According to the WHO rules, monitoring and transfer of information about AD drugs to the VigiBase database can only be carried out by National Pharmacovigilance Centers organized in different countries. Pharmacovigilance documents, pharmacovigilance standard operating procedures (SOPs), master file – all this should be formed according to the same rules.

Each country wishing to become a member of the WHO International Drug Safety Monitoring Program is obliged to organize a database (an administrative system for storing and retrieving data on ADS) and through it submit information on AD drugs to the VigiBase database. According to the website of the Center for International Monitoring of Medicines of WHO, as of November 2017, VigiBase contained more than 16 million reports of suspected HP for medicines, including vaccines and biological products, from 131 countries. Simultaneously with the functioning of a unified database of HPs, each country organized and improved a local system for collecting and processing information on HP for medicines. For example, in the USA in 1969, to monitor the safety of drugs, the FAERS database (FDA Adverse Event Reporting System) was created, containing reports of adverse events in the use of food and drugs, operating on the basis of data provided by the US Food and Drug Administration. sanitary supervision over the quality of food and drugs (Food and Drug Administration, FDA).

The transition to electronic filing of drug safety reports in 1997 provided an increase in the number of HP reports entered into the system from drug manufacturers, healthcare professionals (doctors, pharmacists, nurses) and drug consumers. The number of pharmacovigilance master files and documents has also increased significantly, and pharmacovigilance standard operating procedures (SOPs) have become routine. FAERS is the world’s largest publicly available repository of drug adverse reaction data, with more than 4 million HP reports.

Unlike the United States, the history of creating a single Eudravigilance database for monitoring drug safety in the European Union (EU) began with the creation of local databases on the territory of individual countries. For example, in France, since 1985, the French PharmacoVigilance Database (FPVD) has been operating, containing information on all cases of HP registered since 1984 by regional pharmacovigilance centers located in clinical departments of university hospitals. The specificity of the location of the regional centers and the requirements of French law have led to the fact that the main reporters of data on cases of serious or unexpected adverse reactions are medical practitioners. Thanks to the work of health professionals, between January 1990 and June 2007, nearly 260,000 AD cases for drugs were entered into the French pharmacovigilance database. Pharmacovigilance documents, pharmacovigilance standard operating procedures (SOPs) and a master file according to a single standard allow to unify processes and increase system efficiency.

A.E. Krasheninnikov, A.V. Matveev, E.A. Egorova

Bulletin of VolgGMU.pdf