目的 用药错误(ME)对儿童的影响较成人频繁。化疗药物导致的MEs相对更严重且更难被发现,其中最常涉及的化疗药物就是甲氨蝶呤(MTX)。目的是建立一个多学科的团队,通过多中心前瞻性的风险评估,来发现MTX用药过程中的潜在风险并制定防范策略。方法 从位于中国东南、东北部的3家儿童医院选取医生、护士、药师及患儿家属组成团队参与失效模式效应分析(FMEA)。FMEA是一个以团队为基础的前瞻性的系统性的风险管理方法,步骤包括:制定药物使用流程图、搜集各环节失效模式/风险点并赋分排序、制定防范策略。本次研究主要关注院内外MTX使用的全过程。结果 多学科的用药安全团队由66人组成,制定了包含4个阶段及4个主要环节的用药流程图。根据流程图,发现了56个潜在的风险,其中17个风险优先值(RPN)较高。院内各环节中,最大的风险分别是溶媒错误、贴签时用药频率错误及缺少监测;此外,出院后患儿口服MTX过量的问题也需要重点关注。同时,制定相关防范策略,包括强制性的和推荐性的。结论 FMEA是一种有效的发现MTX使用过程中潜在风险的方法,在以后,希望通过医务工作者及计算机工程师的共同努力,可以减少ME的发生,提高儿童用药安全性。
Abstract
OBJECTIVE Medication errors (ME) more frequently affect pediatric patients than adults. Chemotherapeutic drug MEs seems more serious and less detected, among which, the most commonly involved chemotherapeutic agent was methotrexate (MTX). To engage multidisciplinary teams of childhood malignancy in a multisite study using proactive risk assessment methods to identify how MTX errors occur and propose risk reduction strategies. METHODS We recruited doctors, nurses, pharmacists and parents from three children′s hospitals in the northeast and southeast China to participate in failure mode and effects analyses (FMEA). An FMEA is a systematic team-based proactive risk assessment approach in understanding ways a process can fail and develop prevention strategies. Steps included diagram the process, collect failure modes/risks and prioritize failure modes, and propose risk reduction strategies. We focused on MTX-use process in and out of hospitals. RESULTS A multidisciplinary medication safety team was formed of total 66 members. They developed a four-stage flow diagram with four main phases, based on which, 56 potential risks were recognized and 17 were classified as higher risks by the hazard-scoring matrix. The highest priority failure modes in hospital included wrong solvents, wrong frequency label and lake of monitoring; furthermore, errors involving excessive intake of oral MTX after discharge were worth extra attention. Meanwhile, remediation strategies were developed, consisting of constrained and recommended strategies. CONCLUSION FMEA is a useful tool to identify the risk of MTX MEs and several years later, with the concerted efforts of all the healthcare staff and technicians, we wish to see a reduction in the potential for errors being made and an improvement of children safety.
关键词
甲氨蝶呤 /
失效模式效应分析 /
儿童 /
恶性肿瘤 /
用药错误 /
失效模式
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Key words
methotrexat /
failure mode and effects analyses /
children /
malignancy /
medication error /
failure mode
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中图分类号：
R969.3
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参考文献
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脚注
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基金
国家卫生计生委药政司委托课题资助:保障儿童用药理论政策及基础数据研究
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