45 research outputs found
Complémentarité des méthodes numériques et symboliques en pharmacovigilance
National audienceLa pharmacovigilance a pour objet la surveillance du risque d'effet indésirable résultant de l'utilisation des médicaments et produits à usage humain. Elle consiste à détecter des « signaux » correspondant à des corrélations suspectes entre la prise d'un médicament et l'observation d'un effet indésirable. Les professionnels de santé sont tenus de signaler tout effet indésirable inattendu en envoyant un rapport a leur centre régional de pharmacovigilance, alimentant ainsi une base nationale. Pour faire face à la quantité de rapports stockés, des méthodes numériques fondées sur des mesures de disproportionnalité été proposées ; elles extraient efficacement les couples (médicament, effet indésirable) sur-représentés dans la base, en vue de leur evaluation par un expert. Toutefois, ces approches fournissent peu d'information aux experts pour leur permettre de comprendre pour quelles raisons ces signaux ont eté retenus. De plus, aucune information ne leur est transmise concernant la spécificité eventuelle d'un signal qui concernerait plus particulièrement une sous-population (sexe, âge). L'utilisation d'une approche symbolique comme l'Analyse de Concepts Formels (ACF), en complément des méthodes numériques existantes, nous a permis d'obtenir une meilleure « tracabilité » des signaux extraits en fournissant aux experts une vue synthétique du contenu de la base. De plus, l'utilisation d'une approche fondée sur les treillis permet de réduire l'espace de recherche, de détecter des associations complexes impliquant plusieurs médicaments et effets indésirables et d'identifier les spécificités liées aux diverses sous-populations. Nous illustrons ces atouts par une expérimentation sur la base régionale HEGP
A Knowledge Management Platform for Documentation of Case Reports in Pharmacovigilance
Most countries have developed information systems to report drug adverse effects. However, as in other domains where systematic reviews are needed, there is little guidance on how systematic documentation of drug adverse effects should be performed. The objective of the VigiTermes project is to develop a platform to improve documentation of pharmacovigilance case reports for the pharmaceutical industry and regulatory authorities. In order to improve systematic reviews of adverse drug reactions, we developed a prototype that first reproduces and standardizes search strategies, then extracts information from the Medline abstracts which were retrieved and annotates them. The platform aims at providing transparent access and analysis tools to pharmacovigilance experts investigating relevance of safety signals related to drugs. The platform's architecture consists in the integration of two vendor tools ITM® and Luxid® and one academic web service for knowledge extraction from medical literature. Whereas a manual search performed by a pharmacovigilance expert retrieved 578 publications, the system proposed a list of 229 publications thus decreasing time required for review by 60%. Recall was 70% and additional developments are required in order to improve exhaustivity
Efficacy of prothrombin complex concentrates for the emergency reversal of dabigatran-induced anticoagulation
Clin Pharmacol Ther
Using claims databases of a public healthcare program (Quebec) for the years 2010–2013, we conducted a cohort study of patients with acute ischemic stroke (AIS) to describe secondary prevention treatments and determine how they stood against practice guidelines. We compared the risk of death or AIS recurrence over 1 year in patients treated with anticoagulants, antiplatelets, and/or other cardiovascular drugs. In the month after discharge, 44.3% of the patients did not receive the recommended treatment and > 20% did not have any treatment. Untreated patients were younger, had less comorbidities, and a more severe AIS. Anticoagulants and antiplatelets were associated with a reduced risk of death or recurrence (hazard ratio (HR) 0.27; 95% confidence interval (CI) 0.20–0.36 and HR 0.25; 95% CI 0.16–0.38, respectively) compared with the untreated group. Effect size was similar for the other treatments. Findings confirm treatment benefits shown in clinical trials and emphasize the importance of AIS secondary prevention
Vestibular disorders following BNT162b2 mRNA COVID-19 vaccination: A retrospective case series
International audienceBackground: There are few publications regarding manifestations of vestibular disorders (VDs) following BNT162b2 mRNA COVID-19 vaccination. Purpose: We describe cases of VD potentially related to BNT162b2 vaccination and calculate its reporting rate, in order to enlarge knowledge about this adverse effect. Methods: A retrospective analysis of cases of VD following BNT162b2 vaccination reported to the pharmacovigilance centre of Georges-Pompidou European Hospital (France), in 2021 was performed. In order to identify these cases from the pharmacovigilance database containing all our registered cases, we used the Standardised MedDRA Query (SMQ) ‘vestibular disorders’. Then we analysed cases with vestibular symptoms, based on the association of typical manifestations. The reporting rate was calculated based on the number of VD cases and the number of vaccinated patients. Results: Among 6608 cases reported to our centre related to COVID-19 vaccines during 2021, 34 VDs associated with BNT162b2 administration were included. They were mainly reported in females (79%), 62% occurred after the first dose and 32% were serious. Symptoms had completely resolved in 13 cases (38%). Vertigo was the most common symptom followed by balance disorders. Three patients received second dose without reappearance of VD. The final diagnosis was reported in 10 patients (six cases of vestibular neuritis, two cases of central VD, two cases of benign paroxysmal positional vertigo). The regional reporting rate was 26 [95% CI: 17–34] cases of VD per 1 million persons vaccinated. Conclusion: Although the relationship between vaccination and VD cannot be established, clinicians should be aware of this rare adverse effect
VigiTermes : une plateforme de recherche et d'analyse des publications scientifiques au service de la pharmacovigilance
National audienceLa réglementation impose une identification systématique des effets indésirables des médicaments. La plupart des pays se sont dotés de systèmes d'information d'aide à la documentation de ces effets. La tâche est rendue difficile par la multiplicité des sources et le peu d'outils fédérateurs existant pour accéder, rechercher et analyser l'information autour des médicaments. L'objectif du projet VigiTermes est de développer une plateforme pour améliorer la documentation des rapports de cas de pharmacovigilance et de proposer des outils d'accès et d'analyse pour les experts pharmacovigilants, dont l'objectif est d'enquêter sur la détection de nouveaux cas (signaux). Dans ce cadre, nous avons développé un prototype qui reproduit et standardise les stratégies de recherche documentaire formulées par les pharmacovigilants, récupère les résumés PubMed pertinents et en extrait de l'information autour des médicaments et de leurs effets secondaires potentiels