[Evidence-based drug information for children and adolescents in Germany-Are we moving in the right direction?].

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.