Medical University,summarize the experience and analyze the insufficiency,and provide references for the management mode of the central pharmacy of other clinical trial institutions.Methods:The basic situation of Phase Ⅰ clinical trial pharmacy,the management process of experimental drugs,the use of intelligent cold chain monitoring system,and drug information management were analyzed and summarized in this article.Results and Conclusion:The dif ferent storage areas of Phase Ⅰ clinical trial pharmacy in our hospital can meet the storage requirements of experimental drugs at dif ferent temperatures.The intelligent cold chain temperature monitoring system is used to monitor the temperature of the environment and equipment for 24 hours,so that the over-temperature situation can be detected in time,and measures can be taken as early as possible to minimize the risk of the test.The electronic management of experimental drugs can be dynamically managed online and recorded in real time,which improves the safety and reliability of data management,facilitates data traceability,and improves data quality.

关 键 词：试验用药品管理 临床试验 质量管理 冷链系统 信息管理 

分 类 号：R95[医药卫生—药学]