[The efficiency (cost-effectiveness) of palivizumab as prophylaxis against respiratory syncytial virus infection in premature infants with a gestational age of 32-35 weeks in Spain]. / La eficiencia (coste-efectividad) de palivizumab como profilaxis para la infección por virus respiratorio sincitial en prematuros de 32-35 semanas en España.

OBJECTIVES: To evaluate the efficiency (cost-effectiveness) of palivizumab in preventing severe respiratory syncytial virus (RSV) infection in premature infants with a gestational age of 32-35 weeks (GA 32-35) and two or more risk factors (RF) in Spain. DESIGN: decision tree model using data from the scientific literature and the FLIP I and FLIP II studies (cohort of 326 infants with GA 32-35 and two or more RF who received palivizumab) sponsored by the Spanish Society of Neonatology. Main effectiveness measure: quality-adjusted life years (QALY) gained. PERSPECTIVES: the national health service (NHS), which includes direct costs (administration of palivizumab and hospital admissions), and the societal perspective, which also includes indirect costs (the child's future lost productivity). Discount: 3 % annually for effectiveness and indirect costs. Sensitivity analysis: construction of 37 scenarios modifying variables related to effectiveness and costs. RESULTS: Prophylaxis with palivizumab in premature infants with GA 32-35 and two or more RF produced an incremental cost-effectiveness ratio (ICER) of 13,849 euro/QALY from the NHS perspective, and an ICER of 4,605 euro/QALY from the societal perspective. In the sensitivity analysis, from the NHS perspective the ICER ranged from 5,351 euro/QALY (most favorable scenario) to 23,276 euro/QALY (least favorable scenario). CONCLUSIONS: Palivizumab is a cost-effective therapy as prophylaxis against RSV in infants with GA 32-35 and two or more RF. Its use is efficient from the NHS perspective, since the cost of a QALY, even in the least favorable scenarios, is lower than the threshold of 30,000 Euro/QALY considered socially acceptable in Spain.

[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.

[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.