医疗失效模式与效应分析用于静脉用抗肿瘤药物全流程风险管控

Hospital Failure Mode and Effect Analysis in the Comprehensive Risk Management of Intravenous Antitumor Medications throughout the Entire Treatment Process

摘要: 目的：应用医疗失效模式与效应分析(Hospital Failure Mode and Effect Analysis, HFMEA)，降低静脉用抗肿瘤药品的用药不良事件发生，提高静脉用抗肿瘤药物的配置质量与疗效。方法：成立失效模式与效应分析(Failure Mode and Effect Analysis, FMEA)研究小组，根据流程图，分析静脉用抗肿瘤药物在使用过程中存在的失效点，规定相应的改进措施。结果：开展HFMEA活动后，有效预防静脉用抗肿瘤药物的风险事件产生，风险系数(Risk Priority Number, RPN)总分值由3363降至544；降幅：83.82%，Ρ < 0.01。结论：HFMEA活动有利于减少静脉用抗肿瘤药物的暴露风险，提高静脉用抗肿瘤药物的配置质量。降低风险事件发生的频次，找出静脉用抗肿瘤药使用过程中的风险，有效提高静脉用抗肿瘤药物的配置质量与疗效。

Abstract: Objective: Hospital Failure Mode and Effect Analysis (HFMEA) was implemented to mitigate the incidence of adverse reactions associated with intravenous antitumor agents, thereby enhancing the quality and therapeutic efficacy of such interventions. Methods: A Failure Mode and Effects Analysis (FMEA) research group was established to meticulously examine the failure points inherent in the utilization of intravenous antitumor medications, as delineated in the flowchart, and to devise pertinent enhancement strategies. Results: Following the implementation of the High-Fidelity Failure Mode and Effects Analysis (HFMEA), the occurrence of risk events associated with intravenous antitumor medications was significantly mitigated, leading to a substantial reduction in the total Risk Priority Number (RPN) from 3363 to 544; this corresponds to an 83.82% decrease. The results achieved were statistically significant at the Inner Mongolia level (P < 0.01). Conclusion: HFMEA activities are conducive to mitigating the risk associated with intravenous antitumor drug exposure, thereby enhancing the allocation quality of such medications. These activities aim to diminish the occurrence frequency of potential risks associated with the utilization of intravenous antitumor drugs, identifying these risks during their application, and substantially bolstering the efficacy and quality of intravenous antitumor drug administration.