Clinical course of severe patients with COVID-19 treated with tocilizumab: report from a cohort study in Spain.

Background: We report the long-term outcomes, changes in laboratory parameters, the incidence of secondary nosocomial infections and treatment cost of a Spanish cohort of patients with severe COVID-19 that received tocilizumab (TCZ).Methods: Retrospective cohort of PCR confirmed adult patients who received TCZ from March 1 to 24, 2020 in a tertiary hospital was analyzed. Patients were followed up until 10 May 2020.Results: We included 162 patients (median age 64 years; 70.4% male). At time of TCZ administration, 48.1% of patients were on invasive mechanical ventilation (IMV). Over a median follow-up of 53 days, 46.9% of patients were discharge in good conditions and 19.8% were still hospitalized. The overall mortality was 33.3%, being higher in patients on IMV than those who did not (46.2% vs 26.7%, P < 0.001). A significant improvement in the lymphocyte count, C-reactive protein, lactate dehydrogenase, and D-dimer was observed. Overall, 43.2% patients presented nosocomial infections, causing death in 8%. Infections were more prevalent in ICU units (63.0% vs 17.1%, P < 0.001). The total cost of TCZ was €371,784.Conclusions: Among the patients who used TCZ, one third died, regardless the improvement in some inflammatory biomarkers. The incidence of secondary nosocomial infections was high.

Pharmacy Department management and organization.

The WHO declared the SARS- CoV-2 outbreak a pandemic in March 11, 2020.  Spain has been the third country with the highest number of reported cases of  COVID-19. In the face of the pandemic, the authorities of the Autonomous  Community of Madrid led an unprecedented transformation of hospital services  by increasing the number of beds available, setting up temporary field hospitals  in fairgrounds, and transforming hotels into support centers for patients with  mild symptoms of COVID-19. In the light that this crisis will continue to be a real threat for the years to come, our hospital pharmacies need to be better prepared for similar outbreaks in the future. During the COVID-19 pandemic, the  Department of Hospital Pharmacy of Hospital General Universitario Gregorio  Marañón has faced four challenges: an exponential increase in the demand for  resources, constant changes to therapeutic protocols and approaches, regulatory changes, and a dramatic impact on hospital staff (strain on human resources  and psychological impact). This article is aimed at describing the main  organizational changes implemented to the Department of Hospital Pharmacy of  Hospital GU Gregorio Marañón and its relationship with other hospital  pharmacies of the Community of Madrid. An account is provided of the strategies to be adopted for reorganizing a Department of Hospital Pharmacy and achieve a safe and effective use of medications. Strategies range from the creation of  integral hospital task groups (COVID-crisis task group, protocolization task  group, research task group) to the adaptation of the internal organization of the  Department of Hospital Pharmacy, which encompasses aspects related to  management and leadership; a communication plan (internal and external);  staff management, and the reorganization and adaptation of processes. People,  patients and professionals are at the core of these strategies. This paper is a  reflection on key factors of "humanization in COVID times".

Con fecha 11 de marzo de 2020 la Organización Mundial de la Salud declaró el  estado de pandemia por SARS-CoV-2. En algunos momentos de la crisis, España fue el tercer país del mundo en número de casos. Las autoridades de la  Comunidad de Madrid, una de las más afectadas, han respondido con una  transformación hospitalaria sin precedentes, aumentando el número de camas  disponibles, creando hospitales de campaña en recintos feriales y transformando hoteles en centros de apoyo para pacientes leves. Dado que la aparición de  estas crisis continuará siendo una amenaza real en los próximos años, es  necesario revisar la preparación de nuestros servicios de farmacia para afrontar  este tipo de situaciones. El reto al que se ha enfrentado el Servicio de Farmacia  del Hospital General Universitario Gregorio Marañón durante la crisis de la  pandemia COVID-19 ha venido determinado por cuatro circunstancias:  incremento exponencial de la demanda de recursos, cambios constantes en los  protocolos y decisiones terapéuticas, cambios regulatorios y gran impacto en las personas (gestión de recursos y gestión de las emociones). En este trabajo  se describen los principales cambios organizativos de un servicio de farmacia a  través de la experiencia del Hospital General Universitario Gregorio Marañón y  sus relaciones con otros servicios de farmacia de la Comunidad de Madrid. Se  detallan los procedimientos que deben contemplarse para la reorganización de  un servicio de farmacia para lograr un uso seguro y eficiente de los  medicamentos. Se detallan desde la participación en los comités globales de  hospital (comité de crisis COVID, comité de protocolización y comité de  investigación) hasta la organización interna del servicio de farmacia, que  incluyen: gestión y liderazgo, plan de comunicación (interna y externa), gestión  de las personas, reorganización y adaptación de los procesos. Las personas,  pacientes y profesionales son los grandes protagonistas de esta actuación, por lo  que incluimos una reflexión sobre los factores clave para la "humanización en  tiempos de COVID".

Use of the EFQM excellence model to improve hospital pharmacy performance.

BACKGROUND: Quality management systems are widely used to improve the quality and efficiency of healthcare services. However, evidence regarding the value of the European Foundation for Quality Management (EFQM) model in improving the performance of hospital departments is lacking. OBJECTIVE: To describe the value of the EFQM model as a quality framework for improving the performance of a hospital pharmacy department (PD). DESIGN: A case study describing the development of the Enablers' criteria of the model and the results achieved. SETTING: PD in a tertiary-care teaching hospital of the Madrid Public Health Service (Spain). INTERVENTIONS: Four self-assessments were conducted using the questionnaire "Perfil" during the period 2008-2017. A quality improvement plan was developed on the basis of the results of each self-assessment. A balanced scorecard was used to track progress. Improvement in quality management was externally evaluated by the Spanish Management Excellence Club in 2010, 2013, and 2017. MAIN OUTCOME MEASURES: Change in the scores obtained in the external assessments, the quality improvement initiatives implemented for each Enabler's criteria, and the results of key performance indicators. RESULTS: The EFQM was a useful framework for self-assessment and a good system for identifying improvement initiatives. The model progressively improved the services provided for patients, the safety and efficiency of pharmacotherapy, productivity of the PD, and customer and staff satisfaction. The external assessment scores exceeded 300 points in 2010, 400 points in 2013, and 500 points in 2017. Scores for all of the criteria progressively improved, particularly in 'people'. CONCLUSIONS: The EFQM was a practical tool for improvement of PD performance, especially in areas such as strategic planning, people management, and innovation. The main difficulties were the lack of decision-making capacity in relevant areas and benchmarking with other PDs.

Organización y gestión interna del servicio de farmacia / Pharmacy Department management and organization

Con fecha 11 de marzo de 2020 la Organización Mundial de la Salud declaró el estado de pandemia por SARS-CoV-2. En algunos momentos de la crisis, España fue el tercer país del mundo en número de casos. Las autoridades de la Comunidad de Madrid, una de las más afectadas, han respondido con una transformación hospitalaria sin precedentes, aumentando el número de camas disponibles, creando hospitales de campaña en recintos feriales y transformando hoteles en centros de apoyo para pacientes leves. Dado que la aparición de estas crisis continuará siendo una amenaza real en los próximos años, es necesario revisar la preparación de nuestros servicios de farmacia para afrontar este tipo de situaciones. El reto al que se ha enfrentado el Servicio de Farmacia del Hospital General Universitario Gregorio Marañón durante la crisis de la pandemia COVID-19 ha venido determinado por cuatro circunstancias: incremento exponencial de la demanda de recursos, cambios constantes en los protocolos y decisiones terapéuticas, cambios regulatorios y gran impacto en las personas (gestión de recursos y gestión de las emociones).En este trabajo se describen los principales cambios organizativos de un servicio de farmacia a través de la experiencia del Hospital General Universitario Gregorio Marañón y sus relaciones con otros servicios de farmacia de la Comunidad de Madrid. Se detallan los procedimientos que deben contemplarse para la reorganización de un servicio de farmacia para lograr un uso seguro y eficiente de los medicamentos. Se detallan desde la participación en los comités globales de hospital (comité de crisis COVID, comité de protocolización y comité de investigación) hasta la orga-nización interna del servicio de farmacia, que incluyen: gestión y liderazgo, plan de comunicación (interna y externa), gestión de las personas, reorga-nización y adaptación de los procesos.Las personas, pacientes y profesionales son los grandes protagonistas de esta actuación, por lo que incluimos una reflexión sobre los factores clave para la "humanización en tiempos de COVID"

The WHO declared the SARS- CoV-2 outbreak a pandemic in March 11, 2020. Spain has been the third country with the highest number of reported cases of COVID-19. In the face of the pandemic, the authorities of the Autonomous Community of Madrid led an unprecedented transformation of hospital services by increasing the number of beds available, setting up temporary field hospitals in fairgrounds, and transforming hotels into support centers for patients with mild symptoms of COVID-19.In the light that this crisis will continue to be a real threat for the years to come, our hospital pharmacies need to be better prepared for similar outbreaks in the future. During the COVID-19 pandemic, the Department of Hospital Pharmacy of Hospital General Universitario Gregorio Marañón has faced four challenges: an exponential increase in the demand for resources, constant changes to therapeutic protocols and approaches, regulatory changes, and a dramatic impact on hospital staff (strain on human resources and psychological impact).This article is aimed at describing the main organizational changes implemented to the Department of Hospital Pharmacy of Hospital GU Gregorio Marañón and its relationship with other hospital pharmacies of the Community of Madrid. An account is provided of the strategies to be adopted for reorganizing a Department of Hospital Pharmacy and achieve a safe and effective use of medications. Strategies range from the creation of integral hospital task groups (COVID-crisis task group, protocolization task group, research task group) to the adaptation of the internal organization of the Department of Hospital Pharmacy, which encompasses aspects related to management and leadership; a communication plan (internal and external); staff management, and the reorganization and adaptation of processes. People, patients and professionals are at the core of these strategies. This paper is a reflection on key factors of "humanization in COVID times"

Effectiveness and Safety of Ombitasvir-Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin for HCV Genotype 1 Infection for 12 Weeks Under Routine Clinical Practice.

BACKGROUND: No previous studies exist examining the effectiveness and safety in real clinical practice of the combination of ombitasvir/paritaprevir/ritonavir and dasabuvir (OBV/PTV/r+DSV). OBJECTIVE: To evaluate the effectiveness and safety in real clinical practice of the combination of OBV/PTV/r+DSV with or without ribavirin for 12 weeks in treatment-naïve and previously treated adult patients with chronic hepatitis C virus (HCV) genotype 1 infection. METHODS: This was an observational study of a prospective cohort of treatment-naïve and pretreated adult patients who received 12 weeks of OBV/PTV/r (25/150/100 mg once daily) and DSV (250 mg twice daily) with or without ribavirin. The primary effectiveness outcome was sustained virological response 12 weeks after the end of treatment (SVR12). Safety outcomes were presented by the incidence of adverse events. RESULTS: A total of 116 of 121 patients achieved a SVR12 (95.9%, 95% CI = 90.6-98.6). The SVR12 rate was 93.8% (95% CI = 86.0-97.9) in cirrhotic patients and 100% (95% CI = 91.4-100.0) in noncirrhotic patients. Adverse events occurred in 91.7% of patients, of which 81.8% were grade 1/2, and none led to premature discontinuation. Grade 3 adverse events were reported in 9.9% of patients. The most frequent adverse event was anemia (52.1%), although only 1.6% had a hemoglobin level below 8 g/dL. The incidence of any adverse event was higher in the group of patients who received ribavirin (96.5% vs 80.0%, P = 0.002). CONCLUSIONS: The combination of OBV/PTV/r+DSV with or without ribavirin for 12-week settings achieved a high rate of SVR12, with an acceptable safety profile in routine clinical care.

[Pharmacy]. / Farmacia.

After learning of the scale of the terrorist attacks on 11th March, the main goal of the Pharmacy Service was to guarantee the availability of drugs to meet the needs of a large number of patients in as short a time as possible. Due to an automated storage system, drugs could be ordered from the pharmacuetical laboratories efficiently. One hundred fifty-seven orders for drugs were made, representing an increase of 51% over the daily average. As far as possible, burocratic procedures were avoided. In addition, dispensation of drugs to admission wards was facilitated by an automatic storage and dispensation system (carousels). A total of 249 distinct orders were dispensed (2,755 drugs), concentrated in the Resuscitation and Intensive Care Units, Emergency and Surgical Departments, representing 100% of the activity performed from 8.30 to 13.00 h. After that time, normal dispensing activity to the other clinical units was resumed.

Farmacia / Pharmacy

El 11 de marzo, tras conocer las grandes dimensiones de la catástrofe, el principal objetivo del Servicio de Farmacia fue tratar de garantizar al máximo la disponibilidad de medicamentos para cubrir las necesidades de un elevado número de pacientes en un corto espacio de tiempo. La disponibilidad de un sistema automatizado de almacenamiento permitió organizar un sistema ágil de pedidos a los laboratorios farmacéuticos. Se realizaron 157 pedidos a los laboratorios, que superaba en un 51% la media diaria, evitando en lo posible los trámites burocráticos. Por otro lado, se pudo agilizar la dispensación de medicamentos a las unidades de hospitalización al disponer de un sistema automatizado de almacén y dispensación (carruseles). Se atendieron 249 peticiones distintas (se sirvieron 2.755 medicamentos), concentradas en los Servicios de Reanimación, Unidades de Cuidados Intensivos, de Urgencias y quirófanos, que supusieron el 100% de la actividad realizada desde las 8.30 hasta las 13.00 h. A partir de entonces se reanudó la actividad habitual de dispensación al resto de unidades clínicas (AU)

After learning of the scale of the terrorist attacks on 11th March, the main goal of the Pharmacy Service was to guarantee the availability of drugs to meet the needs of a large number of patients in as short a time as possible. Due to an automated storage system, drugs could be ordered from the pharmacuetical laboratories efficiently. One hundred fifty-seven orders for drugs were made, representing an increase of 51% over the daily average. As far as possible, burocratic procedures were avoided. In addition, dispensation of drugs to admission wards was facilitated by an automatic storage and dispensation system (carousels). A total of 249 distinct orders were dispensed (2,755 drugs), concentrated in the Resuscitation and Intensive Care Units, Emergency and Surgical Departments, representing 100% of the activity performed from 8.30 to 13.00 h. After that time, normal dispensing activity to the other clinical units was resumed (AU)