Search results for "PHARMACOVIGILANCE"

Adverse drug reactions in children reported by means of the yellow card in Spain.

2000

Abstract Objective: To analyze the case reports concerning children (14 years or younger) in the Spanish Pharmacovigilance System over a 10-year period (1982–1991). Findings: The study of 1419 reports of adverse drug reaction (9.8% of all those received) showed the most commonly involved organs and systems to be the skin, digestive tract, and nervous system (62.8%). The most commonly involved pharmacological groups were antibiotics, respiratory medications, and vaccines (69%). The absolute number of reports is higher in children between 1 and 4 years of age (37.9%). There were more reports among males than in females. Less than 5% of the reports notified directly life-threatening or fatal r…

Rivaroxaban-induced hepatotoxicity

2017

Aim/Objective/Background Direct-acting oral anticoagulant drugs are marketed worldwide for the primary and secondary prevention and treatment of thromboembolic disorders. Rivaroxaban, an oral, direct factor Xa inhibitor, is one of the most used. Rivaroxaban-induced hepatotoxicity is unusual, although a number of adverse reports have recently been reported. Here, we report two new cases of rivaroxaban-induced hepatitis. Methods A systematic search of case reports on the MEDLINE database encompassing the years 2008–2016 was carried out.Additional references were obtained following a manual search of the retrieved papers. We report two new cases of adverse events occurred in patients treated w…

Impact of physicians’ participation in non-interventional post-marketing studies on their prescription habits: A retrospective 2-armed cohort study i…

2020

Background Non-interventional post-marketing studies (NIPMSs) sponsored by pharmaceutical companies are controversial because, while they are theoretically useful instruments for pharmacovigilance, some authors have hypothesized that they are merely marketing instruments used to influence physicians’ prescription behavior. So far, it has not been shown, to our knowledge, whether NIPMSs actually do have an influence on prescription behavior. The objective of this study was therefore to investigate whether physicians’ participation in NIPMSs initiated by pharmaceutical companies has an impact on their prescription behavior. In addition, we wanted to analyze whether specific characteristics of…

Pharmacy and pharmacology of biosimilars

2008

Biosimilar medicines are biological medicinal products that can obtain a marketing authorization in the EU after the original product (biological reference medicine) has run out of patent. As a prerequisite, studies including clinical trials are to be conducted to compare the quality, safety, and efficacy of the biosimilar and reference medicine. Due to the specific characteristics of biopharmaceuticals like complex 3-dimensional (glyco) protein structure, immunogenicity, production in living organisms, which causes heterogeneity, complex manufacturing process and analysis, interchangeability of the biosimilar with its reference drug product is not guaranteed. In addition, INN (internationa…

11.5 Blood Pressure Control and Anti-Hypertensive Drugs in 490 Patients with Hypertension and Chronic Kidney Disease

2008

Pharmacovigilance européenne, un système aux multiples visages

2016

International audience; Le système européen de pharmacovigilance fait actuellement cohabiter des systèmes étatiques avec un système central ; or de nombreuses disparités existent entre les différents États membres de l’Union européenne. À travers une étude du niveau central européen puis de quatre systèmes nationaux - différents se trouve mise en évidence la complexité globale d’une telle organisation. Dès lors, se pose la question de l’efficience d’un tel système et des recommandations sont émises pour améliorer cette dernière.

Data for: Cataracts and statins. A disproportionality analysis using data from VigiBase

2019

The file include the number of Individual case safety reports for ICSRs contained in the World Health Organization (WHO) global database of individual case safety reports (VigiBase) in which the following MedDRA preferred terms (PTs): “Cataract”, “Cataract cortical”, “Cataract nuclear” and “Cataract subcapsular” were reported for HMG-CoA reductase inhibitors according to the anatomical therapeutic chemical classification (ATC: C10AA) between inception on Nov 14, 1967, and Jan 15, 2019. Fixed-dose combinations of statins with other drugs were not considered. We also searched for ICSRs for the PTs mentioned above and prednisolone as a positive control – a drug previously known to cause catara…

La formation des professionnels de santé pour une efficience de la pharmacovigilance : une analyse juridique d'un système en manque de pédagogie

2014

Pharmacovigilance is a fundamental discipline for safety and confidence in the medicines. This discipline has evolved over time, and has been strengthened, but still suffers from imperfections. We proposed through this work to provide an original solution for its improvement.In the first part, we describe and analyze the evolution of pharmacovigilance and its current functioning from both the legal and the scientific point of view and at both national and European levels. We analyzed the legal and practical weaknesses and have formulated proposals to address them. Then we review a number of possibilities before developing in the second part an original approach: pedagogy. Having established…

Could telemedicine enhance traditional medicine practices?

2014

International audience; In developing countries, telemedicine and mobile health tools promise to enhance access to high-quality healthcare, to support communication of medical information and to assist pharmacovigilance processes. In this article, we provide some arguments on the potential of telemedicine and mobile health (mHealth) applications to improve the delivery of health care in rural African regions. Specifically, the development of mobile telemedicine could help to lay the foundations of a healthcare approach integrating modern medical knowledge with ancient medical practices on the African continent. Access to information and communication technology (ICT), technical devices or p…

Thrombotic complications of vaccination against SARS-CoV-2: what pharmacovigilance reports tell us – and what they don't

2021

In the present issue of the Journal [1], Smadja et al. present an analysis of global pharmacovigilance reports of thrombotic events following severe acute respiratory distress syndrome coronavirus (SARS-CoV)-2 vaccination. More specifically, the authors analysed the data entered into the World Health Organization (WHO) Global Database for Individual Case Safety Reports (VigiBase) between December 13, 2020 and March 16, 2021, covering, at that time, a population of almost 362 million vaccinated individuals across the world. The study focuses on three of the coronavirus disease (COVID)-19 vaccines available to date, namely the Pfizer-BioNtech (BNT162b2), Moderna (mRNA-1273), and OxfordAstraZe…