Optimización de la función intestinal en pacientes con fibrosis quística mediante la administración de probióticos / Improvement of intestinal function in cystic fibrosis patients using probiotics

Introducción: La fibrosis quística puede cursar con inflamación de la mucosa intestinal y síndrome de hipercrecimiento bacteriano (SHB). Se ha argumentado que los probióticos actúan como inmunomoduladores, antiinflamatorios y reguladores de la microbiota. El objetivo del presente estudio es conocer la prevalencia de SHB en pacientes con fibrosis quística y tratar de optimizar la función intestinal mediante la administración de probióticos. Pacientes y método: Fueron valorados 20 pacientes afectados de fibrosis quística, con una edad media de 10,33 años (rango, 5-17 años). El estudio del SHB se efectuó en 10 pacientes mediante el test de hidrógeno espirado tras una sobrecarga de dextrosa al 20 %, a dosis de 2 g/kg. Tras la prueba se administró Lactobacillus rhamnosus LGG a dosis de1011 ufc dos veces al día durante 4 semanas. La determinación de grasa, nitrógeno, agua y azúcares en las heces se efectuó antes y después del tratamiento mediante análisis de reflexión de infrarrojos (FENIR). Resultados: Cinco pacientes (50%) presentaron SHB. En los valores de H2 se detectó una correlación positiva con respecto a las cifras de esteatorrea (R = 0,57) y de azúcares (R = 0,52). Los valores del FENIR pretratamiento frente a postratamiento, expresados en gramos, fueron: grasa 6,2 +/- 3,3 frente a 4,9 +/- 2,1 (p < 0,5), azúcares 6,7 +/- 3,6 frente a 5 +/- 2,6(p < 0,05) y nitrógeno 0,87 +/- 0,27 frente a 0,91 +/- 0,14 (NS). En 13 pacientes (81,25 %) se evidenció una mejoría de la comodidad intestinal y del aspecto de las deposiciones, yen 9 pacientes (56,25 %) disminuyó el número de deposiciones. Conclusiones: El tratamiento con probióticos mejora la función intestinal en los pacientes afectados de fibrosis quística desde el punto de vista clínico y bioquímico. Su administración podría ser pautada de una manera regular sobre todo en casos de SHB (AU)

Introduction: In some cases, cystic fibrosis may include intestinal inflammation and bacterial overgrowth. Probiotics are considered as immunomodulatory, anti-inflammatory and microbiotic regulator substances. The aim of our study is to determine the prevalence of bacterial overgrowth in cystic fibrosis patients and try to improve the intestinal function with the administration of probiotics. Patients and method: We examined 20 patients with cystic fibrosis (mean age10.33, range 5 to 17 years). The expired hydrogen test with a 2 g/kg of 20 % dextrose overload was performed on 10 patients. After the test, Lactobacillus rhamnosus LGG1011 CFU was administered twice daily for four weeks. Faecal near infrared spectroscopy (FENIR) of water, fat, nitrogen and sugar content in faeces was performed before and after probiotics administration. Results: Five patients (50 %) showed bacterial overgrowth. Weobtained a positive correlation between the hydrogen test and steator rhea (R = 0.57) and sugar in faeces (R = 0.52).The FENIR results pre-treatment vs post-treatment were: fat 6.2 g +/- 3.3 g vs. 4.9 g +/- 2.1 g (p < 0.05), sugar6.7 g +/- 3.6 g vs. 5 g +/- 2.6 g (p < 0.05) and nitrogen 0.87 g +/- 0.27 g vs. 0.91 g +/- 0.14 g (NS) respectively. Thirteen patients (81.25 %) had improved stool appearance and intestinal comfort and nine (56.25 %) decreased the number of daily stools. Conclusions: Probiotics improved not only clinical but also biochemical intestinal function in cystic fibrosis patients. These could be given as a regular treatment in this type of patients and in those with bacterial overgrowth (AU)

[Improvement of intestinal function in cystic fibrosis patients using probiotics]. / Optimización de la función intestinal en pacientes con fibrosis quística mediante la administración de probióticos.

INTRODUCTION: In some cases, cystic fibrosis may include intestinal inflammation and bacterial overgrowth. Probiotics are considered as immunomodulatory, anti-inflammatory and microbiotic regulator substances. The aim of our study is to determine the prevalence of bacterial overgrowth in cystic fibrosis patients and try to improve the intestinal function with the administration of probiotics. PATIENTS AND METHOD: We examined 20 patients with cystic fibrosis (mean age 10.33, range 5 to 17 years). The expired hydrogen test with a 2 g/kg of 20% dextrose overload was performed on 10 patients. After the test, Lactobacillus rhamnosus LGG 10(11) CFU was administered twice daily for four weeks. Faecal near infrared spectroscopy (FENIR) of water, fat, nitrogen and sugar content in faeces was performed before and after probiotics administration. RESULTS: Five patients (50%) showed bacterial overgrowth. We obtained a positive correlation between the hydrogen test and steatorrhea (R = 0.57) and sugar in faeces (R = 0.52). The FENIR results pre-treatment vs post-treatment were: fat 6.2 g +/- 3.3 g vs. 4.9 g +/- 2.1 g (p < 0.05), sugar 6.7 +/- g 3.6 g vs. 5 g +/- 2.6 g (p < 0.05) and nitrogen 0.87 g +/- 0.27 g vs. 0.91 g +/- 0.14 g (NS) respectively. Thirteen patients (81.25%) had improved stool appearance and intestinal comfort and nine (56.25%) decreased the number of daily stools. CONCLUSIONS: Probiotics improved not only clinical but also biochemical intestinal function in cystic fibrosis patients. These could be given as a regular treatment in this type of patients and in those with bacterial overgrowth.

[Osmolality of oral liquid dosage forms to be administered to newborns in a hospital]. / Osmolalidad de las formas farmacéuticas orales líquidas en un hospital para su aplicación en neonatos.

OBJECTIVE: Oral administration of hypertonic solutions can contribute to intestinal damage in the initial stages of neonatal necrotizing enterocolitis. The purpose of this study is to determine the osmolality of oral liquid dosage forms used in a division of neonatology and to establish some recommendations for their dilution. METHOD: The osmolality of 26 oral liquid dosage forms has been measured using the freezing-point depression method. RESULTS: Oral liquid dosage forms used in the division of neonatology present an osmolality greater than 350 mOsm/kg H2O. 19.2% of all the analysed forms presented an osmolality lower than 1500 mOsm/kg H2O, 80.7% were over that figure, while 23% presented an extremely high osmolality (> 5,000 mOsm/kg H2O). CONCLUSIONS: Knowledge of osmolality of oral liquid dosage forms in the division of neonatology enables the risk of intestinal aggression caused by enteral administration of the medication to be assessed.

Osmolalidad de las formas farmacéuticas orales líquidas en un hospital para su aplicación en neonatos / No disponible

Objetivo: La administración oral de soluciones hipertónicaspuede participar en la lesión intestinal en la fase inicial de la enterocolitisnecrotizante neonatal. El objetivo del estudio es determinarla osmolalidad de las fórmulas farmacéuticas orales líquidasutilizadas en una unidad de neonatología y establecer recomendacionesde dilución.Método: Se ha medido la osmolalidad de 26 fórmulas farmacéuticasorales líquidas por el método de descenso crioscópico.Resultados: Las fórmulas farmacéuticas orales líquidas utilizadasen la unidad de neonatología presentan una osmolalidad superiora 350 mOsm/kg H2O. Del total analizado, el 19,2% de las fórmulaspresentaban una osmolalidad inferior a 1.500 mOsm/kgH2O, el 80,7% superior y el 23% presentaban una osmolalidadextremadamente alta (> 5.000 mOsm/kg H2O).Conclusiones: El conocimiento de la osmolalidad de las fórmulasfarmacéuticas orales líquidas administradas en la unidad deneonatología permite valorar el riesgo de agresividad intestinalque produce la administración enteral de la medicación

Objective: Oral administration of hypertonic solutions can contributeto intestinal damage in the initial stages of neonatal necrotizingenterocolitis. The purpose of this study is to determine the osmolalityof oral liquid dosage forms used in a division of neonatologyand to establish some recommendations for their dilution.Method: The osmolality of 26 oral liquid dosage forms hasbeen measured using the freezing-point depression method.Results: Oral liquid dosage forms used in the division ofneonatology present an osmolality greater than 350 mOsm/kgH2O. 19.2% of all the analysed forms presented an osmolalitylower than 1500 mOsm/kg H2O, 80.7% were over that figure,while 23% presented an extremely high osmolality (> 5,000mOsm/kg H2O).Conclusions: Knowledge of osmolality of oral liquid dosageforms in the division of neonatology enables the risk of intestinalaggression caused by enteral administration of the medication tobe assessed

[Administration of anti-infective agents through the inhaled route]. / Administración de antiinfecciosos por vía inhalatoria.

OBJECTIVE: To report the doses of inhaled anti-infective agents described in the literature for both the adult and paediatric population. In the case of anti-infective agents which were not approved for inhaled administration, to propose the optimum manner in which these should be prepared in order to achieve osmolality and pH values as similar as possible to physiological values. METHOD: A search was carried out of Pubmed (between 1960 and 2005) for each of the anti-infective agents using the words "inhalation OR inhaled OR aerosol OR aerosolized OR nebulized". We also consulted text books, Micromedex and the technical specifications of the pharmaceutical products. Nebulised solutions were prepared using the drugs for which information was found. The drugs approved for inhaled administration were prepared according to the manufacturers recommendations. For anti-infective agents which were not approved for inhaled administration, the raw materials and the branded drug products for intravenous administration available at our hospital were diluted using physiological saline solution and/or water for injection up to a final volume of 4-5 ml. The osmolality and pH values of all the solutions were measured. The optimum form of preparation was considered to be one with values as close as possible to between 150 and 550 mOsm/kg for osmolatity osmolality and 7 +/- 0.5 for pH. RESULTS: Information about doses of 18 inhaled anti-infective agents was found (12 antibiotics, 5 antifungals and 1 antiviral); paediatric doses were described in 9 of these. Three of the anti-infective agents reviewed were approved for inhaled use in adult patients and four in paediatric patients. Of the 48 recommendations for dilution suggested for administration, two had an osmolality > 1,100 mOsm/kg and 5 an osmolality of < 100 mOsm/kg. Two dilutions had a pH > 8 and 14 a pH < 5. CONCLUSIONS: There is limited literature regarding the doses of anti-infective agents for inhaled administration. The majority of anti-infective agents are not approved for inhaled administration. The dilution of the raw material or proprietary drugs with water or physiological saline solution for intravenous administration achieved solutions with appropriate osmolality in the majority of cases. Some of the solutions have extreme osmolality and/or pH levels, implying that it is reasonable to expect a greater risk of bronchospasm.

Administración de antiinfecciosos por vía inhalatoria / No disponible

Objetivo: Describir las dosis de los antiinfecciosos inhalados descritas en la literatura tanto en la población adulta como en la pediátrica. Para aquellos antiinfecciosos que no tienen la vía inhalatoria aprobada, proponer la forma óptima de preparación para conseguir una osmolaridad y un pH lo más cercano posible a los valores fisiológicos. Método: Se realizó una búsqueda en PubMed (entre 1960 y 2005) con cada uno de los antiinfecciosos y las palabras "inhalation OR inhaled OR aerosol OR aerosolized OR nebulized". También se consultaron libros de texto, Micromedex y las fichas técnicas de las especialidades farmacéuticas. De los fármacos que se encontró información se prepararon las soluciones para nebulizar. Los fármacos con vía inhalada aprobada se prepararon según las recomendaciones del laboratorio fabricante. Para los antiinfecciosos que no tienen la vía inhalatoria aprobada se prepararon diluciones de la materia prima o de las presentaciones comerciales por vía intravenosa disponibles en nuestro hospital con solución salina fisiológica y/o agua para inyección hasta un volumen final de 4-5 ml. Se midió la osmolaridad y pH de todas las soluciones. Se consideró como forma óptima de preparación, la más próxima posible a una solución de una osmolaridad entre 150 y 550 mOsm/kg y a un pH de 7 ± 0,5. Resultados: Se encontró información sobre dosificación por vía inhalatoria de 18 antiinfecciosos (12 antibióticos, 5 antifúngicos y 1 antivírico), de los cuales en 9 se describe la dosis pediátrica. Tres de los antiinfecciosos revisados tienen la vía inhalatoria aprobada en adultos y 4 en pediatría. De las 48 recomendaciones de dilución propuestas para la administración, dos tienen una osmolaridad > 1.100 mOsm/kg y 5 una osmolaridad 8 y 14 un pH < 5. Conclusiones: La información bibliográfica sobre las dosificaciones de los antiinfecciosos por vía inhalatoria es escasa. La mayoría de antiinfecciosos no tienen aprobada la administración por vía inhalatoria. La dilución de la materia prima o de las especialidades por vía intravenosa con agua o solución salina fisiológica consigue soluciones con osmolaridad adecuada en la mayoría de los casos. Algunas de las soluciones tienen valores extremos de osmolaridad y/o pH con lo que cabe esperar un riesgo mayor de broncoespasmo

Objective: To report the doses of inhaled anti-infective agents described in the literature for both the adult and paediatric population. In the case of anti-infective agents which were not approved for inhaled administration, to propose the optimum manner in which these should be prepared in order to achieve osmolality and pH values as similar as possible to physiological values. Method: A search was carried out of Pubmed (between 1960 and 2005) for each of the anti-infective agents using the words “inhalation OR inhaled OR aerosol OR aerosolized OR nebulized”. We also consulted text books, Micromedex and the technical specifications of the pharmaceutical products. Nebulised solutions were prepared using the drugs for which information was found. The drugs approved for inhaled administration were prepared according to the manufacturers’ recommendations. For anti-infective agents which were not approved for inhaled administration, the raw materials and the branded drug products for intravenous administration available at our hospital were diluted using physiological saline solution and/or water for injection up to a final volume of 4-5 ml. The osmolality and pH values of all the solutions were measured. The optimum form of preparation was considered to be one with values as close as possible to between 150 and 550 mOsm/kg for osmolatity osmolality and 7 ± 0.5 for pH. Results: Information about doses of 18 inhaled anti-infective agents was found (12 antibiotics, 5 antifungals and 1 antiviral); paediatric doses were described in 9 of these. Three of the antiinfective agents reviewed were approved for inhaled use in adult patients and four in paediatric patients. Of the 48 recommendations for dilution suggested for administration, two had an osmolality > 1,100 mOsm/kg and 5 an osmolality of 8 and 14 a pH < 5. Conclusions: There is limited literature regarding the doses of anti-infective agents for inhaled administration. The majority of anti-infective agents are not approved for inhaled administration. The dilution of the raw material or proprietary drugs with water or physiological saline solution for intravenous administration achieved solutions with appropriate osmolality in the majority of cases. Some of the solutions have extreme osmolality and/or pH levels, implying that it is reasonable to expect a greater risk of bronchospasm

[Pharmacokinetic interaction between valproic acid and meropenem]. / Interacción farmacocinética entre ácido valproico y meropenem.

Several reports have described a decrease in valproic acid (VPA) serum concentrations when carbapenem therapy is administered. The exact mechanism of this pharmacokinetic interaction is unknown, although several experimental studies have been carried out in animals. Because of these interactions, plasma concentrations of VPA in these patients should be monitored and, whenever possible, VPA or carbapenem therapy should be substituted by other drugs. We describe the cases of two epileptic children who simultaneously received meropenem and VPA. Concentrations of VPA decreased to subtherapeutic levels. We review the various mechanisms for this interaction proposed to date, as well as all reported cases.

Interacción farmacocinética entre ácido valproico y meropenem / Pharmacokinetic interaction between valproic acid and meropenem

Se ha descrito que la administración de antibióticos carbapenémicos puede producir la disminución de las concentraciones plasmáticas de ácido valproico (VPA). El mecanismo por el que se produce esta interacción farmacocinética no está claro, a pesar de los estudios publicados en modelos animales. Dada la interacción, se aconseja la monitorización de concentración y la sustitución, siempre que sea posible, del VPA por otro antiepiléptico o del carbapenem por un antibiótico de otro grupo. Se describen los casos de 2 niños epilépticos que recibieron simultáneamente meropenem y VPA y en los que se observa una disminución de las concentraciones plasmáticas de VPA hasta niveles subterapéuticos. Se recogen los mecanismos propuestos para la interacción y los casos publicados hasta la fecha

Several reports have described a decrease in valproic acid (VPA) serum concentrations when carbapenem therapy is administered. The exact mechanism of this pharmacokinetic interaction is unknown, although several experimental studies have been carried out in animals. Because of these interactions, plasma concentrations of VPA in these patients should be monitored and, whenever possible, VPA or carbapenem therapy should be substituted by other drugs. We describe the cases of two epileptic children who simultaneously received meropenem and VPA. Concentrations of VPA decreased to subtherapeutic levels. We review the various mechanisms for this interaction proposed to date, as well as all reported cases

[Dosage of drugs for cerebrospinal administration]. / Dosificación de fármacos en administración cerebroespinal.

OBJECTIVE: To review the most appropriate doses and routes within cerebrospinal - intrathecal, intraventricular, epidural - administration for drugs most commonly used in daily practice as reported in the literature, with particular emphasis on pediatric use. METHOD: A systematic, sequential, repetitive search of tertiary sources primarily and then primary sources in MEDLINE (Pubmed) and GOOGLE by combining each individual drug name with "intrathecal OR intraventricular OR epidural", and then differentiating between data referring to the pediatric and adult populations. RESULTS: In all, 28 drugs within 5 groups are described: anti-infectious, analgesic, and anti-neoplastic agents, corticoids, and other. Doses are categorized by population type: pediatric (newborns, infants, children) and adult. CONCLUSIONS: The relevance of this administration route and its potential use do not correlate with its scant reporting in the literature, except for anti-infectious, analgesic and cytostatic agents. Only five of these drug types are officially approved for cerebrospinal administration according to their prescribing information (polymyxin B, colistin, cytarabine, baclofen and morphine). Of these, only polymyxin B and colistin are indicated for the whole of the pediatric population.

Dosificación de fármacos en administración cerebroespinal / Dosage of drugs for cerebrospinal administration

Objetivo: Revisar las dosis y las vías más adecuadas dentro de la administración cerebroespinal -intratecal, intraventricular y epidural de los fármacos más usados en la práctica clínica diaria, descritos en la literatura, con especial énfasis en la utilización pediátrica. Método: Búsqueda sistemática y secuencial, consultando en primer lugar fuentes terciarias y posteriormente fuentes primarias a través de repetidas búsquedas en Medline (Pubmed) y en el buscador Google, cruzando el nombre de cada uno de los fármacos con 'intrathecal OR intraventricular OR epidural' y diferenciando los datos referidos a la población pediátrica y a la adulta. Resultados: Se describen 28 fármacos, divididos en 5 grupos: antiinfecciosos, analgésicos, antineoplásicos, corticoides y otros. Las dosis se clasifican según población: pediátrica (neonatos, lactantes y niños) y adulta. Conclusiones: La importancia de esta vía de administración y sus usos potenciales no se correlacionan con la escasa bibliografía publicada. Son excepción: antiinfecciosos, analgésicos y citostáticos. Tan sólo cinco de los fármacos citados tienen reconocida oficialmente la vía de administración cerebroespinal en la ficha técnica (polimixina B, colistina, citarabina, baclofeno y morfina). De ellos, sólo polimixina B y colistina la tienen en la totalidad de la población pediátrica

Objective: To review the most appropriate doses and routes within cerebrospinal – intrathecal, intraventricular, epidural –administration for drugs most commonly used in daily practice as reported in the literature, with particular emphasis on pediatric use. Method: A systematic, sequential, repetitive search of tertiary sources primarily and then primary sources in MEDLINE (Pubmed) and GOOGLE by combining each individual drug namewith 'intrathecal OR intraventricular OR epidural', and then differentiating between data referring to the pediatric and adult populations. Results: In all, 28 drugs within 5 groups are described: antiinfectious, analgesic, and anti-neoplastic agents, corticoids, and other. Doses are categorized by population type: pediatric (newborns,infants, children) and adult. Conclusions: The relevance of this administration route andits potential use do not correlate with its scant reporting in the literature,except for anti-infectious, analgesic and cytostatic agents. Only five of these drug types are officially approved for cerebrospinal administration according to their prescribing information (polymyxin B, colistin, cytarabine, baclofen and morphine). Of these, only polymyxin B and colistin are indicated for the whole of the pediatric population

[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.