Impact of pharmaceutical validation on prescribing errors in a neonatal intensive care unit. Randomised and controlled study.

Purpose: To compare the frequency of electronic prescription errors when the prescription was validated by the clinical pharmacist vs. when it was not. Methods: This prospective randomised controlled study was conducted in three phases. A randomised phase, in which patients were divided into control and intervention groups, and a pre- and post-intervention phase were consecutively performed to analyse the impact of pharmaceutical validation of prescriptions in a neonatal intensive care unit (NICU). This study was performed at a highly complex NICU at a tertiary hospital. All patients born during the study period who were admitted to the NICU, with a stay lasting ≥24 h, and received active pharmacological treatment were included in the study. Pharmaceutical validation was performed according to the paediatric pharmaceutical care model. A high level of validation was selected for this study. In the intervention group, discrepancies found during the review process were communicated to the medical team responsible for the patients and resolved on the same day. Results: In total, 240 patients were included in this study. Sixty-two patients were allocated to the pre-intervention (n = 38) or post-intervention (n = 24) groups, and 178 patients were randomly sorted into two groups, control (n = 82 newborns) and intervention (n = 96 newborns). During the randomisation phase, the number of prescription errors detected was significantly lower in the intervention group than that in the control group (129 vs. 270; p < 0.001). Similarly, prescription errors reaching the patient were significantly reduced from 40% (n = 108) in the control group to 1.6% (n = 2) in the intervention group. In the pre- and post-intervention periods, the prescription lines containing prescription errors decreased from 3.4% to 1.5% (p = 0.005). Conclusions: This study showed that the pharmaceutical validation process decreased both the number of errors in the electronic prescribing tools and the number of prescription errors reaching the patient.

Evaluación de la interacción de capecitabina con inhibidores de la bomba de protones en pacientes con cáncer de colon metastásico / Evaluation of the interaction of capecitabin with proton pump inhibitors in patients with metastatic colon cáncer

Objetivo: Evaluar el impacto clínico que la interacción de capecitabina con inhibidores de la bomba de protones (IBP) puede tener sobre la efectividad del tratamiento de mantenimiento en pacientes con cáncer de colon metastásico (CCm). Material y métodos: Estudio retrospectivo, observacional descriptivo que incluyó a todos los pacientes con CCm tratados con capecitabina sola o en combinación entre enero 2013-diciembre 2016. Los pacientes fueron divididos en dos grupos según si fueron o no tratados con IBP concomitantemente con capecitabina. Se evaluaron variables demográficas, farmacológicas y clínicas, siendo la supervivencia libre de progresión (SLP) la variable elegida para evaluar el impacto clínico de la interacción. Resultados: Se incluyeron 150 pacientes. De ellos, el 57,33% varones, media de edad 70,10±12,06 años; el 55,33% tuvieron un ECOG 1 y el 58,67% utilizaron IBP. Un 39,33% fueron tratados con capecitabina en monoterapia, 31,33% CapeOx, y 20% capecitabina+bevacizumab y 9,33% CapeOx+bevacizumab. El 53,33% tuvo un tratamiento basado en capecitabina en primera línea, la frecuencia de variaciones de tratamiento fue de 42,0% reducción de dosis, 38,0% retraso, y 12% interrupción tratamiento. El 78,0% presentó alguna toxicidad, destacando 34,67% diarrea y 30,0% (síndrome mano-pie). La SLP media fue de 6,69 vs 6,0 meses (HR=0,97; IC95% 0,68-1,39; p=0,87) en favor de los pacientes que no utilizaron IBP, aunque la relación fue no significativa. Conclusiones: En la población estudiada, los pacientes con CCm que recibieron tratamiento de mantenimiento basado en capecitabina y que utilizaron IBP simultáneamente, presentaron una tendencia no significativa a la disminución de la SLP. (AU)

Objective: To evaluate the clinical impact that the interaction of capecitabine with proton pump inhibitors (PPIs) may have on the effectiveness of maintenance treatment in patients with metastatic colon cancer (mCC). Material and methods: Retrospective, observational, descriptive study that included all patients with CCm treated with capecitabine alone or in combination between January 2013-December 2016. The patients were divided into two groups according to whether or not they were treated with PPIs concomitantly with capecitabine. Demographic, pharmacological and clinical variables were evaluated, with progression free survival (PFS) being the variable chosen to evaluate the clinical impact of interaction. Results:150 patients were included. Of them, 57.33% were men, mean age 70.10±12.06 years; 55.33% had an ECOG 1 and 58.67% used it in PPIs. 39.33% were treated with capecitabine in monotherapy, 31.33% CapeOx, and 20% capecitabine+bevacizumab and 9.33% CapeOx+bevacizumab. 53.33% had a first-line capecitabine-based treatment, the frequency of treatment variations was 42.0% dose reduction, 38.0% delay, and 12% treatment interruption. 78.0% presented any toxicity, (highlighting 34.67% diarrhea and 30.0% hand-foot syndrome). The mean PFS was 6.69 vs 6.0 months (HR=0.97; 95% CI 0.68-1.39; p=0.87) in favor of patients who did not use IBP, although the relationship was not significant. Conclusions: In the population studied, patients with mCC who received maintenance treatment based on capecitabine and who used PPIs simultaneously, showed a non-significant trend towards a decrease in PFS. (AU)

Análisis de las interacciones farmacológicas y recomendaciones terapéuticas asociadas a la utilización de isavuconazol / Analysis of drug interactions and therapeutic recommendations associated with the use of isavuconazole

Objetivos: Identificar, describir las interacciones farmacológicas potenciales de isavuconazol, estudiar el impacto clínico de aquellas más relevantes y establecer recomendaciones terapéuticas para las encontradas en pacientes ingresados.Métodos: Estudio observacional descriptivo retrospectivo que incluyó todos los pacientes tratados con isavuconazol desde su comercialización hasta diciembre 2019.Se recogieron variables demográficas y fármacos concomitantes a isavuconazol durante más de 48 horas que recibió el paciente. Se revisaron los tratamientos con Lexicomp® para detectar interacciones potenciales, se analizó su mecanismo de acción y se relacionó con los fármacos implicados, estableciéndose recomendaciones terapéuticas.Para establecer el impacto clínico, se revisaron las historias clínicas de los pacientes con interacciones de mayor gravedad (D y X de Lexicomp®). En el caso de hallar alguna reacción adversa, se aplicó el algoritmo de Horn para establecer la probabilidad de que el efecto esté producido por la interacción farmacológica.Resultados: Se analizaron 84 ingresos en 59 pacientes. Se produjeron 209 interacciones potenciales en el 84,5% de los ingresos. La mayoría, 84,7% fueron de carácter moderado (categoría C), la más frecuente con tacrolimus. El principal mecanismo de acción fue el efecto inhibidor sobre el citocromo CYP3A4 de isavuconazol (82,8%). Se detectó una paciente con aumento de fosfatasa alcalina coincidente con el inicio concomitante de isavuconazol y claritromicina. Al aplicar el algoritmo de Horn, se consideró la interacción como posible.Conclusiones: Se detectaron interacciones farmacológicas potenciales graves en un porcentaje inferior al 10% de los ingresos y solo se detectó una posible reacción adversa asociada a esta interacción, no pudiéndose clasificar como definitiva. (AU)

Objetive: Identify, describe the potential pharmacological interactions of isavuconazole, study the clinical impact of the most relevant ones and establish therapeutic recommendations for those found in hospitalized patients.Methods: Retrospective descriptive observational study that included all patients treated with isavuconazole from its marketing until December 2019.Demographic variables and drugs concomitant to isavuconazole for more than 48 hours received by the patient were collected. The treatments with Lexicomp® were reviewed to detect possible interactions, its mechanism of action was analyzed and it was related to the drugs involved, establishing therapeutic recommendations.To establish the clinical impact, the medical records of the patients with more severe interactions (D and X for Lexicomp®) were reviewed. In the case of finding any adverse reaction, Horn’s algorithm was applied to establish the probability that the effect is produced by the pharmacological interaction.Results: 84 admissions in 59 patients were analyzed. There were 209 potential interactions in 84.5% of the admissions. The majority, 84.7%, were of a moderate nature (category C), the most frequent with tacrolimus. The main mechanism of action was the inhibitory effect on cytochrome CYP3A4 of isavuconazole (82.8%).A patient with an increase in alkaline phosphatase coinciding with the concomitant initiation of isavuconazole and clarithromycin was detected. When applying Horn’s algorithm, the interaction is considered as possible.Conclusions: Potential serious drug interactions were detected in less than 10% of admissions and only one possible adverse reaction associated with this interaction was detected, and it could not be classified as definitive. (AU)

Inducción de remisión con gentamicina y vancomicina oral en enfermedad inflamatoria intestinal de inicio temprano / Very early onset inflammatory bowel disease remission induced with oral gentamicin and vancomycin

La enfermedad inflamatoria intestinal de inicio temprano se manifiesta en pacientes pediátricos antes de los 6 años de edad. Habitualmente se asocia a diversas causas, siendo descrita frecuentemente la disbiosis como factor desencadenante. Esta población presenta comúnmente refractariedad a los tratamientos inmunosupresores más empleados.Presentamos el caso de un paciente con colitis no clasificable y corticodependiente de un año de evolución ingresado en nuestro centro que no había respondido a terapia inmunosupresora intensificada. Se plantea terapia con antibióticos orales como inducción de la remisión del brote de actividad en combinación con su tratamiento inmunomodulador habitual. Si bien inicialmente se obtiene la remisión clínica, el paciente experimenta posteriormente al alta un nuevo brote de actividad siendo necesaria una segunda reinducción con antibióticos que no resulta eficaz, motivando su suspensión. (AU)

Very early onset inflammatory bowel disease occurs in children under 6 years age. It is frequently associated to a diverse ethiology, dysbiosis being usually described as a triggering factor. Commonly, this population is highly resilient to inmmunosuppressant therapies.We report here a medical case of a patient diagnosed with unclassified and steroid-dependent colitis, with a year of evolution, who had no responded to intensified therapy at home, and, therefore, was hospitalized at our centre. Treatment with oral antibiotics was intended as remission induction in combination with his usual inmmunomodulator treatment. Although clinical remission was observed at first stage, a new activity outbreak emerged requiring a second round of antibiotics therapy, which was unsuccessful and currently withdrawned. (AU)

[Incidence of intravenous colistin nephrotoxicity in hospitalized patients]. / Incidencia de nefrotoxicidad inducida por colistina intravenosa en pacientes hospitalizados.

OBJECTIVE: The increase in infections with multidrug resistant bacteria has forced to return to the use of colistin, antibiotic with known nephrotoxicity. The aim of the study is to determine the incidence of colistin nephrotoxicity nowadays. METHODS: Retrospective-observational-unicentric study was collected hospitalized patients in intravenous colistin treatment during the years 2018-2019. Nephrotoxicity was defined according to the RIFLE scale. The variables to determine it were serum creatinine (sCr) and glomerular filtration (GF). The variables analyzed were age, sex, treatment duration, loading and cumulative dose, empirical/targeted treatment, chronic kidney disease, concomitant use of intravenous contrast and nephrotoxic drugs. RESULTS: A total of 90 patients (60% men) were included, with an average age of 58.2±18.1 years. The mean duration of treatment was 9±8.3 days, with an average cumulative dose of 69.8±71MU. There were no differences between sCr and GF at the beginning and end of treatment. The incidence of nephrotoxicity was 1.73 cases/100 days of treatment (prevalence of 15.56%). CONCLUSIONS: Colistin nephrotoxicity has an important incidence, without developing severe illness.

Variabilidad en el registro de alergias entre niveles asistenciales / Variability in allergies registration between care levels

Objetivo: El objetivo del estudio es comparar el grado de coincidencia en el registro de alergias entre las aplicaciones informáticas de los distintos niveles asistenciales (atención primaria y hospitalaria).Métodos: Estudio observacional descriptivo retrospectivo de 2 meses de duración en el que participaron todas las unidades clínicas con prescripción electrónica. Se incluyó en el estudio a todos los pacientes ingresados con al menos una alergia registrada en la aplicación informática hospitalaria. Se cuantificó el porcentaje de alergias registradas en hospital, atención primaria o ambas.Resultados: Se incluyeron 723 pacientes en los que se registraron 1.280 alergias. El ratio de alergias por paciente fue 1,77. La media de edad fue 62±37 años y el 58,37% eran mujeres. El 80,47% de las alergias registradas fueron farmacológicas.De manera global el 42,11% de todas las alergias fueron registradas en ambas aplicaciones. El 21,20% de las alergias no farmacológicas y el 47,18% de las alergias farmacológicas fueron registradas en ambas aplicaciones. Del total de las alergias farmacológicas detectadas en el estudio, el 68,08% estaban registradas en atención primaria y el 79,13% en atención hospitalaria. Respecto al total de las alergias no farmacológicas el 37,20% estaban registradas en atención primaria y el 84% en la aplicación de atención hospitalaria. Conclusiones: En nuestro estudio hemos encontrado una gran variabilidad en el registro de alergias en los diferentes niveles asistenciales. En menos de la mitad de los casos se registra la alergia en ambos niveles. (AU)

This study aims at comparing the coincidence degree between different allergy-recording computer applications that can be found in distinct levels of the health care system (primary care and hospital care).Methods: Two-month retrospective descriptive and observational study for analyzed records in Clinical Units equipped by electronic prescription. All in-patients who had at least one allergy record registered in the hospital computer application were included in the study. The percentage of allergies registered in hospital, primary care or both applications was quantified.Results: 723 patients were included, among whom 1,280 allergies were recorded. The allergy ratio per patient was 1.77. The average age was 62±37 years and 58.37% were women. 80.47% of the recorded allergies were drug-related.42.11% of global allergies were registered in both applications. 21.20% of non-drug-related allergies and 47.18% of drug-related allergies were registered in both applications. According to the total of drug allergies detected in the study, 68.08% were registered in primary care and 79.13% in hospital care. Regarding to the total of non-drug-related allergies, 37.20% were registered in primary care and 84% in hospital care.Conclusions: Our study reported a high variability in the allergy registration between the different levels of the care health system. Less than the half of allergy cases are registered in both care levels studied. (AU)

Efectividad y seguridad de daratumumab y carfilzomib en el tratamiento del mieloma múltiple refractario / Effectiveness and safety of daratumumab and carfilzomib in the treatment of multiple refractory mieloma

Objetivos: El objetivo del estudio es evaluar la efectividad y seguridad de daratumumab y carfilzomib en práctica clínica, y comparar estos resultados con la literatura disponible y ficha técnica.Material y métodos: Estudio retrospectivo y observacional donde se recogieron pacientes en tratamiento con estos fármacos hasta mayo-2018 fuera de ensayo clínico. Se utilizó el parámetro supervivencia libre de progresión (SLP) para evaluar la efectividad, y la clasificación de la Common Terminology Criteria for Adverse Events y la ficha técnica para evaluar la seguridad.Resultados: Se analizó el tratamiento con daratumumab en 14 pacientes (media de 3,6 líneas de tratamiento previos y 5,1 ciclos de tratamiento) y el de carfilzomib en 21 pacientes (media de 3,1 líneas y 5,8 ciclos). La mediana de SLP observada fue de 4,8 meses para daratumumab y 5,8 meses para carfilzomib. Con daratumumab las reacciones adversas más frecuentes fueron trombocitopenia (50%), neutropenia (42,9%) y tos (42,9%), siendo las dos primeras las de mayor gravedad. Con carfilzomib, fueron anemia (95,2%), infección respiratoria (61,9%) y tos (61,9%), siendo trombocitopenia la más grave.Conclusiones: Daratumumab presenta una efectividad acorde a la literatura, pero inferior a la ficha técnica. Destaca la mayor incidencia de trombocitopenia, incluyendo casos graves. La efectividad de carfilzomib resulta inferior a la de ficha técnica, no siendo posible su comparación con otros estudios de práctica clínica. Se observa un peor perfil de seguridad, destacando la mayor incidencia de cardiotoxicidad y trombocitopenia en los casos más graves. Serán necesarios más estudios para dar solidez a estos hallazgos. (AU)

Objetives: The objective of the study is to evaluate the effectiveness and safety of daratumumab and carfilzomib in clinical practice, as well as to compare these results with the available literature and the fact sheet.Material and methods: Retrospective and observational study which patients were collected on treatment with these drugs until may-2018 out of clinical trial. The progression free survival (PFS) parameter was used to assess the effectiveness, and the classification of the Common Terminology Criteria for Adverse Events and fact sheet to the safety assessment.Outcomes: Treatment with daratumumab was analyzed in 14 patients (mean of 3.6 previous treatment lines and 5.1 treatment cycles) and the carfilzomib treatment in 21 patients (mean of 3.1 lines and 5.8 cycles). The median PFS observed was 4.8 months for daratumumab and 5.8 months for carfilzomib. The most common adverse reactions with daratumumab were thrombocytopenia (50%), neutropenia (42.9%) and cough (42.9%), the first two being the most serious. With carfilzomib, they were anemia (95.2%), respiratory infection (61.9%) and cough (61.9%), with thrombocytopenia being the most severe.Conclusion: Daratumumab has a literature consistent effectiveness but inferior to the fact sheet. It highlights the higher incidence of thrombocytopenia, including the most severe cases. The effectiveness of carfilzomib is lower than the fact sheet, and its comparison with clinical practice studies is not possible. A lower safety profile is observed, highlighting the higher incidence of cardiotoxicity and thrombocytopenia in the most severe cases. Further studies will be needed to give strength to these findings. (AU)

Efectividad y seguridad de ramucirumab en el tratamiento de adenocarcinoma gástrico / Effectiveness and safety of ramucirumab in the treatment of gastric adenocarcinoma

Objetivos: Evaluar la efectividad y seguridad de ramucirumab en el tratamiento de adenocarcinoma gástrico metastático (AGM) o adenocarcinoma de la unión gastroesofágica metastático (AUGEM) en un hospital de clase 5. Métodos: Estudio observacional retrospectivo en el que se incluyeron a todos los pacientes tratados con ramucirumab en el hospital. Se realizó un seguimiento a través de la historia clínica electrónica (HCE) de la que se recogieron edad, sexo, diagnóstico, estado funcional según ECOG y líneas previas de tratamiento. Como variables de efectividad se calcularon la supervivencia libre de progresión (SLP) y supervivencia global (SG). Como variables de seguridad se analizaron los efectos adversos recogidos en la HCE y se categorizaron por gravedad según CTCAE (v.5). Resultados: Se analizó un total de 40 pacientes (20% mujeres) con edad media al inicio del tratamiento de 62,5±12,4 años. Al inicio del tratamiento, el 67,5% de los pacientes tenían ECOG 1. El 78% de los tratamientos con ramucirumab fueron en segunda línea y el 22% en tercera. Respecto a la primera línea, el 100% de los esquemas estaban basados en platino y fluoropirimidinas.EL 90,1% de los pacientes fueron tratados con la combinación de paclitaxel 80 mg/m2 más ramucirumab 8 mg/kg; el resto se trató en monoterapia. Los pacientes recibieron de media 5,1±4,1 ciclos. La SLP fue de 4 (3,1-8,9) meses y la SG fue de 5,8 (4,6-13) meses.En cuanto a la seguridad, el 75,6% de los pacientes (n=31) presentó algún efecto adverso. El efecto adverso más observado fue astenia en el 48,8% de los pacientes (n=20). También se observó: hipertensión (17,1%), rash cutáneo (12,2%), alopecia (12,2%), neutropenia (9,7%), mucositis (9,7%) y náuseas (9,7%). Conclusiones: La SLP fue similar en este estudio a la obtenida en el ensayo clínico pivotal RAINBOW, aunque el valor de la SG obtenida fue de casi la mitad. La seguridad fue similar a la observada en el ensayo clínico mencionado. (AU)

Objetive: To assess the effectiveness and safety of ramucirumab in the treatment of metastatic gastric adenocarcinoma (MGA) or metastatic gastroesophageal junction adenocarcinoma (MGJA) in a class 5 hospital.Methods: Retrospective observational study in which all patients treated with ramucirumab in the hospital were included.A follow-up was carried out through the electronic medical history (HCE) from which age, sex, diagnosis, functional status according to ECOG and previous treatment lines were collected. As effectiveness variables, progression-free survival (PFS) and overall survival (OS) were calculated. As safety variables, the adverse effects recorded in the HCE were analyzed and categorized by severity according to CTCAE (v.5).Results: A total of 40 patients (20% women) with a mean age at the start of treatment of 62.5±12.4 years were analyzed. At the beginning of treatment, 67,5% of patients had ECOG 1.78% of the treatments with ramucirumab were in the second line and 22% in the third. Regarding the first line, 100% of the schemes were based on platinum and fluoropyrimidines.90.1% of the patients were treated with the combination of paclitaxel 80 mg/m2 plus ramucirumab 8 mg/kg; The rest was treated in monotherapy. Patients received on average 5.1±4.1 cycles. The PFS was 4 (3.1-8.9) months and the OS was 5.8 (4.6-13) months.Regarding safety, 75.6% of the patients (n=31) presented some adverse effect. The most observed adverse effect was asthenia in 48.8% of the patients (n=20). It was also observed: hypertension (17.1%), skin rash (12.2%), alopecia (12.2%), neutropenia (9.7%), mucositis (9.7%) and nausea (9.7%).Conclusions: The PFS was similar in this study to that obtained in the pivotal clinical trial RAINBOW, although the value of the OS obtained was almost half. Safety was similar to that observed in the clinical trial. (AU)

[Implementation of the Lean Six Sigma in the improvement of the medication dispensing circuit]. / Implementación Lean Six Sigma en la mejora del circuito de dispensación de medicación.

OBJECTIVE: Lean Six Sigma (LSS) methodology is used to increase productivity and to improve performance, by eliminating processes that do not add value to the customer, as well as reducing variability. In recent years, its application in healthcare sector is increasing in order to improve the efficiency of processes. The aim of this study was to evaluate the results obtained in terms of efficiency in the medication dispensing circuit, after application of LSS methodology. MATERIAL AND METHODS: A multidisciplinary team was created in order to analyse and improve the medication dispensing circuit. The main tools used in LSS methodology were the DMAIC cycle (Define, Measure, Analyse, Improve and Control), SIPOC diagram (Suppliers, Inputs, Process, Outputs, and Customers), a root-cause analysis; a survey to determine the "Customer's voice" about the circuit; and the cost of each task in terms of staff time. Two Pilot Nursing Units (Thoracic Surgery and Cardiology) were selected to introduce the improvement actions. The main analysed variables were: urgent medication orders per day, and percentage of medication orders made online. RESULTS: After the application of LSS methodology, a significant reduction was found in urgent medicament orders per day in both nursing units, and a significant improvement in the electronic processing of urgent orders. The performance of medication dispensing circuit was increased from 60% (1.76 sigma) during initial data analysis, to 93% (3 sigma) in Thoracic Surgery, and from 71% (2.11 sigma) to 81% (2.4 sigma) in Cardiology. Six months after the implementation of improvements, the performance values were increased to 94% (3.1 sigma) and 93% (3 sigma), respectively. Estimated cost savings related to staff were 798.2 € (266 € per month) after implementation, ascending to 2, 228.5 € (371.4 € per month) after 6months. CONCLUSION: The use of LSS methodology has improved the performance of medication dispensing circuits, reducing costs in terms of staff time, and obtaining satisfactory results.

[Impact of a quality improvement plan on the validation of drug prescriptions on the safety of the hospitalised patient]. / Impacto de un plan de mejora de calidad en la validación de la prescripción de fármacos sobre la seguridad de los pacientes hospitalizados.

BACKGROUND AND OBJECTIVES: Medication errors are the most common adverse events in healthcare. Pharmaceutical validation (PV) seeks to reduce them. The aims of this study were to assess the impact of the introduction of an automated tool for the validation (VPAT) of the high clinical relevance drugs prescription (HCRD) over time of pharmaceutical intervention (PI), and to quantify the number of medication errors detected before and after its implementation. MATERIAL AND METHODS: A two phase retrospective-observational single centre study was designed. A pre-intervention phase (Pre-P): PV of beds with Unit Dose Dispensing (October 2015 - February 2016), was followed by a post-intervention phase (Post-P): PV using a VPAT of HCRD in hospital patients (October 2016 - February 2017). HCRD were selected from the list of high-risk drugs of Institute for Safe Medication Practices. The data was obtained from the PI record (Access®) and the computerised prescription. The variables collected were: age and gender of the patients included, data of drugs prescription, and time to PI. RESULTS: A total of 477 PI were analysed in 404 patients, with a mean age of 65.9±19.5 years (53.22% women). The mean time up to PI was 25.6±24.72h in the Pre-P, and 18.87±20.44h in the Post-P (P=0.01). In Pre-P, 106 PI were performed (35.85% prevention of adverse reactions) compared to 371 PI (39.62% medication reconciliation) in Post-P. CONCLUSIONS: The VPAT enabled a greater number of medication errors to be detected and intervened in hospitalised patients, with a significantly reduced time to PI.

Comparison of the traditional pharmaceutical validation method versus an assisted pharmaceutical validation in hospitalized patients.

OBJECTIVE: To analyze pharmaceutical interventions that have been carried out with the support of an automated system for validation of treatments vs. the traditional method without computer support. METHOD: The automated program, ALTOMEDICAMENTOS® version 0, has 925 052 data with information regarding approximately 20 000 medicines, analyzing doses, administration routes, number of days with such a treatment, dosing in renal and liver failure, interactions control, similar drugs, and enteral medicines. During eight days, in four different hospitals (high complexity with over 1 000 beds, 400-bed intermediate, geriatric and monographic), the same patients and treatments were analyzed using both systems. RESULTS: 3,490 patients were analyzed, with 42 155 different treatments. 238 interventions were performed using the traditional system (interventions 0.56% / possible interventions) vs. 580 (1.38%) with the automated one. Very significant pharmaceutical interventions were 0.14% vs. 0.46%; significant was 0.38% vs. 0.90%; non-significant was 0.05% vs. 0.01%, respectively. If both systems are simultaneously used, interventions are performed in 1.85% vs. 0.56% with just the traditional system. Using only the traditional model, 30.5% of the possible interventions are detected, whereas without manual review and only the automated one, 84% of the possible interventions are detected. CONCLUSIONS: The automated system increases pharmaceutical interventions between 2.43 to 3.64 times. According to the results of this study the traditional validation system needs to be revised relying on automated systems. The automated program works correctly in different hospitals.

Objetivo: Analizar las intervenciones farmacéuticas realizadas con el apoyo de un sistema automático de validación de tratamientos vs. el método tradicional sin apoyo informático. Metodos: El programa automatizado, ALTOMEDICAMENTOS ® version 0, cuenta con 925.052 celdas con información de aproximadamente 20.000 medicamentos, analizando dosis, vías de administración, días de tratamiento, dosificación en insuficiencia renal y hepática, control de interacciones, de medicamentos semejantes y de medicamentos por vía enteral. Durante ocho días distribuidos en cuatro hospitales diferentes (alta complejidad con más de 1.000 camas, intermedio de 400 camas, geriátrico y monográfico), los mismos pacientes y tratamientos se analizaron mediante los dos sistemas. Resultados: Se han analizado 3.490 pacientes diferentes con 42.155 tratamientos. Por el sistema tradicional se han realizado 238 intervenciones (0,56% intervenciones/posibles intervenciones) vs. 580 (1,38%) con el automatizado. Las intervenciones farmacéuticas muy significativas fueron 0,14 vs. 0,46%, las significativas 0,38 vs. 0,90%, las no significativas 0,05 vs. 0,01%. Las intervenciones fueron del 1,85% al utilizar los dos sistemas vs. 0.56% usando solo el sistema tradicional. El sistema tradicional detectó el 30,5% de las posibles intervenciones, sin embargo con el sistema automático se detectaron el 84% de dichas intervenciones. Conclusiones: La automatización multiplica entre 2,43 a 3,64 veces las intervenciones farmacéuticas. En base a los resultados de este estudio el sistema tradicional de validación debería ser modificado, apoyándose en sistemas automatizados. El programa automático funciona en diferentes hospitales.

[Treatment with urea as an alternative to tolvaptan for the syndrome of inappropriate secretion of antidiuretic hormone]. / Tratamiento con urea como alternativa al tolvaptán en el síndrome de secreción inadecuada de la hormona antidiurética.

El síndrome de secreción inadecuada de la hormona antidiurética (SIADH) es una afectación que cursa con hiponatremia entre otros síntomas. Actualmente la familia de fármacos de elección para este síndrome son los vaptanes, entre ellos el tolvaptán, antagonistas de la vasopresina. La urea actúa como diurético osmótico produciendo la retención de sodio. Se presenta un caso en el que el cambio desde el tratamiento con tolvaptán a urea en el SIADH permitió mantener la respuesta, a un coste muy inferior. La paciente tenía 83 años, ingresó en nuestro Hospital al diagnosticarle una hiponatremia grave (108 mEq/L) durante una exploración por una caída en su casa. Durante el ingreso ante la sospecha de SIADH se le prescribió sucesivamente tres tipos de tratamientos: Restricción hídrica y suero salino, seguido de tolvaptán 15 mg y para finalizar se le prescribió 15 gr de urea cada 12 horas. Durante el primer tratamiento los niveles de sodio sérico no aumentaron lo suficiente, por lo que se cambió al tolvaptán, durante el cual los niveles de sodio sérico subieron a rangos normales. Al considerar que el tratamiento iba a ser de larga duración se decidió cambiar a la urea, durante el mismo los niveles de sodio sérico tuvo un ligero aumento. La paciente es dada de alta con la pauta de urea de forma indefinida. El coste diario del tratamiento de tolvaptán es de 66,91 euros; el de urea supone 0,30 euros. En casos como el descrito, el uso de urea preparada como fórmula magistral por el área de farmacotécnia del Servicio de Farmacia, es una alternativa al tolvaptán con un coste marcadamente inferior.

[Usage, effectiveness and safety of abiraterone in prostate cancer]. / Uso, efectividad y seguridad de abiraterona en cáncer de próstata.

BACKGROUND AND OBJECTIVE: After the marketing of Abiraterone, an androgen synthesis inhibitor, the aim of the study was to analyze its use, response, and safety in the population of a tertiary care level hospital. MATERIALS AND METHODS: A retrospective observational study was carried out including all patients that were started on Abiraterone within a 21-month period. Demographical, diagnostic, therapeutic, and clinical variables were gathered. The response was assessed through the decreased of PSA as compared to baseline values. To assess the safety, all treatment-related adverse events were recorded. RESULTS: A total of 45 patients were included of which 88.89% could be assessed for the drug effectiveness. The median baseline PSA value was 457.31 (range 9032-2.81). PSA decrease was ≥ 50%, ≥ 90% and < 30% in 16 (40%), 3 (7.5%) y 20 (50%), respectively. The most common grade 1-2 adverse events were fatigue (35.6%), increased liver enzymes (28.9%), hipokalemia (13.3%) and fluid retention (11.1%). CONCLUSIONS: Abiraterone was a well tolerated drug that has shown to be active in prostate cancer patients previously treated with taxans, so it has been postulated as an alternative in this pathology.

Fundamento y objetivo: Tras la comercialización de abiraterona, inhibidor de la síntesis de andrógenos, el objetivo del estudio fue analizar el uso, la respuesta y la seguridad de abiraterona en la población de un hospital de tercer nivel. Material y métodos: Se realizó un estudio observacional retrospectivo en el que se incluyeron todos los pacientes que iniciaron tratamiento con abiraterona en un periodo de 21 meses. Se recogieron variables demográficas, diagnósticas, terapéuticas y clínicas. La respuesta se evaluó de acuerdo con la reducción del PSA con respecto al basal. Para evaluar la seguridad se registraron todas las reacciones adversas secundarias al tratamiento. Resultados: Se incluyó un total de 45 pacientes de los que, fueron evaluables con respecto a la efectividad del fármaco el 88,89%. La mediana de PSA basal era de 457,31 (rango 9032- 2,81). La reducción de PSA fue ≥50%, ≥90% y.

[Lapatinib plus transtuzumab for HER-2 positiva metastatic breast cancer: experience of use]. / Lapatinib en combinación con trastuzumab en el tratamiento del cáncer de mama metastásico HER2 positivo: Experiencia de uso.

OBJECTIVE: To describe the outcomes produced by concomitant use of HER2-receptor inhibitors Lapatinib and Trastuzumab for the treatment of HER 2-positive metastatic breast cancer. METHOD: Retrospective observational study. Patients treated with Trastuzumab and Lapatinib between January of 2010 and May of 2012 were selected. Demographical and clinical data were gathered. RESULTS: 23 patients with metastatic breast cancer (mean age 59.3 ± 13.3 years) were included. All of them had received an average of 5 treatment lines with at least one of them including Trastuzumab. The median progression-free survival rate with combined Lapatinib + Trastuzumab, with or without associated chemotherapy was 7 months (95% CI: 2.78-11.21) and 3 months for the patients only receiving Lapatinib and Trastuzumab. Seven patients experienced adverse events and in four patients the treatment was stopped due to toxicity. CONCLUSIONS: The treatment with HER2-receptor inhibitors in our patients resulted in progression-free survival rates similar to those published in clinical trials with patients receiving Lapatinib + Trastuzumab not combined with any other anti-cancer therapy, with good treatment tolerability.

Objetivo: Describir los resultados obtenidos con la utilización conjunta de dos inhibidores del receptor HER2 (lapatinib y trastuzumab) en el tratamiento del cáncer de mama metastático HER 2 positivo. Método: Estudio observacional retrospectivo. Se seleccionaron pacientes en tratamiento con trastuzumab y lapatinib entre enero de 2010 y mayo de 2012. Se recogieron datos demográficos y clínicos. Resultados: Se incluyeron 23 pacientes con cáncer de mama metastático (edad media de 59,3 ± 13,3 años). Todos ellos habían recibido una media de 5 líneas de tratamiento previo con al menos una línea de tratamiento con trastuzumab. La mediana de supervivencia libre de progresión con lapatinib + trastuzumab combinado con o sin otra quimioterapia asociada fue de 7 meses (IC 95%: 2,78-11,21) y de 3 meses para las pacientes que sólo recibieron lapatinib y trastuzumab. Siete pacientes tuvieron efectos adversos y en cuatro pacientes se suspendió el tratamiento por toxicidad. Conclusiones: El tratamiento con dos inhibidores del receptor HER2 en nuestras pacientes ha resultado en una supervivencia libre de progresión similar a la de los ensayos clínicos publicados cuando las pacientes recibieron lapatinib + trastuzumab y no se combinó con otra terapia antineoplásica, con buena tolerancia al tratamiento.

Implantación de un sistema de trazabilidad en el área de farmacia oncológica en un hospital de tercer nivel / Introduction of a traceability system in the pharmacy oncology area in a tertiary hospital

No disponible