Roi Piñeiro Pérez

Utilidad, implementación e impacto de la red TEDDY en Europa

La Red de Excelencia Task-force in Europe for Drug Development for the Young (TEDDY) se ha implementado durante un periodo de 5 años (junio de 2005junio de 2010), con el soporte del VI Programa marco de la UE (FP6), dentro del apartado de Investigación y Tecnología y el tema prioritario: Ciencias de la Vida, Genómica y Biotecnología de la Salud (Proyecto: LSHB-CT-2005-005216)1. La coordinación se ha realizado desde el Consorzio Per Valutazione Biologiche e Farmacologiche de Pavia, Italia. El objetivo principal de TEDDY ha sido promover la accesibilidad y seguridad de las medicinas disponibles en niños en Europa, integrando la experiencia existente con las normas de buena práctica y estimulando al mismo tiempo la futura investigación. Los objetivos secundarios de TEDDY han sido: optimizar el uso pediátrico de los fármacos disponibles, promover el desarrollo de nuevos medicamentos, armonizar la investigación pediátrica, incorporando aplicaciones farmacogenéticas y desarrollar guías para una mejor práctica clínica. En la Red de Excelencia han participado 17 miembros pertenecientes a 9 países de la UE (Italia, Alemania, Francia, Holanda, Reino Unido, España, República Checa, Bélgica, Suecia) además de Rumanía (miembro de la UE desde el 1 de enero de 2007) e Israel. En España se ha ido desarrollando desde 2005 una red de colaboradores compuesta por un total de 106 investigadores en la actualidad. TEDDY-España ha desarrollado una estrecha colaboración con Sociedades Científicas nacionales e internacionales: Asociación Española de Pediatría (AEP), Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Sociedad Española de Pediatría de Madrid y Castilla La Mancha (SPMYCM), Asociación Española de Pediatría de Atención Primaria (AEPAP), Sociedad Española de Infectología Pediátrica (SEIP), Secretaría Técnica del Plan Nacional del SIDA del Ministerio de Sanidad y Consumo (PNS-MSC), Agencia para la Formación, Investigación y Estudios Sanitarios de la Comunidad de Madrid Pedro Laín Entralgo, Sociedad Europea de Infectología Pediátrica (ESPID) y Fundación PENTA (Pediatric European Network for Treatment of AIDS). a p P b

Recomendaciones para la elaboración y administración de fármacos antituberculosos en niños. Segunda fase del Proyecto Magistral de la Red Española de Estudio de la Tuberculosis Pediátrica (pTBred)

The Spanish Network for the Study of Paediatric Tuberculosis has shown a lack of national consensus on the treatment of tuberculosis in children, partly due to the unavailability of paediatric presentations of antituberculosis drugs. The harmonisation of tuberculosis treatment in children is a priority in Spain. A joint action is proposed by a group of Spanish experts in childhood tuberculosis and in the area of Paediatric Pharmacology. To this end, a pTBred-led workgroup of members from five scientific bodies has been created. Drug pharmaceutical compounding in oral suspensions or oral solutions are recommended as follows: isoniazid 50mg/mL, pyrazinamide 100mg/mL, and ethambutol 50mg/mL. Raw materials, period of validity, and storage conditions are specified. Recommendations for the use of fixed-dose combination drugs are also established. If oral solutions/suspensions or fixed-dose combination drugs are not appropriate, the use of crushed tablets is recommended. Adherence to treatment and optimal dosing of antituberculosis drugs are critical in the control and eradication of TB. This multidisciplinary document provides an opportunity to promote the appropriate treatment of paediatric tuberculosis in Spain, and should become a useful tool for paediatricians and pharmacists.

Actualización del tratamiento de la tuberculosis en niños

Tuberculosis (TB) is the most important infectious disease all over the world, with a high morbidity and mortality. Pediatric tuberculosis has been a neglected epidemic, due to the difficulties in assessing its global impact, reduced incidence and lower infectivity compared to adults. In 2015, the WHO reported 1 million cases of paediatric TB and 169,000 deaths. In Europe, the emergence of MDR TB is a major concern, representing 16% of the new diagnosis in Eastern Europe. In 2014, it was estimated that about 219,000 children were infected by MDR-TB-strains in Europe, and 2,120 developed the disease. Spain is the Western European country with more paediatric cases, with an incidence 4.3/100,000 inhabitants in 2014. Paediatric tuberculosis mortality in Spain is rare, but extra-pulmonary disease is associated with significant complications. The prevalence of paediatric drug resistant TB in Spain is over 4%, higher than the estimated incidence in adult population, representing mayor difficulties for therapeutic intervention. These data reveal that paediatric TB is still a Public Health priority in our country. The difficulties in diagnosis and the lack of optimal paediatric drug formulations are the major challenges for controlling the childhoods tuberculosis epidemic. A group of national paeditric TB experts has reviewed the international guidelines and the most recent evidences, and has established new recommendations for the management of paediatric TB contacts, latent infection and active TB disease, especially focused in drug resistant cases. This document replaces the former national guidelines from the Spanish Society for Pediatric Infectios Diseases, although the prior recommendations on the diagnosis remain valid.

El reto de la administración de antituberculosos en lactantes y preescolares. Proyecto Magistral de pTBred

INTRODUCTION There are no paediatric formulations of anti-tuberculous drugs in Spain, with the only exception being rifampicin. Some paediatricians often prescribe composite formulations (CF), while others prefer to give crushed tablets. Nevertheless, there is no consensus in this regard, or any pharmacokinetic studies validating these procedures. In this situation, the Spanish Network for the Study of Paediatric Tuberculosis (pTBred) has launched the Magistral Project, which has as its first phase aims to analyse the desirability of developing child-friendly pharmaceutical formulations and other aspects regarding the anti-tuberculous drug prescription in children. MATERIAL AND METHODS A cross-sectional, multicentre, nationwide study was conducted, based on an online questionnaire sent to members of pTBred between February and March 2015. RESULTS Fifty-four responses from 67 consulted institutions were received. Most of the respondents reported prescribing crushed tablets. A significant number of those surveyed, although being fewer, prescribe CF, for which availability varies widely among institutions. Eighty-three percent replied that it would be essential to have fixed dose combinations of anti-tuberculous drugs, specifically adapted to paediatric doses and administered by CF or tablets. Among the surveyed institutions, differences were found in the management of latent tuberculosis infection, in the use of directly observed therapy, and in the monitoring of adverse events. CONCLUSIONS Our survey reveals great diversity in anti-tuberculous drug prescription in children, due to the lack of suitable infant formulations, which could have an impact on treatment adherence and outcomes. pTBred intends to develop a pioneering and useful consensus document on the management of anti-tuberculous medication in children.

Consulta de asesoramiento en vacunas: el encuentro es posible

INTRODUCTION There are recommendations for decision-making as regards parents who do not vaccinate their children, but there are few publications analysing this problem. In November 2014, a pioneer medical clinic opened in Spain, for counselling on immunisation practices. The aim of this study is to determine the success of the recommendations of the American and Spanish Paediatrics Associations according to the number of parents who finally accept vaccination. PATIENTS AND METHODS A descriptive, cross-sectional, prospective and single-centre study was conducted from November 2014 to March 2016. Children under the age of 16 not properly vaccinated, according to the immunisation schedule of the region where the study was conducted, were included after signing informed consent. RESULTS A total of 20 families were counselled. The median age of the children was 2 years, and 80% of them received no vaccine. Absolute non-acceptance of vaccination was practiced by 45% of parents. The main reasons for not vaccinating were: 100% thimerosal-containing, 90% risk of autism, 85% aluminium-containing, 70% presence of other stabilisers and preservatives, and 65% risk of anaphylaxis. The immunisation advice was said to be helpful by 90% of parents. Vaccination was accepted by 90% of parents (45% completely). CONCLUSIONS Anti-vaccination ideologies are strong and hard to change. Paediatricians not denying medical care to parents who endanger the lives of their own children are also hard to find. The meeting point is possible, and society needs it. Active listening, empathy, and good quality information were the keys to our results.