试验用药品超温原因分析及处理措施和流程  

Analysis of Causes and Treatment Measures and Procedures for Overtemperature of Clinical Trial Drugs

作　　者：刘欢 LIU Huan(Department of pharmacy,Xi′an International Medical Center Hospital,Xi′an 710100,China)

机构地区：[1]西安国际医学中心医院药学部,陕西西安710100

出　　处：《海峡药学》2024年第12期140-142,共3页Strait Pharmaceutical Journal

摘　　要：目的分析药物临床试验机构药房药品超温的原因,探讨超温的原因及处理措施和流程,保证受试者的安全。方法根据《药物临床试验质量管理规范》(GCP)、《药物临床试验数据现场核查要点》,结合医院药物临床试验机构对试验用药品的管理经验,同时结合本机构2021年8月~2023年8月期间发生的试验用药品的超温事件,分析试验用药品超温的原因,提出一些建议和处理措施。结果通过一系列的处理措施,截止2023年12月,超温事件由7次降低为2次,其中设备问题引起的超温事件由5次降低到2次,没有人员操作不当引起的超温事件。结论冷藏冰箱在使用过程中由于各种原因可能会发生超温现象,通过安装温湿度自动监测仪、完善试验用药品的储存条件、健全试验用药品的管理制度等措施,可有效降低温度超温的发生率。OBJECTIVE To analyze the causes of clinical trial drug over-temperature in pharmacies of drug clinical testing institutions,discuss the causes and treatment measures of over-temperature,so as to ensure the safety of subjects.METHODS Referring to the Good Clinical Practice(GCP)and Key Points for Onsite Verification of Drug Clinical Trial Data,combined with the management experience of Clinical Trial drugs in institution,the same time,combined with the over-temperature events of experimental drugs that occurred in the institution from August 2021 to August 2023,the reasons for over-temperature of Clinical Trial Drugs were analyzed,and some suggestions and handling measures were proposed.RESULTS A series of measures had been taken to reduce the number of incidents of over-temperature from 7 to 2 by the end of December^(2)023,with the number of incidents of over-temperature caused by equipment problems from 5 to 2,there were no over-temperature events caused by improper operation of personnel.CONCLUSION Due to various reasons,refrigerated refrigerators may experience overheating during use.By installing automatic temperature and humidity monitoring devices,improving storage conditions for experimental drugs,and establishing a sound management system for experimental drugs,the incidence of temperature overheating can be effectively reduced.

关 键 词：试验用药品 冷链系统 药品超温 超温原因分析 

分 类 号：R95[医药卫生—药学]