Failure mode and effect analysis of the risk management of non-integral-dosage drug dispensing in PIVAS

基于失效模式与效应分析我院PIVAS开展非整支用量药品调配全流程风险管理实践

To mitigate risks associated with the prescription examination,marking,dispensing,checking,and review of non-integral-dosage drugs in Pharmacy Intravenous Admixture Service(PIVAS),we formed a project team.Employing the failure mode and effect analysis(FMEA)management method,we identified potential risks in four critical steps of the non-integral-dosage drug dispensing process within PIVAS drug management:prescription verification,mixed allocation,and verification.For each step,we assigned scores for severity,incidence,and detectability,subsequently calculating the Risk Priority Number(RPN)to prioritize identified risks.Targeted measures for improvement were developed for steps with the highest RPN values.A total of 31 risk factors were documented in the management of non-integral-dosage drugs,with the dispensing process being particularly vulnerable.Specific measures were devised for eight high RPN risks.Following a 3-month optimization and improvement period,RPN values and incidences of internal differences were significantly reduced.The implemented measures demonstrated effective risk control.Notably,we established a comprehensive conversion system for partial-dose drug dispensing,directly translating into a volume of suction fluid for dispensing personnel based on doctor orders.This eliminated the need for manual secondary calculations,thereby standardizing and automating the dispensing of non-integral-dosage drugs in PIVAS.Simultaneously,our project team conducted a dissolution test on 23 types of drugs with non-integral dosage,revealing that the solvent volume increased for 11 types after dissolution.The dosage conversion for partial dosage was recalibrated based on the volume of the final solution to ensure dosage accuracy.Through the application of failure mode and effect analysis,we systematically managed the risks associated with non-integral-dosage drugs in PIVAS.This approach addressed safety concerns in the dispensing process,reduced errors,and ensured the safe and precise administration of medication to patients.

本研究旨在排除非整支用量药品在PIVAS审方、打签、摆药、核对、调配、成品复核等工作环节全流程存在的风险。通过组建项目团队,使用失效模式与效应分析的管理方法,梳理非整支用量药品在PIVAS药品管理、审方打签、混合调配、核对4个工作环节存在的风险点,针对每个风险点进行严重度(S)、发生率(O)和可侦测度(D)评分,并计算风险点的风险优先值(RPN),对RPN排名前列的风险点制订相应的改进措施,对比措施实施前后RPN值变化情况,观察研究效果。研究梳理了非整支药品全流程存在的风险共31个,主要风险存在于混合调配环节;针对RPN值较高的8项风险制订相应的改进措施,经过3个月的优化改进,RPN值和内差发生率明显降低,改进措施起到了很好的风险控制效果。研究建立了全方位的非整支药品调配剂量换算系统,可按照医嘱剂量直接换算成调配人员抽吸液体体积量,避免人工二次计算,使PIVAS非整支药品调配同质化、标准化、剂量计算的自动化;同时开展了23种非整支用量药品的溶解试验,发现11种药品品种溶解后溶剂体积增加,非整支药品的剂量换算应按照终溶液的体积进行计算才能保证剂量的准确。研究基于失效模式与效应分析在PIVAS开展非整支用量药品全流程风险管理实践,解决了非整支药品调配过程中存在的安全风险,最大限度避免非整支用量药品调配中发生差错,保证患者安全、精准用药。