Estudio multicéntrico de conciliación de la medicación en onco-hematología pediátrica / Multicentre study of medication reconciliation in paediatric onco-hematology

Objetivo determinar la prevalencia de errores de conciliación (EC) al ingreso hospitalario en la población pediátrica onco-hematológica para comprobar si ésta presenta una susceptibilidad similar a la de los adultos para ser afectados por estos EC y describir las características de los pacientes en los que se producen.Métodoestudio prospectivo y multicéntrico de 12 meses de duración, de conciliación de medicación al ingreso en la población pediátrica onco-hematológica para evaluar la incidencia de EC y describir las características de los pacientes en los que se producen.Resultadosse concilió la medicación de 157 pacientes. En 96 pacientes se detectó al menos una discrepancia de la medicación. De las discrepancias detectadas, el 52,1% fueron justificadas por la nueva situación clínica del paciente o por el médico responsable mientras que el 48,9% se consideraron EC. El tipo de EC más frecuente fue la «omisión de algún medicamento», seguido por «una dosis, frecuencia o vía de administración diferente». Se efectuaron un total de 77 intervenciones farmacéuticas, de las que se aceptaron el 94,2%. En el grupo de pacientes con un número igual o mayor a 4 fármacos en tratamiento domiciliario se observó un incremento de 2,1 veces la probabilidad de experimentar un EC.Conclusionespara evitar o reducir los errores en uno de los puntos críticos de seguridad como son las transiciones asistenciales, existen medidas, como la conciliación de la medicación. En el caso de los pacientes pediátricos crónicos complejos, como los pacientes onco-hematológicos, el número de fármacos como parte del tratamiento domiciliario es la variable que se ha asociado a la presencia de EC al ingreso hospitalario, siendo la omisión de algún medicamento la causa principal de estos errores. (AU)

Objective To determine the prevalence of reconciliation errors (RE) on admission to hospital in the paediatric onco-haematological population in order to check whether they are similarly susceptible to these RE as adults and to describe the characteristics of the patients who suffer them.MethodsA 12-month prospective, multicentre study of medication reconciliation on admission in the paediatric onco-haematological population to assess the incidence of RE and describe the characteristics of the patients in whom they occur.ResultsMedication reconciliation was performed in 157 patients. At least 1 medication discrepancy was detected in 96 patients. Of the discrepancies detected, 52.1% were justified by the patient's new clinical situation or by the physician, while 48.9% were determined to be RE. The most frequent type of RE was the "omission of a medication", followed by "a different dose, frequency or route of administration". A total of 77 pharmaceutical interventions were carried out, 94.2% of which were accepted. In the group of patients with a number equal to or greater than 4 drugs in home treatment, there was a 2.1-fold increase in the probability of suffering a RE.ConclusionsIn order to avoid or reduce errors in one of the critical safety points such as transitions of care, there are measures such as medication reconciliation. In the case of complex chronic paediatric patients, such as onco-haematological patients, the number of drugs as part of home treatment is the variable that has been associated with the presence of medication RE on admission to hospital, with the omission of some medication being the main cause of these errors. (AU)

Conciliación de la medicación al ingreso en paciente crónico pediátrico: estudio multicéntrico / Medication reconciliation at admission in paediatric patients with chronic illness: A multicentre study

Introducción: La conciliación de la medicación (CM) es una de las principales estrategias para disminuir los errores de medicación en las transiciones asistenciales. En España existen publicadas diferentes guías con recomendaciones para la implantación y el desarrollo de la CM orientadas a la población adulta, sin estar los pacientes pediátricos incluidos. En el año 2018 se llevó a cabo un estudio que permitió la posterior publicación de un documento con criterios de selección de pacientes pediátricos en los que priorizar la CM. Objetivos: Describir las características de los pacientes pediátricos con mayor probabilidad de sufrir errores de conciliación (EC), para confirmar si los resultados de un estudio previo son extrapolables. Metodología: Estudio prospectivo y multicéntrico con pacientes pediátricos ingresados. Se analizaron los EC detectados durante la realización de la CM al ingreso. La mejor historia farmacoterapéutica posible del paciente fue obtenida utilizando diferentes fuentes de información y confirmándose con una entrevista con el paciente/cuidador. Resultados: Se detectaron 1.043 discrepancias, determinándose como EC 544, afectando a 317 pacientes (43%). La omisión de algún medicamento fue el error más común (51%). La mayoría de los EC se asociaron con los medicamentos de los grupos A (31%), N (23%) y R (11%) de la clasificación ATC. La polimedicación y la enfermedad de base onco-hematológica fueron los factores de riesgo asociados a la presencia de EC con significación estadística. Conclusiones: Los hallazgos de este estudio permiten priorizar la CM en un grupo concreto de pacientes pediátricos, favoreciendo la eficiencia del proceso. Los pacientes onco-hematológicos y la polimedicación se confirman como los principales factores de riesgo para la aparición de EC en la población pediátrica.(AU)

Introduction: Medication reconciliation (MR) is one of the main strategies used to reduce medication errors in care transitions. In Spain, several guidelines have been published with recommendations for the implementation and development of MR processes aimed at the adult population, and not applicable to paediatric patients. In 2018, a study was carried out that allowed the subsequent publication of a document establishing criteria for the selection of paediatric patients in whom CM should be prioritised. Objectives: To describe the characteristics of the paediatric patients most likely to be subject to reconciliation errors (REs) to confirm whether the results of a previous study could be extrapolated. Methodology: Prospective, multicentre study in paediatric inpatients. We analysed the REs detected in the MR at the time of admission. We obtained the best possible medication history of the patient using different sources of information, subsequently confirmed through an interview with the patient/caregiver. Results: 1043 discrepancies were detected, of which 544 were categorised as REs, affecting 317 patients (43%). Omission of a drug was the most common error (51%). Most REs involved drugs in groups A (31%), N (23%) and R (11%) of the ATC classification. Polypharmacy and oncological/haematological disease were the risk factors that exhibited a statistically significant association with the occurrence of REs. Conclusions: The findings of this study allow the prioritisation of MR in a specific group of paediatric patients, contributing to improve the efficiency of the process. Oncological/haematological disease and polypharmacy were confirmed as the main risk factors for the occurrence of REs in the paediatric population.(AU)

Medication reconciliation on admission in paediatric chronic patients: A multicentre study.

INTRODUCTION: Medication reconciliation (MC) is one of the main strategies to reduce medication errors in care transitions. In Spain, several guidelines have been published with recommendations for the implementation and development of MC aimed at the adult population, although paediatric patients are not included. In 2018, a study was carried out that led to the subsequent publication of a document with criteria for selecting paediatric patients in whom CM should be prioritised. OBJECTIVES: To describe the characteristics of paediatric patients most likely to suffer from errors of reconciliation (EC), to confirm whether the results of a previous study can be extrapolated. METHODOLOGY: Prospective, multicentre study of paediatric inpatients. We analysed the CE detected during the performance of the CM on admission. The best possible pharmacotherapeutic history of the patient was obtained using different sources of information and confirmed by an interview with the patient/caregiver. RESULTS: 1043 discrepancies were detected, 544 were identified as CD, affecting 317 patients (43%). Omission of a drug was the most common error (51%). The majority of CD were associated with drugs in groups A (31%), N (23%) and R (11%) of the ATC classification. Polymedication and onco-haematological based disease were the risk factors associated with the presence of CD with statistical significance. CONCLUSIONS: The findings of this study allow prioritisation of CM in a specific group of paediatric patients, favouring the efficiency of the process. Onco-haematological patients and polymedication are confirmed as the main risk factors for the appearance of CD in the paediatric population.

[Translated article] Medication reconciliation in pediatric hemato-oncologic patients: A multicenter study.

OBJECTIVE: To determine the prevalence of reconciliation errors on admission to hospital in the pediatric onco-hematological population in order to check whether they are similarly susceptible to these reconciliation errors as adults and to describe the characteristics of the patients who suffer them. METHODS: A 12-month prospective, multicentre study of medication reconciliation on admission in the pediatric onco-hematological population to assess the incidence of reconciliation errors and to describe the characteristics of the patients. RESULTS: Medication reconciliation was performed in 157 patients. At least a medication discrepancy was detected in 96 patients. Of the discrepancies detected, 52.1% were related to patient's new clinical situation or by the physician, while 48.9% were determined to be reconciliation errors. The most frequent type of reconciliation error was the "omission of a medication", followed by "a different dose, frequency or route of administration". A total of 77 pharmaceutical interventions were carried out, 94.2% of which were accepted. In the group of patients with a number equal to or greater than 4 drugs in home treatment, there was a 2.1-fold increase in the probability of suffering a reconciliation error. CONCLUSIONS: In order to avoid or reduce errors in one of the critical safety points such as transitions of care, there are measures such as medication reconciliation. In the case of complex chronic pediatric patients, such as onco-hematological patients, the number of drugs as part of home treatment is the variable that has been associated with the presence of medication reconciliation errors on admission to hospital, and the omission of some medication was the main cause of these errors.

Multicentre study of medication reconciliation in paediatric onco-hematology. / Estudio multicéntrico de conciliación de la medicación en onco-hematología pediátrica.

OBJECTIVE: To determine the prevalence of reconciliation errors (RE) on admission to hospital in the paediatric onco-haematological population in order to check whether they are similarly susceptible to these RE as adults and to describe the characteristics of the patients who suffer them. METHODS: A 12-month prospective, multicentre study of medication reconciliation on admission in the paediatric onco-haematological population to assess the incidence of RE and describe the characteristics of the patients in whom they occur. RESULTS: Medication reconciliation was performed in 157 patients. At least 1 medication discrepancy was detected in 96 patients. Of the discrepancies detected, 52.1% were justified by the patient's new clinical situation or by the physician, while 48.9% were determined to be RE. The most frequent type of RE was the "omission of a medication", followed by "a different dose, frequency or route of administration". A total of 77 pharmaceutical interventions were carried out, 94.2% of which were accepted. In the group of patients with a number equal to or greater than 4 drugs in home treatment, there was a 2.1-fold increase in the probability of suffering a RE. CONCLUSIONS: In order to avoid or reduce errors in one of the critical safety points such as transitions of care, there are measures such as medication reconciliation. In the case of complex chronic paediatric patients, such as onco-haematological patients, the number of drugs as part of home treatment is the variable that has been associated with the presence of medication RE on admission to hospital, with the omission of some medication being the main cause of these errors.

Impacto de la implantación de la prescripción electrónica asistida en la seguridad del paciente pediátrico / Impact of introducing assisted electronic prescription on paediatric patient safety

OBJETIVO: El efecto de la implantación de la prescripción electrónica asistida en la seguridad de los pacientes pediátricos ha sido poco estudiado. El objetivo de este estudio es comparar los errores de medicación antes y después de su implantación en un hospital terciario. MATERIAL Y MÉTODOS: Estudio cuasiexperimental comparativo de los errores de medicación detectados antes y después de la implantación de la prescripción electrónica. Se analizaron todas las líneas de tratamiento y se recogió el punto de la cadena donde ocurrió el error, el tipo de error y su causa. Se realizó un estudio Delphi sobre la importancia de cada error en el que participaron médicos, enfermeros y farmacéuticos. RESULTADOS: Se incluyeron 166 pacientes (83 en cada etapa). Se detectó algún error en el 92% de los pacientes en la etapa preimplantacional (2,8 ± 2,1 errores/paciente) y en el 7,2% en la etapa postimplantacional (0,1 ± 0,4 errores/paciente). La prescripción electrónica asistida supuso una reducción absoluta del riesgo de error de un 40% (intervalo de confianza del 95% = 35,6-44,4%). Los lapsus/despistes fueron la principal causa de error en ambos grupos. En la etapa preimplantacional se consideraron graves el 9,5% de los errores, y en la etapa postimplantacional todos fueron leves o moderados. CONCLUSIONES: La implantación de la prescripción electrónica con sistemas de ayuda a la prescripción, validación y administración de medicamentos reduce de forma significativa los errores de medicación y elimina los errores graves

OBJECTIVE: There have been very few studies on the effect of assisted electronic prescription on paediatric patient safety. The objective of this study is to compare medication errors that occurred before and after its introduction in a tertiary hospital. MATERIAL AND METHODS: A quasi-experimental comparative study of medication errors detected before and after assisted electronic prescription introduction. All treatment lines were analysed in order to detect the point in the chain where the medication error occurred, as well as its type and cause. A Delphi study was conducted on the importance of each medication error involving doctors, nurses, and pharmacists. RESULTS: The study included 166 patients (83 at each stage). At least one medication error was detected in 92% in the pre-introduction phase patients (2.8 ± 2.1 errors/patient) and 7.2% of post-introduction phase patients (0.1 ± 0.4 errors/patient). The assisted electronic prescription led to an absolute risk reduction of 40% (95% confidence interval = 35.6-44.4%). The main cause of error was lapses and carelessness in both stages. Medication errors were considered serious in 9.5% of cases in the pre-introduction phase, while all of them were mild or moderate in the post-introduction phase. CONCLUSIONS: The assisted electronic prescription implementation with prescription, validation and medication administration assistance systems significantly reduces medication errors and eliminates serious errors

[Impact of introducing assisted electronic prescription on paediatric patient safety]. / Impacto de la implantación de la prescripción electrónica asistida en la seguridad del paciente pediátrico.

OBJECTIVE: There have been very few studies on the effect of assisted electronic prescription on paediatric patient safety. The objective of this study is to compare medication errors that occurred before and after its introduction in a tertiary hospital. MATERIAL AND METHODS: A quasi-experimental comparative study of medication errors detected before and after assisted electronic prescription introduction. All treatment lines were analysed in order to detect the point in the chain where the medication error occurred, as well as its type and cause. A Delphi study was conducted on the importance of each medication error involving doctors, nurses, and pharmacists. RESULTS: The study included 166 patients (83 at each stage). At least one medication error was detected in 92% in the pre-introduction phase patients (2.8±2.1 errors/patient) and 7.2% of post-introduction phase patients (0.1±0.4 errors/patient). The assisted electronic prescription led to an absolute risk reduction of 40% (95% confidence interval=35.6-44.4%). The main cause of error was lapses and carelessness in both stages. Medication errors were considered serious in 9.5% of cases in the pre-introduction phase, while all of them were mild or moderate in the post-introduction phase. CONCLUSIONS: The assisted electronic prescription implementation with prescription, validation and medication administration assistance systems significantly reduces medication errors and eliminates serious errors.

Uso de medicamentos en condiciones no aprobadas en cuidados intensivos neonatales / Use of off-label drugs in neonatal intensive care

Objetivo: Evaluar la prevalencia de prescripciones en condiciones no autorizadas (off-label y unlicensed) en una Unidad de Cuidados Intensivos Neonatales (UCIN) y definir qué características de los neonatos se asocian a un mayor uso de fármacos en estas condiciones. Material y métodos: Estudio observacional prospectivo en una UCIN nivel III-C durante un periodo de 6 meses. Se evaluó la condición de uso de cada fármaco, tomando como referencia su ficha técnica. Se utilizó un algoritmo secuencial para la clasificación de las prescripciones en: aprobadas, unlicensed u off-label (por edad, por indicación, por vía de administración, y por dosis). Resultados: Se incluyeron 84 pacientes y 564 prescripciones. Un total de 127 prescripciones fueron consideradas off-label y 45 unlicensed; lo cual supuso el 22,5% y el 8% del total, respectivamente. El 59,5% de los pacientes recibieron al menos un fármaco en una de estas condiciones, ascendiendo este porcentaje al 100% en los grandes prematuros y en los pacientes quirúrgicos (p < 0,001). Se encontró una correlación lineal positiva entre la estancia en UCIN y el número de prescripciones off-label (coeficiente de correlación 0,6 p < 0,001). Conclusiones: La prescripción de fármacos en condiciones no autorizadas es habitual en UCIN, siendo especialmente frecuente en los pacientes con mayor vulnerabilidad. Estos resultados ponen de manifiesto la necesidad de avanzar en la investigación y homogeneizar la información existente sobre los fármacos en neonatología, con el objetivo de realizar una prescripción eficaz y segura

Objective: To evaluate the prevalence of non-approved prescriptions (off-label and unlicensed) in a Neonatal Intensive Care Unit (NICU), and to describe factors of the neonate associated with its use. Materials and methods: Observational prospective study in a level III NICU during a 6-month period. Every prescription was analysed using the summary of product characteristics as a reference. A sequential algorithm was used to create a classification of prescriptions based on current status: approved, unlicensed, off-label (by age, route of administration, dosage, or indication). Results: The study included 84 patients and 564 prescriptions. A total of 127 (22.5%) prescriptions were considered off-label, and 45 (8%) were considered unlicensed. More than half (59.5%) of the patients received at least one of these drugs, and this increases to 100% among very preterm neonates and surgical patients (P < .001). A positive linear correlation was found between duration of NICU stay and the number of off-label prescriptions (correlation coefficient 0.6; P < .001). Conclusions: Non-licensed drugs are frequently prescribed in NICU, especially in the most vulnerable patients. Our results show the need to move forward on clinical research in order to homogenise the existing data about neonatology drugs, with the aim of making an efficient and safe prescription

¿Cuál es la dosis óptima de clopidogrel en pacientes pediátricos? / What is the optimal dose of clopidogrel in pediatric patients?

Introducción: El objetivo de este estudio fue recopilar datos retrospectivos sobre la prescripción de clopidogrel y describir las condiciones de uso en la población pediátrica de un hospital de referencia de nivel terciario y evaluarlas con base en la evidencia disponible. Pacientes y métodos: Estudio observacional, descriptivo y retrospectivo realizado entre marzo de 2010 y marzo de 2017. Los criterios de inclusión fueron: 100% de los pacientes menores de 18 años que fueron dados de alta de nuestro hospital con clopidogrel como tratamiento domiciliario en el período de estudio. Se recogieron los siguientes datos: datos demográficos, diagnóstico, indicación de clopidogrel, fecha de inicio y de finalización del tratamiento, presencia o ausencia de tratamiento concomitante con ácido acetilsalicílico u otros antiagregantes plaquetarios o anticoagulantes, tratamiento concomitante con inhibidores de la bomba de protones, efectividad y efectos adversos. Resultados: Un total de 11 pacientes se incluyeron en el estudio (45% hombres). La edad promedio fue de 3,1 años (rango: 1 mes-8 años). La dosis recomendada de clopidogrel fue de 0,2 mg/kg/día en todos los individuos, recibiendo tratamiento concomitante con ácido acetilsalicílico 10/11 pacientes para optimizar la terapia antiplaquetaria. Ningún niño recibió tratamiento concomitante con anticoagulantes y solo uno de ellos recibió tratamiento con inhibidores de la bomba de protones. No se observaron trastornos hemorrágicos u otros efectos adversos asociados con clopidogrel. Conclusión: Según nuestra experiencia, la dosis de clopidogrel de 0,2 mg/kg/día demostró ser una estrategia segura y efectiva, independientemente de la edad del paciente. La buena tolerancia observada podría estar asociada con el ajuste de la dosis óptima para lograr la agregación plaquetaria sin aumentar el riesgo de efectos adversos

Introduction: The aim of this study was to collect retrospective data on the prescription of clopidogrel, describe the conditions of its use in the paediatric population of a tertiary referral hospital, and evaluate its use based on the current scientific evidence. Patients and methods: We conducted a retrospective, observational and descriptive study between March 2010 and March 2017. We included all patients under the age of 18 who were discharged from our hospital for home treatment with clopidogrel within the study period. We collected data on the following: demographic data, diagnosis, indication for clopidogrel, start and end date of treatment, presence or absence of concomitant treatment with acetylsalicylic acid or other antiplatelet or anticoagulant drugs, concomitant treatment with proton pump inhibitors, effectiveness, and adverse effects. Results: The study included a total of 11 patients (45% male). The mean age was 3.1 years (range, 1 month-8 years). The prescribed dose of clopidogrel was 0.2 mg/kg/day in all patients, and 10/11 patients received concomitant treatment with acetylsalicylic acid with the purpose of optimising antiplatelet therapy. None of the children received concomitant treatment with anticoagulants, and only one of them received treatment with a proton pump inhibitor. We did not find evidence of haemorrhagic complications or other adverse effects associated with clopidogrel. Conclusion: Based on our experience, a clopidogrel dose of 0.2 mg/kg/day is a safe and effective treatment, regardless of the patient's age. The good tolerance observed in our study could be related to the adjustment of the optimal dose with the aim of achieving platelet aggregation without increasing the risk of adverse effects

[Use of off-label drugs in neonatal intensive care]. / Uso de medicamentos en condiciones no aprobadas en cuidados intensivos neonatales.

OBJECTIVE: To evaluate the prevalence of non-approved prescriptions (off-label and unlicensed) in a Neonatal Intensive Care Unit (NICU), and to describe factors of the neonate associated with its use. MATERIALS AND METHODS: Observational prospective study in a level III NICU during a 6-month period. Every prescription was analysed using the summary of product characteristics as a reference. A sequential algorithm was used to create a classification of prescriptions based on current status: approved, unlicensed, off-label (by age, route of administration, dosage, or indication). RESULTS: The study included 84 patients and 564 prescriptions. A total of 127 (22.5%) prescriptions were considered off-label, and 45 (8%) were considered unlicensed. More than half (59.5%) of the patients received at least one of these drugs, and this increases to 100% among very preterm neonates and surgical patients (P<.001). A positive linear correlation was found between duration of NICU stay and the number of off-label prescriptions (correlation coefficient 0.6; P<.001). CONCLUSIONS: Non-licensed drugs are frequently prescribed in NICU, especially in the most vulnerable patients. Our results show the need to move forward on clinical research in order to homogenise the existing data about neonatology drugs, with the aim of making an efficient and safe prescription.

[What is the optimal dose of clopidogrel in pediatric patients?] / ¿Cuál es la dosis óptima de clopidogrel en pacientes pediátricos?

INTRODUCTION: The aim of this study was to collect retrospective data on the prescription of clopidogrel, describe the conditions of its use in the paediatric population of a tertiary referral hospital, and evaluate its use based on the current scientific evidence. PATIENTS AND METHODS: We conducted a retrospective, observational and descriptive study between March 2010 and March 2017. We included all patients under the age of 18 who were discharged from our hospital for home treatment with clopidogrel within the study period. We collected data on the following: demographic data, diagnosis, indication for clopidogrel, start and end date of treatment, presence or absence of concomitant treatment with acetylsalicylic acid or other antiplatelet or anticoagulant drugs, concomitant treatment with proton pump inhibitors, effectiveness, and adverse effects. RESULTS: The study included a total of 11 patients (45% male). The mean age was 3.1 years (range, 1 month-8 years). The prescribed dose of clopidogrel was 0.2mg/kg/day in all patients, and 10/11 patients received concomitant treatment with acetylsalicylic acid with the purpose of optimising antiplatelet therapy. None of the children received concomitant treatment with anticoagulants, and only one of them received treatment with a proton pump inhibitor. We did not find evidence of haemorrhagic complications or other adverse effects associated with clopidogrel. CONCLUSION: Based on our experience, a clopidogrel dose of 0.2mg/kg/day is a safe and effective treatment, regardless of the patient's age. The good tolerance observed in our study could be related to the adjustment of the optimal dose with the aim of achieving platelet aggregation without increasing the risk of adverse effects.

Implantación de consultas externas monográficas de atención farmacéutica en un servicio de farmacia hospitalaria / Implementation of specialized pharmaceutical care hospital outpatient clinics in a hospital pharmacy department

Objetivo: Describir la organización asistencial de Consultas Externas Monográficas de Atención Farmacéutica de un Servicio de Farmacia Hospitalaria, evaluar su calidad asistencial y la calidad percibida por los pacientes externos. Método: Estudio observacional retrospectivo en un servicio de farmacia de un hospital de nivel terciario durante tres períodos (años 2010, 2013 y 2016); descripción de la organización asistencial a nivel de estructura, recursos humanos, recursos materiales y procedimientos de trabajo; evaluación de la calidad asistencial mediante el análisis de tres variables de procedimiento: cumplimiento cita previa, tiempo de espera y documentación de la atención farmacéutica; evaluación de la calidad percibida por los pacientes externos mediante encuestas de satisfacción; análisis estadístico comparativo de medias (t Student) y proporciones (chi cuadrado Pearson). Resultados: 15 consultas monográficas abiertas atendidas por 18 farmacéuticos; entre el período inicial y el período final del estudio (2010 vs. 2016) el cumplimiento de cita previa fue del 61,3% vs. 88,8% (p< 0001), el tiempo de espera fue 27,6±12,1 vs. 12,1±5,4 minutos (p< 0,0001), la documentación de la atención farmacéutica en la historia clínica del 2,3% vs. 9,81% (p< 0,0001) y la satisfacción global percibida por los pacientes del 6,63±2,36 vs. 9,16±1,27 (p< 0,01). Conclusiones: El modelo de Consulta Externa Monográfica de Atención Farmacéutica expuesto, centrado en el paciente y con continuidad asistencial, ha mejorado la calidad asistencial y la calidad percibida por los pacientes y se encuentra en condiciones óptimas para investigar su aportación a los resultados en salud del paciente y al sistema sanitario a través de una mejor calidad, seguridad y eficiencia de la farmacoterapia (AU)

Objective: To describe the organization of patient care into Specialized Pharmaceutical Care Hospital Outpatient Clinics in a Hospital Pharmacy Department, to evaluate their healthcare quality, and the quality perceived by outpatients. Method: A retrospective observational study in a High-Level Hospital Pharmacy Department during three periods (years 2010, 2013 and 2016); description of the organization at the levels of structure, human resources, material resources and working procedures; evaluation of healthcare quality through the analysis of three variables in terms of procedure: prior appointment compliance, waiting time and documentation of pharmaceutical care; evaluation of quality perceived by outpatients through a satisfaction survey; comparative statistical analysis of means (Student's t) and proportions (Pearson's chi square). Results: Fifteen (15) specialized outpatient clinics were opened and managed by 18 pharmacists; between the initial and final periods of the study (2010 vs. 2016), the compliance with previous appointments was of 61.3% vs. 88.8% (p < 0001), waiting time was 27.6±12.1 vs. 12.1±5.4 minutes (p < 0.0001), documentation of pharmaceutical care in the clinical record was of 2.3% vs. 9.81% (p < 0.0001), and the overall satisfaction perceived by the patients was 6.63±2.36 vs. 9.16±1.27 (p< 0.01). Conclusions: The model of Specialized Pharmaceutical Care Hospital Outpatient Clinics exposed, focused on the patient and with continuity of care, has improved the quality of care and the quality perceived by the patients and it´s in optimal conditions to investigate its contribution on health outcomes and on the health system through a better quality, safety and efficiency of pharmacotherapy (AU)

Implementation of Specialized Pharmaceutical Care Hospital Outpatient Clinics in a Hospital Pharmacy Department.

OBJECTIVE: To describe the organization of patient care into Specialized Pharmaceutical Care Hospital Outpatient Clinics in a Hospital Pharmacy Department, to evaluate their healthcare quality, and the quality  perceived by outpatients. METHOD: A retrospective observational study in a High-Level Hospital Pharmacy Department during three periods (years 2010, 2013 and 2016); description of  the organization at the levels of structure, human resources, material resources  and working procedures; evaluation of healthcare quality through the analysis of  three variables in terms of procedure: prior appointment compliance, waiting  time and documentation of pharmaceutical care; evaluation of quality perceived  by outpatients through a satisfaction survey; comparative statistical analysis of  means (Student's t) and proportions (Pearson's chi square). RESULTS: Fifteen (15) specialized outpatient clinics were opened and managed by 18 pharmacists; between the initial and final periods of the study (2010 vs. 2016), the compliance with previous appointments was of 61.3% vs. 88.8% (p <0001), waiting time was 27.6±12.1 vs. 12.1±5.4 minutes (p  <0.0001), documentation of pharmaceutical care in the clinical record was of  2.3% vs. 9.81% (p <0.0001), and the overall satisfaction perceived by the  patients was 6.63±2.36 vs. 9.16±1.27 (p <0.01). CONCLUSIONS: The model of Specialized Pharmaceutical Care Hospital Outpatient  Clinics exposed, focused on the patient and with continuity of care, has improved the quality of care and the quality perceived by the patients and it´s in optimal conditions to investigate its contribution on health outcomes and on the health system through a better quality, safety and efficiency of pharmacotherapy.

Objetivo: Describir la organización asistencial de Consultas Externas Monográficas de Atención Farmacéutica de un Servicio de Farmacia Hospitalaria, evaluar su calidad asistencial y la calidad percibida por los pacientes externos.Método: Estudio observacional retrospectivo en un servicio de farmacia de un hospital de nivel terciario durante tres períodos (años 2010, 2013 y 2016); descripción de la organización asistencial a nivel de estructura, recursos humanos, recursos materiales y procedimientos de trabajo; evaluación de la calidad asistencial mediante el análisis de tres variables de procedimiento: cumplimiento cita previa, tiempo de espera y documentación de la atención farmacéutica; evaluación de la calidad percibida por los pacientes externos mediante encuestas de satisfacción; análisis estadístico comparativo de  medias (t Student) y proporciones (chi cuadrado Pearson).Resultados: 15 consultas monográficas abiertas atendidas por 18 farmacéuticos; entre el período inicial y el período final del estudio (2010 vs. 2016) el cumplimiento de cita previa fue del 61,3% vs. 88,8% (p<0001), el tiempo de espera fue 27,6±12,1 vs. 12,1±5,4 minutos (p<0,0001), la documentación de la atención farmacéutica en la historia clínica del 2,3% vs. 9,81% (p<0,0001) y la satisfacción global percibida por los pacientes del 6,63±2,36 vs. 9,16±1,27 (p<0,01).Conclusiones: El modelo de Consulta Externa Monográfica de Atención Farmacéutica expuesto, centrado en el paciente y con continuidad asistencial, ha mejorado la calidad asistencial y la calidad percibida por los pacientes y se encuentra en condiciones óptimas para investigar su aportación a los resultados en salud del paciente y al sistema sanitario a través de una mejor calidad, seguridad y eficiencia de la farmacoterapia.

Experience with levosimendan in 32 paediatric patients.

The aim of this study was to describe the off-label conditions of use for levosimendan in the paediatric population of a tertiary referral hospital. This is a retrospective observational study conducted between January 2007 and January 2014. Inclusion criteria were as follows: 100 % of paediatric patients who received intravenous perfusions of levosimendan during the study period. The following data were gathered: age, sex, diagnosis, dose administered, duration and date of the perfusion, number of perfusions per patient, previous inotropic and concomitant treatment, side effects and survival. A total of 32 patients were included in the study (56 % male). The mean age at the moment of administration was 4 months (range 2 days-15 years). During the study period, a total of 70 infusions were recorded. Fifteen of the 32 patients (46.9 %) received repeat doses, with a mean interval between doses of 8 days (range 3-37 days). The doses used were between 0.05 and 0.2 mcg/kg/min. Loading doses were not used in any cases. At the moment of receiving the infusion, all of the patients were receiving conventional treatment without any response, including inotropic support in 88 % of the cases. The administration of levosimendan was only suspended in one case due to the appearance of severe hypotension. In the rest of the administrations, it was well tolerated, without registering any severe side effect during the infusion process. Levosimendan proved to be a safe, effective strategy in our paediatric population. The good tolerance observed may be related to the absence of an initial bolus or loading dose.

Efficacy and safety comparison of two amoxicillin administration schedules afterthird molar removal. A randomized, double-blind and controlled clinical trial

Objective: The aim of this comparative double-blind, prospective, randomized, clinical trial was to evaluate two amoxicillin administration patterns. The first was a short prophylactic therapy and the second a long postoperative regimen.Study Design: The study population consisted of 160 patients who under went mandibular third molar extraction.Patients were randomized into two equal groups. In group 1, 2 grams of amoxicillin were administered 1 hour before the procedure and 1 gram 6 hours after surgery. In group 2, patients received 1 gram of amoxicillin 6 hours after surgery followed by 1 gram every 8 hour for 4 days. All patients received the same number of tablets thanks to the use of placebo pills. A total of 25 variables were evaluated, such as alveolitis, surgical infection, number of analgesic needed, subjective pain scale, post-surgical inflammation, consistency of the diet, axillary temperature and millimetres of mouth opening loss after the surgery.Results: No statistically significant post-operative differences were found within the recorded parameters between the groups.Conclusions: Postoperative 4-days amoxicillin therapy is not justified (AU)

Efficacy and safety comparison of two amoxicillin administration schedules after third molar removal. A randomized, double-blind and controlled clinical trial.

OBJECTIVE: The aim of this comparative double-blind, prospective, randomized, clinical trial was to evaluate two amoxicillin administration patterns. The first was a short prophylactic therapy and the second a long postoperative regimen. STUDY DESIGN: The study population consisted of 160 patients who underwent mandibular third molar extraction. Patients were randomized into two equal groups. In group 1, 2 grams of amoxicillin were administered 1 hour before the procedure and 1 gram 6 hours after surgery. In group 2, patients received 1 gram of amoxicillin 6 hours after surgery followed by 1 gram every 8 hour for 4 days. All patients received the same number of tablets thanks to the use of placebo pills. A total of 25 variables were evaluated, such as alveolitis, surgical infection, number of analgesic needed, subjective pain scale, post-surgical inflammation, consistency of the diet, axillary temperature and millimeters of mouth opening loss after the surgery. RESULTS: No statistically significant post-operative differences were found within the recorded parameters between the groups. CONCLUSIONS: Postoperative 4-days amoxicillin therapy is not justified.