中国医院用药评价与分析2025，Vol.25Issue(12)：1457-1460,1463,5.DOI:10.14009/j.issn.1672-2124.2025.12.010
PIVAS临床试验药品闭环管理系统建设及评价
Construction and Evaluation of Closed-Loop Management System for Clinical Trial Drugs in PIVAS
摘要
Abstract
OBJECTIVE:To probe into the constructional method and strategy of the closed-loop management system for clinical trial drugs in Pharmacy Intravenous Admixture Services(PIVAS).METHODS:Questionnaire survey was adopted to investigate and organize problems related to clinical trial drugs management in PIVAS in Chongqing University Cancer Hospital.In combination with the closed-loop management thinking,an information system contained four foundational modules was constructed.The effectiveness of the system construction was evaluated by using semi-structured interviews.RESULTS:Investigation results of management problems(with a final sample of 122 valid questionnaires)indicated that in terms of comprehensive management optimization,process optimization(63.9%,78/122)and information system upgrade(60.7%,74/122)were the most important,followed by staff training(47.5%,58/122),supervision and inspection(39.3%,48/122)and equipment maintenance(33.6%,41/122).Hospital staff and non-hospital staff showed different agreement rate in terms of information system upgrade,process optimization and staff training,which manifested as significantly higher agreement rate in hospital staff than non-hospital staff,with statistically significant differences(P<0.05).Through system status record and coded management,a full-process closed-loop tracking was achieved that covering medical orders by clinician,verification by nurse,prescription review by pharmacist,dispensing and drug distribution,warehousing and configuration,ex-warehouse compliance,delivery handover and use in patient.Interviews with 20 respondents indicated that except for the efficiency improvements of drug handover and dispensing were rated at 60%,all other stages received 100%positive evaluations.CONCLUSIONS:The project team successfully constructs a closed-loop management system for clinical trial drugs in PIVAS,which has systematically exposited its design framework,technological path,application outcomes and evaluation results,provides theoretical foundations and practical references for constructing information management system for clinical trial drugs in PIVAS.关键词
静脉用药调配中心/临床试验/信息化建设/管理Key words
Pharmacy intravenous admixture services/Clinical trial/Information construction/Management分类
医药卫生引用本文复制引用
WANG Xia,WANG Hongmei,XING Changcui,HU Xiaogang..PIVAS临床试验药品闭环管理系统建设及评价[J].中国医院用药评价与分析,2025,25(12):1457-1460,1463,5.基金项目
重庆市卫生健康委医学科研项目(No.2024WSJK095) （No.2024WSJK095）
重庆市沙坪坝区2024年度技术创新项目(No.2024158) （No.2024158）
