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Objectives: Sexually transmitted infections are a prevalent global health care problem. Treatment guidelines have recently been updated as a result of antimicrobial resistance and public health trends. The aim of the study was to assess the appropriateness of empirical antibiotic therapy prescribed for cervicitis and urethritis in the emergency department. Methods: We designed a retrospective observational cohort study. We included adult patients with suspected cervicitis or urethritis who attended the emergency department of a tertiary hospital in 2020. We excluded patients with suspected pelvic inflammatory disease, pregnancy or prostatitis and those requiring admission to hospital. Appropriateness of empirical antibiotic therapy was evaluated taking into account 4 aspects: indication, dosing, duration of therapy, and route of administration. Data were obtained from the electronic medical record, the electronic prescription program, and the discharge summary. Results: The study population comprised 176 patients; mean age was 28.9 years (SD = 7.7), and 90.9% were men. The most prescribed treatment was the combination of ceftriaxone and azithromycin (83.0%). Treatment was inappropriate in 71.6% of patients. A total of 159 drug errors were recorded. The most frequent cause was undertreatment (36.4%) related to underdosing (46.5%), particularly with regard to ceftriaxone. The percentage of errors was 11.9% for indication, 84.9% for dosing, 3.1% for duration, and 0% for route of administration. Conclusions: A high percentage of patients who attended the emergency department for suspected cervicitis or urethritis received an inappropriate empirical antibiotic regimen. The main reason was undertreatment due to underdosing.

To present the results of a survey about the Telemedicine outpatients experience and satisfaction of a pharmaceutical care program through Telepharmacy, carried out from hospital pharmacy departments in Spain during COVID-19 Pandemic (ENOPEX survey), and identify differences across regions in Spain.An analysis of results of the national survey ENOPEX on outpatient Telepharmacy services during the lockdown due to the COVID‑19 pandemic, analyzed by autonomous community in Spain. Data was collected in relation to point of delivery; pharmacotherapeutic follow-up; patient's opinion and satisfaction with Telemedicine; confidentiality; future development of pharmaceutical care, through Telepharmacy services; and coordination with the patient care team. Four multilevel regressions were performed to evaluate the differences between Spanish regions on the most relevant variables of the study, using the R version 4.0.3 software.A total of 8,079 interviews were valid, 52.8% of respondents were female, age was 41-65 years in 54.3% of participants; 42.7% had been receiving treatment for more than 5 years; 42.8% lived 10-50 km from the hospital; the journey to hospital took more than one hour for 60.2% of participants. Globally, 85.7% received medicines at home. However, medicines were delivered at a community pharmacy in some communities, such as Cantabria (95.8%), or at primary care centers as in Castile La Mancha (16.5%). In total, 96.7% of participants were satisfied or very satisfied with Telemedicine pharmaceutical care, through Telepharmacy services, with differences across communities, with users in Andalusia reporting the highest satisfaction (OR = 1.58), and users in Castile-León being less satisfied with Telepharmacy services (OR = 0.66). Users in Catalonia are the ones more clearly in favor of Telemedicine pharmaceutical care, through Telepharmacy services as a complementary service, with an OR = 5.85 with respect to other users. The Telemedicine most frequently mentioned advantage was that Telepharmacy services avoided visits, especially in Cantabria (92.5%) and Extremadura (88.4%). Most patients prefer informed delivery of medicines at home when they do not have an appointment at the hospital: total of 75.6 %, from 50.1% of users in Cantabria to 96.3% in Catalonia (plt; 0.001). The users less willing to pay for Telepharmacy services were the ones from Castile- León and Galicia, with users in Catalonia and Navarra showing higher willingness.In general terms, patients were satisfied with Telemedicine pharmaceutical care, through Telepharmacy services during the COVID‑19 pandemic, being mostly in favor of maintaining these services to avoid travels.Describir los resultados de la encuesta sobre experiencia y atisfacción de la Telemedicina en pacientes externos relativo a un programa de atención farmacéutica a través de la Telefarmacia, realizado desde los servicios de farmacia durante la pandemia COVID-19 (encuesta ENOPEX) e identificar las diferencias entre las comunidades autónomas de España.Método: Se analizaron los resultados de la encuesta nacional ENOPEX sobre Telefarmacia en pacientes externos durante el confinamiento debido a la pandemia COVID-19, realizado en las diferentes comunidades autónomas de España. Se recogieron datos relativos a lugar de entrega, seguimiento farmacoterapéutico, opinión y satisfacción del paciente con la Telefarmacia, confidencialidad, desarrollo futuro de la atención farmacéutica a través de los servicios de Telefarmacia, y coordinación con el equipo de atención al paciente. Se realizaron cuatro regresiones multinivel para evaluar las diferencias entre comunidades autónomas sobre las variables más relevantes del estudio por medio del software R versión 4.0.3.Un total de 8.079 entrevistas fueron válidas: el 52,8% eran mujeres, el 54,3% tenía entre 41-65 años, el 42,9% estaban en tratamiento prodesde hacía más de 5 años, el 42,8% vivía a 10-50 km del hospital y el 60,2% tardaba más de una hora en acudir al hospital. globalmente, el 85,7% recibieron medicación a domicilio, aunque hubo comunidades autónomas en las que se optó también por las oficinas de farmacia, como en Cantabria (95,8%), o los centros de atención primaria, como en Castilla‑La Mancha (16,5%). El 96,7% de los pacientes refirieron estar satisfechos o muy satisfechos con la Telemedicina en la atención farmacéutica mediante el uso de la Telefarmacia, detectándose variabilidad en cuanto a la opinión entre comunidades, desde la mejor opinión en Andalucía (odds ratio =1,58) y la menos favorable en Castilla y León (odds ratio = 0,66). Por su parte, Cataluña es la comunidad que estaría más claramente a favor de la Telemedicina en la atención farmacéutica de usar la Telefarmacia como actividad complementaria, con una odds ratio de 5,85 respecto al resto. Las ventajas más mencionadas de la Telemedicina fue que los servicios de Telefarmacia evitaban desplazamientos, especialmente en Cantabria (92,5%) y Extremadura (88,4%). Los pacientes mayoritariamente prefieren el acercamiento y entrega informada de la medicación a domicilio cuando no tienen que acudir al hospital, el 75,6% globalmente, desde el 50,1% de pacientes de Cantabria al 96,3% en Cataluña (plt; 0,001). Las comunidades autónomas menos dispuestas a pagar por el servicio de Telefarmacia fueron Castilla y León y Galicia, y las que más, Cataluña y Navarra.En líneas generales, los pacientes están satisfechos con la Telemedicina aplicada a la atención farmacéutica a través de los servicios de Telefarmacia durante la pandemia COVID-19, estando mayoritariamente a favor de mantenerla para evitar desplazamientos.

Worldwide organisations advocate standardising the management of intravenous drugs as an essential strategy to increase safety in paediatric healthcare settings. Intravenous administration is a route associated with some potential complications. Many adverse events are related to the use of intravenous medications, and the great variability in their handling and preparation represents an added risk that jeopardises the safety of children.To standardise the dilutions of intravenous drugs most commonly administered to Spanish hospitalised paediatric and neonatal patients.The process leading to the standardisation of concentrations was undertaken following a two-round modified Delphi procedure. The consensus included the most common drugs administered by continuous or intermittent intravenous infusion to hospitalised and/or critically ill paediatric patients.For paediatric patients, the proposal included a total of 102 drugs (45 continuous infusion and 59 intermittent infusion), with 192 concentrations to be standardised. The final consensus included 101 drugs (99%), of which 44 were continuous infusion and 59 intermittent infusion; 160 concentrations were standardised (72.7%). For neonates, the initial proposal included 80 drugs (38 continuous infusion and 43 intermittent infusion), with 189 concentrations to be standardised. The final consensus included 80 drugs (100%), of which 38 were continuous infusion and 43 were intermittent infusion; 120 concentrations were standardised (49.2%).This proposal showed that standardisation is a feasible approach that can be reached by other healthcare institutions. It can be used in other centres and contribute in the future to unifying paediatric clinical practice.

Objetivo: Determinar la incidencia, gravedad y evitabilidad de los incidentes por medicamentos detectados en los pacientes que acuden a los servicios de urgencias pediátricas, e identificar los grupos de edad de mayor riesgo y los medicamentos implicados.Método: Estudio multicéntrico observacional prospectivo, realizado entre marzo y junio de 2017, en pacientes entre 0 y 16 años que acudieron a los servicios de urgencias pediátricas de ocho hospitales públicos españoles. Se recogieron tres tipos de incidentes: eventos adversos por medicamentos, errores de medicación e intoxicaciones accidentales. Los incidentes se caracterizaron atendiendo a su gravedad, evitabilidad, grupos de edad afectados y medicamentos implicados.Resultados: Durante el periodo de estudio se registraron 99.797 visitas a los servicios de urgencias pediátricas y se recogieron 334 incidentes por medicamentos en 334 pacientes, de los cuales el 52,4% fueron varones, con una media de edad de 47,1 ± 44,4 meses. La incidencia de pacientes con incidentes fue del 0,3%. Del total de incidentes, 264 (79%) fueron considerados prevenibles y 158 (47,3%) produjeron daño a los pacientes. Los incidentes detectados fueron 144 (43,1%) eventos adversos por medicamentos, 218 (65,2%) errores de medicación (74 de ellos errores con daño, que se incluyen asimismo como eventos adversos prevenibles) y 46 (13,7%) intoxicaciones accidentales. Los preescolares (edad: 1-5 años) presentaron el 60,8% de los incidentes, siendo también el grupo de edad con un mayor porcentaje de incidentes prevenibles (64%). Un total de 351 medicamentos estuvieron implicados en los incidentes y pertenecieron mayoritariamente a tres grupos terapéuticos: antiinfecciosos de uso sistémico (171; 48,7%), sistema nervioso (66; 18,8%) y sistema respiratorio (41; 11,7%).Conclusiones: La incidencia de incidentes por medicamentos en los pacientes pediátricos que acudieron a servicios de urgencias fue inferior a la referida en pacientes adultos, si bien prácticamente la mitad de los incidentes detectados causaron daños a los pacientes. Los niños preescolares (1-5 años) fueron identificados como el grupo de edad con mayor riesgo. Los incidentes registrados estuvieron causados por un número reducido de medicamentos. Un elevado porcentaje de los incidentes fueron prevenibles, lo que confirma la imperiosa necesidad de implementar medidas de prevención de incidentes en esta población.Objetivo: Determinar la incidencia, gravedad y evitabilidad de los incidentes por medicamentos detectados en los pacientes que acuden a los servicios de urgencias pediátricas, e identificar los grupos de edad de mayor riesgo y los medicamentos implicados.Método: Estudio multicéntrico observacional prospectivo, realizado entre marzo y junio de 2017, en pacientes entre 0 y 16 años que acudieron a los servicios de urgencias pediátricas de ocho hospitales públicos españoles. Se recogieron tres tipos de incidentes: eventos adversos por medicamentos, errores de medicación e intoxicaciones accidentales. Los incidentes se caracterizaron atendiendo a su gravedad, evitabilidad, grupos de edad afectados y medicamentos implicados.Resultados: Durante el periodo de estudio se registraron 99.797 visitas a los servicios de urgencias pediátricas y se recogieron 334 incidentes por medicamentos en 334 pacientes, de los cuales el 52,4% fueron varones, con una media de edad de 47,1 ± 44,4 meses. La incidencia de pacientes con incidentes fue del 0,3%. Del total de incidentes, 264 (79%) fueron considerados prevenibles y 158 (47,3%) produjeron daño a los pacientes. Los incidentes detectados fueron 144 (43,1%) eventos adversos por medicamentos, 218 (65,2%) errores de medicación (74 de ellos errores con daño, que se incluyen asimismo como eventos adversos prevenibles) y 46 (13,7%) intoxicaciones accidentales. Los preescolares (edad: 1-5 años) presentaron el 60,8% de los incidentes, siendo también el grupo de edad con un mayor porcentaje de incidentes prevenibles (64%). Un total de 351 medicamentos estuvieron implicados en los incidentes y pertenecieron mayoritariamente a tres grupos terapéuticos: antiinfecciosos de uso sistémico (171; 48,7%), sistema nervioso (66; 18,8%) y sistema respiratorio (41; 11,7%).Conclusiones: La incidencia de incidentes por medicamentos en los pacientes pediátricos que acudieron a servicios de urgencias fue inferior a la referida en pacientes adultos, si bien prácticamente la mitad de los incidentes detectados causaron daños a los pacientes. Los niños preescolares (1-5 años) fueron identificados como el grupo de edad con mayor riesgo. Los incidentes registrados estuvieron causados por un número reducido de medicamentos. Un elevado porcentaje de los incidentes fueron prevenibles, lo que confirma la imperiosa necesidad de implementar medidas de prevención de incidentes en esta población.

BACKGROUND The use of azoles for antifungal prophylaxis after familial allogeneic stem cell transplantation in children (SCT) is hindered by adverse events and drug interactions especially in children affected by sickle cell disease. Intermittent, higher dose of micafungin could be an alternative. METHODS A prospective, observational, longitudinal, single-center study was conducted between May 2015 and June 2018. The study included 30 patients between 2 and 18 years old who underwent allogeneic SCT and received prophylaxis with micafungin on alternating days after the bone marrow engraftment phase. FINDINGS Fifty transplants performed, 30 included prophylaxis against IFIs, with micafungin in an alternating pattern according to the previously described protocol. The indication for HSCT was hemoglobinopathies in 76.7%, acute leukemia in 20.0% and Fanconi anemia in 3.3%. The prophylaxis duration was 2.33 months (1.53 to 3.98). In our study, 40.0% (12/30) of the patients had acute GVHD, and 6.7% (2/30) had chronic GVHD, which prolonged the duration of alternating prophylaxis. No serious adverse effects of the use of micafungin were observed in any of the patients. There was also no breakthrough Invasive fungal infection (IFI) during alternating prophylaxis. CONCLUSION: In selected patients, micafungin was well tolerated without breakthrough IFI in our study.

Background: We report the long-term outcomes, changes in laboratory parameters, the incidence of secondary nosocomial infections and treatment cost of a Spanish cohort of patients with severe COVID-19 that received tocilizumab (TCZ). Methods: Retrospective cohort of PCR confirmed adult patients who received TCZ from March 1 to 24, 2020 in a tertiary hospital was analyzed. Patients were followed up until 10 May 2020. Results: We included 162 patients (median age 64 years; 70.4% male). At time of TCZ administration, 48.1% of patients were on invasive mechanical ventilation (IMV). Over a median follow-up of 53 days, 46.9% of patients were discharge in good conditions and 19.8% were still hospitalized. The overall mortality was 33.3%, being higher in patients on IMV than those who did not (46.2% vs 26.7%, P

In January 2019, the Community of Madrid's Health Department published a guide about the use of antimicrobials in outpatient children. Taking this regional Guide as reference, this study was aimed at estimating the adequacy of the antimicrobial stewardship at discharge from a pediatric Emergency Department (ED). Secondarily, the differences in adequacy according to the diagnosis and the prescriber were studied, and the agreement between this Guide and the protocols of the ED was assessed.An observational, descriptive, retrospective study was conducted on patients under 16 years old, with a diagnosis included in the regional Guide who were discharged from a pediatric ED between March of 2018 and February of 2019. Prescription was considered adequate when the indication, the antibiotic and the posology (dosage, dosing interval, length of treatment and route of administration) were correct.165 out of 648 (25,5%) infectious diseases processes analyzed received antimicrobial treatment. In 23 processes treated with antimicrobial, the adequacy could not be evaluated due to the absence of data necessary to assess any aspect of posology. Therapy was considered appropriate in 550/625 processes (88.0%). When antimicrobial treatment was prescribed, 70/142 (49.3%) were appropriate and no statistically significant differences in adequacy were found between prescribers. Posology was the worst handled point of the prescription (26.3%). Tract urinary infection, conjunctivitis and otitis media were the pathologies with the lowest adecuacy (44.4%; 50.0% and 52.2%) and presented the highest discrepancy between the Guide and the center protocols (κ = 0.308; κ = 0.000; κ = 0.586).The adequacy of the management of infectious processes to the reference Guide in our pediatric ED was high, but it was below 50% when antimicrobial treatment was required. The degree of adequacy to the local protocols of the center was greater than to the regional Guide. This reveals a discrepancy between the 2 documents that should be analyzed and corrected according to the available scientific evidence.

Purpose: To analyze the prevalence of use of off-label and unlicensed drugs in a paediatric intensive care unit of a University Hospital. Method: An observational, descriptive, prospective six week pilot study in a paediatric intensive care unit. Hospitalized patients aged between 0 and 18 years were included. Each prescribed drug was evaluated taking into account indication and condition of use, according to the information available on the summary of product characteristics established by the European Medicines Agency. A sequential algorithm was defined allowing drug classification in unlicensed, off-label or approved. Results: 42 patients were included. A total of 696 prescriptions, involving 102 different drugs, were analyzed. All patients had at least one off-label prescription, and a median of 8.9 off-label prescriptions were obtained. Of the total prescriptions, 8.6% were unlicensed and 53.9% corresponded to off-label use. The main reason for off-label use was by indication, followed by age and dose. A lineal tendency between off-label drug use and patient age was observed, where off-label use increased as patient age decreased. The drugs most commonly used off-label were: atropine, etomidate, dipyrone and ranitidine, and unlicensed drugs: spironolactone, sildenafil, acetazolamide and hydrochlorothiazide. Conclusion: Paediatric intensive care units are characterized by a high ratio of off-label and unlicensed prescriptions. The scarce number of studies performed in this specific and complex sub-population added inconveniency to the current lack of data on safety and efficacy for drugs in paediatrics. Performing studies with these characteristics allowing us to document practice on paediatric drug utilization is required. Resumen: Objetivo: Evaluar el perfil de utilización de medicamentos en situaciones no autorizadas en una unidad de cuidados intensivos pediátricos de un hospital universitario. Métodos: Se realizó un estudio observacional descriptivo prospectivo durante 6 semanas en una unidad de cuidados intensivos pediátricos. Se incluyeron pacientes ingresados con edades entre 0-18 años. Se evaluó cada uno de los medicamentos prescritos, indicación o condición de uso, según la información reflejada en las fichas técnicas autorizadas por la Agencia Europea de Medicamentos. Se definió un algoritmo secuencial para clasificar de manera estandarizada los medicamentos según la condición de prescripción en unlicensed, off-label o aprobado. Resultados: Se incluyeron 42 pacientes, analizándose un total de 696 prescripciones, que implicaron 102 fármacos diferentes. Todos los pacientes tuvieron al menos un tratamiento off-label. El 8,6% del total de tratamientos analizados se utilizaron en condiciones unlicensed y el 53,9% en off-label. El principal motivo de uso off-label fue por indicación, seguido de la edad y dosis. Existe una relación lineal entre frecuencia de uso de medicamentos en condiciones off-label y la edad del paciente, aumentando esta frecuencia según disminuye la edad del paciente. Los medicamentos más utilizados en condiciones off-label fueron: atropina, etomidato, metamizol y ranitidina, y en condiciones unlicensed fueron: espironolactona, sildenafilo, acetazolamida e hidroclorotiazida. Conclusión: La unidad de cuidados intensivos pediátricos se caracteriza por un alto ratio de medicamentos prescritos en condiciones no autorizadas. La realización de estudios de estas características permite documentar la práctica clínica respecto al uso de medicamentos en condiciones distintas a las autorizadas.

Resumen: Objetivo: Evaluar el perfil de utilización de medicamentos en situaciones no autorizadas en una unidad de cuidados intensivos pediátricos de un hospital universitario. Métodos: Se realizó un estudio observacional descriptivo prospectivo durante 6 semanas en una unidad de cuidados intensivos pediátricos. Se incluyeron pacientes ingresados con edades entre 0-18 años. Se evaluó cada uno de los medicamentos prescritos, indicación o condición de uso, según la información reflejada en las fichas técnicas autorizadas por la Agencia Europea de Medicamentos. Se definió un algoritmo secuencial para clasificar de manera estandarizada los medicamentos según la condición de prescripción en unlicensed, off-label o aprobado. Resultados: Se incluyeron 42 pacientes, analizándose un total de 696 prescripciones, que implicaron 102 fármacos diferentes. Todos los pacientes tuvieron al menos un tratamiento off-label. El 8,6% del total de tratamientos analizados se utilizaron en condiciones unlicensed y el 53,9% en off-label. El principal motivo de uso off-label fue por indicación, seguido de la edad y dosis. Existe una relación lineal entre frecuencia de uso de medicamentos en condiciones off-label y la edad del paciente, aumentando esta frecuencia según disminuye la edad del paciente. Los medicamentos más utilizados en condiciones off-label fueron: atropina, etomidato, metamizol y ranitidina, y en condiciones unlicensed fueron: espironolactona, sildenafilo, acetazolamida e hidroclorotiazida. Conclusión: La unidad de cuidados intensivos pediátricos se caracteriza por una alto ratio de medicamentos prescritos en condiciones no autorizadas. La realización de estudios de estas características permite documentar la práctica clínica respecto al uso de medicamentos en condiciones distintas a las autorizadas. Abstract: Purpose: To analyze the prevalence of use of off-label and unlicensed drugs in a pediatric intensive care unit of a University Hospital. Method: An observational, descriptive, prospective six week pilot study in a Pediatric Intensive Care Unit. Hospitalized patients aged between 0 and 18 years were included. Each prescribed drug was evaluated taking into account indication and condition of use, according to the information available on the Summary of Product Characteristics established by the European Medicines Agency. A sequential algorithm was defined allowing drug classification in unlicensed, off-label or approved. Results: Forty-two patients were included. A total of 696 prescriptions, involving 102 different drugs, were analyzed. All patients had at least one off-label prescription, and a median of 8.9 off-label prescriptions was obtained. Of the total prescriptions, 8.6% were unlicensed and 53.9% corresponded to off-label use. The main reason for off-label use was by indication, followed by age and dose. A lineal tendency between off-label drug use and patient age was observed, where off-label use increased as patient age decreased. The drugs most commonly used off-label were: atropine, etomidate, dipyrone and ranitidine, and unlicensed drugs: spironolactone, sildenafil, acetazolamide and hydrochlorothiazide. Conclusion: Pediatric Intensive Care Units are characterized by a high ratio of off-label and unlicensed prescriptions. The scarce number of studies performed in this specific and complex sub-population added inconveniency to the current lack of data on safety and efficacy for drugs in paediatrics. Performing studies with these characteristics allows us to document practice on paediatric drug utilisation are required.

Resumen Objetivos Estimar el impacto de la implantacion de bombas de infusion inteligentes en una unidad de cuidados intensivos pediatricos en cuanto al numero y tipo de errores de administracion interceptados Diseno Estudio observacional, prospectivo, realizado de enero de 2010 a marzo de 2015 con las bombas volumetricas y de jeringa disponibles en el hospital. Ambito Unidad de Cuidados Intensivos Pediatricos de un hospital general de tercer nivel . Participantes Todas las infusiones programadas con bomba de infusion en los pacientes ingresados en la Unidad de Cuidados Intensivos Pediatricos. Intervenciones Elaboracion de una biblioteca de farmacos con limites de seguridad a traves de la cual se programarian todas las infusiones intravenosas prescritas. Variables principales Se analizo la adherencia a la biblioteca de farmacos y el numero y tipo de errores evitados segun las alarmas generadas en el sistema. Resultados Se interceptaron 283 errores reales de programacion durante los 62 meses que duro el estudio. En el 58% de los errores estuvo implicado un farmaco de alto riesgo, como agonistas y antagonistas adrenergicos, sedantes, analgesicos, bloqueantes neuromusculares, opiaceos, potasio e insulina. Durante este periodo, la adherencia media de los usuarios al software de seguridad fue del 84%. Conclusiones La implantacion de bombas de infusion inteligentes ha demostrado ser eficaz en la intercepcion de errores de programacion relacionados con farmacos de alto riesgo. Esta herramienta es susceptible de implantarse en otras unidades de pacientes criticos, tanto adultos como pediatricos. La colaboracion multidisciplinar es clave para el exito del proceso.

Objectives To estimate the impact of smart pump implementation in a pediatric intensive care unit in terms of number and type of administration errors intercepted. Design Observational, prospective study carried out from January 2010 to March 2015 with syringe and great volumen infusion pumps available in the hospital. Setting A tertiary level hospital pediatric intensive care unit. Participants Infusions delivered with infusion pumps in all pediatric intensive care unit patients. Interventions Design of a drug library with safety limits for all intravenous drugs prescribed. Main variables Users’ compliance with drug library as well as number and type of errors prevented were analyzed. Results Two hundred and eighty-three errors were intercepted during 62 months of study. A high risk drug was involved in 58% of prevented errors, such as adrenergic agonists and antagonists, sedatives, analgesics, neuromuscular blockers, opioids, potassium and insulin. Users’ average compliance with the safety software was 84%. Conclusions Smart pumps implementation has proven effective in intercepting high risk drugs programming errors. These results might be exportable to other critical care units, involving pediatric or adult patients. Interdisciplinary colaboration is key to succeed in this process.

Resumen: Introducción: En España no existen presentaciones pediátricas de fármacos antituberculosos, salvo para rifampicina. Algunos pediatras prescriben fórmulas magistrales (FM), mientras que otros administran comprimidos triturados. No existe consenso al respecto, ni estudios de farmacocinética que avalen estos procedimientos. Ante esta situación, la Red Española de Estudio de la Tuberculosis Pediátrica (pTBred) desarrolla el Proyecto Magistral, con el objetivo de analizar, en su primera fase, la conveniencia de desarrollar formas farmacéuticas específicas para niños, así como estudiar otros aspectos relacionados con la administración de antituberculosos en niños. Material y métodos: Estudio transversal, multicéntrico y de ámbito nacional, mediante encuesta on-line enviada por correo electrónico a los instituciones pertenecientes a pTBred entre febrero y marzo del 2015 Resultados: Se recibieron 54 respuestas de 67 instituciones consultadas. La mayoría de los centros trituran los comprimidos. Un porcentaje elevado, aunque menor, administra FM, cuya disponibilidad es variable entre las instituciones. El 83% responde que sería ideal disponer de combinaciones fijas de antituberculosos, adaptadas a las dosis pediátricas y administradas mediante FM o en un comprimido. Entre las instituciones encuestadas existen diferencias en el tratamiento de la infección tuberculosa latente, el uso de la terapia directamente observada y la monitorización de efectos adversos. Conclusiones: Nuestra encuesta revela gran heterogeneidad en la prescripción de antituberculosos en niños debido a la falta de formulaciones específicas para esta edad, que podría tener implicaciones en la adherencia al tratamiento y evolución. pTBred propone elaborar un pionero y útil documento de consenso sobre la administración de medicación antituberculosa en niños. Abstract: 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.

Valproic acid (VPA) is the most commonly used antiepileptic drug in pediatric patients, but its major drawback is its multiple pharmacological interactions. Objective To study children who had been simultaneously treated with carbapenems and valproic acid, considering drug levels, pharmacological interactions and clinical follow-up. Material and methods Retrospective study of children who simultaneously received treatment with VPA and carbapenems between January 2003 and December 2011. Demographic variables, indication of treatment, dose, VPA plasma levels, interactions, clinical manifestations and medical management were analyzed. Results 28 children with concomitant treatment with both drugs were included in the study. 64.3% were males. 78.6% of the interactions were observed in the Intensive Care Unit. 60.7% of children had been previously treated VPA and its major indication were generalized seizures. Basal plasma levels of VPA were recorded in 53% and at 24 h after admittance in 60%. “40% of basal VPA levels were below therapeutic range prior to the administration of carbapenem. After the introduction of carbapenem 88% of level determinations were below therapeutic range”. 54.5% of the patients that were chronically receiving VPA and had good control of epilepsy before admission had seizures during the coadministration. One patient that was on VPA before admission but with bad control of epilepsy worsened, and one patient that acutely received VPA did not achieve seizure freedom. In these cases it was necessary to either increase VPA dose or change to a different antiepileptic drug. Conclusions Little is known about the mechanism of pharmacologic interactions between carbapenems and VPA, but it leads to a reduction in plasma levels that may cause a loss of seizure control, so simultaneous use of both drugs should be avoided when possible. If not, VPA levels should be monitored.

Resumen: La Red Española de Estudio de la Tuberculosis Pediátrica ha evidenciado una falta de consenso nacional en la administración de antituberculosos en niños, propiciada por la escasez de presentaciones pediátricas específicas. Es prioritario homogeneizar el tratamiento de la tuberculosis en niños en nuestro país. Un grupo de expertos españoles en tuberculosis infantil y en el área de medicamentos pediátricos proponen una actuación conjunta, con la finalidad de mejorar esta situación en nuestro medio. Para ello se constituye un Grupo de Trabajo, liderado por pTBred, en el que participan otras 5 sociedades e instituciones científicas. Se proponen las siguientes fórmulas magistrales en forma de suspensión o solución oral para el tratamiento de la tuberculosis en niños: isoniacida 50 mg/ml, pirazinamida 100 mg/ml y etambutol 50 mg/ml. Se especifican materias primas, periodo de validez y condiciones de conservación y administración. Se establecen recomendaciones para el uso de fármacos combinados a dosis fijas. Si no se consigue la dosis apropiada mediante fármacos combinados a dosis fijas, y no se dispone de fórmula magistral, se recomienda la administración mediante comprimidos triturados. El adecuado cumplimiento terapéutico y la administración de dosis óptimas de los fármacos antituberculosos constituyen pilares fundamentales en el control y erradicación de la enfermedad. La oportunidad de disponer de este documento multidisciplinar en España favorecerá el correcto tratamiento de la tuberculosis pediátrica, y será una guía útil para todos los pediatras y farmacéuticos que lo precisen. Abstract: 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 50 mg/mL, pyrazinamide 100 mg/mL, and ethambutol 50 mg/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.

Background: No previous studies exist examining the effectiveness and safety in real clinical practice of the combination of ombitasvir/paritaprevir/ritonavir and dasabuvir (OBV/PTV/r+DSV). Objective: To evaluate the effectiveness and safety in real clinical practice of the combination of OBV/PTV/r+DSV with or without ribavirin for 12 weeks in treatment-naïve and previously treated adult patients with chronic hepatitis C virus (HCV) genotype 1 infection. Methods: This was an observational study of a prospective cohort of treatment-naïve and pretreated adult patients who received 12 weeks of OBV/PTV/r (25/150/100 mg once daily) and DSV (250 mg twice daily) with or without ribavirin. The primary effectiveness outcome was sustained virological response 12 weeks after the end of treatment (SVR12). Safety outcomes were presented by the incidence of adverse events. Results: A total of 116 of 121 patients achieved a SVR12 (95.9%, 95% CI = 90.6-98.6). The SVR12 rate was 93.8% (95% CI = 86.0-97.9) in cirrhotic patients and 100% (95% CI = 91.4-100.0) in noncirrhotic patients. Adverse events occurred in 91.7% of patients, of which 81.8% were grade 1/2, and none led to premature discontinuation. Grade 3 adverse events were reported in 9.9% of patients. The most frequent adverse event was anemia (52.1%), although only 1.6% had a hemoglobin level below 8 g/dL. The incidence of any adverse event was higher in the group of patients who received ribavirin (96.5% vs 80.0%, P = 0.002). Conclusions: The combination of OBV/PTV/r+DSV with or without ribavirin for 12-week settings achieved a high rate of SVR12, with an acceptable safety profile in routine clinical care.

Resumen: La parada cardiorrespiratoria (PCR) se puede presentar en cualquier lugar y en cualquier momento y por ello todos los centros sanitarios y los servicios de urgencias extrahospitalarias deben disponer de personal y material adecuado para realizar una reanimación cardiopulmonar (RCP). Estas recomendaciones son el consenso de expertos del Grupo Español de Reanimación Cardiopulmonar Pediátrica y Neonatal sobre el material y medicación de RCP pediátrica y neonatal y su distribución y utilización.Los carros y mochilas de RCP deben tener el material y la medicación para llevar a cabo de forma rápida y eficiente una RCP pediátrica. Debe existir al menos un carro de RCP accesible en cada centro de atención primaria, unidad de cuidados intensivos pediátricos, unidad de cuidados intensivos neonatales, servicio de urgencias, servicio de urgencias extrahospitalarias, planta de pediatría, área de consultas y zona de radiología. El carro de RCP debe contener solo el material y la medicación imprescindibles para realizar una RCP y atender a las urgencias vitales. El material debe ser conocido por el personal, incluir los repuestos necesarios y ser revisado y repuesto periódicamente.La estandarización y unificación del contenido (material y medicación) de los carros y mochilas de RCP pediátrica, así como el entrenamiento del personal en su utilización, son una parte esencial de la organización asistencial de la RCP pediátrica. Abstract: Cardio-respiratory arrest (CPA) is infrequent in children, but it can occur in any place and at any time. This fact means that every health care facility must always have the staff and material ready to resuscitate a child. These recommendations are the consensus of experts of the Spanish Paediatric and Neonatal Resuscitation Group on the material and medication for paediatric and neonatal resuscitation and their distribution and use.CPR trolleys and backpacks must include the essential material to quickly and efficiently perform a paediatric CPR. At least one CPR trolley must be available in every Primary Care facility, Paediatric Intensive Care Unit, Emergency Department, and Pre-hospital Emergency Areas, as well as in paediatric wards, paediatric ambulatory areas, and radiology suites. This trolley must be easily accessible and exclusively include the essential items to perform a CPR and to assist children (from newborns to adolescents) who present with a life-threatening event. Such material must be familiar to all healthcare staff and also include the needed spare parts, as well as enough drug doses. It must also be re-checked periodically.The standardisation and unification of the material and medication of paediatric CPR carts, trolleys, and backpacks, as well as the training of the personnel in their use are an essential part of the paediatric CPR.

To analyze the prevalence of use of off-label and unlicensed drugs in a pediatric intensive care unit of a University Hospital.An observational, descriptive, prospective six week pilot study in a Pediatric Intensive Care Unit. Hospitalized patients aged between 0 and 18 years were included. Each prescribed drug was evaluated taking into account indication and condition of use, according to the information available on the Summary of Product Characteristics established by the European Medicines Agency. A sequential algorithm was defined allowing drug classification in unlicensed, off-label or approved.Forty-two patients were included. A total of 696 prescriptions, involving 102 different drugs, were analyzed. All patients had at least one off-label prescription, and a median of 8.9 off-label prescriptions was obtained. Of the total prescriptions, 8.6% were unlicensed and 53.9% corresponded to off-label use. The main reason for off-label use was by indication, followed by age and dose. A lineal tendency between off-label drug use and patient age was observed, where off-label use increased as patient age decreased. The drugs most commonly used off-label were: atropine, etomidate, dipyrone and ranitidine, and unlicensed drugs: spironolactone, sildenafil, acetazolamide and hydrochlorothiazide.Pediatric Intensive Care Units are characterized by a high ratio of off-label and unlicensed prescriptions. The scarce number of studies performed in this specific and complex sub-population added inconveniency to the current lack of data on safety and efficacy for drugs in paediatrics. Performing studies with these characteristics allows us to document practice on paediatric drug utilisation are required.

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 aims at its first phase 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. Resumen: Introducción: En España no existen presentaciones pediátricas de fármacos antituberculosos, salvo para rifampicina. Algunos pediatras prescriben fórmulas magistrales (FM), mientras que otros administran comprimidos triturados. No existe consenso al respecto, ni estudios de farmacocinética que avalen estos procedimientos. Ante esta situación, la Red Española de Estudio de la Tuberculosis Pediátrica (pTBred) desarrolla el Proyecto Magistral, con el objetivo de analizar, en su primera fase, la conveniencia de desarrollar formas farmacéuticas específicas para niños, así como estudiar otros aspectos relacionados con la administración de antituberculosos en niños. Material y métodos: Estudio transversal, multicéntrico y de ámbito nacional, mediante encuesta on-line enviada por correo electrónico a los instituciones pertenecientes a pTBred entre febrero y marzo del 2015. Resultados: Se recibieron 54 respuestas de 67 instituciones consultadas. La mayoría de los centros trituran los comprimidos. Un porcentaje elevado, aunque menor, administra FM, cuya disponibilidad es variable entre las instituciones. El 83% responde que sería ideal disponer de combinaciones fijas de antituberculosos, adaptadas a las dosis pediátricas y administradas mediante FM o en un comprimido. Entre las instituciones encuestadas existen diferencias en el tratamiento de la infección tuberculosa latente, el uso de la terapia directamente observada y la monitorización de efectos adversos. Conclusiones: Nuestra encuesta revela gran heterogeneidad en la prescripción de antituberculosos en niños debido a la falta de formulaciones específicas para esta edad, que podría tener implicaciones en la adherencia al tratamiento y evolución. pTBred propone elaborar un pionero y útil documento de consenso sobre la administración de medicación antituberculosa en niños.

Resumen: La infección por citomegalovirus es frecuente en pacientes trasplantados cardiacos. Foscarnet se utiliza, con evidencia limitada, como tratamiento de segunda línea tras el fracaso de ganciclovir en estos pacientes. Presentamos un caso de alteraciones electrolíticas por foscarnet administrado para el tratamiento de infección por citomegalovirus en un paciente pediátrico trasplantado cardiaco. La infección se resolvió tras 6 semanas de tratamiento, apareciendo niveles de calcio iónico bajos durante la infusión del fármaco e hipomagnesemia mantenida tratada con suplementos, que revirtieron al retirar el fármaco. Abstract: Cytomegalovirus infection is common in cardiac transplant patients. Foscarnet is used, with limited evidence, as second-line treatment after ganciclovir failure in these patients. We describe the case of a paediatric cardiac transplant patient who developed electrolyte disturbances during foscarnet treatment for cytomegalovirus infection. The infection resolved after 6 weeks of treatment. Low ionized calcium and magnesium levels were observed during the drug infusion, which were treated with supplements. The serum levels reverted to normal after drug withdrawal.

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 50 mg/mL, pyrazinamide 100 mg/mL, and ethambutol 50 mg/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. Resumen: La Red Española de Estudio de la Tuberculosis Pediátrica ha evidenciado una falta de consenso nacional en la administración de antituberculosos en niños, propiciada por la escasez de presentaciones pediátricas específicas. Es prioritario homogeneizar el tratamiento de la tuberculosis en niños en nuestro país. Un grupo de expertos españoles en tuberculosis infantil y en el área de medicamentos pediátricos proponen una actuación conjunta, con la finalidad de mejorar esta situación en nuestro medio. Para ello se constituye un Grupo de Trabajo, liderado por pTBred, en el que participan otras 5 sociedades e instituciones científicas. Se proponen las siguientes fórmulas magistrales en forma de suspensión o solución oral para el tratamiento de la tuberculosis en niños: isoniacida 50 mg/ml, pirazinamida 100 mg/ml y etambutol 50 mg/ml. Se especifican materias primas, periodo de validez y condiciones de conservación y administración. Se establecen recomendaciones para el uso de fármacos combinados a dosis fijas. Si no se consigue la dosis apropiada mediante fármacos combinados a dosis fijas, y no se dispone de fórmula magistral, se recomienda la administración mediante comprimidos triturados. El adecuado cumplimiento terapéutico y la administración de dosis óptimas de los fármacos antituberculosos constituyen pilares fundamentales en el control y erradicación de la enfermedad. La oportunidad de disponer de este documento multidisciplinar en España favorecerá el correcto tratamiento de la tuberculosis pediátrica, y será una guía útil para todos los pediatras y farmacéuticos que lo precisen.

Background Meeting chronic patient needs is essential to improve health outcomes. Purpose To design a pharmaceutical care plan for chronic paediatric patients using a risk stratification tool. Material and methods The care plan was developed in 4 steps from April to June 2014: 1. Literature review. 2.4 workshops were held with experts. The chronic conditions and the variables of each patient with their corresponding relative weights were defined, varying from 1(low) to 4(high risk) in ascending order of risk, and resulted in a risk matrix with increasing levels, which included the pharmaceutical care actions to be carried out in each level. 3. pre-test was developed and used in 195 patients from 7 hospitals. 4.5 case studies were performed. Results The care plan was applied to patients with different chronic conditions, classified into 15 groups (autoimmune, gastrointestinal, oncology, etc.). 13 variables divided into 3 categories were defined: demographic (age, obesity/malnutrition, social/cognitive problems); clinical (visits to the emergency room), comorbidities, clinical conditions that require special monitoring);and drug treatment (polypharmacy, complex patterns, changes in regular regimen, suspected non-adherence, suspicion/risk of medication-related problem, high-risk medicine). Afterwards, 4 risk levels were defined according to the total variable score: level 4, for patients with ≤17 points; level 3, 18 to 22 points; level 2, 23 to 26 points; and level 1, for ≥27 points. For each risk level 3 types of care actions were defined: pharmacotherapy monitoring, training/education to patient/parent/caregiver, and coordination activities with the care team. We evaluated the distribution of 195 real patients into the defined risk levels: 60% were scored into level 4, 20% into level 3, 13% into level 2 and 7 into level 1. This was considered an adequately stratified population distribution. Conclusion The pharmaceutical care plan adequately stratified chronic paediatric patients into different risk levels and can be used to prioritise those patients that will benefit more from our interventions. References and/or Acknowledgements We would like to thank Abbvie and Ascendo consulting for their logistic support. No conflict of interest.