A significant amount of data from spontaneous messages about drug abuse, detected at the stages of clinical trials and post-registration circulation, as well as the legal requirements of the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union (EAEU), contribute to the introduction of information technologies in the system for collecting and analyzing messages about drug abuse by marketing authorization holders (DRU ). In this regard, the pharmacovigilance documents, pharmacovigilance standard operating procedures (SOPs) and the master file should be unified as much as possible.

The effectiveness of the use of DRUs of such information technologies in the pharmacovigilance system was previously assessed by pharmaceutical companies in the EU and the USA, where special automated pharmacovigilance programs have been used by drug manufacturing companies for several years. The volume of the software market for pharmacovigilance, according to the research organization Grand View Research, in 2015 alone was estimated at 117.3 million US dollars. The forecast for 2024 is USD 207.3 million, with the main growth in demand expected in the BRIC countries (Brazil, Russia, India, China). Among the suppliers of software for automating pharmacovigilance processes are Oracle, ArisGlobal, Ennov and FlexDatabase. All of them worked on the pharmacovigilance documents, pharmacovigilance standard operating procedures (SOPs), and the master file form. The expediency of using information technologies by the holders of registration certificates is due to the possibility of optimizing pharmacovigilance processes and ensuring the effective implementation of one of the critical processes of the pharmacovigilance system: procedures for working with individual messages about NR drugs (collection, processing, management, quality control, obtaining missing data, classification, control data duplication, assessment and timely data reporting). The limiting factors of software implementation at DRU are the cost of its cost, the need for individual additional program settings and special training of the employee.

A significant increase in the number of spontaneous reports of adverse drug reactions requires the introduction of information technology in order to improve the pharmacovigilance system. Harmonization of pharmacovigilance documents, pharmacovigilance standard operating procedures (SOPs) and master file is an integral part of this process. Over the past 30 years, there has been a transition from local (regional) databases to unified consolidated information systems for drug safety. Distinctive advantages of such systems are the use of harmonized forms for reporting HP on drugs, ensuring the possibility of automated exchange of information and increasing, when using them, the number of subjects of drug circulation reporting about HP (health professionals, pharmacy organizations, the population). The organization and maintenance of databases of NR DRU is a regulatory requirement of the Rules of Good Pharmacovigilance Practice of the EAEU. Methods for collecting and analyzing information about HP (paper media, Microsoft Office programs) widely used in the drug safety system may not ensure the high-quality performance of the critical pharmacovigilance process. The introduction of automated software products for working with HP on DRU drugs allows you to optimize and effectively manage the process of working with HP in the pharmacovigilance system and provide a systematic approach to the implementation and maintenance of the pharmacovigilance quality system at an appropriate level.

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

Bulletin of VolgGMU.pdf