RESUMO
WHAT IS KNOWN AND OBJECTIVE: Tocilizumab is an IL-6 receptor inhibitor agent which has been proposed as a candidate to stop the inflammatory phase of infection by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). However, safety data of tocilizumab in pregnant women and their newborn are scarce. We aimed to describe maternal and neonatal safety outcomes associated with tocilizumab treatment in pregnant women with severe COVID-19. METHODS: This is a retrospective study of severe COVID-19 pregnant women, treated with tocilizumab in two Spanish hospitals between 1 March and 31 April 2020. Demographics, medical history, clinical and radiologic findings, treatment information and laboratory data of mothers and their newborns were collected from electronic medical records. RESULTS AND DISCUSSION: A total of 12 pregnant women were identified to have received tocilizumab during pregnancy in the two hospitals. Median gestational age at admission was 27.7 weeks (interquartile range, 18.0-36.4). Most of them received lopinavir/ritonavir, azithromycin and hydroxychloroquine, two patients received corticosteroids and one received interferon beta 1B. All 12 pregnancies resulted in live births. Somatometric values were normal for all newborns, and evolution at 14 and 28 days was favourable for all of them. Hepatotoxicity was observed in 2 patients, which improved or resolved at discharge. Cytomegalovirus reactivation was detected in another patient who had also received corticosteroids for 15 days, causing a congenital infection in her newborn. Both hepatotoxicity and viral reactivation adverse events were classified as possibly related to tocilizumab administration according to Naranjo's causality algorithm. WHAT IS NEW AND CONCLUSIONS: It does not appear that tocilizumab has detrimental effects for the mother and newborn. Close monitoring of infections should be considered, especially if other immunosuppressive agents are used.
Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Tratamento Farmacológico da COVID-19 , Complicações Infecciosas na Gravidez/tratamento farmacológico , Adulto , Anticorpos Monoclonais Humanizados/efeitos adversos , Feminino , Humanos , Recém-Nascido , Gravidez , Estudos Retrospectivos , SARS-CoV-2 , Índice de Gravidade de Doença , Espanha , Resultado do TratamentoRESUMO
OBJECTIVE: To determine the perception of patients and practitioners regarding the role of the hospital pharmacist along the care continuum. METHOD: This was a multicenter cross-sectional observational analytical study, carried out in two phases between 15 October and 31 December 2020. In the first phase, a literature search was carried out to identify specific questionnaires that measured the overall satisfaction of patients in relation to the work of hospital pharmacists. Subsequently, a specific consensus-based questionnaire was developed, structured into three areas: care, relationships, and capacity-building and training. The study included patients treated in the participating centers and served by patient associations. They had to be older than 18 years, present with a chronic condition, and be treated with medication for hospital use. In the second phase, a qualitative study was carried out using focus group discussions to analyze how hospital pharmacists are perceived and how they would like to be recognized by patients. Four meetings were held in different territories of Spain. Previously, the research team agreed on the questions to be asked, which were grouped into four sections: healthcare, relational, training and information. RESULTS: A total of 482 surveys were obtained. The percentage of patients who expressed a positive view of the role of the hospital pharmacist was 88.0% (n = 424). In the multivariate analysis, the most positive opinions about these professionals were expressed by women and by patients who had received previous care in the hospital, those who had a high opinion of the coordination of these professionals with the rest of the care team, and those who had received the greatest amount of emotional support. Integration of the pharmacist with the healthcare team was found to vary across different hospitals and the hospitals' public image we seen to be related to the way they were pharmacoeconomically managed. In the sections related to capacity-building and training and challenges for the future, respondents emphasized the need to promote the introduction of new patient monitoring technologies. CONCLUSIONS: Patients have a good opinion of the service provided by hospital pharmacists, although many are unaware of the significance of their role.
Objetivo: Determinar la percepción de los pacientes y profesionales especto al papel del farmacéutico de hospital en el proceso asistencial sanitario.Método: Estudio multicéntrico, observacional, analítico y transversal, realizado en dos fases entre el 15 de octubre y el 31 de diciembre de 2020. En la primera fase se realizó una búsqueda bibliográfica para identificar cuestionarios específicos que midieran la satisfacción global de los pacientes en relación con la actividad asistencial de los farmacéuticos de hospital. Al no identificarse ninguno validado y adaptado, se elaboró un cuestionario específico. Se estructuró en tres áreas: asistencial, relacional y de capacitación y formación. Se incluyeron pacientes atendidos en los centros participantes y asociaciones de pacientes colaboradoras en el proyecto, mayores de 18 años, con patología crónica y tratamiento con medicación de uso hospitalario. En la segunda fase se llevó a cabo un estudio cualitativo en formato focus group para analizar cómo son percibidos y cómo les gustaría ser reconocidos a los farmacéuticos de hospital por parte de los pacientes. Se realizaron cuatro reuniones en diferentes territorios de España. Previamente el equipo investigador acordó el guion y las preguntas a llevar a cabo, incluyéndose 13, agrupadas por bloques: asistencial, relacional, formación e información. Resultados: Se obtuvieron un total de 482 encuestas. El porcentaje de pacientes que valoraron positivamente el papel del farmacéutico de Abstract hospital fue del 88,0% (n = 424). Se identificó que tienen mejor opinión sobre los farmacéuticos hospitalarios las mujeres, los pacientes que habían recibido atención previa en el hospital, los que valoraron mejor la coordinación de estos profesionales con el resto del equipo y aquellos con mayor apoyo emocional previo recibido. En la segunda fase se identificó que la integración del farmacéutico con el equipo varía en función de los centros y que la imagen que se tiene es la relacionada con la gestión farmacoeconómica. En el bloque de capacitación y formación, así como retos de futuro, se identificó la necesidad de fomentar la introducción de nuevas tecnologías para el seguimiento de los pacientes.Conclusiones: Los pacientes tienen una buena opinión del servicio prestado por el farmacéutico de hospital, aunque muchos desconocen su papel.
Assuntos
Continuidade da Assistência ao Paciente , Farmacêuticos , Atitude do Pessoal de Saúde , Estudos Transversais , Feminino , Hospitais , Humanos , Equipe de Assistência ao Paciente , Papel ProfissionalRESUMO
OBJECTIVE: To establish a series of recommendations based on available evidence for monitoring surface contamination in the areas devoted to compounding hazardous drugs in pharmacy departments. METHOD: Based on a literature search in the Medline and Embase databases (search period: January 2009 to July 2019), as well as on a review of standards and recommendations issued by different healthcare organizations, a committee of experts from the Spanish Society of Hospital Pharmacists defined a series of safe practices for handling hazardous drugs and monitoring compounding work surfaces. Recommendation decisions were adopted by consensus among the members of the expert group, considering the recommendations reviewed, the monitoring situation in Spanish hospital departments, and the associated costs. RESULTS: Ten recommendations were formulated, structured into eight sections. They include aspects related to the drugs to be monitored; the areas to be monitored; when samples should be taken; risk determination and preparation of a sampling protocol; analytical techniques; contamination thresholds; and design of an action plan based on the sampling and decontamination results obtained. CONCLUSIONS: Surface monitoring allows hazardous drugs detection and evaluation of the effectiveness of current protocols for the safe handling of such drugs in hospital pharmacy departments. The evaluation should include an analysis of the efficacy of engineering controls, work practices and cleaning and decontamination processes.
Objetivo: Establecer unas recomendaciones, en base a la evidencia disponible, para la monitorización de la contaminación de superficies en las áreas de elaboración de medicamentos peligrosos de los Servicios de Farmacia.Método:A partir de una revisión bibliográfica en las bases de datos Medline y Embase desde enero de 2009 a julio de 2019, así como de la consulta de documentos de estándares y recomendaciones de organizaciones sanitarias, un comité de expertos de la Sociedad Española de Farmacia Hospitalaria ha definido una serie de prácticas seguras sobre manipulación de medicamentos peligrosos y monitorización de superficies de trabajo. Las decisiones de recomendación se tomaron por consenso entre el grupo de expertos teniendo en cuenta las recomendaciones encontradas, la situación en nuestro entorno y los costes asociados a la monitorización.Resultados: Se han definido 10 recomendaciones estructuradas en ocho secciones. Se incluyen aspectos relacionados con los medicamentos a monitorizar; localizaciones a monitorizar; momento de la toma de muestras; determinación del riesgo y plan de muestreo; técnicas analíticas; umbrales de contaminación; plan de acción según los resultados del muestreo y descontaminación.Conclusiones: La monitorización de superficies permite determinar la presencia de medicamentos peligrosos y evaluar la eficacia del programa de manejo seguro de los mismos en los Servicios de Farmacia. La evaluación debería incluir un estudio de la eficacia de los controles de ingeniería, de las prácticas laborales y de los procesos de limpieza y descontaminación.
Assuntos
Antineoplásicos , Exposição Ocupacional , Serviço de Farmácia Hospitalar , Farmácia , Consenso , Composição de Medicamentos , Hospitais , Humanos , FarmacêuticosRESUMO
BACKGROUND: The epidemiological and clinical characteristics of solid organ transplant (SOT) patients during the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) epidemic remains unclear. We conducted a matched retrospective cohort study to compare clinical outcomes among SOT recipients with the general population and to assess immunosuppression management. METHODS: Adult SOT recipients with laboratory polymerase chain reaction-confirmed SARS-CoV-2 infection admitted to a tertiary-care hospital in Barcelona, Spain, from March 11 to April 25, 2020, were matched to controls (1:4) on the basis of sex, age, and age-adjusted Charlson's Index. Patients were followed for up to 28 days from admission or until censored. Primary endpoint was mortality at 28 days. Secondary endpoints included admission to the intensive care unit and secondary complications. Drug-drug interactions (DDI) between immunosuppressants and coronavirus disease 2019 (COVID-19) management medication were collected. RESULTS: Forty-six transplant recipients and 166 control patients were included. Mean (SD) age of transplant recipients and controls was 62.7 (12.6) and 66.0 (12.7) years, 33 (71.7%) and 122 (73.5%) were male, and median (interquartile range) Charlson's Index was 5 (3-7) and 4 (2-7), respectively. Mortality was 37.0% in SOT recipients and 22.9% in controls (P = 0.51). Thirty-three (71.7%) patients underwent transitory discontinuation of immunosuppressants due to potential or confirmed DDI. CONCLUSIONS: In conclusion, hospitalized SOT recipients with COVID-19 had a trend toward higher mortality compared with controls, although it was not statistically significant, and a notable propensity for DDI.