Análisis e implementación de un modelo asistencial basado en la integración de un farmacéutico de hospital en un Servicio de Hematología y Hemoterapia / Analysis and implementation of a healthcare model based on the integration of a hospital pharmacist in a Hematology and Hemotherapy Service

Objetivo: Analizar el impacto sanitario y económico, así como evaluar la actividad clínica y asistencial, que supone la integración de un farmacéutico de hospital en un Servicio de Hematología y Hemoterapia. Material y métodos: Se trata de un estudio observacional prospectivo, unicéntrico, realizado en un hospital de tercer nivel desde enero de 2014 hasta febrero de 2019, diseñado para definir las funciones y las actividades clínicas a realizar por un farmacéutico de hospital integrado en un Servicio de Hematología de un hospital de tercer nivel y medir los resultados que se obtienen mediante la adopción de este nuevo modelo asistencial integrado Hematología-Farmacia, basado en la multidisciplinariedad. Resultados: El farmacéutico se integró totalmente en la actividad clínica diaria del equipo multidisciplinar perteneciente al Servicio de Hematología y Hemoterapia, siendo un facilitador del trabajo diario de los profesionales del Servicio de Hematología y un mediador de las necesidades de ambos servicios implicados (Hematología y Farmacia). Esta integración permitió garantizar la seguridad en la administración de tratamientos hematológicos en 9.125 pacientes hematológicos, reducir los errores de medicación en un 95%, detectar y notificar 45 reacciones adversas a medicamentos, diseñar medidas de eficiencia y seguimiento de las mismas en patologías de elevado impacto económico como mieloma múltiple, leucemia linfática crónica, leucemia mieloide crónica y hemofilia, consiguiendo un ahorro de 1.500.000 euros, entre otros resultados. Conclusiones: La integración de un farmacéutico de hospital en un Servicio de Hematología constituye una medida de innovación y eficiencia, mejora la calidad asistencial, garantiza la seguridad, favorece la sostenibilidad del sistema sanitario y facilita la incorporación de innovación. (AU)

Objective: To analyze the health and economic impact and to evaluate the clinical and care activity of the integration of a hospital pharmacist in a Hematology and Hemotherapy Service. Material and methods: This is a prospective, single-centre, observational study conducted in a tertiary hospital from January 2014 to February 2019, designed to define the functions and clinical activities to be performed by a hospital pharmacist integrated into a Hematology and Hemotherapy Service of a tertiary hospital and to measure the results obtained by adopting this new integrated Hematology-Pharmacy care model, based on multidisciplinarity. Results: The pharmacist was fully integrated into the daily clinical activity of the multidisciplinary team belonging to the Hematology and Hemotherapy Service, being a facilitator of the daily work of the professionals of the Hematology Service and a mediator of the needs of both services involved (Hematology and Pharmacy). This integration made it possible to guarantee safety in the administration of hematological treatments in 9,125 hematological patients, to reduce medication errors by 95%, to detect and notify 45 adverse drug reactions, to design efficiency measures and follow-up of these in pathologies with a high economic impact such as multiple myeloma, chronic lymphatic leukemia, chronic myeloid leukemia and hemophilia, achieving savings of 1,500,000 euros, among other results. Conclusions: The integration of a hospital pharmacist in a Hematology and Hemotherapy Service constitutes a measure of innovation and efficiency, improves the quality of care, guarantees safety, favours the sustainability of the health system and facilitates the incorporation of innovation. (AU)

Manejo de altas dosis de metotrexato en un caso de leucemia aguda linfoblástica / Management of high doses of methotrexate in a case of acute lymphoblastic leukemia

Se presenta un caso de un paciente diagnosticado de leucemia aguda linfoblástica Pro-T, que se trata con altas dosis de metotrexato. Se describe el manejo de niveles tóxicos de metotrexato que resulta de la colaboración entre el farmacéutico de hospital y el hematólogo. (AU)

We present a case of a patient diagnosed with acute Pro-T lymphoblastic leukemia, who is treated with high doses of methotrexate. The management of toxic levels of methotrexate resulting from the collaboration between the hospital pharmacist and the hematologist is described. (AU)

Individualized measurement of disease-related malnutrition's costs.

BACKGROUND & AIMS: Disease-related malnutrition has a significant economic impact in hospitals, but accurate measurements of these costs have rarely been reported. The aim of this study is to calculate the actual costs of disease-related malnutrition in hospitals, taking into account every cost that patients generate during their hospital stay. METHODS: Patients admitted to medical wards were included in this study. Nutritional evaluation was carried out by two methods (Nutritional Risk Screening 2002 and Short Nutritional Assessment Questionnaire) at admission and/or at discharge. Hospitalization costs were measured for each patient individually, considering the cost of the bed, the Intensive Care Unit, the physicians' services, the laboratory tests and diagnostic procedures, and the drug costs. Differences in costs between malnourished patients and non-malnourished patients were calculated. RESULTS: Malnourished patients incurred higher costs than non-malnourished ones. The cost increase for malnourished patients ranged between 45% and 102%. The nutritional status accounted for most of this increase. The most outstanding difference in patients' costs was between those patients who maintained their nutritional status, either well or malnourished, during their hospital stay. CONCLUSIONS: Disease-related malnutrition clearly has an impact on the cost of hospital care provision, particularly in malnourished patients who do not improve their nutritional status during their hospital stays. Individualized cost analyses are needed to identify the real costs of malnutrition.

Revisión sistemática: evaluación de la adherencia del tratamiento de pacientes naive con hepatitis C / Systematic review: evaluation of adherence among treatment naïve patients with hepatitis C

Introducción: El VHC en los seres humanos puede causar diferentes enfermedades hepáticas. La característica más significativa de la enfermedad es su alta tendencia a cronificarse. Objetivo: Realizar una revisión sistemática de estudios que evalúan la adherencia en pacientes con hepatitis C tratados con PEG-IFN/RBV y si una mejor adherencia hace conseguir un mayor número de pacientes que obtengan una RVS. Métodos: Los datos se obtuvieron mediante la búsqueda en Pubmed de revisiones sistemáticas en inglés publicadas en los últimos 5 años, empleando como palabras claves: «VHC treatment adherence», «Sustained Virologic Response». Se seleccionaron los estudios que evalúan la adherencia al tratamiento antiviral en pacientes sin coinfección con otra viremia. En una segunda búsqueda se utilizaron «telaprevir and boceprevir review». Resultados: En especial, en los pacientes con genotipo 1, una buena adherencia aumenta significativamente RVS (63% vs 34%). Las tasas de RVS con los nuevos antivirales han logrado aumentar en relación con la terapia dual hasta un 70% en naives, 30% en no respondedores y 80% recurrentes. Conclusión: Los pacientes con genotipo 1 deben mantener una mejor adherencia que pacientes con genotipo no 1. La interrupción del tratamiento, falta de adherencia por pérdidas de dosis de PEG-INF/RBV y los efectos adversos son los principales obstáculos para alcanzar la RVS

Introduction: In human beings, HCV might cause different liver diseases. The most significant feature of this disease is its high tendency to become chronic. Objective: To do a systematic review of several studies evaluating adherence in patients with hepatitis C who are treated with Peg-IFN/RBV. In addition, it is important to know if a better adherence let get a greater number of patients who obtained an SVR. Methods: Data were obtained by looking for Pubmed systematic reviews published in English in the last 5 years, using the following keywords: «HCV treatment adherence» and «Sustained Virologic Response». The selected studies were the ones that evaluate the adherence to antiviral therapy in patients without co-infection with another viremia. In a second search, the keywords used were «telaprevir and boceprevir review». Results: Particularly, in patients with genotype 1, a good adherence increases significantly SVR (63% vs 34%). With the new antivirals, SVR rates have increased in relation with dual therapy up to 70% in naïve, 30% in non-responders and 80 % in recurrent patients. Conclusion: Patients with genotype 1 have to maintain a better adherence than patients with genotype no 1. Discontinuation of treatment, lack of adherence caused by PEG-INF/RBV missing doses and adverse effects are the main obstacles to achieving SVR

Elaboración y caracterización de una suspensión oleosa de omeprazol para su administración en pediatría / Preparation and characterization of an oily suspension for administration of omeprazole in children

Objetivo: Desarrollar una suspensión de omeprazol oral destinada a la población pediátrica. Métodos: Para el desarrollo de la formulación se empleó el principio activo en polvo en lugar de pellets, que es lo que habitualmente se utiliza. Por la inestabilidad del fármaco en medio ácido, se desarrolló una preparación de carácter oleoso. Se realizaron estudios para caracterizar el vehículo oleoso, características organolépticas, volumen de sedimentación y se utilizó la técnica de calorimetría diferencial de barrido (DSC) para los estudios de viscosidad y compatibilidad fármaco-excipientes. Resultados: Los porcentajes donde la fórmula no emulsionó fueron: 1,54% de viscosizante y 4,1% de tensioactivo. En el termograma se observó que la temperatura de fusión de pico y los valores de alfaHf entalpía de omeprazol se vieron disminuidos por la presencia de aspartamo y también un cambio en el pico de fusión igual a 10 °C, indicando una posible interacción entre omeprazol y aspartamo. Conclusiones: Hasta donde llegó el estudio se consiguió estabilizar todos los componentes de la fórmula, salvo el edulcorante que debe ser sustituido por otro de potencia similar para llegar a la fórmula deseada(AU)

Aim: Develop an oral omeprazole suspension for use in the pediatric population. Methods: For the development of the formulation was used active ingredient in powder instead of pellets, which is usually used. By instability of the drug in acid medium, we developed a preparation of an oily character. Studies were conducted to characterize the oil vehicle, organoleptic characteristics, sedimentation volume and used the technique of differential scanning calorimetry (DSC) for studies of viscosity and drug-excipient compatibility. Results: The percentages in which the emulsified non formula were 1,54% and 4,1% surfactant agent. In the thermogram was observed that the peak melting temperature and enthalpy values of omeprazole were diminished by the presence of aspartame and also a change in the melting peak equal to 10ºC, indicating a possible interaction between omeprazole and aspartame. Conclusions: As far as the study did managed to stabilize all components of the formula, except the sweetener should be replaced by another similar power to reach the desired formula(AU)

Hospitalización domiciliaria y hospital de día como medidas de mejora de adherencia / Home hospitalization and day hospital as interventions for improving adherency

Paciente con tuberculosis multirresistente (estreptomicina, isoniazida y rifampicina) debido a un incumplimiento reiterado del tratamiento, debido a factores como analfabetismo, pobreza, alcoholismo y razones socioculturales, por lo que se procedió a un ingreso programado de 18 meses para supervisión del tratamiento y vigilancia de la evolución del cuadro clínico. Al alta hospitalaria se realizaron 5 visitas a domicilio dirigidas por la Subdirección Médica, Farmacia y los Servicios Sociales para dispensarle la medicación semanal en un pastillero, verificar el cumplimiento del tratamiento y proporcionar educación sanitaria para evitar la transmisión de la enfermedad. Si durante la realización de estas visitas el farmacéutico consideraba que el paciente no era adherente al tratamiento, la Subdirección Médica ordenaría el ingreso de éste para finalizar el tratamiento tuberculostático indicado por la unidad de infecciosos. Hubo un ingreso dirigido por el Servicio de Farmacia en el Servicio de Respiratorio debido a expectoración hemoptoica autolimitada y tuberculosis pulmonar en proceso cicatricial. Tras una placa de tórax sin índice de cavernas y una baciloscopia y cultivo de micobacterias negativos se continuó con el seguimiento. Desde que el paciente empezó a acudir semanalmente a consultas de farmacia a modo de hospital de día, donde se le realizaba el Test de Adherencia SMAQ, el paciente tomaba la dosis correspondiente al día de la cita delante del farmacéutico y se le dispensaba su tratamiento semanal, siendo adherente con un 95% de cumplimiento terapéutico, evitando el ingreso hospitalario hasta la finalización del tratamiento(AU)

Patient with multidrug-resistant tuberculosis (streptomycin, isoniazid and rifampicin) due to reiterative nonfulfillment of the treatment, owing to factors such as analphabetism, poverty, alcoholism and socio-cultural reasons. A programmed hospital admission was carried out for 18 months to supervise the treatment and to keep under surveillance the evolution of the clinic profile. After the hospital discharge, 5 domiciliary visits were coordinated between the Sub-divisions of Medicine, Pharmacy and Social Services in order to dispense the weekly medication in a pillbox, to verify the fulfilment of the treatment and to give the sanitary education to avoid the transmission of the disease. During domiciliary visits, the pharmacist evaluated the adherence of the patient and, in the case that was not achieved; the Sub-division of Medicine would order hospital admission to conclude the tuberculostatic treatment. The Service of Pharmacy determined the need of admission in the Respiratory Service due to an auto-limited hemoptoic expectoration and pulmonary tuberculosis with cicatrisation process. The treatment was resumed after inspection of a thoracic radiography and negative Mycobacterium culture and baciloscopy. It was observed that since the patient started to visit the Service of Pharmacy as a day hospital, where the SMAQ adherence test was applied, he took his daily drug dose and followed the treatment. He also received his weekly treatment and reached adherence with a 95% of therapeutic fulfilment, avoiding hospital readmission until the end of the treatment(AU)

No relationship between leptin and cortisol in obese children and adolescents.

Recent findings have shown that leptin downregulates the steroid producing system in the adrenal. We studied the interactions of leptin, insulin and cortisol in obese children and adolescents at different stages of maturation. In 44 boys (age 11+/-3.1 yr, body mass index [BMI] 29+/-5.3 [mean +/- SD]) and 35 girls (age 11.4+/-2.6 yr, BMI 29+/-4.3), blood levels of leptin, insulin, cortisol, and glucose were determined. Fat mass (FM) was calculated by bioelectrical impedance. No significant differences were found between boys and girls with respect to humoral and anthropometric characteristics. When children were divided according to maturation stage (prepubertal, pubertal, and late/postpubertal) insulin was higher in the more mature groups (p<0.01) and leptin was higher in the pubertal group (p=0.03). In the prepubertal and pubertal groups, the expected positive relationship between adiposity and leptin was found although the magnitude of this association decreased with maturity. In none of the groups studied was cortisol significantly correlated to leptin. Insulin (p=0.03) and glucose (p=0.01) were positively associated with cortisol in the prepubertal group after adjustment for adiposity. However, in the pubertal group an inverse correlation was found between insulin and cortisol (p=0.03), and between insulin and glucose after control for adiposity. In the late/ postpubertal group, no significant correlations were found between estimates of adiposity and humoral parameters even after adjustment for gender. Stepwise multiple regression failed to detect a significant influence of cortisol to explain the variation in leptin, and vice versa. BMI contributed to the variation in leptin (adj. R2 =0.275, p<0.0001), and glucose added 5% to the variation in cortisol (p=0.03). The results do not confirm the inverse association between leptin and cortisol found in adults. Although BMI reflects levels of leptin, it is likely that several other factors in conjunction with fatness modulate the relationship with leptin. Whether leptin per se exerts an influence on the hypothalamic-adrenal-adipo axis remains to be investigated in longitudinal studies.

Normal values of reactive oxygen metabolites on the cord-blood of full-term infants with a colorimetric method.

The main end-point of the study was to evaluate the normal values of reactive oxygen metabolites (ROMs) in healthy full-term babies. Secondary end-points were differences between groups related to modality of delivery, Apgar score, birth weight, gestational age and sex. All apparently healthy babies born at our institution between 8 a.m. and 8 p.m. Monday to Friday with gestational age 37-42 weeks, delivered both vaginally or by caesarean section and without foetal distress and perinatal asphyxia. ROMs were evaluated by a colorimetric method (d-ROM test) on cord-blood immediately after birth. The values are reported as arbitrary unit U. Carr. Statistical analysis was performed by t-test and by multiple and stepwise regression analysis. We have analyzed 80 babies with mean birth weight 3301 +/- 446 g. and mean gestational age 39.5 +/- 1.0 weeks. The male:female ratio was 1.56 and the median (range) Apgar score was 9 (7-10) at 1' and 10 (9-10) at 5'. The babies born by vaginal delivery were 37 out of 80 while the remaining 43 were delivered by cesarean section. Because the two groups did not differ for the clinical characteristics they were considered together for the determination of the mean value of ROMs and indicated as "total". The mean value +/- SD of ROMs of the "total" was 115.5 +/- 32.6 U. Carr. Significant differences in the mean value of ROMs were not found related to type of delivery, birth weight, gestational age, and Apgar score at 1' and 5'. Instead the female infants had a significantly lower mean value of ROMs than the male babies (respectively 104.4 +/- 32.2 vs 120.2 +/- 30.6 U. Carr.; p = 0.031). Multiple and stepwise regression analyses both demonstrated that the sex of the neonate is able to independently influence the value of ROMs (respectively p = 0.025 and p = 0.035). The main end-point of the study was to determine the standard reference values for this method in the healthy full-term infant at birth: the values of ROMs we found in the "total" population are lower than those of healthy adults (between 250-300 U. Carr.) and similar to those of adults treated with steroids or antioxidant drugs. The finding that the female sex is able to independently determine lower values of ROMs at birth compared to the male sex, lets speculate that the female infants are less prone to oxidative stress in the first moments of life.

Evaluation of reactive oxygen metabolites with micromethod in neonates: determination of standards of normality in full-term babies.

We have evaluated the value of reactive oxygen metabolites (ROMs) in 98 full-term neonates at 72 +/- 6 hours of life with a new colorimetric simple and rapid method (d-ROMs Test, Diacron s.r.l.) to establish the normal values for infants. The mean value of ROMs we have obtained in the total of the population was 127.9 +/- 39.2 U.Carr. We have then considered subgroups of infants on the basis of vaginal delivery vs cesarean section, and asphyxia vs non asphyxia during the delivery. We have found no difference within these groups and between the subgroups and the total population for the value of ROMs. We have preferred to consider as reference value for normality that of babies without intrapartum asphyxia, independently of the mode of delivery. This value is 125.2 +/- 27.6 U.Carr. The value of normality for full-term infants is lower than that reported for adults (between 250-300 U.Carr). This can be interpreted as a particular response of full-term baby to oxidative stress.