Factors associated with the off-label use of psychotropic medicines in children and adolescents: A scoping review

Objective: Psychotropic medicines are widely prescribed to children and adolescents, despite limited regulatory approvals. Off-label use of psychotropic medicines is therefore common in paediatric mental health care. This scoping review aimed to identify and synthesise factors associated with the off-label use of psychotropic medicines among children and adolescents with mental health conditions. Methods: A systematic scoping review was conducted in accordance with the Joanna Briggs Institute (JBI) methodology. MEDLINE, Embase, APA PsycINFO, International Pharmaceutical s, and Scopus were searched for English-language studies examining factors associated with off-label psychotropic use in mental health care in individuals aged 18 years or younger (January 2014–April 2025). Data were extracted into a structured form and synthesised inductively. Results: In total, 43 studies across 16 countries were included, most using observational designs. Antipsychotics (n = 28) were the most studied psychotropic drug class. Factors associated with off-label psychotropic use were synthesised across five domains. Diagnosis/indication-level factors were most frequently reported (n = 29), particularly for disruptive behaviour disorders and attention-deficit/hyperactivity disorder, followed by drug- (n = 23), patient- (n = 21), regulatory/system- (n = 13), and prescriber-level (n = 11) factors. Most studies reported combinations of factors across two or more domains (n = 28). Four interrelated themes emerged: regulatory approval frameworks; developmental and diagnostic patterns; symptom-targeted patterns of use; and governance, health system structure, and service availability. Conclusions: Off-label psychotropic use emerges from the interaction of broader regulatory, clinical, and health system contexts. These findings support a more informed interpretation of off-label use patterns across countries and highlight priorities for future research, policy, and governance in paediatric mental health care.