Adverse events reported after administration of BNT162b2 and mRNA-1273 COVID-19 vaccines among hospital workers: a cross-sectional survey-based study in a Spanish hospital.

BACKGROUND: The World Health Organization declared COVID-19 a pandemic in March 2020. The first vaccine became available in December, with practically no post-marketing data. METHODS: An analytical cross-sectional survey-based study was conducted in a third-level hospital in Spain between March and April 2021 to describe the difference in adverse events with the BNT162b2 and mRNA-1273 COVID-19 vaccines. The participants were hospital workers who completed a survey voluntarily at least 14 days after the last vaccine. The STROBE checklist was followed. RESULTS: One thousand two hundred and forty-nine respondents completed the survey; 48% (599) received mRNA-1273 and 52% (650) BNT162b2. Fourteen thousand four hundred and two adverse reactions were recorded, 6896 local (3939 with mRNA-1273 and 2957 with BNT162b2 (6.6 vs 4.4 reactions per patient)) and 7506 systemic (4460 with mRNA-1273 and 3046 with BNT162b2 (7.4 vs 4.7 per patient)). Local reactions were more frequent after the first dose, while systemic reactions were higher after the second, for both vaccines and in a higher percentage with mRNA-1273 compared to BNT162b2 (p-value<0.05). CONCLUSIONS: Licensed mRNA vaccines were highly safe when administered under post-marketing conditions among working-age adults. The main adverse events were mild, although they occurred in most patients, especially after the mRNA-1273 vaccine.

Standardization and Chemical Characterization of Intravenous Therapy in Adult Patients: A Step Further in Medication Safety.

BACKGROUND: Intravenous drug administration is associated with potential complications, such as phlebitis. The physiochemical characteristics of the infusate play a very important role in some of these problems. AIM: The aim of this study was to standardize the dilutions of intravenous drugs most commonly used in hospitalized adult patients and to characterize their pH, osmolarity and cytotoxic nature to better guide the selection of the most appropriate vascular access. METHODS: The project was conducted in three phases: (i) standardization of intravenous therapy, which was conducted using a modified double-round Delphi method; (ii) characterization of the dilutions agreed on in the previous phase by means of determining the osmolarity and pH of each of the agreed concentrations, and recording the vesicant nature based on the information in literature; and (iii) algorithm proposal for selecting the most appropriate vascular access, taking into account the information gathered in the previous phases. RESULTS: In total, 112 drugs were standardized and 307 different admixtures were assessed for pH, osmolarity and vesicant nature. Of these, 123 admixtures (40%), had osmolarity values >600 mOsm/L, pH < 4 or > 9, or were classified as vesicants. In these cases, selection of the most suitable route of infusion and vascular access device is crucial to minimize the risk of phlebitis-type complications. CONCLUSIONS: Increasing safety of intravenous therapy should be a priority in the healthcare settings. Knowing the characteristics of drugs to assess the risk involved in their administration related to their physicochemical nature may be useful to guide decision making regarding the most appropriate vascular access and devices.

Nationwide current situation of hospital pharmacists in intensive care units.

OBJECTIVE: To describe the current situation of the hospital pharmacist in intensive care units and their activity in care, in teaching  and in research. METHOD: Multicenter and prospective study through a survey  disseminated by the Spanish Society of Hospital Pharmacy, which  consisted of several sections: personal and hospital's data, hospital's  characteristics, pharmacist's involvement in intensive care units and  teaching. RESULTS: A number of 58 completed surveys were obtained. The  number of pharmacists involved in intensive care units was 1 in 77.6%  of cases, assisting an average of 30.8 beds (5-70). Experience of  pharmacists in the intensive care unit was 5 years on average (2  months-25 years). Visitor's pass assistance and shift changes were  between "never" by 36.2% to "daily" by 22.4%. Out of respondents,  93.1% reported a part-time intensive care unit involvement. Regarding  activities undertaken, between 40-60% of pharmacists manage  narcotics, teaching at intensive care unit, conciliation and safety.  Between 60-80%, pharmacists cover clinical nutrition, notarization,  optimization of pharmacokinetics and antibiotics; and 84.5% perform  pharmacotherapy follow-up. Out of the surveyed pharmacists, 77.6%  have specialized medical training, rotating intensive care unit residents  in 86% of cases. CONCLUSIONS: Most of the surveyed hospitals have one part-time  pharmacist in these units. In order to improve the quality of  pharmaceutical care of critically ill patients, it would be necessary to  extend the involvement in time and staff, regarding the current  situation, and a greater number of hospitals should include pharmacists  in hospital intensive care units.

Objetivo: Describir la situación actual del farmacéutico de hospital en las unidades de cuidados intensivos, su actividad asistencial, docente  e investigadora.Método: Estudio multicéntrico, prospectivo mediante encuesta  difundida por la Sociedad Española de Farmacia Hospitalaria, la cual  constaba de varios apartados: datos personales y del hospital,  características del hospital, implicación del farmacéutico en la unidad de  cuidados intensivos y docencia.Resultados: Se obtuvieron 58 encuestas completadas. El número de farmacéuticos implicados en unidades de cuidados intensivos era 1  en el 77,6% de los casos, atendiendo una media de 30,8 camas (5-70).  La experiencia en la unidad de cuidados intensivos del farmacéutico fue  de 5 años de mediana (2 meses-25 años). La asistencia al pase de visita  o cambios de guardia fue entre "nunca" en un 36,2% a  "diariamente" en un 22,4%. El 93,1% de los encuestados reportaron  dedicación a tiempo parcial en la unidad de cuidados intensivos.  Respecto a actividades desarrolladas, entre el 40-60% gestiona  estupefacientes, docencia en unidad de cuidados intensivos, conciliación  y seguridad; entre el 60-80% abarca nutrición clínica,  protocolización, optimización de antibióticos y farmacocinética, y un  84,5% realizan seguimiento farmacoterapéutico. Un 77,6% cuenta con  formación sanitaria especializada, rotando los residentes en la unidad de  cuidados intensivos en un 86% de los casos.Conclusiones: La mayor parte de los hospitales encuestados cuenta con un solo farmacéutico a tiempo parcial en estas unidades. Con objeto de mejorar la calidad de la atención farmacéutica del paciente crítico sería necesario ampliar la dedicación en tiempo y personal respecto a la  situación actual y que más centros incluyan al farmacéutico en las unidades de cuidados intensivos hospitalarias.