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There are a few stages in development of global pharmacovigilance system. These stages include evolution from establishment of first regional institutions such as Food and Drug Administration in USA in 1862 to formation of international systems for adverse drug reactions monitoring (i.e. WHO collaborating center in Sweden Uppsala Monitoring Center); from local regulatory acts, such [...]

A significant role in the development of adverse drug reactions in childhood belongs to ignoring officially approved instructions for medication use. The main medications prescribed «off-label» are cephalosporins; most frequent in pediatric practice are cases of an irrational choice of doses, and also violation of the drug introduction schedule. In order to improve the quality of drug therapy in childhood further development and improvement of the pharmacological surveillance system is necessary.

Matveev A.V., Krasheninnikov A.E., Egorova E.A. Timely high-quality detection, collection and analysis of information on adverse drug reactions is possible only with the presence and active functioningof pharmacovigilance system. One of the most effective methods used to control drug safety is the system of registration and analysis of spontaneous reports. The article is devoted to [...]

DOI: 10.15690/vsp.v18i3.2032 Background. Nonsteroidal anti-inflammatory drugs safety profile (NSAIDs) is well-studied in clinical trials. Meanwhile, the monitoring of adverse effects (AEs) of this drug class and analysis of AEs structure in pediatrics is essential. Our aim was to study AEs related to NSAIDs in children. Methods. Retrospective analysis of doctor reports about AEs associated with drugs from N02B and M01A [...]

Yu. V. Olefir, B. K. Romanov, R. N. Alyautdin, V. K. Lepakhin,A. E. Krasheninnikov, E. V. Shubnikova The risk-based approach to pharmacovigilance control implemented in Russia since January 1, 2018 increases the responsibility of manufacturers and developers of medicines. The purpose of the work is to assess the system of Express reporting and Periodic reporting [...]

The aim of study was to analyze and investigate the severity of adverse reactions (AR) on drugs used for arterial hypertension treatment in patients living in the Republic of Crimea for the period 2011—2016.Materials and methods. We studied notification cards about AR registered in the regional database of spontaneous messages ARCADe. We analyzed 211 notification cards about AR in [...]