P(S)DCA联用模式在提升试验用药品管理质量中的应用  

Application of P(S)DCA United Model in Improving the Quality of Clinical Trial Drugs Management

作　　者：李文静 恽一飞 孙军 陆超 LI Wen-jing;YUN Yi-fei;SUN Jun;LU Chao(Changzhou Tumor Hospital,Drug Clinical Trial Institution,Changzhou 213000,China;Changzhou Tumor Hospital,Department of radiotherapy,Changzhou 213000,China;Changzhou Tumor Hospital,Information division,Changzhou 213000,China)

机构地区：[1]常州市肿瘤医院药物临床试验机构,江苏常州213000 [2]常州市肿瘤医院放疗科,江苏常州213000 [3]常州市肿瘤医院信息科,江苏常州213000

出　　处：《海峡药学》2024年第12期133-137,共5页Strait Pharmaceutical Journal

基　　金：常州市科技局应用基础研究指导性项目(编号:CJ20239029)。

摘　　要：目的为提高试验用药品管理质量、规范工作流程,保障受试者的用药安全。方法统计在研项目试验用药品管理记录,采用P(S)DCA联用模式,对改善前后的差错发生数据进行统计分析。结果改善前、PDCA循环后及SDCA循环后,试验用药品管理差错事件的发生频次从86件减少至50件,最终降低至29件;目标达成率从66.00%(PDCA循环后)提高至113.79%(SDCA循环后),进步率提升至66.28%;团队能力得到提升。结论PDCA循环可在较短时间内提升试验用药品管理水平,而SDCA循环能更加标准化地对改进策略予以维持和巩固,P(S)DCA联用模式促进了试验用药品管理水平的稳步提升。OBJECTIVE In order to improve the quality of clinical trial drugs management,standard workflow,and ensure the safety of the subjects.METHODS Statistic the management records of clinical trial drugs in research projects,using P(S)DCA united model to analyze the error data before and after improvement.RESULTS Before improvement,after PDCA cycle and after SDCA cycle,the frequency of errors in drugs administration was reduced from 86 to 50 and finally to 29;the target rate increased from 66.00%(after PDCA cycle)to 113.79%(after SDCA cycle),the progress rate increased to 66.28%;the ability of the team was improved.CONCLUSION PDCA cycle can improve the management level of clinical trial drugs in a short time,but the SDCA cycle is more standardized to maintain and consolidate the improvement strategy,P(S)DCA united model promotes the steady improvement of the management level of clinical trial drugs.

关 键 词：PDCA循环 SDCA循环 药物临床试验 试验用药品管理 

分 类 号：R95[医药卫生—药学]