Off-Label Prescribing of Antipsychotics in a Danish Child and Adolescent Mental Health Center: A Register‐Based Study

Objective: We analyzed prescribing patterns of antipsychotics for children and adolescent affiliated with a Danish Child and Adolescent Mental Health Center) with respect to age, sex, medicine, diagnoses, off‐label status, and time. Methods: We included all patients below 19 years of age prescribed antipsychotics during 2007–2008 and as of November 1, 2014. Prescription data included all antipsychotic prescriptions and prescriptions of concomitant psychotropic medications. We defined an antipsychotic user as a patient receiving at least one prescription during the study period, irrespective of any previous history of antipsychotic use. We defined off‐label prescribing as prescriptions outside the licensed age group and approved indication. Findings: We analyzed 404 antipsychotic prescriptions that were located for 150 patients. The patients were between 7 and 18 years of age. Two‐thirds of the prescriptions were for girls and two‐thirds of prescriptions for olanzapine and quetiapine. Totally, 92% of all prescribed antipsychotics were used off‐label. For typical antipsychotics, this share was 96% and for atypical antipsychotics 90%. As of November 1, 2014, the total share of off‐label antipsychotic prescriptions was 96%, and 63% of these were for medications prescribed outside the approved age group, and 26% for nonlicensed indication(s). Conclusion: This study demonstrated a high level of off‐label prescribing over time with respect to age and indication. The prescribing patterns underpin the need for further economic incentives for pharmaceutical companies to register pediatric indications, particular for off‐patent products.