[Off-label use of psychotropic medications in pediatric wards: a prospective study]. / Utilisation hors autorisation de mise sur le marché (AMM) des psychotropes en pédiatrie: une étude prospective.

ABSTRACT

PURPOSE: 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. METHODS: 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. RESULTS: 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%). CONCLUSION: 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.