Key Drivers and Mitigation Strategies of Oncology Drug Shortages 2023 to 2025

Drug shortages remain a problem in the United States, jeopardizing patient care. To help inform solutions, this study reviewed recent oncology drug shortages for causes and mitigation strategies. Using the FDA's Drug Shortage Database, 15 oncology drugs with shortages between 2023 and 2025 were identified. Twelve drugs had shortages lasting >2 years (maximum: >13 y). Searches of PubMed and Google Scholar, online media sources, and FDA documents uncovered 9 main causes: manufacturing quality problems, limited-source dependency, regulatory bottlenecks, global over-reliance, absence of buffer stocks, demand surges, low economic incentives, active pharmaceutical ingredient shortages, and shelf-life constraints. Mitigation strategies involved 4 stakeholders: regulators (expedited regulatory action, importation, expiration extensions), manufacturers (capacity expansion), providers (dose-sparing regimens, therapeutic alternative protocols, allocation prioritization), and purchasers-distributors including GPOs (supply collaboration). Policies to mitigate drug shortages should include new approaches to identify vulnerable markets and involve multiple stakeholders. Factors identified in this study also offer pathways for shortage prevention.