Prescriber-recorded indications for antipsychotic use in children and adolescents in Spain, 2015-2023: a population-based, real-world study

Autores de FISABIO

• Anibal Garcia Sempere

  Autor

• Isabel Hurtado Navarro

  Autor

• Celia Robles Cabaniñas

  Autor

• Maria Fernanda Carrillo Arenas

  Autor

• Fran Llopis Cardona

  Autor

• Veronica Gamon

  Autor

• 

  Clara Liliana Rodriguez Bernal

  Autor

• 

  Salvador Peiro Moreno

  Autor

• Gabriel Sanfelix Gimeno

  Autor

Autores ajenos a FISABIO

• Oltra, AL
• Tabarés-Seisdedos, R
• Baeza, I

Grupos de Investigación

• GRUPO 023. GRUPO DE INVESTIGACIÓN EN SERVICIOS DE SALUD Y FARMACOEPIDEMIOLOGÍA

  Investigador/a Principal

  Gabriel Sanfelix Gimeno

Abstract

The use of antipsychotics (APs) in children and adolescents has increased notably worldwide, often beyond approved indications. However, most real-world studies lack direct information on the clinical reasons for prescribing. In this population-based study conducted in the region of Valencia, Spain, we analysed 128,057 AP treatments, comprising 741,213 prescriptions, issued to 30,383 individuals aged 0-19 years between 2015 and 2023, using real-world data that uniquely includes prescriber-recorded indications. We described the distribution and temporal evolution of the number of AP treatments by indication, age, sex, and active substance. The most frequent indications were disorders of personality and behaviour (20.2% of treatments), attention-deficit/hyperactivity disorder (14.2%), autism spectrum disorders (13.9%), anxiety-related disorders (11.4%), and psychotic disorders (5.8%). Among the most frequent indications, depression treatments showed the steepest increase (5.7-fold). Sharp rises also were observed for suicidal ideation (30.7-fold), psychoactive drug use (2.8-fold), eating disorders (2.3-fold), and autism-related conditions (2.2-fold). Changes were more pronounced in females and older adolescents, particularly after 2020. The number of ADHD treatments declined substantially over time. Sulpiride was almost exclusively prescribed for dizziness, a non-psychiatric but approved indication in adults in Spain. Our findings align with international trends but provide greater specificity thanks to the direct link between prescriptions and indications. This study highlights an increase in the volume of AP treatments in paediatric populations, mostly in non-approved, and potentially high-risk indications, some of which have not been previously documented. Our results underscore the need for close monitoring and further evaluation of the appropriateness and safety of antipsychotic prescription in the youth.

Keywords

• Antipsychotic agents; Child; Adolescent; Off-Label Use; Trends