The general objective of this project is to inform the development of public health policies and rational use of APs in children and adolescents in Spain, generating new, original and relevant information on the use patterns of antipsychotic drugs in the SNS environment and analyzing the most relevant aspects of efficacy and safety of the therapies used in our child and adolescent population.
The project will generate strategic intelligence for management and at a scientific level on the trends in the use of AP in childhood and adolescence in our country, the characteristics of the patients to whom it is prescribed, the indications for which it is used, including all those unauthorized indications, and their effects on the health of our young people.
This information will allow obtaining a detailed diagnosis of potential areas of action in terms of public health and rational use of the medicine. To achieve this, the project will have the participation of the four Autonomous Communities with the largest population in the country (Andalusia, Catalonia, Community of Madrid and Valencian Community) as well as the Basque Country. In this way, we will have real-life data on 64% of the Spanish population, which will allow the results of the project to be broadly representative.
Specific objectives are:
First, to describe trends in the use of antipsychotics (AP) among patients aged 0 to 19 years (by Autonomous Communities and across all participating regions): temporal trends in the volume of prescriptions, number of patients treated with AP, and the evolution of prevalence and incidence rates of AP treatment. Trends will be described both overall and for specific APs of major interest (those with the highest prescription levels: risperidone, aripiprazole, paliperidone, olanzapine, quetiapine, lurasidone, and other APs). All descriptive analyses will stratify data by variables of interest, such as age groups (0–4, 5–9, 10–14, 15–19), sex assigned at birth, family income level, and country of origin.
Second, to create a dynamic cohort (initially covering 2015–2023) of patients aged 0 to 19 years undergoing AP treatment in the participating Autonomous Communities. Multiple subcohorts (aggregated and by Autonomous Community) will be generated for initiators of the most frequently prescribed APs (risperidone, aripiprazole, paliperidone, olanzapine, quetiapine, lurasidone).
For each cohort, the following descriptive and analytical objectives will be pursued:
• To describe baseline sociodemographic and clinical characteristics of patients initiating AP treatment.
• To detail pharmacotherapeutic management patterns: prescribed indications, duration of treatment episodes, concomitant treatments (e.g., antidepressants, anxiolytics, antiepileptics), adherence indicators, and analysis of potential inadequacies based on the prescription indication. Stratified analyses will be performed for variables such as age groups, sex assigned at birth, family income, and country of origin.
• To describe the incidence of clinically relevant events in the cohorts of AP initiators.
• To assess the comparative safety of the main APs (olanzapine, risperidone, quetiapine, paliperidone, aripiprazole, lurasidone) for key prescribed indications and/or those identified as warranting special monitoring. Various potential adverse events will be evaluated, including neurological, motor, psychiatric, gastroenterological, metabolic, and cardiovascular events.
• To evaluate the comparative effectiveness of the main APs for key prescribed indications or identified priority indications, using appropriate operational definitions for outcome measures derived from clinical history data in large databases (e.g., incidence of healthcare service contacts related to the condition for which the AP was prescribed, use of healthcare services, and concomitant medication use).