[Improve safety monitoring of antipsychotics in the French pediatric population]
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Published on: May 30, 2015
M-L Menard1, F Askenazy1, P Auby2
1Service universitaire de psychiatrie de l'enfant et de l'adolescent, hôpitaux pédiatriques de Nice, CHU Lenval, 57, avenue de la Californie, 06200 Nice, France.
Insights
The ETAPE study monitors adverse events in children prescribed antipsychotics, addressing a critical lack of safety data in France. This research aims to improve prescribing decisions and enhance drug safety for young patients.
Area of Science:
- Pharmacovigilance in child and adolescent psychiatry.
- Pediatric psychopharmacology and adverse event monitoring.
Context:
- Rising prescription rates of second-generation antipsychotics in pediatric populations globally and in France.
- Limited safety data and relevant methodological tools for pediatric antipsychotic use in France compared to other nations.
- Identification of potentially serious adverse events in young patients, including neuromuscular, metabolic, and cardiovascular issues.
Purpose:
- To report current French and international knowledge on antipsychotic use in pediatric populations.
- To introduce the ETAPE study, a safety monitoring procedure for antipsychotic-naive pediatric patients.
- To determine the incidence of adverse events associated with antipsychotic drugs in this vulnerable group.
Summary:
- The ETAPE study involves 12-month safety monitoring with clinical and laboratory assessments at predefined intervals (pre-treatment, 1, 3, 6, 9, 12 months).
- The study focuses on antipsychotic-naive pediatric patients to accurately capture incident adverse events.
- Funding was provided by the National Security Agency of Medicines (ANSM 2012 No. 40).
Impact:
- Contribute to educating healthcare practitioners on pediatric antipsychotic adverse events.
- Aid prescribers in making informed decisions regarding antipsychotic drug selection and management in children.
- Reinforce France's adverse event monitoring system for atypical antipsychotics and inform recommendations for improved pediatric safety.
Abstract:
In France, as in the rest of the world, the prescription of second generation antipsychotics is on the rise in the pediatric population. At the same time, the use of first generation antipsychotics continues, although it is declining in France as in other countries. In France, we lack data on the pediatric population to ensure a safe prescription, unlike other countries such as Canada and the United States. This is disturbing when many adverse events, potentially serious for young patients' health (neuromuscular complications, risk factors, cardiovascular problems) are beginning to be identified. This article reports the current French and international knowledge on antipsychotics in the pediatric population. It appears that data in the French population are nearly nonexistent and that the methodological tools used are not always relevant (population already exposed to psychotropic drugs, short studies, debatable rating scale and somatic parameters). Within this context, a safety monitoring procedure for the naive pediatric population treated with antipsychotics was developed (ETAPE study) to determine the incidence of adverse events appearing with these drugs. Safety monitoring during the 12-month study period will include clinical assessments and laboratory testing. These assessments will be performed before treatment and at 1, 3, 6, 9, and 12 months after the introduction of the antipsychotic drug. This study received funding from the National Security Agency of Medicines (ANSM 2012 No. 40). The results should contribute to educating all practitioners (general physicians, pediatricians, psychiatrists, child psychiatrists) on adverse events, helping practitioners with prescribing decisions, reinforcing the French system of monitoring adverse events caused by atypical antipsychotic drugs, and developing recommendations to improve the safety of atypical antipsychotic drugs in child psychiatry.

