药物临床试验辅助药品管理系统的建设与应用  

Construction and application of a supplementary drug management system for drug clinical trial

作　　者：王肖雲[1] 卫丹[1] 陈光 张瀚文 张银玲 张晓坚[1] WANG Xiao-yun;WEI Dan;CHEN Guang;ZHANG Han-wen;ZHANG Yin-ling;ZHANG Xiao-jian(Department of Pharmacy,the First Affiliated Hospital of Zhengzhou University,Henan Zhengzhou 450002,China;Finance Office,the First Affiliated Hospital of Zhengzhou University,Henan Zhengzhou 450002,China)

机构地区：[1]郑州大学第一附属医院药学部,河南郑州450002 [2]郑州大学第一附属医院财务处,河南郑州450002

出　　处：《中国医院药学杂志》2022年第22期2411-2414,共4页Chinese Journal of Hospital Pharmacy

基　　金：重大新药创制科技重大专项(编号:2020ZX09201-009)。

摘　　要：目的:建立药物临床试验辅助药品管理体系,保证该部分药品的合理使用。方法:建立药物临床试验辅助药品管理流程,设计相应软件,与药物临床试验项目管理系统和医院信息管理系统建立数据接口,实施上述管理流程。结果:郑州大学第一附属医院运行药物临床试验项目的30%需要辅助药品,药品种类繁多。通过抽样数据对比发现,辅助药品管理系统上线初期至中期受试者人数和处方药品数量大幅增加,上线中后期受试者人数和药品数量趋于稳定,提示系统上线成功。与上线前数据比较,系统上线后授权药师审核处方的比例显著增加,处方药物为方案指定辅助药品的比例显著上升。结论:建立药物临床试验辅助药品管理系统,在有效保障辅助药品的院内供应的前提下,满足了辅助药品费用支付流程的伦理性、合规性,实现了该类处方前置审核,是药物临床试验数字化进程中的重要创新。OBJECTIVE To ensure the rational use of these drugs, establish a management system for supplementary drugs for drug clinical trials METHODS We establish the supplementary drug management process of drug clinical trials, design the corresponding software, and establish a data interface with the drug clinical trial project management system and the hospital information management system.Finally, we implement the above management process.RESULTS 30% of the drug clinical trial projects running in our hospital involve supplementary drugs, with a wide variety of drugs.Through the comparison of sampling data, it is found that the number of subjects and the number of prescription drugs have increased significantly from the initial to mid-term of the the supplementary drug management system, and the number of subjects and drugs tend to be stable in the middle and late stage of the system, suggesting that the system has been successfully launched.Compared with the data before this sysstem went on, both the proportion of authorized pharmacists reviewed prescriptions and the proportion of supplementary drugs supported by clinical trail protocols are significantly increasing after it went on.CONCLUSION The establishment of supplementary drug management system for drug clinical trials, effectively ensuring the hospital supply of supplementary drugs for subjects, realizes the accurate pre audit of such prescriptions, and realizes the ethics and compliance of the cost payment process of supplementary drugs for subjects.It is an important innovation in the digital process of drug clinical trials.

关 键 词：药物临床试验 辅助药品管理 药师 数字化 

分 类 号：R95[医药卫生—药学]