应用PDCA提升儿科临床试验用药品管理质量

Application of PDCA to improve the management quality of investigational products in pediatric clinical trials

目的:加强儿科临床试验项目实施过程中试验用药品管理的规范性,提升儿科临床试验质量。方法:应用根本原因分析法对我院2010—2013年儿科临床试验实施过程中发现的药品管理相关问题进行分析,并依据试验用药品管理的复杂多样性及儿童生理特性、用药特点,应用PDCA质量改善循环法于2014—2017年期间完善药品管理流程,规范操作细节,加强人员培训,对比管理改善前后临床试验问题数量、种类等数据,研究改进效果。结果:管理改善后,我院儿科临床试验用药品管理质量大幅提高,临床试验问题数量由39个降为5个,问题种类由6种降为3种。同时,GCP中心药房管理工作获得了研究者和申办者的一致好评。结论:运用PDCA循环法改善药品管理有助于提升儿科临床试验质量。

Objective:To strengthen the standardization of investigational products management in the implementation of pediatric clinical trials,to improve the quality of pediatric clinical trials as well.Methods:The Root Cause Analysis Method was used to analyze the issues related to investigational products management during the implementation of pediatric clinical trials in our hospital from 2010 to 2013.According to the complex of investigational products management and the characteristics of the children’s physiological and medication,the PDCA Quality Improvement Circulation Method was used to improve the management procedures,to standardize operating procedures,and to strengthen personnel training from 2014 to 2017.The effect of implementation of PDCA was analyzed by comparing the data on the number and the types of pediatric clinical trials’problems before and after the improvement.Results:After the improvement of management procedures,the quality of the management of pediatric investigational products in our hospital has been greatly improved.The number of problems found has decreased from 39 to 5,and the number of problem types has been reduced from 6 to 3,and the management of GCP central pharmacy was highly appreciated by the researchers and the sponsors.Conclusion:The use of the PDCA Circulation Method is helpful to improve the quality of pediatric clinical trials.