Screening of Off-Label Drug Use in Pediatric Out-Patient Clinic

Authors

1 Pediatrics, Faculty of Medicine for Boys, Al-Azhar University, Cairo, Egypt

2 Pharmacology, Faculty of Medicine for Boys, Al-Azhar University, Cairo, Egypt

Abstract

Background: Off-label drug prescriptions are widespread, representing 21% to 32.3% of all prescriptions. This practice is especially concerning for vulnerable groups, including pediatric patients, where off-label usage is particularly high. Aim: To assess the prevalence of off-label drug use in pediatric outpatient clinics. Methods: The study included 900 children, aged 2 months to 14 years, treated at El Hussein and Said Galal University Hospitals between November 2023 and May 2024. Results: Off-label drug use was found in 85.2% of the children. Females were more frequently prescribed off-label drugs than males. The highest rates were observed among neonates and children under 6 years. Antimicrobial and intramuscularly administered drugs were most commonly used off-label. General practitioners and pharmacists were the leading prescribers of off-label medications. Conclusion: Pediatric outpatient clinics had a high rate of off-label drug use, particularly in younger children and females, antimicrobial drugs and intramuscular medications, with general practitioners and pharmacists being the main prescribers.