Outpatient antipsychotic drug use in children and adolescents in Germany between 2004 and 2011

Abstract

Studies from different countries showed increasing use of antipsychotics in pediatric patients. However, these studies were methodologically limited and could not assess underlying diagnoses and off-label use sufficiently. This is the first study to examine antipsychotic prescriptions in a representative sample of minors over a long period, looking at changes regarding substances and drug classes, underlying diagnoses, and the rate of off-label use. Claims data of about two million pediatric subjects were used to calculate annual prevalences and incidence rates of antipsychotic prescriptions for the years 2004-2011. Analyses were stratified by sex, age, and drug type. Numbers of prescriptions, frequencies of diseases/disorders, the prescribing physicians' specialties, and the share of off-label prescriptions were examined. During the study period, the prevalence of antipsychotic prescriptions ranged between 2.0 and 2.6 per 1000 minors. Antipsychotic prescriptions in children younger than 6 years decreased from 2.42 per 1000 subjects in 2004 to 0.48 in 2011. Among antipsychotic users, 47.0 % had only one prescription and hyperkinetic disorder was, by far, the most frequent diagnosis. The annual share of off-label prescriptions varied between 61.0 and 69.5 %. Antipsychotics were mainly prescribed to manage aggressive and impulsive behaviors in hyperkinetic disorder patients. This explains the high share of off-label prescriptions but raises concerns, since efficacy and safety of antipsychotics in this indication have not been sufficiently investigated. The decreasing antipsychotic use in younger children and the high proportion of antipsychotic users with one-time prescriptions are striking and should be further investigated in the future.

Extent and Risks of Antipsychotic Off-Label Use in Children and Adolescents in Germany Between 2004 and 2011

“…Throughout the study period, off-label AP use in minors occurred frequently. As reported previously, hyperkinetic disorder was by far the most frequent diagnosis among AP users in Germany (Schröder et al 2016). Our work shows that this diagnosis was even more frequent among those with an AP prescription off-label by indication.…”

New Users of Antipsychotics Among Children and Adolescents in 2008–2017: A Nationwide Register Study

“…The prescribing of psychotropic drugs in children and adolescents has increased in many countries during the last decade (1)(2)(3)(4). This change is mainly due to the growing use of stimulants (2), but the use of antipsychotic drugs is also on the rise (2,3,(5)(6)(7). The prevalence of antipsychotic use in children and adolescents varies from 0.5 to 30.8 per 1000 individuals in different countries (6).…”

“…In children and adolescents, antipsychotic drugs are frequently used off-label (17,18). In subjects under 18 years of age, 69% to 92% of the antipsychotics are prescribed without official indications (3,19,20). In the US and Europe, the three most commonly prescribed SGAs are in descending order risperidone, quetiapine, and aripiprazole (6,16,21).…”

“…A retrospective study in US showed that attention-deficit hyperactivity disorder (ADHD) was the most common diagnosis in children and adolescents treated with SGAs (17). Other frequent diagnoses in SGA users were conduct disorders, autism, mood disorders, bipolar disorder, tic, Tourette syndrome, aggression, insomnia, and anxiety disorders (1,3,16,23,24). These data suggest that antipsychotics may be prescribed liberally for many conditions.…”

Paediatric Medicines: Formulation Considerations

“…Many medicines already available on the market for adults continue to be used on children without appropriate studies in paediatric population and the use of unlicensed and off-label medicines in children is still a reality [4][5][6][7][8][9][10].…”