Abstract
Refrigeration is essential for maintaining the stability and efficacy of many pharmaceuticals, including vaccines, biologics, and certain antibiotics. However, unintentional exposure of refrigerated medications to room temperature may occur during transport delays, power outages, or handling errors, raising concerns about compromised potency and patient safety. Despite frequent real-world cold chain breaches, evidence-based guidance on acceptable room temperature excursions remains limited. This study aimed to review and summarize available data regarding the stability of refrigerated medications when exposed to room temperature, providing a practical reference tool for healthcare providers. All U.S. Food and Drug Administration (FDA)-approved unopened refrigerated pharmaceutical and biological products up to June 30, 2024, were screened from our institutional formulary. Stability data were collected from drug SmPCs, package inserts, regulatory agency databases (FDA, European Medicines Agency (EMA), Saudi Food and Drug Authority (SFDA)), published literature, and tertiary drug information resources (Lexicomp, Micromedex, UpToDate). Where data were lacking, manufacturers were contacted directly. Medications were categorized based on documented stability at room temperature (20°C-25°C), and a reference table was developed summarizing acceptable excursion durations. A total of 150 refrigerated medications were identified with available data supporting room temperature stability. Out of them, 22.8% of the products remained stable for at least 24 hours, while several demonstrated stabilities for extended durations. Notable variability was observed across brands containing the same active substance, such as recombinant human growth hormone products. This review provides an updated, comprehensive resource summarizing the stability of refrigerated medications at room temperature. The findings underscore the clinical and economic importance of minimizing unnecessary wastage following cold chain excursions. Brand-specific data must be prioritized, as stability profiles differ even among products with the same active ingredient. Broader transparency from pharmaceutical manufacturers regarding temperature excursion studies is urgently needed to support evidence-based decision-making in pharmacy practice, patient safety, and cost containment.