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.

Mortality rates for Parkinson's disease are increasing in Spain. An age-period-cohort and joinpoint analysis of mortality rates from 1981 to 2020.

BACKGROUND: Mortality in Parkinson's disease is increasing worldwide, but Spanish data need further study. OBJECTIVE: To analyse the mortality trends of Parkinson's disease in Spain between 1981 and 2020. METHODS: This observational retrospective study assessed the Parkinson's disease mortality data from 1981 to 2020 collected from the National Statistics Institute of Spain. Age-standardised mortality rates were analysed by age and sex groups, detecting significant mortality trends through a joinpoint analysis. Age-period-cohort effect and potential years of life lost analyses were conducted. The European standard population of 2013 was considered for the analyses. RESULTS: A total of 88 034 deaths were assessed. The overall age-standardised mortality rate rose throughout the period from 3.67 to 8.57 per 100 000 inhabitants. Mortality rates in men were higher than in women, 11.63 versus 6.57 deaths per 100 000 inhabitants. The sex ratio showed an increase in premature mortality in men during 2020. The overall joinpoint analysis recorded a rise in mortality, primarily since the 20th century, mainly in male and older groups, that matched with a period effect. The age effect was detected, confirming higher mortality at an older age. The analysis of potential years of life lost detected a growth in this rate, changing from 0.66 in 1981 to 1.06 in 2020. CONCLUSIONS: Mortality data for Parkinson's disease in Spain rose significantly in forty years. Mortality rate was higher in the male and age group above 75 years of age. The sex ratio showed premature mortality in men in 2020, which will need further study.

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)

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)

Análisis de las prescripciones nuevas al alta de un Servicio de Urgencias Hospitalario. Impacto en la seguridad y eficiencia / Analysis of new prescriptions at discharge in an Emergency Deparment. Impact on drug safety and efficiency

Objetivo: Analizar las prescripciones nuevas al alta del Servicio de Urgencias Hospitalario: perfil de utilización, grado de adecuación a la Guía Farmacoterapéutica del hospital (GFT), calidad de la prescripción y estimación de costes.Método: Estudio descriptivo transversal. Las variables incluyeron número de medicamentos prescritos, si se hizo según Denominación Oficial Española, financiación por el Sistema Nacional de Salud, adecuación a la GFT y existencia de alternativa más económica. También se comprobó la cumplimentación de datos básicos y coste de las prescripciones.Resultados: En un total de 1.252 episodios hubo 2.152 prescripciones nuevas al alta. Del total de prescripciones, se adecuaron a la Guía Farmacoterapéutica del hospital el 78,0% y estaban financiadas el 88,9%. Los fármacos más comunes fueron: paracetamol metamizol, ibuprofeno, dexketoprofeno y omeprazol. La cumplimentación deficitaria de la prescripción comprometió la dispensación en 231 prescripciones (10,7%). En 20 presentaciones se concentra el 57,5% del gasto y el 73% del ahorro. Extrapolando los resultados a las prescripciones de un año se obtiene que el gasto farmacéutico sería de 1.161.608,8€, esperándose una reducción en 370.846,2€ tras la adecuación a la guía o de 571.323,3€ añadiendo la entrega de medicación. Conclusiones: Las prescripciones nuevas al alta se concentran en un número bajo de medicamentos. Actuar sobre los mismos permite un amplio margen de mejora económico y aumenta la seguridad. Evitar la prescripción de medicamentos no financiados y garantizar la entrega de la medicación al alta en el Servicio de Urgencias, son otro de las puntos de mejora identificados. (AU)

Objective: To analyze the new prescriptions at discharge from the Emergency Department: utilization profile, degree of adaptation to the Pharmacotherapeutic Guide, quality of the prescription and cost estimation.Method: Cross-sectional descriptive study. The variables included the number of prescribed medications, if it was done according to the Spanish Official Denomination, financing by the National Health System, adaptation to the Pharmacotherapeutic Guide and the existence of a cheaper alternative. The completion of basic data and cost of prescriptions was also checked.Results: A total of 1,252 episodes received 2,152 prescriptions with a mean of 2.1 per episode. Out of them 78% were adapted to the hospital pharmacotherapeutic guide and 88.9% financed drugs. Most common drugs were: acetaminophen, metamizole, ibuprofen, desketoprofen and omeprazole. The deficit filling of the prescription compromised the dispensation in 231 prescriptions (10.7%). In 20 drugs, 57.5% of spending and 73.0% of saving were concentrated. Extrapolating the results to the prescriptions of one year, it is obtained that the expense would be €1,161,008.8, expecting for a reduction in €370,846.2 after adaptation to the guide or € 571,323.3 by adding the medication delivery strategy.Conclusions: New prescriptions at discharge are concentrated in a low number of medications. Acting on them allows a wide margin of economic improvement and increases security. Avoiding the prescription of non-financed medicines and guaranteeing the delivery of the medication upon discharge from the Emergency Department are another of the points of improvement identified. (AU)

Efectividad y seguridad de regorafenib y trifluridina/tipiracilo en cáncer colorrectal metastático / Effectiveness and safety of regorafenib versus trifluridine/tipiracil in metastatic colorectal cancer

OBJETIVOS: Comparar la efectividad y seguridad de regorafenib y trifluridina/tipiracilo en pacientes con cáncer de colon metastático en la práctica clínica real. MÉTODOS: Estudio retrospectivo observacional entre febrero 2013 y mayo 2017. Se incluyeron todos los pacientes con cáncer de colon metastático que empezaron tratamiento con regorafenib o trifluridina/tipiracilo. Se recogieron variables demográficas, diagnósticas y terapéuticas; y los efectos adversos y reducciones de dosis para evaluar la seguridad. La supervivencia global (SG) y supervivencia libre de progresión (SLP) se calcularon con el método de Kaplan-Meier, evaluándose las diferencias mediante la determinación del hazard ratio (HR) con un modelo de riesgo proporcional de Cox. RESULTADOS: Se incluyeron 39 pacientes (61,54% mujeres, edad media: 62,69 ± 11,51 años, 76,92% ECOG1, mediana de líneas de tratamiento previas 3,28 ± 1,02; 58,97% RAS mutado, 61,54% presentaban metástasis en el diagnóstico): 10 iniciaron regorafenib y 29 trifluridina/tipiracilo. La mediana de SLP fue 1,77 meses con regorafenib y 2,46 con trifluridina/tipiracilo (HR 1,35 (0,64-2,85), p = 0,428), y de SG 7,00 meses con ambos (HR 1,45 (0,68-3,09), p = 0,335). Las diferencias no fueron estadísticamente significativas. La media de efectos adversos por paciente fue 3,70 ± 2,35 con regorafenib y 2,55 ± 2,16 con trifluridina/tipiracilo, siendo los más frecuentes con regorafenib astenia, diarrea, síndrome mano-pie, hiporexia y mucositis; y con trifluridina/tipiracilo astenia, neutropenia y náuseas. El 30,00% de pacientes con regorafenib y el 27,58% con trifluridina/tipiracilo necesitaron reducir la dosis por toxicidad. CONCLUSIÓN: En nuestro estudio, regorafenib y trifluridina/tipiracilo tienen una efectividad similar y modesta. Los distintos perfiles de toxicidad de los fármacos deben tenerse en cuenta en la selección del tratamiento

PURPOSE: To compare effectiveness and safety of regorafenib and trifluridine/tipiracil in patients with metastatic colorectal cancer in real clinical practice. METHODS: A retrospective observational study including all patients with metastatic colorectal cancer who started treatment with regorafenib or trifluridine/ tipiracil (February 2013-May 2017) was carried out. Demographic, diagnostic and therapeutic variables were collected. Adverse effects and dose reductions were recorded to measure safety. Median progression free survival (PFS) and overall survival (OS) were recorded. Differences in survival were evaluated using the Cox's proportional hazard models to determine the hazard ratio. RESULTS: Throughout the period of the study 39 patients were included (61.54% women, median age 62.69 ± 11.51 years, 76.92% ECOG1, median previous lines 3.28 ± 1.02, 58.97% mutant RAS, 61.54% had metastasis in the diagnosis): 10 patients started treatment with regorafenib and 29 with trifluridine/tipiracil. The median PFS with regorafenib was 1.77 months and with trifluridine/tipiracil 2.46 months (HR 1.35 (0.64-2.85), p = 0.428), and the median OS was 7.00 months with both drugs (HR 1.45 (0.68-3.09), p = 0.335). Differences in survival were not statistically significant

[Effectiveness of Wii Fit Balance board in comparison with other interventions for post-stroke balance rehabilitation. Systematic review and meta-analysis]. / Efectividad de la Wii Fit Balance frente a otras intervenciones para la recuperacion del equilibrio en pacientes postictus. Revision sistematica y metaanalisis.

INTRODUCTION: Virtual reality is a booming therapeutic tool within the neurorehabilitation field. Among the different non-inmersive virtual reality systems, the most outstanding is the platform, Wii Fit Balance. AIM: To review the scientific literature published in recent years about the effectiveness of Wii Fit Balance tool. The use of this platform for balance training in patients who have suffered a stroke compared to conventional therapies is going to be analyzed from a quantitative and qualitative point of view. SUBJECTS AND METHODS: A search of the databases has been carried out: PubMed, Lilacs, PEDro, Scopus, Web of Science and Cochrane Library. Descriptors employed were «Wii Fit Balance¼, «Wii¼, «stroke¼, «ictus¼ and «balance¼. Studies were analyzed methodologically by PEDro Scale. For those possible variables a meta-analysis was elaborated. RESULTS: Sixteen randomized clinical trials were selected for the systematic review and six of them were included in the meta-analysis. Results for the descriptive analysis were heterogeneous. This situation is confirmed through the meta-analysis results, because the analyzed variables for static and dynamic balance show intra-group improvement and no significant differences between groups post-intervention. CONCLUSION: Wii Fit Balance, virtual reality platform, is an available therapeutic tool which has been shown at least as effective as conventional balance training in post-stroke patients.

TITLE: Efectividad de la Wii Fit Balance frente a otras intervenciones para la recuperacion del equilibrio en pacientes postictus. Revision sistematica y metaanalisis.Introduccion. La realidad virtual es una herramienta terapeutica en auge dentro del campo de la neurorrehabilitacion. Entre los sistemas de realidad virtual no inmersiva mas empleados destaca la videoconsola Wii Fit Balance. Objetivo. Revisar la literatura cientifica publicada en los ultimos años acerca de la efectividad de la herramienta Wii Fit Balance para el entrenamiento del equilibrio en pacientes que han sufrido un ictus en comparacion con las terapias convencionales y analizar dicha informacion desde un punto de vista cuantitativo y cualitativo. Sujetos y metodos. Se ha llevado a cabo una busqueda en las bases de datos PubMed, Lilacs, PEDro, Scopus, Web of Science y Cochrane Library. Los descriptores de busqueda utilizados fueron «Wii Fit Balance¼, «Wii¼, «stroke¼, «ictus¼ y «balance¼. Se analiza la calidad metodologica de los estudios incluidos a traves de la escala PEDro. Para las variables que fue posible, se llevo a cabo un metaanalisis. Resultados. Se seleccionaron 16 ensayos clinicos aleatorizados para la revision sistematica, y seis de ellos se incluyeron en el metaanalisis. Dentro del analisis descriptivo se observo heterogeneidad de resultados. Esta misma situacion se confirmo a traves de los resultados del metaanalisis, ya que tanto para las variables de equilibrio estatico como dinamico analizadas se observaron mejoras intragrupo, pero sin que existieran diferencias significativas entre grupos postintervencion. Conclusiones. La plataforma de realidad virtual Wii Fit Balance es una herramienta terapeutica valida que ha demostrado ser al menos igual de efectiva que el entrenamiento convencional del equilibrio en pacientes postictus.

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

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 mamametastático (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 receptorHER2 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 (AU)

Objective: To describe the outcomes produced by con comitantuse 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 inour 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 (AU)

[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

Atención farmacéutica especializada en los servicios de urgencias hospitalarios / Pharmaceutical care in hospital emergency department

No disponible

Desensibilización a lenalidomida / Desensitization to lenalidomide

No disponible

Enema de tacrolimus para el tratamiento de la enfermedad inflamatoria intestinal / Tacrolimus enema for the treatment of Inflammatory Bowel Disease

No disponible