METHOD OF SPONTANEOUS REPORTS AS AN INSTRUMENT CONTROLING WIDELY USED INTERCHANGEABLE DRUGS


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Abstract

Method of spontaneous reports was used to identify adverse reactions associated with the replacement of the drugs with the same international nonproprietary name. The analysis of 7224 spontaneous reports in Russian data base for the period from 1 January 2015 to 30 June 2015 was done. Information about adverse reactions that occur when there was the replacement of drugs was detected in 1.9% of cases. The obtained results allowed to detect the following groups of drugs for which it was revealed the largest number of spontaneous reports of adverse reactions associated with the replacement of drugs: anti-epileptic drugs (45.9%), drugs with a narrow therapeutic index (39.2%), biologic drugs (3.7%), pancreatin (4.4%), ipratropium bromide+fenoterol (2.2%), drugs used in pediatrics (34.1%). Data that were obtained via method of spontaneous reports can be used for the primary and repeated evaluation interchangeability of medicinal drugs.

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About the authors

E. Pasternak

Email: Pasternak@expmed.com
Scientific Centre for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation Moscow

K. Zatolochlna

Candidate of Medical Sciences Scientific Centre for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation Moscow

R. Alyautdln

Professor MD Scientific Centre for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation Moscow

Yu. Oleflr

MD Scientific Centre for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation Moscow

B. Romanov

MD Scientific Centre for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation Moscow

I. Asetskaya

Candidate of Medical Sciences Informational-Methodological Center for the Expertise, Accounting and Analysis of Medical Products Circulation under Roszdravnadzor Moscow

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