FMEA联合集束化干预策略在PIVAS抗肿瘤药物混合调配风险管理中的实践  

Application of FMEA Combined with Bundle Intervention Strategy in the Mixed Formulation of PIVAS Antineoplastic Drugs

作　　者：职晶晶 李坤 刘克锋[1] 张丁丁 聂春杰[1] ZHI Jingjing;LI Kun;LIU Kefeng;ZHANG Dingding;NIE Chunjie(Department of Pharmacy,the First Affiliated Hospital of Zhengzhou University,Zhengzhou 450052,China)

机构地区：[1]郑州大学第一附属医院药学部,河南郑州450052

出　　处：《河南医学研究》2024年第23期4360-4366,共7页Henan Medical Research

摘　　要：目的识别抗肿瘤药物混合调配流程中的风险,制定有效策略降低抗肿瘤药物混合调配的操作风险。方法运用失效模式与效应分析法(FMEA)识别抗肿瘤药物混合调配过程中的风险因素,针对中高风险等级的失效模式制定集束化干预措施。通过比较干预前后的风险优先值、职业防护措施和调配操作不规范事件发生例数评价集束化干预策略在降低抗肿瘤药物混合调配过程中相关风险的作用。结果静脉用药调配中心(PIVAS)抗肿瘤药物调配全流程包括:静态环境管理、人员管理、物品管理、调配前准备、混合调配环节、成品输液核查环节、清场清洁共7大环节及62项潜在失效模式,其中24项中高风险等级的失效模式纳入集束化干预策略管理中。经过干预,24项中高风险因素下降至3项。风险优先指数(RPN)值下降480个,下降幅度达55%。职业防护操作不规范事件每月发生例数由每月(63.5±9.01)例下降至每月(35.17±5.60)例,调配操作不规范事件由每月(50.5±7.56)例下降至每月(29.67±3.83)例,差异有统计学意义(P<0.05)。结论失效模式与效应分析法有助于发现PIVAS抗肿瘤药物混合调配过程中的潜在失效模式,集束化干预策略可明显降低风险优先指数以及调配操作和防护措施中不规范事件的发生,两种方法相结合可有效降低抗肿瘤药物混合调配流程中的不规范操作风险。Objective Identify the risks in the process of mixing and blending antineoplastic drugs,and develop effective strategies to reduce the operational risks of mixing and blending antineoplastic drugs.Methods Failure mode and effects analysis(FMEA)was used to identify risk factors in the mixing and blending process of antieoplastic drugs,and to develop bundled intervention measures for failure modes with medium to high risk levels.The risk priority values,occupational protection measures,and the number of incidents of non-standard dispensing operations before and after intervention were compared to evaluate the role of bundled intervention strategies in reducing the related risks in the mixed dispensing process of antieoplastic drugs.Results The entire process of PIVAS antineoplastic drug mixing and blending includes seven major steps:static environment management,personnel management,item management,pre-dispensing preparation,mixed blending,finished infusion verification,and site cleaning,as well as 62 potential failure modes,among them,24 failure modes with medium to high risk levels are included in the management of bundled intervention strategies.After intervention,the 24 item high-risk factors with medium to high risk factors decreased to 3.The RPN value decreased by 480,with a decrease of 55%.The number of non-standard occupational protection measures decreased from 63.5±9.01 to 35.17±5.60,and the number of incidents of non-standard blending operations per month decreased from 50.5±7.56 to 29.67±3.83,the differences were statistically significant(P<0.05).Conclusion The FMEA method is helpful to discover the potential failure modes in the PIVAS anti-tumor drug mixing process.The bundled intervention strategy can significantly reduce the risk priority index,and the occurrence of non-standard events in the mixing and blending process and protective measures.The combination of the two methods can effectively reduce the risk of non-standard operations in the anti-tumor drug mixing process.

关 键 词：失效模式与效应分析 集束化干预策略 静脉用药调配中心 抗肿瘤药物 

分 类 号：R9[医药卫生—药学]