Publications by authors named "V Le Pera"
Background: While medication errors (MEs) have been studied in the European Medicines Agency's EudraVigilance, extensive characterisation and signal detection based on sexes and age groups have not been attempted.
Objectives: The aim of this study was to characterise all ME-related individual case safety reports in EudraVigilance and explore notable signals of disproportionate reporting (SDRs) among sexes and age groups for the 30 most frequently reported drugs.
Methods: Individual case safety reports were used from EudraVigilance reported between 2002 and 2021.
Article Synopsis
- Medication errors (MEs) pose significant health risks and financial strains in healthcare, making their characterization essential for developing prevention strategies.* -
- A study examined ME reports in the FDA's Adverse Event Reporting System (FAERS) from 2004 to 2020, identifying 488,470 reports, predominantly from consumers, with a notable majority linked to females.* -
- The research found that about one-third of reports involved serious health outcomes; the most common error was incorrect dosing, and adalimumab was frequently associated with MEs, indicating areas for future analysis and prevention efforts.*
Monoclonal antibodies (mAbs) targeting immunoglobulin E (IgE) [omalizumab], type 2 (T2) cytokine interleukin (IL) 5 [mepolizumab, reslizumab], IL-4 Receptor (R) α [dupilumab], and IL-5R [benralizumab]), improve quality of life in patients with T2-driven inflammatory diseases. However, there is a concern for an increased risk of helminth infections. The aim was to explore safety signals of parasitic infections for omalizumab, mepolizumab, reslizumab, dupilumab, and benralizumab.
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- This study investigates how different interpretations of an observational study's design can affect the results when independent researchers attempt to reproduce it.
- The researchers found that out of ten criteria for including patients, teams only agreed, on average, 4 of 10 times, leading to significant variability in the size and characteristics of the resulting patient cohorts.
- The study concludes that providing open analytical code and a standardized data model can improve reproduction accuracy and consistency in observational research.
Objective: The Multi-Ethnic New Zealand Study of Acute Coronary Syndromes (MENZACS) was established to investigate the drivers of secondary events after first-time acute coronary syndrome (ACS), including addressing inequitable outcomes by ethnicity. Herein, the first clinical outcomes and prognostic modelling approach are reported.
Methods: First, in 28 176 New Zealanders with first-time ACS from a national registry, a clinical summary score for predicting 1-year death/cardiovascular readmission was created using Cox regression of 20 clinical variables.