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Safety and Risk of Pharmacotherapy

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COMPARATIVE EVALUATION OF INFORMATION ON ADVERSE REACTIONS TO MEDICINES

Abstract

Comparative evaluation of information about adverse reactions to medicinal products was carried out on the basis of the research data registered in specialized databases WHO, Russia, Switzerland, USA and the Republic of Kazakhstan. Comparative evaluation of the results of safety monitoring medicines showed that in the Russian Federation the average reporting about adverse reactions below the level recommended by WHO and countries with the most effective system of pharmacovigilance, such as the USA or Switzerland, but higher than in the Republic of Kazakhstan.

About the Authors

V. K. Lepakhin
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products», Ministry of Health of the Russian Federation
Russian Federation


A. P. Pereverzev
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products», Ministry of Health of the Russian Federation
Russian Federation


B. K. Romanov
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products», Ministry of Health of the Russian Federation
Russian Federation


References

1. WHO Collaborating Centre for Drug Monitoring. URL: http://www.who-umc.org (cited 2014 Dec 22) (in Russian).

2. Global patterns of adverse drug reactions over a decade: an alyses of spontaneous reports to VigiBase™ / L. Aagaard, J. Strandell., L. Melskens [et al.] // Drug Saf. 2012. V. 35. P. 1171–1182.

3. Harmonization of information on identified in Russia unwanted side reactions with the results of monitoring drug safety, conducted by WHO and other intern ation al organizations: research report (intermediate) / FSBI "SCEEMP" of Ministry of Health of the Russian Federation; Mironov A.N.; Romanov B.K. [et al.]. M., 2013. 189 p. SR № 01201275291. Inv. № DC 643 980 (in Russian).


Review

For citations:


Lepakhin V.K., Pereverzev A.P., Romanov B.K. COMPARATIVE EVALUATION OF INFORMATION ON ADVERSE REACTIONS TO MEDICINES. Safety and Risk of Pharmacotherapy. 2015;(1):30-36. (In Russ.)

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ISSN 2312-7821 (Print)
ISSN 2619-1164 (Online)