Background
The prescription of antipsychotics (AP), and especially second generation AP, is increasing worldwide in the pediatric population. Most prescriptions are off-label and despite the identification of frequent and potentially severe adverse events (AE), there are only a few guidelines for the safety management. France is one of the countries with no official safety guidelines.

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Preliminary and ongoing French multicenter prospective naturalistic study of adverse events of antipsychotic treatment in naive children and adolescents

Introduction In France, over recent years, the prescription rate of antipsychotic (AP) remained stable in children and adolescents. Prescription of second-generation antipsychotics increased, whereas prescription of first-generation antipsychotics decreased. Off-label prescriptions are very frequent in this population. Adverse events (AEs) in youth treated with AP are common and may be severe. AEs have hitherto been poorly monitored in naturalistic studies independent from industry. Method and analysis We describe a French prospective multicentre study in an AP-naive paediatric population named Etude de la Tolerance des AntiPsychotique chez l9Enfant (ETAPE). The study started in April 2013. So far, 200 patients have been included. The inclusion criteria are: male or female inpatients aged from 6 to 18 years, treated with an AP drug for less than 28 days, never been treated or having received AP for less than 3 months, discontinued at least 6 months prior to inclusion. These assessments of AE are performed at inclusion, as well as at 3, 6, 9 and 12 months after the introduction of the AP. The monitoring period will end in May 2016. Ethics and dissemination The study protocol was approved by the Ethics Committee ‘Sud Mediterrane V’ (number 12.082) and by the French National Agency for Medicines and Health Products Safety (number 2012-004546-15). All patients and their parents signed informed consent on enrolment in the study. We will submit the results of the study to relevant journals and offer national and international presentations. This study will enable better characterisation of the prescription of AP drugs. The results will further help to develop quality standards and recommendations for monitoring AE during the prescription of AP. Trial registration number NCT02007928.

https://bmjopen.bmj.com/content/bmjopen/6/4/e011020.full.pdf

Incidence of adverse events in antipsychotic-naïve children and adolescents treated with antipsychotic drugs: a French multicentre naturalistic study protocol (ETAPE)

Second-generation antipsychotics (SGAs) have been proven effective in treating several psychiatric conditions in children and adolescents. These atypical antipsychotic medications are being used with increasing frequency in Europe, the U.S., and Canada. We aim to expose short-term and long-term adverse effects (AEs) of SGAs in youth populations and to provide management recommendations for major adverse effects. These proposals are based on (1) an in-depth literature review of both short- and long-term studies on the use of SGAs in youth; (2) our own clinical experience in managing such treatment in this population; and (3) the work of the Canadian Alliance for Monitoring Effectiveness and Safety of Antipsychotics in Children (CAMESA). AEs are frequent in youth treated with SGAs, and include primarily weight gain, metabolic and hormonal changes, somnolence, extrapyramidal syndrome, and QT modifications. However, frequency and type of AE vary according to compound, and each compound’s AE profile is specific. Acknowledgment of these distinct profiles should aid clinicians in making treatment decisions. After an SGA is prescribed, routine monitoring of AEs is recommended, and should an AE occur, clinical management recommendations should be followed. To date, there are no clinically validated monitoring recommendations.

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Management of Adverse Effects of Second-generation Antipsychotics in Youth

Resume En France, comme dans le reste du monde, la prescription d’antipsychotiques de seconde generation (ASG) tend a augmenter chez l’enfant et l’adolescent. Parallelement, l’utilisation des antipsychotiques de premiere generation perdure bien qu’elle soit en diminution. Nous manquons en France de donnees documentees chez l’enfant pour aboutir a une prescription securisee contrairement a d’autres pays comme le Canada et les Etats-Unis. Cela pose probleme alors que des evenements indesirables nombreux et potentiellement graves (complications neuromusculaires, facteurs de risques cardiovasculaires) commencent a etre repertories. Cet article fait l’etat des connaissances sur les ASG utilises chez l’enfant. Les donnees francaises sont quasiment inexistantes et les outils methodologiques utilises ne sont pas toujours pertinents (population deja exposee a un antipsychotique, temps d’exposition court, echelle d’evaluation et parametres somatiques discutables). Nous avons elabore, dans le cadre d’un appel a projets 2012 de l’Agence nationale de securite du medicament et des produits derives, un calendrier de surveillance optimise pour l’enfant naif afin de mieux connaitre l’incidence des evenements indesirables (EI) apparaissant sous antipsychotique, l’objectif final etant d’ameliorer la qualite de la prescription chez l’enfant ainsi que la prise en charge des EI. Il parait necessaire de sensibiliser le corps medical (pediatres, medecins traitants, psychiatres, pedopsychiatres) charge de la sante des enfants et des adolescents a la tolerance des antipsychotiques afin que leur prescription ne soit pas banalisee.

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Améliorer la surveillance de la tolérance pédiatrique des antipsychotiques en France

Sécuriser la prescription des antipsychotiques en population pédiatrique : une étude multicentrique française en population naïve

Evaluation de l’incidence des événements indésirables sous antipsychotique en population pédiatrique naïve (Etude ETAPE : Etude de la Tolérance des AntiPsychotiques chez l’Enfant)

F. Askenazy

Papers

Evaluation de l’incidence des événements indésirables sous antipsychotique en population pédiatrique naïve (Etude ETAPE : Etude de la Tolérance des AntiPsychotiques chez l’Enfant)