[Results from the 2012-2013 paediatric national survey on off-label drug use in children in Spain (OL-PED study)]. / Conocimiento sobre el uso de fármacos off-label en Pediatría. Resultados de una encuesta pediátrica nacional 2012-2013 (estudio OL-PED).

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.

[Use of health resources and costs associated with the diagnosis and treatment of each episode of deep vein thrombosis and bleeding in patients undergoing orthopaedic surgery for hip or knee]. / Utilización de recursos sanitarios y costes asociados al diagnóstico y tratamiento de cada episodio de trombosis venosa profunda y sangrado en pacientes intervenidos de cirugía ortopédica de cadera o rodilla.

OBJECTIVE: To determine the use of healthcare resources and costs associated with the diagnosis and treatment of thrombosis and bleeding patients who have undergone elective hip or knee replacement surgery, in routine clinical practice conditions. PATIENTS AND METHODS: This multicentre observational and retrospective study extracted data from the medical records of three Spanish public hospitals (2010). Patients ≥ 40 years who had received prophylaxis-anticoagulation were included. They were randomised into three groups: a) control (no hospital complications), b) bleeding, and c) thrombosis. General variables, use of resources and costs were analysed. STATISTICAL ANALYSIS: logistic regression and ANCOVA for model correction, (P<.05) was included. RESULTS: A total of 141 patients (control: 60; bleeding: 60; and thrombosis: 21), with a mean age 68.7 (SD: 10.4) years, and 68.1% females were identified. Hip arthroplasty was more frequent (71.6%). The bleeding risk was associated with age (OR=1.1) and thrombosis with COPD (OR=1.8); P<.05). The average length of stay for the thrombosis, bleeding and control groups was 13.9, 11.5 and 7.4 days, respectively; P<.001). The total costs for each group were €10,484.3; €8,766.4 and €6,496.1 respectively; P<.05. All grouped results were comparable between them according to the hospital analysed and the type of replacement. CONCLUSIONS: Costs were higher for thrombosis and bleeding patients, respectively. Costs were associated with length of stay and hospital-acquired infections.