Center for Patient Safety, Dana-Farber Cancer Institute, Boston, MA.
J Oncol Pract. 2011 Jan;7(1):2-6. doi: 10.1200/JOP.2010.000064. Epub 2010 Dec 8.
Oral chemotherapies represent an emerging risk area in ambulatory oncology practice. To examine the hazards associated with five oral chemotherapies, we performed a proactive risk assessment.
WE CONVENED INTERDISCIPLINARY TEAMS AND CONDUCTED FAILURE MODE AND EFFECTS ANALYSES (FMEAS) FOR FIVE ORAL CHEMOTHERAPY AGENTS: capecitabine, imatinib, temozolomide, 6-mercaptopurine, and an investigational agent. This involved the creation of process maps for each medication, identification of failure modes, selection of high-risk failure modes, and development of recommendations to mitigate these risks. We analyzed the number of steps and types of failure modes and compared this information across the study drugs.
Key vulnerabilities include patient education about drug handling and adverse effects, prescription writing, patient self-administration and medication adherence, and failure to monitor and manage toxicities. Many of these failure modes were common across the five oral chemotherapies, suggesting the presence of common targets for improvement. Streamlining the FMEA itself may promote the dissemination of this method.
Each stage of the medication process poses risks to the safe use of oral chemotherapies. FMEAs may identify opportunities to improve medication safety and reduce the risk of patient harm.
口服化疗药物代表了门诊肿瘤学实践中一个新兴的风险领域。为了评估与五种口服化疗药物相关的危害，我们进行了积极的风险评估。
我们召集了跨学科团队，对五种口服化疗药物（卡培他滨、伊马替尼、替莫唑胺、巯嘌呤和一种研究药物）进行失效模式和影响分析（FMEA）。这涉及为每种药物创建流程图、确定失效模式、选择高风险失效模式以及制定减轻这些风险的建议。我们分析了步骤数量和失效模式类型，并比较了研究药物之间的信息。
关键的弱点包括患者对药物处理和不良反应、处方书写、患者自我管理和用药依从性的教育，以及未能监测和管理毒性的情况。这些失效模式中的许多在五种口服化疗药物中都很常见，这表明存在共同的改进目标。简化 FMEA 本身可能会促进该方法的传播。
药物使用过程的每个阶段都存在安全使用口服化疗药物的风险。失效模式和影响分析可能会为提高药物安全性和降低患者伤害风险提供机会。
