R Piñeiro Pérez1, M B Ruiz Antorán2, C Avendaño Solá2, E Román Riechmann3, L Cabrera García4, M J Cilleruelo Ortega3, M J Mellado Peña5. 1. Servicio de Pediatría, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, España; Comité de Medicamentos de la Asociación Española de Pediatría (CM-AEP), España. Electronic address: roipineiro@telefonica.net. 2. Servicio de Farmacología Clínica, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, España. 3. Servicio de Pediatría, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, España. 4. Servicio de Farmacología Clínica, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, España; Comité de Medicamentos de la Asociación Española de Pediatría (CM-AEP), España. 5. Servicio de Pediatría, Hospital Carlos III, Hospital Universitario La Paz, Madrid, España; Comité de Medicamentos de la Asociación Española de Pediatría (CM-AEP), España.
Abstract
INTRODUCTION: 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. MATERIAL AND 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.
INTRODUCTION: 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. MATERIAL AND 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.
Keywords:
Children; Community surveys; Drug approval; Drug use; Encuestas comunitarias; Legislación de medicamentos; Niños; Off-label use; Uso de medicamentos; Uso off-label