[Translated article] Pharmacokinetics of eculizumab in adult and pediatric patients with atypical hemolytic uremic syndrome and C3 glomerulopathy.

Objective: The objective of the study was to analyze and describe the concentrations of eculizumab and the complement blockade in patients with atypical hemolytic uremic syndrome (aHUS) and C3 glomerulopathy, and to define a therapeutic margin where there is a high probability of achieving therapeutic efficacy.

Methods: Observational, ambispective, and multicenter study that included adult and pediatric patients diagnosed with aHUS and C3 glomerulopathy from September 2020 to October 2022 in 5 hospitals in Spain. Eculizumab was administered at the doses recommended by the data sheet according to the European Medicines Agency (EMA).

Pharmacokinetics of eculizumab in adult and pediatric patients with atypical hemolytic uremic syndrome and C3 glomerulopathy.

Objective: The objective of the study was to analyze and describe the concentrations of eculizumab and the complement blockade in patients with atypical hemolytic uremic syndrome (aHUS) and C3 glomerulopathy, and to define a therapeutic margin where there is a high probability of achieving therapeutic efficacy.

Methods: Observational, ambispective and multicenter study that included adult and pediatric patients diagnosed with aHUS and C3 glomerulopathy from September 2020 to October 2022 in five hospitals in Spain. Eculizumab was administered at the doses recommended by the data sheet according to the European Medicines Agency (EMA).

Antimicrobial Defined Daily Dose in Neonatal Population: Validation in the Clinical Practice.

Background: Currently, there is no validated method for estimating antimicrobial consumption in the neonatal population, as it exists for adults using Defined Daily Doses (DDD). In neonatology, although there are different methods, each one with advantages and disadvantages, there is no unified criterion for use. The aim of this study is to validate the neonatal DDD designed as a new standardised form of antimicrobial consumption over this population.

Standardisation of intravenous infusion therapy for paediatrics: big challenges for the little patients.

Background: Worldwide organisations advocate standardising the management of intravenous drugs as an essential strategy to increase safety in paediatric healthcare settings. Intravenous administration is a route associated with some potential complications. Many adverse events are related to the use of intravenous medications, and the great variability in their handling and preparation represents an added risk that jeopardises the safety of children.

Multicenter randomized clinical trial comparing dexamethasone versus placebo in preventing upper airway obstruction after extubation in critically ill children.

To analyze the effectiveness of dexamethasone in preventing upper airway obstruction (UAO) symptoms after extubation and the need of reintubation in critically ill children. Multicenter, prospective, double-blind, randomized, phase IV clinical trial involving five pediatric intensive care units. Children between 1 month and 16 years-of-age intubated for more than 48 h were included.

Adecuacy of pediatric antimicrobial prescribing in the Emergency Department at discharge.

Introduction: In January 2019, the Community of Madrid's Health Department published a guide about the use of antimicrobials in outpatient children. Taking this regional Guide as reference, this study was aimed at estimating the adequacy of the antimicrobial stewardship at discharge from a pediatric Emergency Department (ED). Secondarily, the differences in adequacy according to the diagnosis and the prescriber were studied, and the agreement between this Guide and the protocols of the ED was assessed.

Antimicrobial defined daily dose in neonatal population.

Background: Antimicrobial defined daily dose (DDD), a standardized metric to assess antimicrobial consumption in adult population, has limitations hampering its use in neonatal patients. This study proposes an alternative DDD design applicable for neonates.

Methods: Neonates (<1 month-old) from 6 Spanish hospitals during a 12-months period were included.

Antimicrobial defined daily dose in neonatal population.

Background: Antimicrobial defined daily dose (DDD), a standardized metric to assess antimicrobial consumption in adult population, has limitations hampering its use in neonatal patients. This study proposes an alternative DDD design applicable for neonates.

Methods: Neonates (<1 month-old) from 6 Spanish hospitals during a 12-months period were included.

[Adecuacy of pediatric antimicrobial prescribing in the Emergency Department at discharge].

Introduction: In January 2019, Community of Madrid's Health Department published a guide about the use of antimicrobials in outpatient children. Taking this regional Guide as reference, this study was aimed at estimating the adequacy of the antimicrobial stewardship at discharge from a pediatric Emergency Department (ED). Secondarily, the differences in adequacy according to the diagnosis and the prescriber were studied, and the agreement between this Guide and the protocols of the ED was assessed.

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

: 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).: 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.

Bromocriptine for the treatment of postoperative cerebellar mutism syndrome in pediatric patients: Three case reports.

Introduction: Cerebellar mutism syndrome (CMS) is a common complication after posterior fossa tumor resection. It is characterized by a significant lack or loss of speech. Its biological origin remains unclear and there are no standardized treatments.

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.

COVID-19 in hospitalised patients in Spain: a cohort study in Madrid.

Few large series describe the clinical characteristics, outcomes and costs of COVID-19 in Western countries. This cohort reports the first 1255 adult cases receiving anti-COVID-19 treatment at a Spanish hospital (1-24 March 2020). Treatment costs were calculated.

A comparative study of contamination in three closed systems for the preparation of hazardous drugs through simulations with fluorescein.

Objective: The objective of this study was to compare the environmental contamination generated during the preparation of cytostatic  agents using three different methods through simulations using fluorescein, and  the time required for preparation of each method.

Method: A comparative study of the processing of fluorescein mixtures using three types of closed systems was conducted at the centralized unit for  hazardous drugs of the Pharmacy Department of a General Teaching Hospital. Environmental contamination was detected in critical points of  connection, and in splashes produced at any other points.

Downbeat nystagmus due to ranitidine in a pediatric patient.

Background: Ranitidine has not been considered as a potential cause of ocular movement conditions. However, it is known that the vestibular nucleus complex, that has a key role in gaze control and vestibule-ocular reflexes, receives hypothalamic histaminergic innervations. Some studies reported the effect of ranitidine blocking the excitatory responses of vestibular nuclei neurons to histamine.

Comparative study of preparation of hazardous drugs with different closed-system drug transfer devices by means of simulation with fluorescein.

Objectives: The level of environmental contamination generated during preparation and administration of hazardous drugs using different valve closed-systems and their combinations was compared. The actual impact on the overall time of preparation of cytostatics and the economic cost of the different modalities were also compared.

Methods: Comparative study of the preparation of fluorescein mixtures with different modalities of valve closed-system combinations.

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.

[Off-label and unlicensed drug use: Results from a pilot study in a pediatric intensive care unit].

Purpose: To analyze the prevalence of use of off-label and unlicensed drugs in a pediatric intensive care unit of a University Hospital.

Method: An observational, descriptive, prospective six week pilot study in a Pediatric Intensive Care Unit. Hospitalized patients aged between 0 and 18 years were included.

Risks in the implementation and use of smart pumps in a pediatric intensive care unit: application of the failure mode and effects analysis.

Objectives: The aim of this study was to identify risk points in the different stages of the smart infusion pump implementation process to prioritize improvement measures.

Methods: Failure modes and effects analysis (FMEA) in the pediatric intensive care unit (PICU) of a General and Teaching Hospital. A multidisciplinary team was comprised of two intensive care pediatricians, two clinical pharmacists and the PICU nurse manager.

Implementation of smart pump technology in a paediatric intensive care unit.

Patient safety is a matter of major concern that involves every health professional. Nowadays, emerging technologies such as smart pumps can diminish medication errors as well as standardise and improve clinical practice with the subsequent benefits for patients. The aim of this paper was to describe the smart pump implementation process in a paediatric intensive care unit (PICU) and to present the most relevant infusion-related programming errors that were prevented.

Preparation of intravenous drug administration guidelines for a pediatric intensive care unit.

Drug administration is one of the main sources of errors in pediatric intensive care units (PICUs). An available guide for intravenous drug administration might be useful. The aim of this article is to present the methodology and results for the development of a guide for intravenous drug administration in a PICU.