Abstract: A Risk Analysis Model to Evaluate Safe Delivery and Use of the First Chemotherapy Injection for Home Administration: Omacetaxine Mepesuccinate

 

Abstract: A Risk Analysis Model to Evaluate Safe Delivery and Use of the First Chemotherapy Injection for Home Administration: Omacetaxine Mepesuccinate

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.