Drug shortages may lead to interruption of ongoing treatment, delays in therapy initiation, or the need to modify therapeutic regimens. This represents a current and persistent problem that requires systematic and long-term solutions, as it may be a significant contributing factor to off-label prescribing. Between 2018 and 2020, the occurrence of drug shortages increased up to twentyfold, accompanied by a growing demand for essential medicines. The aim of this study was to analyse the occurrence of off-label prescribing in the paediatric population in a community pharmacy and to assess a possible association between the unavailability of a selected medicine and an increase in off-label use of a therapeutic alternative. A retrospective analysis was conducted using data obtained from pharmacy software and the national eHealth system for the period 2021-2024. A total of 6,366 paediatric patients were included in the analysis, with off-label prescribing identified in 705 cases (11.07%). Off-label use most frequently involved antibiotics for systemic use and ophthalmological medicines, with the highest proportion of off-label prescribing within an ATC group observed for ophthalmological drugs. In evaluating the relationship between the unavailability of Pamycon and increased off-label prescribing of Uniflox 0.3% eye drops, no statistically significant association was demonstrated (p > 0.05). Off-label prescribing is a common component of paediatric pharmacotherapy and is influenced by multiple factors beyond medicine availability alone. Pharmacists play an important role in ensuring safe treatment by identifying potential risks, educating parents or caregivers, and supporting the rational use of medicines. Strengthening collaboration among healthcare professionals and consistent pharmacovigilance are essential for improving the safety of off-label treatment in children.
Keywords: age group; drug shortages; off-label; paediatric population; pediatric population; prescriptions.