Module 1 2021

01/07/2021

Off-label use

• Large part of the medicines is used off-label • In the general Dutch hospitals 44%; • Higher for neonates and intensive care;

The Organisation for Professionals in Regulatory Affairs

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Problems with off label use:

• Insufficient efficacy • Adult and paediatric disease are not comparable • Exposure in children is lower • Higher chance on toxicity • Exposure in children is higher • Dosing errors • Excipients not suitable for children • No formulation available that is suitable for children • Administration to children is difficult • Extemporaneous preparations; no quality control, no consistent manufacturing procedures

The Organisation for Professionals in Regulatory Affairs

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