[Proton pump inhibitors in paediatrics]. / Inhibidores de la bomba de protones en pediatría.

In last years the use in the pediatric area of proton pump inhibitors (omeprazole, lansoprazole, pantoprazole, rabeprazole and esomeprazole) is more often, nevertheless the clinical trials carried out are poor. The aim of this work is to analyse the bibliography published about this kind of drugs in children and to make a revision of its use in the last seven years. More studies with omeprazole and lansoprazole have been developed, to be exact omeprazole and lansoprazole is present in 122 bibliographic appointments and 34 for lansoprazole, which include studies that demonstrate a good tolerance and efficacy. The remaining proton pump inhibitors count with very few studies. The main therapeutic indications were the eradication of Helicobacter pylori, gastroesophageal reflux disease and esophagitis. The number of patients included in the reviewed studies is quite heterogeneous, from 8 to 122 and the age range between 8 days and 17 years. On the other hand, it could be highlighted the non-existence of formulations adapted to the pediatric population and the difficulty of administration specially in the youngest patients. As in many other drugs, it would be necessary to carry out clinical trials in order to determinate the pharmacologic parameters at difference ages, which will allow a safe and effective administration, and its authorization by all Health Authorities.

Inhibidores de la bomba de protones en pediatría / Proton pump inhibitors in pediatrics

En los últimos años el uso de los inhibidores de la bomba de protones(omeprazol, lansoprazol, pantoprazol, rabeprazol y esomeprazol), en pediatría es cada vez más frecuente; sin embargo los ensayos clínicos realizados son escasos. El objetivo de este trabajo es analizar la bibliografía publicada sobre este grupo de fármacos en niños y hacer una revisión de su utilización en los últimos siete años. De todos ellos, omeprazol y lansoprazol son los que cuentan con mayor número de estudios, en concreto de omeprazol se han encontrado 122 citas bibliográficas y de lansoprazol 34 citas bibliográficas, que incluyen estudios que demuestran una buena tolerancia y eficacia. El resto de fármacos de la serie cuenta con muy pocos estudios. Las patologías que motivaron la prescripción fueron principalmente erradicación de Helicobacter pylori, reflujo gastroesofágico y esofagitis. El número de pacientes incluidos en los estudios revisados es muy heterogéneo, desde 8 a 122 y las edades estaban comprendidas entre 8 días y 17 años. Por otra parte, cabe destacar la inexistencia de formulaciones adaptadas a la población pediátrica y la dificultad que supone su administración, sobre todo a los pacientes de menor edad. Como ocurre con otros muchos fármacos, sería necesario realizar ensayos clínicos que determinaran todos los parámetros farmacológicos en los distintos grupos de edad, y así permitir una administración segura y eficaz, así como su autorización por los diferentes registros sanitarios

In last years the use in the pediatric area of proton pump inhibitors (omeprazole, lansoprazole, pantoprazole, rabeprazole and esomeprazole) is more often, nevertheless the clinical trialscarried out are poor. The aim of this work is to analyse the bibliography published about this kind of drugs in children and to make a revision of its use in the last seven years. More studies with omeprazole and lansoprazole have been developed, to be exact omeprazole and lansoprazole is present in 122 bibliographic appointments and 34 for lansoprazole, which include studies that demonstrate a good tolerance and efficacy. The remaining proton pump inhibitors count with very few studies. The main therapeutic indications were the eradication of Helicobacter pylori, gastroesophageal reflux disease and esophagitis. The number of patients included in the reviewed studies is quite heterogeneous, from 8 to 122 and the age range between 8 days and 17 years. On the other hand, it could be highlighted the non-existence of formulations adapted to the pediatric population and the difficulty of administration specially in the youngest patients. As in many other drugs, it would be necessary to carry out clinical trials in order to determinate the pharmacologic parameters at difference ages, which will allow a safe and effective administration, and its authorization by all Health Authorities

[Drug use in neonatology units of 6 Spanish hospitals]. / Utilización de medicamentos en Unidades de Neonatología de 6 hospitales españoles.

OBJECTIVE: To determine the status of drug use in Neonatology units regarding: 1. Frequency of use for drugs unauthorised by DirecciA(3)n General de Farmacia y Productos Sanitarios. 2. Suitability of commercial presentations regarding actual needs of patients. METHOD: Two cut-off points were established for 100% of patients admitted to Neonatology Units in 6 Spanish hospitals. Data on demography and therapeutic drug profile were collected, as well as on whether doses were or not prepared by Pharmacy departments. Approval for each drug regarding indication, age range, dosage and administration route was assessed. RESULTS: The number of patients included was 346. In all, 17.6% of patients were under treatment with unauthorised drugs, the reason being age in 78.7% and indication in 21.3%. Master formula preparation was needed for 22% of patients because of a lack of commercial preparations suited for paediatric age. Pharmacy departments prepared 25% of prescribed drugs. CONCLUSIONS: The use of unauthorised drugs in Neonatology is a common fact. Pharmacy departments are actively involved in Neonatology-related drug therapies: counselling and/or processing for compassionate unauthorised drug use, master formula preparation, intravenous mixtures, etc. Therapeutics in Neonatology benefits from specialised pharmaceutical involvement.