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.

BACKGROUND: Off-label drug use is a common practice in paediatrics. The aim of the present study was to estimate the knowledge of Spaniard paediatricians on off-label use.
METHODS: Cross-sectional, multicentre, descriptive and national study from July 2012 to March 2013 using an on-line questionnaire on off-label use in children. An e-mail was sent to paediatricians who were members of the Spanish Association of Paediatrics (AEP) or its Regional or Paediatric Specialties Societies.
RESULTS: Out of 673 responses were received, 75.1% of Spanish paediatricians knew the meaning of off-label use, 61% of them prescribed medicines outside the conditions authorised in their Summary of Product Characteristics (SPC) and 47% knew of the importance of noting the off-label use in the medical record. However, just under half of paediatricians informed parents, and only 22% wrote it down in the medical record.
CONCLUSIONS: Most Spanish paediatricians do not meet current regulations regarding off-label use. This regulation demands: justifying the decisions when off-label use is needed, and to write down in the medical record that, at least an oral consent from the parents has been obtained. This study reveals a fact that Spanish paediatricians must change. Meanwhile, it is a priority to continue with the implementation of consensus and clinical guidelines, to obtain more data on the efficacy and safety of off-label drug use in children, and to incorporate them into the SPC.