OBJECTIVES: In 2014, omacetaxine mepesuccinate became the first cytotoxic chemotherapy approved for subcutaneous injection by patients/caregivers at home. The FDA issued a post-market requirement (PMR) to identify associated risks using failure modes and effect analysis (FMEA). FMEA is a structured approach to identify process failures and implement corrective actions. Our objective is to apply FMEA to identify risks associated with the patient/caregiver and healthcare provider (HCP), and implement processes to improve patient outcomes associated with omacetaxine home administration. METHODS: The PMR is ongoing until May 2017. Data regarding prescribing behavior, training, and administration practices are collected through standardized telephone interviews with HCPs and patients/caregivers. Spontaneous reports of adverse events (AEs) and product complaints (PCs) are also collected. These data are being used to identify additional “system failures” related to administration errors or inadequate training/ educational materials. System failures will be rated on a 5-point scale for severity, frequency, and detection to prioritize risks and corrective actions, and conduct a root cause analysis. Following implementation of corrective actions, risks will be reassessed in the subsequent waves. RESULTS: FMEA design and interim data from 8 patient and 7 HCP interviews are presented. Seven (88%) patients reported a safety risk with syringe disposal; 2 (29%) HCPs reported delays with medication shipments. Two of 90 (2%) AE reports identified system failures and 1 of 3 (33%) PCs were associated with syringe functionality. Corrective actions were implemented: follow-up by the specialty pharmacy nurse to reinforce safe handling and disposal practices, and educational materials were strengthened. Updated data as available will be presented. CONCLUSIONS: As the availability of oncology products for home administration increases, HCPs and pharmaceutical companies will be increasingly accountable for safety monitoring and reporting. FMEA findings may support patient selection and end-user educational initiatives to improve patient outcomes.