Evidenzbasierte Arzneimittelinformationen für Kinder und Jugendliche in Deutschland – Sind wir auf dem richtigen Weg?

Möhrle R, Eberl S, Gramlich U, Haering-Zahn J, Ahne G, van der Zanden T, de Wildt S, Rascher W, Neubert A (2026)

Publication Type: Journal article

Publication year: 2026

Journal

Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz Springer

DOI: 10.1007/s00103-026-04239-1

Abstract

Introduction: Children and adolescents are disadvantaged when it comes to drug therapy, as drugs are frequently used off-label for this age group. Despite regulatory measures such as the EU Paediatric Regulation, off-label use in paediatrics remains widespread. Since 2021, the online platform “Kinderformularium.DE” has been providing evidence-based dosing recommendations for on- and off-label drug use in Germany, establishing itself as reliable source of information in paediatric practice. This study aims to analyse the scope of age-appropriate (off-label) dosage recommendations provided and to evaluate usage patterns and user satisfaction. Methods: Drug monographs were examined to determine the availability and licensing status of age-specific dosing recommendations, taking into account different indications and routes of administration. A user survey was conducted between November 2024 and February 2025 and analysed using a mixed-methods approach. Results: Kinderformularium.DE contains 637 monographs with 5536 individual age-specific dosage recommendations. Both the number of dosage recommendations and the licensing status vary by age: there is less dosage information available for preterm and newborn infants, and this information is more frequently classified as off-label. The survey confirms the platform’s high level of acceptance—it is used frequently, particularly by doctors—and highlights its importance in the care of paediatric patients. Discussion: With its age-specific (off-label) dosage recommendations, Kinderformularium.DE is an important tool for ensuring medication safety in paediatric clinical practice in Germany. The platform must continue to be updated and expanded on an ongoing basis.

Authors with CRIS profile

Ramona Möhrle Department of Paediatrics and Adolescent Medicine Sonja Eberl Department of Paediatrics and Adolescent Medicine Ursula Gramlich-Günther Department of Paediatrics and Adolescent Medicine Julia Haering-Zahn Department of Paediatrics and Adolescent Medicine Wolfgang Rascher Department of Paediatrics and Adolescent Medicine Antje Neubert Department of Paediatrics and Adolescent Medicine

Involved external institutions

Erasmus MC - Sophia Children’s Hospital NL Netherlands (NL)

How to cite

APA:

Möhrle, R., Eberl, S., Gramlich, U., Haering-Zahn, J., Ahne, G., van der Zanden, T.,... Neubert, A. (2026). Evidenzbasierte Arzneimittelinformationen für Kinder und Jugendliche in Deutschland – Sind wir auf dem richtigen Weg? Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz. https://doi.org/10.1007/s00103-026-04239-1

MLA:

Möhrle, Ramona, et al. "Evidenzbasierte Arzneimittelinformationen für Kinder und Jugendliche in Deutschland – Sind wir auf dem richtigen Weg?" Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz (2026).

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