[Off-label pediatric medicines in Spain]

Abstract

Since 2009, the use of off-label and unlicensed drugs has been regulated in Spain. In pediatrics, this exceptional use is more common than in other medical specialties. It varies from 10% to 90% of all prescriptions in children. This variability is due to differences in methodology, classification and sources of information used, and also to the different pediatrics subspecialties. In addition, the knowledge of several pediatricians on this issue is limited and more than half do not comply with the law, in many cases due to ignorance. However, the use of off-label and unlicensed drugs is legal and necessary. The Medicines Committee of the Spanish Association of Pediatrics (CM-AEP) considers that it is necessary to improve the existing information on medicines in the pediatric population. Therefore, the CM-AEP works out a document where suggestions and actions are proposed to achieve it, because children's health deserves it.

Keywords: Children; Drug approval; Drug use; Legislación de medicamentos; Niños; Off-label use; Unlicensed use; Uso de medicamentos; Uso off-label; Uso unlicensed.