Security monitoring

Promotion of effective, safe and rational use of medicines in national medical practice by assessing the risks of adverse reactions in the course of medical care in medical institutions, identifying factors that increase the risk of such reactions, developing proposals for optimizing pharmacotherapy, consulting healthcare professionals and industry on the safety of medicines.

Information-analytical and expert support of measures for monitoring the safety of medicines

Information-analytical and expert support for measures to monitor the safety of medicines is regulated by Section 1 of The state task for the Institution for 2014 and the planning period 2015 and 2016, which was approved by the Federal service for supervision of health care on 27.12.2013.

The execution of the specified section of the State Assignment at the Institution in 2014 was carried out by the Center for Monitoring the Effective, Safe and Rational Use of Medicines (6 staff units). As part of the implementation of Section 2 of the State Assignment, 52 weekly reports and 12 monthly reports were generated and prepared; Pharmakonadzor database of AIS of Roszdravnadzor was updated daily - 249 updates. Also, the Center translated 34 scientific and practical publications into Russian as part of the activities regulated by the State Task and prepared 1 methodological recommendation on the organization of a pharmacovigilance system in healthcare institutions. In addition, the Center staff participated in the preparation of 7 articles on various aspects of drug safety monitoring, as well as an information letter on the organization of a pharmacovigilance system.

These indicators are shown in Table No. 1

Table No. 1 Quantitative performance indicators of Section 2 of the State Assignment.
Report Value
Database Updates 249
Weekly Report 52
Monthly Report 12
Translation of Scientific and Practical Publications 34
Guidelines for the organization of a pharmacovigilance system in healthcare institutions 1
Participation in the preparation of articles and newsletters 8

In addition, the Center constantly monitored the sites of foreign regulatory agencies in order to identify new data on the safety of medicines registered and approved for use in the Russian Federation. Based on the results of the monitoring, 32 new drug safety problems were identified, in some cases confirmed by reports of adverse reactions in the AIS of Roszdravnadzor. This information was submitted to Roszdravnadzor as part of weekly and monthly reports in order to submit it to the Ministry of Health of the Russian Federation for decision-making on the need to amend the instructions for medical use.

According to the results of an expert analysis of reports of adverse reactions recorded in the AIS of Roszdravnadzor, 20 cases were identified that were potentially associated with medicine quality problems.

Information about them was transmitted to Roszdravnadzor as part of weekly reports to consider the need for organizing quality control of suspected batches of medicines.

Statistical data on monitoring the safety of drugs is shown in diagrams No. 1 and No. 2

Диаграмма №1. Динамика поступления сообщений о нежелательных реакциях лекарственных препаратов в течение 2014 года
Диаграмма №2. Динамика поступления сообщений о нежелательных реакциях лекарственных препаратов в период 2010 – 2014г.г.