Pharmaceuticals for human use in circulation in the Russian Federation are subject to monitoring of efficiency and safety in order to identify possible negative consequences of their use, individual intolerance, prevention and protection of health workers and patients from the use of such drugs.

Pharmacovigilance is a type of activity to monitor the efficacy and safety of drugs, aimed at identifying, assessing and preventing undesirable effects of drug use.

In Russia, monitoring within the framework of Pharmacovigilance is carried out by the Federal Service for Surveillance in Healthcare (Roszdravnadzor) and includes the organization and conduct of inspections of compliance with the requirements to storage, transportation, release, sale of medicines, as well as requirements for their use.

It is worth noting that the creation of a monitoring mechanism for drugs began in the 1960s after the “talidomide tragedy”. This story began on October 1, 1957, when Grüenthal launched a new Talidomide drug called Contergan. The drug had a pronounced sedative and sleeping effect, showed good tolerability and was not addictive. Since Contergan was considered a safe drug, it was assigned to pregnant women in the first trimester.

However, in 1961 W. Lenz, a pediatrician from Hamburg, informed Grünenthal about the possible relationship between the use of talidomide among pregnant women and congenital malformations in newborns. After 12 days, the company withdrew the drug from the market. However, during the four years of Contergan’s entry into the European market, talidomide has caused severe congenital malformations in about 10,000 children.

In Russia, the national system of Pharmacovigilance began working more than 20 years ago with the development of a form of notification of undesirable reaction (UR). In addition, a network of regional monitoring centers for the safety of drugs was established and Russia’s participation in the WHO international monitoring program was initiated.

В настоящий момент на сайте Росздравнадзора функционирует автоматизированная система «Фармаконадзор» (http://www.roszdravnadzor.ru/services/npr_ais), предназначенная для сбора и анализа информации о случаях побочных действий, не указанных в инструкции по применению ЛП, о серьезных нежелательных реакциях, непредвиденных нежелательных реакциях при применении ЛП, об особенностях взаимодействия ЛП с другими ЛП.

Employees of Roszdravnadzor, specialists of involved expert organizations, employees of monitoring centers of drugs, responsible employees of pharmaceutical organizations and other healthcare professionals have access to the system.

In addition, in 2017 the order of Roszdravnadzor № 1071 “On the procedure for the implementation of pharmacovigilance” was adopted. The purpose of this order is to bring national requirements for express reporting, periodic reporting in accordance with the norms of GVP (Good Pharmacovigilance Practice). The order also expanded the range of situations subject to urgent reporting. The mandatory provision of information on life-threatening and lethal undesirable reactions has been reduced to three working days.

Pharmacovigilance is carried out by Roszdravnadzor on the basis of information received in the form of:

• Messages of subjects of treatment of drugs
• Periodic Safety Reports (PSP), which are sent by the RC holders or authorized representatives (AR).
• Periodic safety report of the developing drugs (PSRDD), sent by legal entities in whose name a sample import permission has been issued or legal representatives.
• Information obtained in the course of state control in the field of treatment of drugs.

Periodicity and timing of reporting shall be determined according to the list of pharmaceuticals for human use.  For drugs whose international generic name (INN) is not included in this list, the periodicity of PSP is as follows:

– every 6 months from the first date of registration in the world for the first 2 years;

– annually for the next 2 years;

– then every 3 years.

References:

1. Федеральный закон “Об обращении лекарственных средств” от 12.04.2010 N 61-ФЗ (последняя редакция)
2. Приказ Росздравнадзора от 15.02.2017 № 1071 «Об утверждении Порядка осуществления фармаконадзора»
3. Белоусов Ю.Б. Постмаркетинговая безопасность лекарств -фармаконадзор/Ю.Б. Белоусов, А.Н. Грацианская//Лечебное дело. -2007. -№2. -С. 17-22.
4. http://www.roszdravnadzor.ru/services/npr_ais

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©Beawire – June 2019.