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Introduction <p>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.</p> Methods <p>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&#xa0;user survey was conducted between November 2024 and February 2025 and analysed using a&#xa0;mixed-methods approach.</p> Results <p>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.</p> Discussion <p>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.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月8日

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  • Ramona Möhrle,
  • Sonja Eberl,
  • Ursula Gramlich,
  • Julia Haering-Zahn,
  • Gabriele Ahne,
  • Tjitske van der Zanden,
  • Saskia de Wildt,
  • Wolfgang Rascher,
  • Antje Neubert

摘要

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.