First-Time Users of ADHD Medication Among Children and Adolescents in Germany: An Evaluation of Adherence to Prescribing Guidelines Based on Claims Data

Abstract

Background: Drug utilization studies based on real-world data are vital for the identification of potentially needed improvements to rational prescribing. This is particularly important for the pharmacological treatment of children and adolescents with attention-deficit hyperactivity disorder (ADHD) due to the associated potential side effects and the frequent use. Whereas prevalent use is well-characterized, studies on first-time use of ADHD medication are scarce. This study aimed to evaluate off-label prescribing in first-time users of ADHD medication among children and adolescents in Germany based on three criteria: (i) lack of a documented ADHD diagnosis; (ii) first-time pharmacological treatment with a second-line drug; and (iii) patient age below 6 years.Methods: Based on German claims data, we included children and adolescents aged 0–17 years with a first-time dispensation of any ADHD medication in the period 2015–2017. These first-time users were characterized with regard to sex, age, specialty of the prescribing physician, documentation of an ADHD diagnosis, psychiatric hospitalization, psychiatric comorbidities, and history of other psychopharmacological drugs at first-time use.Results: The study population comprised 18,703 pediatric first-time users of ADHD medication. Of these, 9.8% had no documented ADHD diagnosis. Most of the ADHD drug users received first-line ADHD pharmacotherapy (methylphenidate, atomoxetine), whereas 2.6% were prescribed second-line ADHD medication (lisdexamfetamine, guanfacine, dexamfetamine, multiple ADHD drugs) as first drug. Overall, 1.2% of first-time users were aged below 6 years. A total of 12.7% of the study population met any off-label criterion.Conclusions: About 13% of pediatric first-time users of ADHD medication in Germany received an off-label pharmacotherapy at first-time use. Prescribing ADHD medication without a confirmed ADHD diagnosis was the most common of the three assessed off-label criteria. Off-label prescribing regarding drug choice and age of patients only occurred in a small percentage of initial pharmacological ADHD treatment. Our results suggest the need for improvement in rational prescribing, especially with regard to diagnostic requirements.

Clinicians' Adherence to Guidelines When Initiating Methylphenidate Treatment

“…The high off-label use we encountered is in line with the 32% off-label use in children, according to a report from the French Pharmacovigilance Database (Trenque et al 2014) and also in line with Canadian data that indicated that around 25% of ADHD medications were prescribed to school age children for a reason other than ADHD (Brault and Lacourse 2012). In Germany, off-label use of ADHD medication appears considerably lower, accounting for 12.7% of all prescriptions (Scholle et al 2021).…”

Practical clinical guidelines and pharmacological treatment for attention‐deficit hyperactivity disorder in Asia

“…In almost all Asian countries, barring Japan, MPH is the mainstay pharmacological treatment for ADHD. Although the approval status and guidelines recommend MPH and ATX as the first‐line pharmacologic treatment in many European countries, the Canadian ADHD Resource Alliance (CADDRA), and NICE guidelines recommend ATX and GXR as second‐line treatment 4,21,22 . Pharmacological treatment trends in Asian countries and regions may be based on these highly evaluated clinical practice guidelines.…”

“…Although the approval status and guidelines recommend MPH and ATX as the first‐line pharmacologic treatment in many European countries, the Canadian ADHD Resource Alliance (CADDRA), and NICE guidelines recommend ATX and GXR as second‐line treatment. 4 , 21 , 22 Pharmacological treatment trends in Asian countries and regions may be based on these highly evaluated clinical practice guidelines. The prevalence of ADHD in school‐aged children varies considerably between countries; for example, white individuals have higher rates of ADHD than Asian individuals.…”

Ambulante psychotherapeutische Versorgung von Kindern und Jugendlichen in Deutschland: Status quo und Trends im Zeitraum 2009–2018

“…Betrachtet man die wenigen Studien, die störungsspezifisch den Anteil psychotherapeutisch behandelter Kinder und Jugendlicher untersucht haben, zeigt sich diesbezüglich eine große Spannbreite: In einer Untersuchung zur Behandlung der posttraumatischen Belastungsstörung erhielten im Jahr 2017 zwischen 50 % und 78 % aller Kinder und Jugendlichen irgendeine Form von Psychotherapie, hiervon waren etwa 40 % Richtlinientherapie [17]. Eine Studie zur Psychotherapie bei ADHS mit Daten der Jahre 2015-2017 fand hingegen nur einen Anteil von 13 % psychotherapeutisch behandelter Kinder (Anteil von Richtlinienpsychotherapie: 92 %) [26]. In einer Studie zur Therapie von Essstörungen (Anorexie/Bulimie) lag die Psychotherapiequote im Jahr 2009 zwischen 75,7 % und 78,5 % [27] und in einer Studie zur Behandlung depressiver Störungen bei etwa 69 % im Jahr 2009 [28].…”