As of today, pharmacovigilance, as the system of measures aimed at study, assessment and prevention of adverse effects of pharmacotherapy, is one of the promising tools of safety improving and optimization of therapy in general. The urgency and need for an effective pharmacovigilance system is due to a significant role of this component in addressing medico-social problems related to both pharmacological and toxicological properties of medicinal products and other unwanted effects of their application, including deviations of quality, consequences of medical errors, applications not according to the established indications, sale on the Internet and many others. The effectiveness of the pharmacovigilance system is a timely detection of adverse deviations of safety profile of medicinal products and realization of the necessary measures to ensure their application when the benefits exceed the risk.
There are no doubts that the monitoring of safety of medicinal products сan be successful only on condition of its global implementation by combining as many countries as possible into a unified system of data collection on unwanted effects of pharmacotherapy, signal processing and detection of the safety profile change. Over the period of 47 years, this problem is being solved by the World Health Organization with direct involvement of the WHO Collaborating Centre for International Drug Monitoring, located in Uppsala. The WHO Programme units 151 countries, the database includes information on 11 million of adverse reactions and represents a powerful tool of the fastest identification of all risks not previously revealed, associated with the application of medicinal products.
The 38th Annual Meeting of Representatives of National Pharmacovigilance Centers participating in the WHO Programme for International Drug Monitoring, which was attended by the representatives of the Center for Examinations and Tests in Health Service, was held in November 2015, in New Delhi (India). The experts from different countries discussed a number of topical issues of pharmacovigilance, including the optimization of approaches for identification and validation of signals (new information on safety), implementation of methods of active monitoring of safety, approaches for the analysis of the reasons of risk occurrence and reduction of medical errors, development of new tools for working with security databases, development and introduction of effective ways of risk minimization and much more. The Meeting showed the effectiveness of the global as well as national pharmacovigilance system, demonstrated a tendency toward a continuous development and improvement of the tools used for monitoring and ensuring safety of pharmacotherapy, shaped the prospects for further efficiency improvement of the national systems, confirmed the strategic focus on precautionary risk management of the pharmacovigilance system at the global and national levels. When evaluating the work of the member countries of the Programme, the level of quality of safety data submitted by the Republic of Belarus was noted as one of the highest.
During the expired period, a considerable work on improvement and enhancement of effectiveness of the pharmacovigilance system was carried out in our country; the legislative framework corresponding to the level of the best international practices was developed and implemented; the projects of the active safety monitoring were executed; every effort is made in order to increase the degree of involvement of health and pharmaceutical workers into the work on pharmacovigilance and awareness of responsibility of manufacturers for efficacy and safety of the produced medicinal products. We hope that the joint efforts of all parties concerned will contribute to the creation of the system of ensuring the maximum patient safety and protection against all unreasonable risks connected with the application of medicinal products.