Preview

Vestnik of North-Eastern Federal University. Medical Sciences

Advanced search

DETECTION OF DRUG-ASSOCIATED ADVERSE EVENTS IN FRANCE

https://doi.org/10.25587/SVFU.2019.4(17).54743

Abstract

Pharmacovigilance is an activity relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. The risk of side effects exists with any medication. The article describes of the organization of a pharmacovigilance system in France as a part of a common European system where using standard methods and technologies for recording drug-associated adverse events. The authors describe different levels of organization of pharmacovigilance, the movement of information in the system. The regional pharmacovigilance centers are the main unit whose tasks include collecting information from patients and healthcare professionals, evaluating and documenting this information, and transferring it to the National Health Agency. In addition, the Centers also train students, pharmaceutical workers, healthcare practitioners, members of the public and patients. It is shown that a feature of the French system for monitoring side effects of drugs is the assessment of causality, relation between taking the drug and the manifestation of side effects. To record these events, artificial intelligence technologies are widely used, in the form of Internet portals for medical workers and patients.

About the Authors

M. Drici
Department of Clinical Pharmacology and Centre Régional de Pharmacovigilance University of Nice-Côte d’Azur Medical Center, Nice, France
Russian Federation


T. Klimova
Institute of Medicine, M.K.Ammosov North-Eastern Federal University
Russian Federation


References

1. Montastruc JL, Sommeta A, Lacroix I, Oliviera P, Durrieu G, Damase-Michel C, Lapeyre-Mestre M, Bagheri H. Pharmacovigilance for evaluating adverse drug reactions: value, organization, and methods. Joint Bone Spine 2006; 73: 629-632.

2. Begaud B, Evreux JC, Jouglard J, Lagier G. Imputation of the unexpected or toxic effects of drugs: actualization of the method used in France. Therapie 1985; 40:111-8.

3. https://www.ema.europa.eu>committees as accessed on June 3rd 2019

4. Viard D, Parassol-Girard N, Romani S, Van Obberghen E, Rocher F, Berriri S, Drici MD. Spontaneous adverse event notifications by patients subsequent to the marketing of a new formulation of Levothyrox® amidst a drug media crisis: atypical profile as compared with other drugs. Fundam Clin Pharmacol. 2018 [doi: 10.1111/fcp.1244].


Review

For citations:


Drici M., Klimova T. DETECTION OF DRUG-ASSOCIATED ADVERSE EVENTS IN FRANCE. Vestnik of North-Eastern Federal University. Medical Sciences. 2019;(4):50-56. (In Russ.) https://doi.org/10.25587/SVFU.2019.4(17).54743

Views: 96


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.


ISSN 2587-5590 (Online)