Oral Chemotherapy Safety in Ambulatory Oncology: A Proactive Risk Assessment

描述（由申请人提供）：口服化疗是门诊肿瘤学中新兴的药物安全危害。为了描述风险的性质和程度，我们建议完成五种口服化疗药物的失效模式和效果分析，包括解决这类药物相关危害的改进计划。本研究将分四个部分进行。首先，研究人员将使用来自不同来源的数据来描述与口服化疗相关的药物错误和伤害，包括提示医师报告、患者焦点小组、去识别事件报告和从13个综合癌症中心获得的根本原因分析。其次，研究人员将召集跨学科团队，为研究地点（新英格兰最大的癌症中心）的成人和儿科门诊患者使用的五种口服化疗制定详细的流程图。第三，同一跨学科团队将识别，分析和优先考虑与五种口服化疗相关的失败模式。第四，结果将被整合到一个改进计划中，其中包括一系列干预措施，以解决高优先级失效模式。将采用改进的德尔菲方法促进关键组织之间的共识

DESCRIPTION (provided by the applicant): Oral chemotherapy is an emerging medication safety hazard in ambulatory oncology. To characterize the nature and magnitude of risk, we propose to complete failure mode and effect analyses for five oral chemotherapy agents, including an improvement plan for addressing the hazards associated with these classes of medications. The study will proceed in four parts. First, researchers will characterize oral chemotherapy-related medication errors and injuries using data from various sources, including prompted physician reporting, patient focus groups, and de-identified incidents reports and root cause analyses elicited from 13 comprehensive cancer centers. Second, the researchers will convene interdisciplinary teams to develop detailed process maps for five oral chemotherapies used by adult and pediatric ambulatory patients at the study site, New England's largest cancer center. Third, the same interdisciplinary team will identify, analyze, and prioritize failure modes associated with five oral chemotherapies. Fourth, the results will be integrated into an improvement plan that includes a portfolio of interventions to address high-priority failure modes. A modified Delphi approach will be employed to facilitate consensus among key organizational stakeholders -- including patient safety professionals, oncologists, administrative leaders, board members, and cancer patients -- based on the risks and benefits of potential interventions as well as their cost and ease of implementation. Few cancer centers have in place safety precautions for monitoring or managing the risk of oral chemotherapies. Therefore, a structured and high-quality risk assessment in this area may identify opportunities for improvement that could spread quickly in US oncology care. As the use of oral chemotherapy grows, the results of this study may inform practice at a critical time. Lessons about oral chemotherapy safety are applicable to other high-alert medications in ambulatory care.