Trends in antipsychotic drug utilisation and indication in the paediatric population: a nationwide cohort study in Sweden.

Abstract

Background: Data on antipsychotic use for the Swedish paediatric population is limited.

Objective: We assessed the incidence, likely indication and extent of off-label antipsychotic use among children and adolescents in Sweden.

Methods: In this nationwide register-based study, individuals younger than 18 years with at least one antipsychotic dispensing between 1 January 2008 and 31 December 2021 were identified. Yearly age-standardised and sex-standardised incidence per 1000 persons was estimated and temporal trends were assessed using Poisson log-linear regression. We also assessed the likely indication and the proportion of on-label and off-label use.

Findings: Among 4 108 171 individuals who were children or adolescents at some point during the study period, 24 742 initiated antipsychotic treatment at least once, contributing 25 576 incident dispensings during the study period. Incidence increased from 0.48 to 1.28 per 1000 persons (risk ratio, RR per year 1.08, 95% CI 1.05 to 1.11; cumulative increase 180%), with a more pronounced rise in females (0.43 to 1.51 per 1000; RR 1.11, 95% CI 1.10 to 1.12; 284%) than males (0.53 to 1.06 per 1000; RR 1.06, 95% CI 1.05 to 1.07; 113%), driven by adolescents aged 12-17 years. The largest drug-specific increases were observed for quetiapine (0.04 to 0.33 per 1000; RR per year 1.18, 95% CI 1.17 to 1.19; cumulative increase 804%) and aripiprazole (0.03 to 0.36 per 1000; RR per year 1.16, 95% CI 1.14 to 1.18; cumulative increase 608%). A likely indication was identified in 64.3% (n=16 455) of incident dispensings, most commonly autism spectrum disorder (15.4%), attention-deficit hyperactivity disorder (10.9%) and anxiety disorders (9.6%). Among those with an identifiable indication, 81% were dispensed off label, mainly due to non-approved indications (64.8%) and most frequently among adolescent females.

Conclusions: In the paediatric population in Sweden, incidence of antipsychotic use increased between 2008 and 2021, especially among adolescent females and most incident dispensing with an identifiable indication were off label, underscoring the need to evaluate the long-term effectiveness and safety of antipsychotics in children and adolescents.

Clinical implications: These patterns highlight the need to evaluate the long-term effectiveness and safety of antipsychotics in children and adolescents.