Search results for "Reporting system"

Atypical thrombosis associated with VaxZevria (R) (AstraZeneca) vaccine: Data from the French Network of Regional Pharmacovigilance Centres

2021

The current COVID-19 pandemic is an exceptional health situation including for drug use. As there was no known effective drug for COVID-19 at the beginning of the pandemic, different candidates were proposed. In this short article, we present the French public pharmacovigilance activities during this health crisis. Although COVID-19 is a confounding factor per se, owing to its potential for multi-organ damage including the heart and kidney, the quality of the transmitted data in adverse drug reaction reports, the timeliness of feedback from clinicians, and the real-time pharmacological and medical analysis by the French network of the regional pharmacovigilance centers made it possible to s…

Gastric plasma biomarkers and Operative Link for Gastritis Assessment gastritis stage

2011

Introduction The Operative Link for Gastritis Assessment (OLGA) staging system has been proposed as a histopathological reporting system of gastric atrophy. Noninvasive methods for indirect evaluation of gastric mucosal atrophy by biomarkers are also being introduced. Objectives To analyze gastric mucosal atrophy by biomarkers, pepsinogen I (PgI), pepsinogen II (PgII), PgI/PgII ratio, fasting gastrin-17 (G-17), stimulated gastrin-17 (sG-17), in relation to OLGA gastritis stage. Patients and methods Gastric biopsies were taken from 269 prospective patients referred for upper endoscopy because of dyspeptic problems and evaluated by two expert pathologists (D.J. and P.S.). Atrophy was assessed…

Assessment of EVAR Complications using CIRSE Complication Classification System in the UK Tertiary Referral Centre: A ∼6-Year Retrospective Analysis …

2021

Purpose: To retrospectively analyse complications in endovascular aortic repair (EVAR) interventions and evaluate if the CIRSE (Cardiovascular and Interventional Radiological Society of Europe) complication classification system is appropriate as a standardized classification tool for EVAR patients. Materials and Methods: Demographic, procedural and complication data in 719 consecutive patients undergoing EVAR at one institution from January 2014 to October 2019 were retrospectively reviewed. Data (imaging reports, procedural reports, nurse notes, discharge summary reports) were collected consulting the electronic patient record system (EPR) of the hospital and cleaned and stored in a Micro…

Surveillance for adverse events following immunization (AEFI) for 7 years using a computerised vaccination system

2016

Objectives: The surveillance of vaccine safety is an essential requirement in vaccination programmes. Computerized immunization registries such as the Vaccination Information System (SIV) of Valencian Community (Spain) offer the opportunity to estimate the incidence of adverse events according to individual information. The aim of the study was to analyze adverse events following immunization reported through SIV from 2005 to 2011 by age, sex, type of vaccine and dose, and adverse event, and highlight the advantages of this type of reporting. Study design: A retrospective cohort study of subjects vaccinated in the Valencian Community using population health databases was carried out. Method…

Natalizumab: a country-based surveillance program

2008

Natalizumab is a humanized monoclonal antibody with a selective adhesion-molecule inhibitor effect, and a demonstrated efficacy in decreasing the frequency of relapses and progression of disability in relapsing-remitting multiple sclerosis (RR MS). After the approval of FDA and EMEA in MS cases unresponsive to immunomodulating therapy or in severe MS patients also not previously treated with interferons, and considering the concern on the possible side effects, an accurate program of surveillance was organized in our country by a combined effort of AIFA, Cineca, Department of Pharmacology of University of Bologna, and a group of neurologists appointed by the National Society of Neurology (S…

Experiences of a Poison Center Network with Renal Insufficiency in Acetaminophen Overdose: An Analysis of 17 Cases

2005

Renal insufficiency is less common than liver failure in acetaminophen overdose but renal tubular damage occurs even in the absence of hepatotoxicity. Data published on this topic are rare consisting mostly of case reports or reports in a small number of patients. Presently, a larger number of patients with renal insufficiency associated with acetaminophen overdose should be analyzed using a multicenter approach.Retrospective analysis of patients with acetaminophen-related nephrotoxicity reported to a poison center network from 1995 to 2003. Renal insufficiency was defined as elevated serum creatinine of more than double of the normal range (2.4 mg/dL [212 micromol/L]). Patients were classi…

Cataracts and statins. A disproportionality analysis using data from VigiBase.

2019

The basis of the association between statin use and cataract has been explored using the World Health Organization (WHO) global database of individual case safety reports (ICSRs) for drug monitoring (VigiBase) through January 2019. The reporting odds ratios (RORs) as a measure of disproportionality for reported cataracts and individual statins have been calculated. Subgroup analyses according statin lipophilicity, sex, and age groups have been performed. Moreover, RORs have been calculated for non-statin lipid lowering drugs. An increased disproportionality have been found for most individual statins lovastatin: [ROR: 14.80, 95% confidence interval (CI): 13.30, 16.46)], atorvastatin (ROR: 3…

Glossitis, stomatitis, and black tongue with lansoprazole plus clarithromycin and other antibiotics

1997

Nationwide evaluation of day-to-day clinical pharmacists' interventions in German hospitals.

2015

tudy Objective To describe and evaluate the extent and diversity of nationwide data from clinical pharmacists’ interventions (PIs) in German hospitals. Design Retrospective analysis. Data Source The ADKA-DokuPIK German database, a national anonymous self-reported Internet-based documentation system for routine PIs as well as for medication errors reported by German hospital pharmacists. Measurements and Main Results Data sets from ADKA-DokuPIK entered between January 2009 and December 2012 were analyzed descriptively. A total of 27,610 PIs were entered, mainly by ward-based clinical pharmacists (82.5%). Most of the PIs were performed on surgical wards (37.8%), followed by anesthesiology/int…

Crónica de la jurisprudencia del Comité Europeo de Derechos Sociales - 2020

2021

La presente crónica aborda un año crucial (2020) en el que la actividad del Comité Europeo de Derechos Sociales se ha enfrentado a la grave crisis provocada por la pandemia de la Covid-19. En este sentido, la jurisprudencia del Comité sobre el sistema de informes se ha centrado en un grupo temático particularmente afectado por dicha crisis (¿Empleo, formación e igualdad de oportunidades¿). Por otro lado, la jurisprudencia del Comité sobre el procedimiento de reclamaciones colectivas se ha visto especialmente reforzada, con ocasión de la resolución de quince importantes reclamaciones, por los nuevos perfiles en materia de lucha contra la brecha salarial de género y la representación de las m…