关于我院PIVAS试验用药品管理的探讨  

Management of Investigational products in Clinical trials of PIVAS in Hospital

作　　者：郭小娜[1] 郁长治[1] 袁明奎[1] 刘春丽[1] 陈迹[1] GUO Xiao-na;YU Chang-zhi;YUAN Ming-kui;LIU Chun-li;CHEN Ji(Pharmaceutical Department of the First Affiliated Hospital of Xinjiang Medical University,Urumqi,83000)

机构地区：[1]新疆医科大学第一附属医院药学部,乌鲁木齐830000

出　　处：《农垦医学》2019年第5期467-471,共5页Journal of Nongken Medicine

摘　　要：为了充分利用医院资源、合理规范管理临床试验用药品,利用我院的GCP药房和PIVAS,对PIVAS试验用药品的管理进行初步探讨。通过对试验用药品的接收、存放、配置等流程及特点的分析,发现采用该模式可以规范试验用药品的管理,既降低了药品调配差错及污染、破盲的风险和研究护士的职业风险,又保障了临床试验用药品的安全性及可靠性、试验数据的真实性和受试者的权益。Objective:In order to make full use of hospital resources and rationally regulate the management of drugs used in clinical trials,the management of drugs used in trials of PIVAS was preliminarily discussed by using the GCP pharmacy and PIVAS in our hospital.Based on the experimental drug configuration process of receiving,storage,and the analysis of the characteristics,we found that this mode can standardize the management of experimental drugs,not only reduce the risk of drug allocation errors,pollution and blindness,but also reduce the occupational risk of research nurses.

关 键 词：GCP 试验用药品 PIVAS 管理 临床试验 

分 类 号：R197.323.3[医药卫生—卫生事业管理]