LAUSR

Medication use in children represents 15–20% of total drug sales. More than 50% of children receive at least one prescription medication a year. Despite this, few drugs have a paediatric formulation available. Furthermore, 80% of paediatric prescriptions are considered off‐label. Off‐label use is defined as the use of products that differ in dose, indication or route of administration from the one established in the summary of product characteristics. Off‐label use is associated with an increased risk of adverse drug reactions, including therapeutic failure. The US Food and Drug Administration and the European Medicines Agency have made changes to regulations to incentivize the development of paediatric formulations.