DOI: https://doi.org/10.36347/sasjm.2026.v12i08.006

Pages: 798-807

Background: Off-label prescribing of psychotropic medications is common in child and adolescent psychiatry because of the limited number of drugs approved for pediatric use. However, data from North Africa remain scarce. This study aimed to estimate the prevalence of off-label psychotropic prescribing in a Moroccan child and adolescent psychiatry department and to identify the clinical and therapeutic factors associated with this practice. Methods: We conducted a retrospective observational study in the Child and Adolescent Psychiatry Department of Ar-Razi University Psychiatric Hospital (Salé, Morocco). Medical records and prescriptions issued between May and July 2026 were reviewed. Off-label status was determined according to U.S. Food and Drug Administration (FDA) labeling with regard to indication, age, dosage, route of administration, and contraindications. Descriptive analyses were performed, and associations between off-label prescribing and demographic or clinical variables were assessed using Pearson's chi-square test or Fisher's exact test, with the Mann– Whitney test used for continuous age comparisons. Results: A total of 112 patients (mean age 13.2 ± 3.9 years; 54.5% male) were included. Overall, 52.7% (95% CI: 43.5–61.7) of patients received at least one off-label psychotropic prescription. Off-label prescribing occurred in 32.1% (95% CI: 24.2–41.3) of first-line psychotropics and 77.8% (95% CI: 61.9–88.3) of second-line psychotropics. Nearly all offlabel prescriptions were related to non-approved indications. Anxiety disorders (100%) and attention-deficit/hyperactivity disorder (78.9%) showed the highest proportions of off-label prescribing. All clonidine prescriptions and 50% of sertraline prescriptions were off-label, whereas off-label use was uncommon for risperidone (3.7%) and fluoxetine (19.4%). Younger age, primary diagnosis, and prescribed molecule were significantly associated with off-label prescribing (all p < 0.05), whereas sex was not.