The Development of Pharmacovigilance system in Russia

The problem of drug safety is extremely important. Adverse reactions that occur with the use of drugs are not only dangerous for the patient, but also have a negative impact on the whole health care system. Russia is one of the ten countries with the highest consumption of drugs. According to the WHO Regional Office for Europe, the risk of complications as a result of drug therapy is 1 in 300. Large consumption of drugs entails the need for careful monitoring of the safety of their use, since mortality due to complications of pharmacotherapy is already in fourth place in the world. Pharmacovigilance is an activity related to the identification, assessment and prevention of adverse reactions and any other problems associated with a drug. Our country has gone through a difficult path in the formation of the pharmacovigilance system - from a centralized system in the USSR, the lack of collection of ICSR in the 90s of the 20th century to joining the WHO Program in 1997 and the gradual folding of both the legislative framework of the pharmacovigilance and the system of regulatory bodies in the field of monitoring of drug safety. With the advent of Good Pharmacovigilance Practice in 2016 and the harmonization of the domestic regulatory and legal framework of the PV, the number of ICSR has increased. As a result of the survey of medical, pharmaceutical workers and drug consumers, it was revealed how weakly they are involved in the drug safety monitoring system in our country. The respondents do not know how the system for collecting adverse reactions to drugs is arranged and, accordingly, practically do not report on emerging adverse reactions to drugs to the regulatory agency - Roszdravnadzor. An analysis of the work of the pharmacovigilance departments of two companies showed a low receipt of spontaneous messages and the formal operation of the pharmacovigilance system. The problems of the PV system include not only a small number of ICSRs, the lack of involvement of participants in the drug circulation system in the PV and poor motivation of companies to collect ICSR, but also the absence of a coherent system for monitoring the safety of drugs at the level of medical organizations. A complex system of relations between regulators in the field of drug circulation, the lack of an available base of adverse reactions to drugs, introduces additional chaos into the system of drug abuse. The improvement of the PV system, in our opinion, must begin with a change in the attitude towards the safety of drug therapy in general and the global introduction of pharmacovigilance into the health care system. It is necessary to create new centralized, integrated approaches to increase the involvement and awareness of all drug consumers and manufacturers, doctors and pharmworkers in the system for collecting adverse reactions. This can be facilitated by the introduction of software products into the system for collecting ICSR, studying the PV and medicinal product safety issues in educational institutions, increasing the convenience of submitting notifications about ICSR, creating a medicinal product safety monitoring system at the level of medical organizations, reforming the medicinal product safety monitoring system at the level of medicinal product manufacturers, creation of a single regulatory agency for the circulation of medicinal drugs in Russia.