Search results for "Adverse Drug Reaction Reporting Systems"

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…

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…

Evaluation of Internet Social Networks using Net scoring Tool: A Case Study in Adverse Drug Reaction Mining

2015

Suspected adverse drug reactions (ADR) reported by patients through social media can be a complementary tool to already existing ADRs signal detection processes. However, several studies have shown that the quality of medical information published online varies drastically whatever the health topic addressed. The aim of this study is to use an existing rating tool on a set of social network web sites in order to assess the capabilities of these tools to guide experts for selecting the most adapted social network web site to mine ADRs.First, we reviewed and rated 132 Internet forums and social networks according to three major criteria: the number of visits, the notoriety of the forum and th…

Dydrogesterone use during pregnancy: Overview of birth defects reported since 1977

2009

Between 1977 and 2005, 28 cases of potential links between maternal dydrogesterone use during pregnancy and congenital birth defects were reported. The types of defects were very diverse, with no evidence of a pattern of abnormalities. The data do not provide evidence for congenital malformations associated with dydrogesterone use.

French organization for the pharmacovigilance of COVID-19 vaccines: A major challenge.

2021

International audience; In this special issue, we present the main highlights of the first weeks of pharmacovigilance monitoring of coronavirus disease 2019 (COVID-19) vaccines in this unprecedented situation in France: the deployment of a vaccination during an epidemic period with the aim of vaccinating the entire population and the intense pharmacovigilance and surveillance of these vaccines still under conditional marketing authorizations. In this unprecedented situation, the cross approach and interaction between the French pharmacovigilance network and French National Agency for the Safety of Medicines and Health Products (ANSM) has been optimized to provide a real-time safety related …