Oral Chemotherapy Safety in Ambulatory Oncology: A Proactive Risk Assessment

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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.