In recent years, psychotropic drug use among children and adolescents in Europe and USA has increased. However, the majority of psychotropic drugs are not formally approved for use in children and adolescents, and consequently, use is often off-label. The objectives were to describe time trends in off-label prescribing rates and the most commonly used types of psychotropic drugs by age and gender in Danish children and adolescents. Using the Register of Medicinal Product Statistics, we identified all prescriptions for sedatives, hypnotics and antidepressants filled for children and adolescents in 2006-2012. Information on diagnoses was obtained from the Danish National Registry of Patients and allowed classification of prescriptions as either on- or off-label. We identified 186,831 prescriptions filled for 29,851 children and adolescents: 88.0% of these were classified as off-label. During 2006-2012, off-label rates for sedatives and hypnotics increased significantly, except for prescriptions for girls aged 15-17 years [range 24.1-98.2% (girls), 31.9% to 99.0% (boys)]. In the same period, the number of registered melatonin prescriptions (all off-label) increased expansively. For antidepressants, we found decreasing trends in off-label rates over time [range 94.5-65.6% (girls), 93.8-71.2% (boys)]. Off-label prescribing of psychotropic drugs to Danish children and adolescents is common. Off-label rates for sedatives and hypnotics increased in the period of 2006-2012, whereas off-label rates for antidepressants declined. Off-label rates might be underestimated and should be considered a conservative estimate.
This study aimed to describe the level of off-label treatment with psychotropic drugs at a child and adolescent psychiatric outpatient clinic in Denmark. We performed a cross-sectional study assessing records on patients treated with medicine at two outpatient clinics at the child and adolescent psychiatric ward, on 1 day in 2014. Prescriptions of drugs from ATC group N05-N06 were classified according to label status. Six hundred and fifteen drug prescriptions distributed on nine different drugs were prescribed to 503 children eligible for this study. Overall results showed that 170 of the 615 prescriptions were off-label, which corresponds to 27.6 %. Attention deficit hyperkinetic disorder (ADHD) drugs were prescribed 450 times (73.2 %) of which 11 prescriptions were off-label (2.4 %). Other psychotropic drugs comprised 165 (26.8 %) prescriptions and of these 159 (96.4 %) were off-label. With 106 prescriptions, melatonin was the most prescribed of these drugs; all prescriptions were off-label. The main reasons for classifying prescriptions as off-label were age and indication of treatment. This cross-sectional study reveals that medical treatment of children with other psychotropic drugs than ADHD drugs is usually off-label. ADHD drugs were, as the only drug group, primarily prescribed on-label. Although off-label prescription may be rational and even evidence based, the responsibility in case of, e.g. adverse drug reactions is a challenge, and clinical trials in children should be incited.
Cognitive biases towards disorder-specific stimuli are suggested to be crucial in the development and maintenance of symptoms in adults with functional gastrointestinal disorders (FGID). Functional abdominal pain disorders (FAPD), a subtype of FGID, are common in children and adolescents, but the influence of cognitive biases is sparsely examined. The aim of this study was to 1) develop a new experimental design for assessing cognitive biases towards gastrointestinal stimuli in children and adolescents (age 8-17 years) and 2) test its feasibility on a healthy sample exploring potential sex- and age-related differences. The online experimental design – BY-FAP (Bias in Youth with Functional Abdominal Pain) includes a word task and a picture task. Stimuli in both tasks are related to general and gastrointestinal symptoms and the design includes three phases: 1) encoding, 2) free recall and 3) recognition. Results from 96 healthy participants (Mage = 12.3, 47.9% female) found no significant difference between sex or age groups in recall and recognition of either words or pictures. The results support that the design is feasible for children and adolescents. In the future, BY-FAP can be used to explore possible cognitive biases in children and adolescents with FAPD.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.