ABSTRACT
En 2011, la Asociación Española de Pediatría decide apoyar el proyecto más ambicioso de su recién creado Comité de Medicamentos: Pediamécum. Se trata de la primera base de datos on-line, de acceso libre, con información sobre medicamentos de uso pediátrico en España. El 17 de diciembre del 2012 se inaugura http://pediamecum.es/. Un año después, Pediamécum tiene 580 fichas. La web supera durante 2013 el millón de páginas vistas. Con motivo del aniversario de Pediamécum, se realiza una encuesta recabando la opinión de los usuarios. Se obtienen 483 respuestas. Un 95% afirma que es fácil navegar por la web y un 74% que casi siempre resuelve sus dudas sobre el uso de medicamentos en niños. La valoración global de Pediamécum es de 7,5/10. Los objetivos de Pediamécum se están cumpliendo; se refleja fundamentalmente en ser una herramienta útil para todos aquellos profesionales que atienden a niños en su práctica clínica diaria
In 2011, the Spanish Association of Pediatrics decided to support the most ambitious project of its newly created Committee for Medicinal Products: Pediamécum. This is the first free on-line database with information on medicinal products for pediatric use in Spain. The web page http://pediamecum.es/ started on December 17 December 2012. One year later, Pediamécum includes 580 registered drugs. The website achieved more than one million page views by the end of 2013. Because of the first anniversary of Pediamécum, a survey was performed to request the feeling of users. Four hundred eighty-three responses were obtained. Ninety-five percent believed that it is easy to navigate through the web, and 74% said that their doubts about the use of medicines in children were always resolved. The overall rating of Pediamécum is 7.5/10. The aims of Pediamécum are being accomplished; which is reflected essentially due to it becoming a useful tool for all professionals who care for children in their daily clinical practice
Subject(s)
Humans , Male , Female , Child , Adolescent , Pharmaceutical Preparations/administration & dosage , Pharmaceutical Preparations , Data Collection/supply & distribution , Data Collection/statistics & numerical data , Data Collection/trends , Pediatrics/methods , Pediatrics/trends , Primary Health Care/trends , Dosage/methodsABSTRACT
INTRODUCCIÓN: Un número elevado de fármacos se prescriben en niños bajo condiciones no autorizadas en ficha técnica (uso off-label). El objetivo principal del estudio es estimar el conocimiento sobre el uso de fármacos fuera de ficha técnica por parte de los pediatras españoles. MATERIAL Y MÉTODOS: Estudio transversal, multicéntrico, descriptivo, de ámbito nacional, mediante encuesta on-line, enviada por correo electrónico a pediatras socios de la Asociación Española de Pediatría o de sus sociedades de Especialidades y Regionales, entre julio del 2012 y marzo del 2013. RESULTADOS: Se recibieron 673 respuestas. Un 71,5% de los pediatras españoles conocen el significado del término off-label, el 61% afirma que prescribe fármacos con indicaciones fuera de ficha técnica y un 47% conoce que dicho uso debe quedar reflejado en la historia clínica. Sin embargo, algo menos de la mitad informa a los padres y solo el 22% lo deja anotado en la historia clínica. CONCLUSIONES: Muchos pediatras no cumplen con la normativa actual con respecto al uso de fármacos en condiciones no autorizadas en ficha técnica. Esta normativa exige: justificar las decisiones de uso off-label y registrar en la historia clínica que se ha obtenido el consentimiento, al menos verbal, de los padres. Se pone de manifiesto una realidad que los pediatras españoles deben cambiar. Mientras tanto, es prioritario continuar con la realización de documentos de consenso y guías de práctica clínica para ampliar la información sobre la eficacia y seguridad de los usos off-label en niños, y poder incorporarlos a las fichas técnicas autorizadas
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 SPCien
Subject(s)
Humans , Male , Female , Child , Drugs, Investigational/therapeutic use , Drug Utilization/statistics & numerical data , Off-Label Use/statistics & numerical data , Drug Approval , Child Health Services/statistics & numerical data , Patient Safety , Health Knowledge, Attitudes, Practice , /statistics & numerical data , Compassionate Use TrialsABSTRACT
In 2011, the Spanish Association of Pediatrics decided to support the most ambitious project of its newly created Committee for Medicinal Products: Pediamécum. This is the first free on-line database with information on medicinal products for pediatric use in Spain. The web page http://pediamecum.es/ started on December 17 December 2012. One year later, Pediamécum includes 580 registered drugs. The website achieved more than one million page views by the end of 2013. Because of the first anniversary of Pediamécum, a survey was performed to request the feeling of users. Four hundred eighty-three responses were obtained. Ninety-five percent believed that it is easy to navigate through the web, and 74% said that their doubts about the use of medicines in children were always resolved. The overall rating of Pediamécum is 7.5/10. The aims of Pediamécum are being accomplished; which is reflected essentially due to it becoming a useful tool for all professionals who care for children in their daily clinical practice.
Subject(s)
Databases, Factual , Internet , Mobile Applications , Pediatrics , Prescription Drugs , Child , Humans , Societies, Medical , Spain , Surveys and Questionnaires , Time FactorsABSTRACT
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.
Subject(s)
Health Knowledge, Attitudes, Practice , Off-Label Use/statistics & numerical data , Pediatrics , Adult , Child , Cross-Sectional Studies , Female , Humans , Male , Middle Aged , Spain , Surveys and Questionnaires , Time FactorsABSTRACT
Introducción: Actualmente existen diversas guías nacionales sobre el uso empírico adecuado de antibióticos en niños. Desconocemos si los pediatras españoles emplean dichas guías al seleccionar antimicrobianos. Material y métodos: Estudio transversal de ámbito nacional, mediante encuesta on-line sobre la selección empírica de antibióticos en niños, enviada por correo electrónico a pediatras socios de la Asociación Española de Pediatría o de sus sociedades de especialidades y regionales, entre abril y junio del 2012. Para considerar la adecuación de las respuestas se tuvieron en cuenta las guías, los documentos de consenso y los protocolos recientes. Resultados: Se recibieron 1.214 respuestas. Los tratamientos seleccionados se ajustan en un 85% a las recomendaciones. Los resultados menos adecuados se obtienen en enfermedades infecciosas en las que no existe un documento de consenso nacional en el momento de realizar la encuesta (73% de adecuación en este caso). Conclusiones: La elección empírica de antibióticos por parte de los pediatras españoles es bastante adecuada a las guías recientes. Sin embargo, la interpretación de los datos debe ser crítica, ya que existen aspectos del manejo racional de antibióticos en niños que podrían mejorar en nuestro país. Se plantea como necesidad continuar con la realización e implementación de documentos de consenso nacionales para el manejo de enfermedades infecciosas pediátricas. Proponemos que este tipo de encuestas se realicen periódicamente, así como análisis similares en otras áreas de capacitación específicas, incluyendo estudios de prescripción real, para promover el uso racional de todos los fármacos pediátricos en nuestro país (AU)
Introduction: There are currently several national guidelines on the appropriate empirical use of antibiotics in Spanish children. But, do the Spanish paediatricians use these guidelines when prescribing antimicrobials. Material and methods: A national study from was conducted from April to June 2012 using an on-line questionnaire on the empirical selection of antibiotics in children. An e-mail was sent to paediatrician members of the Spanish Association of Paediatrics (AEP) or its Regional or Paediatric Specialties Societies. Current guidelines and consensus documents were used to determine the appropriateness of the responses. Results: A total of 1214 responses were received. Eighty five per cent of the treatments selected by Spanish paediatricians were adjusted to guidelines. The least appropriate responses were obtained in those infectious diseases with no national consensus document at the time of the survey (73% in this case). Conclusions: Spanish paediatricians mainly select empirical antibiotics in accordance with current guidelines. However, there are features that could be improved in our country. The preparing and implementation of national consensus documents on the management of paediatric infectious diseases should be continued. We propose to regularly perform these kinds of surveys, including real prescription studies, and to also extend it to other paediatric specialities, in order to promote appropriateness of use of all the paediatric drugs in our country (AU)
Subject(s)
Humans , Male , Female , Child , Anti-Bacterial Agents/therapeutic use , Anti-Bacterial Agents/administration & dosage , Communicable Diseases/epidemiology , Communicable Disease Control/instrumentation , Communicable Disease Control/statistics & numerical data , Cross-Sectional Studies/instrumentation , Cross-Sectional Studies/methods , Cross-Sectional Studies , Health Surveys/methods , Data Collection/methods , Data Collection , Confidence Intervals , Logistic Models , Primary Health Care/methodsABSTRACT
INTRODUCTION: There are currently several national guidelines on the appropriate empirical use of antibiotics in Spanish children. But, do the Spanish paediatricians use these guidelines when prescribing antimicrobials? MATERIAL AND METHODS: A national study from was conducted from April to June 2012 using an on-line questionnaire on the empirical selection of antibiotics in children. An e-mail was sent to paediatrician members of the Spanish Association of Paediatrics (AEP) or its Regional or Paediatric Specialties Societies. Current guidelines and consensus documents were used to determine the appropriateness of the responses. RESULTS: A total of 1214 responses were received. Eighty five per cent of the treatments selected by Spanish paediatricians were adjusted to guidelines. The least appropriate responses were obtained in those infectious diseases with no national consensus document at the time of the survey (73% in this case). CONCLUSIONS: Spanish paediatricians mainly select empirical antibiotics in accordance with current guidelines. However, there are features that could be improved in our country. The preparing and implementation of national consensus documents on the management of paediatric infectious diseases should be continued. We propose to regularly perform these kinds of surveys, including real prescription studies, and to also extend it to other paediatric specialities, in order to promote appropriateness of use of all the paediatric drugs in our country.
Subject(s)
Anti-Bacterial Agents/therapeutic use , Drug Utilization/standards , Pediatrics , Practice Patterns, Physicians' , Surveys and Questionnaires , Adult , Child , Cross-Sectional Studies , Female , Humans , Male , Middle Aged , SpainABSTRACT
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