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失效模式与效应危害分析在静脉用药调配中心细胞毒药物安全管理的应用
马双双,蔡伦,沈巍
0
(南京医科大学附属宿迁第一人民医院,江苏宿迁 223800)
摘要:
目的:降低静脉用药调配中心(PIVAS)细胞毒药物调配过程中的差错和溢出风险。 方法:利用失效模式与效应危害分析(FMECA)对南京医科大学附属宿迁第一人民医院 PIVAS 细胞毒药物在药品领用、医嘱审核、贴签摆药、药品配制、成品核对和分拣外送等流程中的失效模式进行分析并评估其危害等级。 通过比较改进措施实施前后风险优先值(RPN)和差错事件评价整改效果。 结果:找出 15 个高等和中等危害等级的失效模式,并积极实施改进措施。 改进措施实施后 15 项失效模式 RPN 平均降幅 54. 4%,差错事件发生率明显降。 结论:运用 FMECA 对细胞毒药物调配各环节进行风险防范管理,可有效减少细胞毒药物调配差错,保障患者和医护人员安全。
关键词:  失效模式与效应危害分析  细胞毒药物  静脉用药调配中心  调配差错  溢出
DOI:10.13407/j.cnki.jpp.1672-108X.2023.08.008
基金项目:江苏省药学会项目,编号 H202055。
Failure Mode, Effects and Criticality Analysis on Cytotoxic Drug Safety Management in Pharmacy Intravenous Admixture Services
Ma Shuangshuang, Cai Lun, Shen Wei
(The Affiliated Suqian First People’ s Hospital of Nanjing Medicine University, Jiangsu Suqian 223800, China)
Abstract:
Objective: To reduce the errors and overflow risks in the preparation of cytotoxic drugs in pharmacy intravenous admixture services (PIVAS). Methods: Failure mode, effects and criticality analysis (FMECA) was used in the preparation of cytotoxic drugs including drug requisition, medical order review, labeling and drug placement, dosing, finished infusion checking and sorting out, failure modes and hazard ratings were evaluated. Effect of the rectification was evaluated by comparing the risk priority value (RPN) and error events before and after the implementation of FMECA. Results: Totally 15 failure modes with high and medium hazard rating were identified and active measures were implemented. After the implementation of FMECA, RPN was reduced by 54. 4%, as well as error events were significantly reduced. Conclusion: The use of FMECA for risk prevention management in the preparation of cytotoxic drugs can effectively reduce error events and ensure the safety of patients and medical staff.
Key words:  failure mode, effects and criticality analysis  cytotoxic drugs  pharmacy intravenous admixture services  dispensing errors  overflow

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