曲妥珠单抗治疗HER-2阳性乳腺癌门诊化疗风险评估及费用评价

目的：对Her-2阳性乳腺癌患者使用曲妥珠单抗进行门诊化疗开展前瞻性的风险评估及防范策略制定，优化流程的同时减少用药错误的发生，提高医院管理水平；同时与住院化疗对比，从药物经济学角度为降低患者医疗支出提供参考。方法：运用医疗失效模式与效应分析法（healthcare failure mode and effect analysis，HFMEA），确立主题，组建项目团队，绘制曲妥珠单抗门诊化疗流程图，对各环节潜在的风险进行风险指数分析，制定并实施改进措施；同时将2018年度使用曲妥珠单抗单药治疗的Her-2（+）乳腺癌患者分成门诊化疗组和住院化疗组，对其住院时间，药物费用、其他费用等进行经济学评价，从而对2种化疗方式进行比较。结果：共发现6个环节17条潜在风险，主要包括余药过期、药品储存、药物剂量、用药信息匹配、输液速度问题等，同时对药物储存、药物配制，以及医、药、护、患各环节进行防范策略的制定并实施；门诊化疗和住院化疗相比，住院时间、总费用及其他（除药品以外）费用都要明显优于住院化疗（P<0.001）。结论：HFMEA可以系统性、前瞻性地降低曲妥珠单抗门诊化疗风险，实现门诊化疗安全、有效、经济、便捷，同时门诊化疗较住院化疗更具经济学效益，以最小的时间经济成本实现目标疗效。

Risk assessment and cost evaluation of trastuzumab outpatient chemotherapy for patients with HER-2 positive breast cancer

OBJECTIVE To carry out prospective risk assessment and prevention strategy development for the use of trastuzumab in outpatient chemotherapy for patients with HER-2 positive breast cancer, optimize the process while reducing the occurrence of medication errors, and improve the hospital management level, so as to provide a reference for reducing the medical expenditure of patients from the perspective of pharmacoeconomics compared with inpatient chemotherapy. METHODS Healthcare failure mode and effect analysis (HFMEA) was used to establish the theme, form project team, draw trastuzumab outpatient chemotherapy flow chart, perform risk index analysis on potential risks in each link, and formulate and implement improvement measures; meanwhile, Her-2 (+) breast cancer patients treated with trastuzumab monotherapy in 2018 were divided into outpatient chemotherapy group and inpatient chemotherapy group, and their hospitalization time, drug cost, and other costs were evaluated economically to compare the two chemotherapy methods. RESULTS A total of 17 potential risks were identified in 6 links, mainly including drug expiry, drug storage, drug dosage, drug information matching, infusion speed problems, etc. At the same time, preventive strategies were developed and implemented for drug storage, drug preparation and medical, drug, nursing and patient care; compared with inpatient chemotherapy, the length of hospital stay, total cost and other (except for drugs) costs were significantly better than inpatient chemotherapy (P< 0.001). CONCLUSION HFMEA can systematically and prospectively reduce the risk and provide safety, effectiveness, economics and convenience to outpatient chemotherapy. At the same time, outpatient chemotherapy has more economic benefits than inpatient chemotherapy and can achieve the target efficacy with minimum time and cost.