{Reference Type}: English Abstract
{Title}: [Results from the 2012-2013 paediatric national survey on off-label drug use in children in Spain (OL-PED study)].
{Author}: Piñeiro Pérez R;Ruiz Antorán MB;Avendaño Solá C;Román Riechmann E;Cabrera García L;Cilleruelo Ortega MJ;Mellado Peña MJ;
{Journal}: An Pediatr (Barc)
{Volume}: 81
{Issue}: 1
{Year}: Jul 2014
{Factor}: 2.377
{DOI}: 10.1016/j.anpedi.2013.10.004
{Abstract}: <B>BACKGROUND: </B>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.<BR><B>METHODS: </B>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.<BR><B>RESULTS: </B>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.<BR><B>CONCLUSIONS: </B>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.