[Development of the Q-PEX standard for quality certification of pharmaceutical care for outpatients of Pharmacy services]. / Desarrollo de la norma Q-PEX de certificación de calidad de la atención farmacéutica a pacientes externos de los servicios de Farmacia.

OBJECTIVE: The objective of this study is to describe the process of creation and development of the quality certification standard for pharmaceutical care for outpatients of the Pharmacy services. METHOD: The methodology was carried out by a group of experts from the Spanish Society of Hospital Pharmacy (SEFH) and consisted of three phases: situation analysis, development of the standard and definition of the self-assessment tool and, finally, piloting in several hospitals, determining its feasibility, carrying out a new revision and readaptation. RESULTS: A standard was defined with 118 items distributed in ten areas. Of these, 19 were considered compulsory, 36 basic, 40 medium and 23 advanced. Three levels of certification were established, as well as the definition and percentages of compliance with the requirements. The certification process was divided into two stages, the one of previous preparation and the audit itself, where the initial certification would be covered, with four phases - first three led by the certification Company, and the last one by SEFH and the subsequent follow-up and re-certification audits. Two hospitals piloted the process carried out the piloting of the whole process, both obtaining a basic level after the adoption of measures and corrective actions, after which the final definition of the external evaluation of the standard and the name of the standard was agreed upon «Q-PEX¼, as well as, the registration of the intellectual property of said standard in July-2020. CONCLUSIONS: The standard for certification of the quality of pharmaceutical care for outpatients developed aims to help the continuous advancement of Hospital Pharmacy services.

High-dose versus low-dose corticosteroid treatment strategy in patients hospitalised with COVID-19: effect on ICU admission rate / Estrategia de tratamiento corticoide en altas dosis versus bajas dosis en pacientes COVID-19 hospitalizados: efecto en la tasa de ingreso en UCI

Objective: COVID-19 is associated with lung damage and a high mortality rate in hospitalised patients. Corticoids may reduce the evolution to respiratory failure and death. This study aims to assess the effect on the ICU admission rate of a change in corticosteroid treatment strategy, administering low versus high doses. Methods: A retrospective, observational study was designed. Confirmed COVID-19 patients indicated to start treatment with corticosteroids were enrolled. To study the association between the type of corticosteroid used and admission to the ICU, a binary logistic regression model was constructed. This model included variables that could cause confusion or influence the response: gender, age, comorbidities, and analytical data. Results: From 190 admitted patients, 127 were enrolled in the study. In both groups, patients received a minimum of two doses of corticosteroids during admission. 12.4% (12/97) of the patients who received methylprednisolone (high doses) were subsequently admitted to the ICU, compared to 30.0% (9/30) of the patients who received dexamethasone (low doses). In the logistic regression model constructed, the type of corticosteroid (low-dose dexamethasone) (p=0.002), male gender (p=0.023), age over 50 years (p=0.014) and IL-6 level >70 pg/mL (p=0.004) remained as predictive factors for admission to the ICU.Conclusions: In the studied population of patients hospitalised for COVID-19, the use of high-dose methylprednisolone is associated with a lower rate of admission to the ICU than the administration of low-dose dexamethasone. (AU)

Objetivo: La COVID-19 está asociada a daño pulmonar y alta tasa de mortalidad en pacientes ingresados. Los corticoides pueden reducir la progresión a insuficiencia respiratoria y muerte. El objetivo del presente estudio es evaluar el efecto sobre la tasa de ingreso en UCI tras el cambio de estrategia en el tratamiento con corticoides, administración de bajas dosis frente a altas dosis. Métodos: Se diseñó un estudio retrospectivo observacional en el que se seleccionaron pacientes COVID-19 confirmado con indicación de inicio de tratamiento con corticoides. Para estudiar la asociación entre el tipo de corticoide utilizado y el ingreso en UCI, se construyó un modelo de regresión logística binaria en el que se incluyeron variables que podrían causar confusión o influir en la respuesta: sexo, edad, comorbilidades y datos analíticos. Resultados: De 190 pacientes ingresados, 127 se incluyeron en el estudio. En ambos grupos los pacientes recibieron un mínimo de dos dosis de corticoides durante el ingreso. El 12,4% (12/97) de los pacientes que recibieron metilprednisolona (altas dosis) ingresaron posteriormente en UCI, frente al 30,0% (9/30) de los pacientes que recibieron dexametasona (bajas dosis). En el modelo de regresión logística construido permanecieron como factores predictivos de ingreso en UCI el tipo de corticoide (dexametasona a bajas dosis) (p=0,002), el sexo masculino (p=0,023), edad superior a 50 años (p=0,014) y nivel de IL-6 >70 pg/mL (p=0,004).Conclusiones: En la población estudiada de pacientes hospitalizados por COVID-19, el uso de metilprednisolona a altas dosis se asocia a una menor tasa de ingreso en UCI que dexametasona a bajas dosis. (AU)

Absorción sistémica de un jarabe de vancomicina oral para el tratamiento de la infección por Clostridium difficile / Systemic absorption of an oral vancomycin syrup for the treatment of Clostridium difficile infection

La infección por Clostridium difficile (ICD) ha aumentado su incidencia en los últimos años, convirtiéndose en una de las infecciones más comunes adquiridas en el ámbito hospitalario, causando una diarrea infecciosa que está fuertemente asociada al uso de antibióticos. En la actualidad, los antibióticos para su tratamiento son la vancomicina oral y fidaxomicina, siendo la vancomicina oral la más coste-efectiva para el Sistema Nacional de Salud.Se describe el caso de una paciente pluripatológica sometida a dos sesiones de hemodiálisis semanales, que es diagnosticada de ICD evolucionada a colitis pseudomembranosa confirmada por endoscopía. Se inició tratamiento para la ICD con una fórmula magistral de vancomicina oral a una dosis de 250 mg cada 6 horas. La terapia con vancomicina oral no fue efectiva ni segura en la paciente, produciéndose una absorción sistémica significativa de vancomicina llegando a concentraciones plasmáticas de 15,57 mcg/mL. Fueron necesarios 8 días para completar la eliminación de la vancomicina, durante los cuales la paciente se sometió a 4 sesiones de hemodiálisis.El caso descrito pone de manifiesto la necesidad de monitorizar las concentraciones plasmáticas de vancomicina durante el tratamiento de ICD, especialmente en pacientes con elevadas dosis de fármaco, con insuficiencia renal y afectación de la integridad del tracto gastrointestinal. (AU)

Clostridium difficile infection (CDI) has increased its incidence in recent years, becoming one of the most common infections acquired in the hospital setting, causing an infectious diarrhea that is strongly associated with the use of antibiotics. Currently, the antibiotics used for this treatment are oral vancomycin and fidaxomycin, being oral vancomycin the most cost-effective for the National Health System.We describe the case of a pluripatological patient who underwent two weekly hemodialysis sessions, which is diagnosed as having developed CDI to pseudomembranous colitis confirmed by endoscopy. Treatment for CDI was initiated with a master formula of oral vancomycin at a dose of 250 mg every 6 hours. Oral vancomycin therapy was not effective and safe in the patient, resulting in significant systemic absorption of vancomycin reaching plasma vancomycin concentrations of 15.57 mcg/mL. It took 8 days to complete the elimination of vancomycin, during which the patient underwent 4 hemodialysis sessions.The described case highlights the need to monitor vancomycin plasma concentrations during the treatment of CDI, especially in patients with high doses of drug, with renal insufficiency and impairment of the integrity of the gastrointestinal tract. (AU)

Evaluación de la seguridad y efectividad del intercambio de tenofovir disoproxilo a tenofovir alafenamida en vida real / Evaluation of the safety and effectiveness of the exchange of tenofovir disoproxil to tenofovir alafenamide in real life

OBJETIVOS: Evaluar la seguridad y efectividad en vida real del intercambio en el tratamiento antirretroviral de tenofovir disoproxilo (TDF) a tenofovir alafenamida (TAF) en pacientes VIH. MATERIAL Y MÉTODOS: Estudio retrospectivo observacional durante 2017 en el que se incluyeron todos los pacientes del departamento de salud en tratamiento con TAF. Se evaluó la población obtenida y además se dividió en dos subgrupos no comparativos según el intercambio realizado: subgrupo 1, de elvitegravir/cobicistat/TDF/emtricitabina (EVG/c/TDF/FTC) a EVG/c/TAF/FTC; y subgrupo 2, de TDF/FTC a TAF/FTC. Para la seguridad se midió antes y después del intercambio: creatinina (Cr), urea y velocidad de filtrado glomerular (VFG). Para la efectividad carga viral (CV) y linfocitos CD4. La CV se tomó como variable binaria interpretándose como pacientes respondedores (<20 copias/mL) o no. Las variables numéricas se expresaron en medianas y las cualitativas en porcentaje e intervalo intercuartílico (IQR). Las pruebas utilizadas fueron W de Wilcoxon y chi cuadrado respectivamente. RESULTADOS: Se obtuvo una muestra de 55 pacientes en los que hubo una variación antes y después del cambio de Cr=0,9 mg/dL (IQR=0,8-1) a Cr=0,8 mg/dL (IQR=0,7-0,9) (p < 0,001), de urea=29 mg/dL (IQR = 24-36) a urea = 28 mg/dL (25-34,5) (p = 0,06) y de VFG = 92,8 mL/min (79,3-102,1) a VFG = 103,6 (IQR=95,9-111,1) (p < 0,001). En cuanto a efectividad hubo un incremento desde el 51% al 59,9% (p = 0,821) y para CD4 de 668 CD4/mcL (IQR = 496-824) a 684 CD4/mcL (IQR = 611-807) (p = 0,084). Los resultados por subgrupos fueron similares. CONCLUSIONES: Este estudio muestra en una misma población en vida real, que tras el cambio en la sal de tenofovir se mantiene un buen perfil de seguridad con mejora de parámetros analíticos de la función renal sin perjuicio en la efectividad

OBJECTIVE: To assess safety and effectiveness in real world of the switch in the antiretroviral treatment (ART) of tenofovir disoproxil (TDF) to tenofovir alafenamide (TAF) in HIV patients. MATERIAL AND METHODS: Observational retrospective study during 2017 in which all the patients of the health department under treatment with TAF were included. The population obtained was evaluated and also divided into two non-comparative subgroups according to the switch performed: subgroup 1, from elvitegravir/cobicistat/TDF/emtricitabine (EVG/c/TDF/FTC) to EVG/c/TAF/FTC; and subgroup 2, from TDF/FTC to TAF/FTC. To evaluate safety, before and after the switch, was measured: creatinine (Cr), urea and glomerular filtration rate (GFR). To evaluate effectiveness was measured viral load (VL) and CD4 lymphocytes (CD4). VL was interpreted as binary variable: responder patients (<20 copies/mL) or non-responder patients. Numerical variables were expressed as medians (Md) and qualitative variables as percentage and interquartile interval (IQR). The statistical tests used were W of Wilcoxon and chi square respectively. RESULTS: A sample of 55 patients was obtained. There was a variation, before and after the switch, of Cr=0.9 mg/dL (IQR=0.8-1) to Cr = 0.8 mg/dL (IQR=0.7-0.9) (p < 0.001), from urea=29 mg/dL (IQR = 24-36) to urea=28 mg/dL (IQR = 25-34.5) (p = 0.06) and from GFR = 92.8 mL/min (IQR = 79.3-102.1) to GRT=103.6 (IQR = 95.9-111.1) (p < 0.001). In terms of effectiveness there was an increase from 51% to 59.9% (p = 0.821) responding patients and for CD4 from 668 CD4/mcL (IQR = 446-824) to 684 CD4/mcL (IQR = 611-807) (p = 0.058). The results by subgroups were similar. CONCLUSION: This study showed in real world after the change of tenofovir salt within the same population that a good safety profile is manteined with an improvement of analytical parameters of renal function without affecting its effectiveness

Diagnóstico de intoxicación por Nerium oleander: ¿un único método analítico es suficiente?. Réplica / No disponible

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Intoxicación por Nerium oleander (baladre): dos casos clínicos / No disponible

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