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1.
An. pediatr. (2003, Ed. impr.) ; 75(6): 380-395, dic. 2011. tab
Artigo em Espanhol | IBECS | ID: ibc-92369

RESUMO

Introducción: Una baja adherencia al tratamiento antirretroviral (TARV) es la causa más frecuente de fracaso terapéutico tanto en niños como en adultos que viven con el VIH, siendo especialmente importante durante la adolescencia. En consecuencia, cualquier análisis de la efectividad del TARV deberá considerarse incompleto si no incluye una evaluación de la adherencia. El objetivo de este estudio es evaluar la utilidad de un programa de valoración de la adherencia al TARV en una población de pacientes pediátricos infectados por el VIH. Pacientes y métodos: Se trata de un estudio observacional y transversal, dentro del «Programa de educación sanitaria para la optimización de la adherencia en pacientes pediátricos con VIH», que forma parte del proyecto «No estoy solo». La adherencia se estudió simultáneamente mediante una combinación de diferentes métodos: entrevista personal, evolución de la carga viral y del recuento de linfocitos TCD4+, determinación de concentraciones plasmáticas de fármacos y registros de dispensación de farmacia. Resultados: Se incluyó un total de 20 pacientes (50% mujeres, edad mediana: 14,5 años). Se obtuvo un porcentaje de adherencia completa informada por el propio paciente o cuidador del 90% (IC 95%: 70-97,2%); sin embargo, el porcentaje medio de adherencia según los registros de dispensación fue significativamente inferior (83,3%; DE=32,88). La media de principios activos/día y de medicamentos/día fue de 3,5 (DE=0,83) y 5,5 (DE=2,72), respectivamente. Hubo una relación inversa entre el n.° de medicamentos/día y las puntuaciones de adherencia (F=13,8; p=0,002). Ninguno de los métodos de evaluación se relacionó de manera estadísticamente significativa con la adherencia, presentando la determinación de concentraciones plasmáticas una tendencia a la significación. Conclusiones: La adherencia global al TARV fue elevada y se vio favorecida por el uso de pautas posológicas sencillas. La adherencia informada por el paciente y/o el cuidador sobreestimó la verdadera adherencia al TARV. Recomendamos la utilización simultánea de diversos métodos de valoración de la adherencia en los niños y adolescentes que viven con el VIH (AU)


Introduction: Poor adherence to antiretroviral treatment (ART) is the commonest cause of treatment failure in children and adults living with HIV, and this is especially important during adolescence. Therefore, any analysis of ART effectiveness in children should include an evaluation of adherence to ART. The aim of this study is to assess the usefulness of an ART adherence monitoring program in an HIV-infected paediatric population. Patients and methods: An observational and cross-sectional study was performed, within the framework of the “Health Education Program for Optimising Adherence in Paediatric Patients with HIV”, which is part of the “I am not alone” project. Adherence was assessed simultaneously by different methods: personal interview, therapeutic drug monitoring, pharmacy dispensing records and evolution of viral load and T CD4+ lymphocyte count. Results: Twenty patients were included (50% female, median age 14.5 years). Percentage of self-reported full adherence was 90% (95% CI: 70-97.2%); however, the median adherence percentage according to pharmacy dispensing records was significantly lower (83.3%, SD=32.88). The average of drugs and dosage forms per day were 3.5 (SD=0.83) and 5.5 (SD=2.72), respectively. There was an inverse relationship between the number of dosage forms per day and adherence scores (F=13.8; P=0.002). No single method was statistically related to adherence, although therapeutic drug monitoring showed a trend towards significance. Conclusions: Global adherence to ART was high and was easier with simpler regimens. Self-reported adherence overestimated real adherence to ART in our cohort. The simultaneous use of different methods to assess adherence is recommended in HIV-infected children (AU)


Assuntos
Humanos , Masculino , Feminino , Criança , Adolescente , Antirretrovirais/administração & dosagem , /estatística & dados numéricos , Infecções por HIV/tratamento farmacológico , Cooperação do Paciente/estatística & dados numéricos , HIV
2.
An Pediatr (Barc) ; 75(6): 380-95, 2011 Dec.
Artigo em Espanhol | MEDLINE | ID: mdl-21757410

RESUMO

INTRODUCTION: Poor adherence to antiretroviral treatment (ART) is the commonest cause of treatment failure in children and adults living with HIV, and this is especially important during adolescence. Therefore, any analysis of ART effectiveness in children should include an evaluation of adherence to ART. The aim of this study is to assess the usefulness of an ART adherence monitoring program in an HIV-infected paediatric population. PATIENTS AND METHODS: An observational and cross-sectional study was performed, within the framework of the "Health Education Program for Optimising Adherence in Paediatric Patients with HIV", which is part of the "I am not alone" project. Adherence was assessed simultaneously by different methods: personal interview, therapeutic drug monitoring, pharmacy dispensing records and evolution of viral load and T CD4+ lymphocyte count. RESULTS: Twenty patients were included (50% female, median age 14.5 years). Percentage of self-reported full adherence was 90% (95% CI: 70-97.2%); however, the median adherence percentage according to pharmacy dispensing records was significantly lower (83.3%, SD=32.88). The average of drugs and dosage forms per day were 3.5 (SD=0.83) and 5.5 (SD=2.72), respectively. There was an inverse relationship between the number of dosage forms per day and adherence scores (F=13.8; P=.002). No single method was statistically related to adherence, although therapeutic drug monitoring showed a trend towards significance. CONCLUSIONS: Global adherence to ART was high and was easier with simpler regimens. Self-reported adherence overestimated real adherence to ART in our cohort. The simultaneous use of different methods to assess adherence is recommended in HIV-infected children.


Assuntos
Antirretrovirais/uso terapêutico , Infecções por HIV/tratamento farmacológico , Adesão à Medicação , Inquéritos e Questionários , Adolescente , Criança , Pré-Escolar , Estudos Transversais , Feminino , Humanos , Lactente , Masculino , Estudos Retrospectivos
3.
Farm Hosp ; 31(5): 311-4, 2007.
Artigo em Espanhol | MEDLINE | ID: mdl-18052634

RESUMO

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.


Assuntos
Hospitais , Administração Oral , Tratamento Farmacológico , Enterocolite Necrosante/tratamento farmacológico , Humanos , Recém-Nascido , Concentração Osmolar
4.
Farm. hosp ; 31(5): 311-314, sept.-oct. 2007. tab
Artigo em Es | IBECS | ID: ibc-63238

RESUMO

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


Assuntos
Humanos , Masculino , Feminino , Recém-Nascido , Concentração Osmolar , Soluções Hipertônicas/análise , Enterocolite Necrosante/induzido quimicamente , Enterocolite Necrosante/prevenção & controle , Preparações Farmacêuticas/análise , Soluções Hipertônicas/administração & dosagem , Unidades de Terapia Intensiva Neonatal
5.
Farm Hosp ; 31(2): 112-9, 2007.
Artigo em Espanhol | MEDLINE | ID: mdl-17590120

RESUMO

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.


Assuntos
Anti-Infecciosos/administração & dosagem , Administração por Inalação , Humanos
6.
Farm. hosp ; 31(2): 112-119, mar.-abr. 2007. tab
Artigo em Es | IBECS | ID: ibc-057800

RESUMO

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


Assuntos
Humanos , Anti-Infecciosos/administração & dosagem , Administração por Inalação , Anti-Infecciosos/farmacologia , Terapia Respiratória , Concentração Osmolar , Concentração de Íons de Hidrogênio
7.
An Pediatr (Barc) ; 64(1): 93-5, 2006 Jan.
Artigo em Espanhol | MEDLINE | ID: mdl-16539924

RESUMO

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.


Assuntos
Antibacterianos/farmacocinética , Anticonvulsivantes/farmacocinética , Tienamicinas/farmacocinética , Ácido Valproico/farmacocinética , Criança , Pré-Escolar , Interações Medicamentosas , Feminino , Humanos , Masculino , Meropeném
8.
An. pediatr. (2003, Ed. impr.) ; 64(1): 93-95, ene. 2006.
Artigo em Es | IBECS | ID: ibc-044499

RESUMO

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


Assuntos
Criança , Pré-Escolar , Humanos , Antibacterianos/farmacocinética , Anticonvulsivantes/farmacocinética , Tienamicinas/farmacocinética , Ácido Valproico/farmacocinética , Interações Medicamentosas
9.
Farm Hosp ; 29(3): 185-90, 2005.
Artigo em Espanhol | MEDLINE | ID: mdl-16013945

RESUMO

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.


Assuntos
Injeções Epidurais , Injeções Intraventriculares , Injeções Espinhais , Preparações Farmacêuticas/administração & dosagem , Adulto , Criança , Pré-Escolar , Humanos , Lactente , Recém-Nascido
10.
Farm. hosp ; 29(3): 185-190, mayo-jun. 2005. tab
Artigo em Es | IBECS | ID: ibc-039189

RESUMO

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


Assuntos
Masculino , Feminino , Criança , Adulto , Humanos , Vias de Administração de Medicamentos , Injeções Espinhais/métodos , Injeções Epidurais/métodos , Injeções Intraventriculares/métodos , Anti-Infecciosos/administração & dosagem , Analgésicos/administração & dosagem , Antineoplásicos/administração & dosagem
11.
Farm Hosp ; 29(1): 26-9, 2005.
Artigo em Espanhol | MEDLINE | ID: mdl-15773799

RESUMO

INTRODUCTION: Many drugs prescribed in pediatric units do not meet the conditions of use defined in their corresponding prescription information sheets, or their use has not been approved by the Spanish Health Authorities. The lack of clinical trials in children, and of adequate dosage forms, reduces drug safety, assuming both the physician and the pharmacist the responsibility for the drug use. OBJECTIVE: To assess drug prescription status within a neonatal intensive care unit in a third-level hospital. MATERIAL AND METHODS: A 3-months prospective study was performed, and information was collected from all admitted children along four time periods. Sixty-one complete therapies were evaluated, with a total of 236 drugs prescribed. Fifty percent were off-label, 13% were unlicensed, and 37% were correctly used. CONCLUSIONS: These figures resemble those from, similar studies carried out in other European hospitals. This is therefore a common practice resulting from the need to treat. Health authorities should encourage clinical trials so that drug therapies for children become evidence-based.


Assuntos
Unidades de Terapia Intensiva Neonatal
12.
Farm. hosp ; 29(1): 26-29, ene.-feb. 2005. tab
Artigo em Es | IBECS | ID: ibc-036301

RESUMO

Introducción: Muchos de los fármacos pautados en unidades pediátricas, no siguen las condiciones de uso marcadas en su correspondiente ficha técnica (fármacos denominados “off-label”)o no están autorizados por la Dirección General de Farmacia y Productos Sanitarios (“unlicensed”). La falta de ensayos clínicos en niños y de formulaciones adecuadas, disminuye la seguridad de uso de los medicamentos, recayendo la responsabilidad en el médico y el farmacéutico. Objetivo: Evaluar la situación de la prescripción de medicamentos dentro de la unidad de cuidados intensivos neonatal en un hospital de tercer nivel. Material y métodos: Para ello se realizó un estudio prospectivo de tres meses de duración, recogiéndose la información de todos los niños ingresados en un total de cuatro cortes. Se evaluaron 61 tratamientos completos, con un número total de 236 fármacos pautados. El 50% fue “off-label”, el 13% “unlicensed” y el 37% se utilizaba bajo las condiciones correctas. Conclusiones: Esta cifra se asemeja a la de estudios similares realizados en hospitales europeos. Es por tanto un práctica habitual que resulta de la necesidad de tratar al paciente. Las autoridades sanitarias deben incentivar la realización de ensayos clínicos para que los tratamientos farmacológicos en niños estén basados en la evidencia


Introduction: Many drugs prescribed in pediatric units do not meet the conditions of use defined in their corresponding prescription information sheets, or their use has not been approvedby the Spanish Health Authorities. The lack of clinical trials in children, and of adequate dosage forms, reduces drug safety,assuming both the physician and the pharmacist the responsibility for the drug use. Objective: To assess drug prescription status within a neonatal intensive care unit in a third-level hospital. Material and methods: A 3-months prospective study was performed, and information was collected from all admitted children along four time periods. Sixty-one complete therapies were evaluated, with a total of 236 drugs prescribed. Fifty percent were “off-label”, 13% were“unlicensed”, and 37% were correctly used. Conclusions: These figures resemble those from, similar studies carried out in other European hospitals. This is therefore a common practice resulting from the need to treat. Health authorities should encourage clinical trials so that drug therapies for children become evidence-based


Assuntos
Recém-Nascido , Lactente , Recém-Nascido , Humanos , Berçários Hospitalares , Uso de Medicamentos/legislação & jurisprudência , Medicina Baseada em Evidências/legislação & jurisprudência , Iloprosta/administração & dosagem , Iloprosta/uso terapêutico , Uso de Medicamentos/estatística & dados numéricos , Iloprosta/efeitos adversos
13.
Farm Hosp ; 28(4): 243-50, 2004.
Artigo em Espanhol | MEDLINE | ID: mdl-15369434

RESUMO

OBJECTIVE: To financially assess a device for the preparation of intravenous mixtures (DPIVM) --Grifill system-- such as IV gammaglobulin, salbutamol, ondansetron/dexametasone, cisplatin rehydrating solution and mesna. MATERIAL AND METHODS: The most relevant resources used in the preparation and rebottling of each of the above-mentioned intravenous mixtures (for both the DPIVM and the commonly used alternative system) are assessed, as well as unitary costs (obtained from six Spanish hospitals enrolled), and an approach to the real cost by system used is obtained. A sensitivity analysis is performed considering most influencing variables. Results are calculated for one month of system operation. RESULTS: For IV gammaglobulin, mesna, salbutamol, ondansetron/dexametasone and polyionic solutions DPIVM resulted in financial benefit, but it did not in the preparation of cisplatin rehydrating solution. CONCLUSIONS: An individualized study in each center is needed to achieve reliable financial data on the system's profitability at hospital pharmacy departments. DPIVM may allow significant financial savings in centers and hospital departments using high-cost pharmaceuticals susceptible of customized dosing --e. g., IV gammaglobulin, other blood derivatives, monoclonal antibodies and/or antibiotics-- or intravenous mixtures requiring pharmaceuticals usually purchased directly from the manufacturer that may be prepared from low-cost raw materials (for instance, salbutamol and polyionic solution) requiring high-quality manipulation (e. g., sterility and precision).


Assuntos
Combinação de Medicamentos , Composição de Medicamentos/economia , Composição de Medicamentos/instrumentação , Infusões Intravenosas/economia , Serviço de Farmácia Hospitalar/economia , Albuterol , Cisplatino , Dexametasona , Custos de Medicamentos , Custos Hospitalares , Humanos , Mesna , Ondansetron , Espanha , gama-Globulinas
14.
Farm Hosp ; 28(3): 170-9, 2004.
Artigo em Espanhol | MEDLINE | ID: mdl-15222870

RESUMO

OBJECTIVE: To integrally assess an intravenous mixture preparation device (IMPD) from the point of view of perceived healthcare improvement in a center (operational and organizational changes of the hospitals pharmacy department, staff nurse satisfaction and end-user satisfaction). MATERIAL AND METHODS: An observational, multicenter and domestic healthcare technology assessment project (an analysis to estimate relative value and contribution of a specific healthcare technology to both individual and collective health) is under discussion. Data were obtained from 6 Spanish hospitals. RESULTS: In 3 out of 4 Pharmacy Departments surveyed, reports on the use of IMPD showed that this system contributed to time saving, as well as improved preparation quality and system safety. From a nursing standpoint, the use of IMPD was mostly considered satisfactory, whereas most patients (81%) reported increased satisfaction with care provided after IMPD was included in their medication process. CONCLUSIONS: IMPD demonstrated satisfactory characteristics that were deemed positive by hospital pharmacy departments, nursing departments and patients.


Assuntos
Composição de Medicamentos/instrumentação , Infusões Intravenosas/instrumentação , Preparações Farmacêuticas/administração & dosagem , Serviço de Farmácia Hospitalar , Composição de Medicamentos/métodos , Humanos , Satisfação do Paciente , Inquéritos e Questionários
15.
Farm. hosp ; 25(3): 129-134, mayo 2001. tab
Artigo em Es | IBECS | ID: ibc-8354

RESUMO

Daclizumab es un anticuerpo monoclonal humanizado utilizado en la prevención del rechazo agudo en el trasplante renal. Se une específicamente a la subunidad del receptor de la interleucina-2 de la superficie de los linfocitos T activados, inhibiendo así la proliferación de linfocitos T, una vía determinante en la respuesta inmune del rechazo del injerto. La administración intravenosa de cinco dosis de 1 mg/kg, una 24 horas antes del trasplante y las otras cuatro a intervalos de 14 días, ha demostrado ser segura y eficaz en la reducción de la incidencia de rechazo agudo en los ensayos clínicos, siendo un fármaco bien tolerado que no aumenta la incidencia de neoplasias e infecciones oportunistas de forma significativa (AU)


Assuntos
Humanos , Rejeição de Enxerto/cirurgia , Rejeição de Enxerto/prevenção & controle , Muromonab-CD3/uso terapêutico , Muromonab-CD3/efeitos adversos , Transplantes/efeitos adversos , Transplante de Rim/efeitos adversos , Imunossupressores/efeitos adversos , Imunossupressores/uso terapêutico
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