Le but de cette étude était d’évaluer l’utilisation hors autorisation de mise sur le marché (AMM) des psychotropes dans un hôpital universitaire pédiatrique.

Une analyse prospective de l’utilisation des médicaments psychotropes a été effectuée sur une période de 6 mois. Les données ont été collectées à partir du logiciel de prescription. Ces données ont concerné le patient (sexe, âge et poids) et la prescription médicamenteuse (dénomination commune internationale [DCI], dose, fréquence d’administration, voie d’administration et indication). Pour chaque médicament, il a été déterminé le cadre d’utilisation : conforme à l’AMM ou hors AMM.

Un total de 1629 prescriptions a été effectué pour 472 patients. Soixante-huit pour cent de toutes les prescriptions étaient hors AMM et elles concernaient plus de la moitié des patients (66 %). Les fréquences de prescription hors AMM par classe médicamenteuse étaient : antiparkinsoniens 100 % ; hypnotiques 100 % ; antidépresseurs 92 % ; antipsychotiques 69 % ; anxiolytiques 65 % ; antiépileptiques 51 % et psychostimulants 30 %. Les 5 médicaments les plus communément prescrits hors AMM étaient la rispéridone (12 %), le clobazam (12 %), l’amitriptyline (11 %), l’hydroxyzine (10 %) et le diazépam (7 %). Près de la moitié (47 %) des prescriptions hors AMM concernaient 3 indications : symptômes d’anxiété (24 %), troubles du comportement avec agressivité (12 %) et douleurs (11 %).

L’importante utilisation hors AMM des psychotropes chez l’enfant met en exergue la nécessité d’études prospectives évaluant l’efficacité et la sécurité de ces médicaments en pédiatrie.

The aim of this study was to investigate the use of psychotropic medications for both labeled and off-labeled indications in a French paediatric teaching hospital.

A prospective analysis of all psychotropic drug prescriptions was conducted during a 6-month interval. Details were recorded from the computerized prescription order entry system. They included demographic data (sex, age and weight) and psychotropic medications (name, dosage, schedule, route of administration and indication). The physicians specified the indication when prescribing the psychotropic medication. All prescriptions were assessed for off-label use. Off-label prescriptions were defined as: use of a different dose or dose schedule, use for an indication not included in the license or approved for adults only, drug use outside the age range of the product license, use of medicines for which no paediatric information was available, use when the product was contraindicated, use of drug preparations that were manufactured by the hospital pharmacy, use of licensed drugs that were modified by the hospital pharmacy and use of new drugs available under a special manufacturing license. Each prescription was compared with data available in the National French Formulary.

A total of 1629 drug prescriptions were written for 472 patients. Sixty-eight percent of all drug prescriptions were for off-label uses: indication not included in the license or approved for adults only in 40%, no paediatric information available in 37%, different dose or dose schedule in 7%, licensed drugs that were modified by the hospital pharmacy in 5%, administration to children outside the age range of the product license in 4%, drug preparations that were manufactured by the hospital pharmacy in 4%, contraindication in 2% and new drugs available under a special manufacturing license in 1%. Sixty-six percent of the patients were prescribed a psychotropic drug in an off-label manner. Over half of the off-label prescriptions were given to adolescents (62%), followed by children (29%), infants (8%) and neonates (1%). The percentage of off-label prescriptions by age was: neonates 91%; adolescents 74%; children 59% and infants 58%. The percentage of off-label prescriptions by medication class are presented in decreasing order of prescription frequency: anxiolytics 65%; antipsychotics 69%; antidepressants 92%; antiepileptics 51%; stimulants 30%; antiparkinsonians 100% and hypnotics 100%. The 5 drugs most commonly prescribed off label were risperidone (12%), clobazam (12%), amitriptyline (11%), hydroxyzine (10%) and diazepam (7%). Nearly half (47%) of all off-label prescriptions were associated with 3 indications: anxiety (24%), disruptive behaviour (12%) and pain (11%).

The high rates of off-label prescription documented here and elsewhere highlight the need for further controlled clinical trials to evaluate the risks and benefits of psychotropic medication in children and adolescents.