Off-label prescribing in the pediatric population: perceptions and practices of community pharmacists in Kosovo - a cross-sectional survey.

Off-label drug prescribing in pediatric populations is a common practice worldwide due to the limited availability of approved formulations and clinical data for children. While often necessary, it raises concerns regarding safety, efficacy, and ethical considerations. Pharmacists play a key role in ensuring the safe use of off-label drugs; however, their perspectives in low-resource settings like Kosovo remain under-investigated. A cross-sectional, questionnaire-based survey was conducted among 296 community pharmacists across Kosovo between December 2024 and January 2025. The 27-item structured survey collected demographic data and assessed pharmacists' familiarity, practices, and perspectives on pediatric off-label use. Data were analyzed using IBM SPSS 22.0. Of the pharmacists surveyed, 49% reported moderate familiarity with pediatric off-label use, and 79% had not received formal training. Nearly all participants (99%) had encountered off-label prescriptions, most commonly involving anti-infectives and respiratory medications. Although 98% acknowledged that off-label use is sometimes necessary, many expressed concerns about safety and effectiveness. Only 21% had observed adverse drug reactions, while 96% reported no treatment failures. Communication with prescribers was rated as good by 49% of respondents, though 71% emphasized the need for stronger interdisciplinary collaboration. This study provides the first national insight into community pharmacists' perspectives on pediatric off-label prescribing in Kosovo. The findings highlight the urgent need for targeted pharmacist education, the development of standardized national guidelines, and enhanced collaboration between pharmacists and prescribers to improve medication safety in pediatric patients.