ORGANIZATION OF A PHARMACOVIGILANCE SYSTEM IN THE DISTRIBUTION SEGMENT OF THE PHARMACEUTIC MARKET

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DOI: https://doi.org/10.29296/25419218-2018-07-07
Issue: 
7
Year: 
2018

B.K. Romanov(1, 2), A.E. Krasheninnikov(3) 1-N.I. Pirogov Russian National Research Medical University; 12, Ostrovityanov St., Moscow 117997, Russian Federation; 2-Research Center for Examination of Medical Products, Ministry of Health of the Russian Federation; 8, Petrovsky Boulevard, Build. 2, Moscow 127051, Russian Federation; 3-National Research Center of Pharmacovigilance; 2, Malaya Sukharevskaya Square, Build. 2, Moscow 127051, Russian Federation

Introduction. The Russian pharmacovigilance system, a national element of the World Health Organization for ensuring safe drug circulation, is based on the regulatory requirement for monitoring benefit/risk changes when using medicines at all stages of their circulation, including a distribution stage. Objective: to develop ways to improve the collection of information about adverse reactions by drug distributors on the basis of studies of their actual role in the pharmacovigilance system. Material and methods. The studies included an expert survey of pharmacovigilance managers at the level of state executive authority and registration certificate holders, as well as a questionnaire survey of pharmacy pharmacists. Results. The investigation of the effectiveness of pharmacovigilance interaction in the registration certificate holder-distributor system revealed the insufficient practical activity of distributors in the pharmacovigilance system. At the same time, it can be said that there is a channel for transmission of adverse reaction information from the pharmacy to the distributor in the pharmacovigilance system. Conclusion. It is necessary to improve the collection of information on adverse reactions in the pharmacovigilance of drug distribution, by introducing novel approaches to delegating pharmacovigilance powers in the sample agreement between drug manufacturers and distributors.
Keywords: 
pharmacovigilance
drug distributor
adverse reaction
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