The development of information channels for improving the processes of monitoring and analyzing information on the safety of medicinal products is an important critical process of pharmacovigilance and the duty of the authorized person for pharmacovigilance (FDA) at the manufacturer of medicinal products. As part of the effective implementation of this routine process in the company, algorithms for working with non-medical sources of information (social networks, data from non-specialized magazines, forums, websites of patient organizations, etc.) acquire a special role as an integral part of the modern interaction of participants in the FN system. Meanwhile, the formation of Form No. 682 when registering medicinal products is regulated by the Order of the Ministry of Health of the Russian Federation of September 7, 2016 No. 682n “On approval of the form of the document containing the results of monitoring the effectiveness and safety of a medicinal product for medical use carried out by the holder or owner of the registration certificate of the medicinal product or a legal entity authorized by him “
According to experts, more than 2.3 billion active users of social networks are currently registered, between whom a colossal amount of information is continuously exchanged, including data on health status and problems with the use of drugs. As part of good pharmacovigilance practice, the maximum number of adverse reactions should be taken into account when generating both Periodic Safety Update Reports and Form No. 682 when registering medicinal products.
A distinctive feature of information from the Internet and social networks is the format of an unofficial message about HP in the form of an unbiased review and opinion of a drug consumer sufficient for validation. The additional value of such an informal notification of HP is represented by the high frequency and ease of use of this information channel by drug consumers, the data transfer rate, the possibility of territorial analysis, identification of medical errors and the use of the drug for other purposes (“off-label”). Difficulties in working with these resources can be the ability to investigate data about HP, verify the sender of the message, and determine the exact timing for reporting (day “0”). According to sociological studies of the National Scientific Center for Pharmacovigilance, the percentage of mentions of data about HP in non-specialized sources can be up to 23% of all identified information on safety in databases. Given the globalization of the use of non-specialized information channels for the interaction of participants in the national pharmacovigilance system (drug manufacturers, distributors, pharmacy organizations, medical institutions, the population), the use of modern computer technologies in order to improve information algorithms for work in this direction is relevant for the timely identification of safety signals and the implementation of measures minimizing the risk of developing HP.
An equally promising direction in the development of information technologies in the pharmacovigilance system is the improvement of regional, national and international databases on safety (DB) as an international key tool for a reliable assessment of the benefit / risk ratio of the drugs used and a platform for creating conditions for early detection of signals and implementation of risk minimization measures the use of drugs. One of such significant information platforms at present is VigiBase (the database of the International Drug Safety Monitoring Program of the World Health Organization). A significant amount of processed information, limited resources will be catalysts for the active implementation of modern IT technologies, improving the processes of automating monitoring algorithms, assessment, detection of duplicate HPs and searching for drug safety signals. This data will also contribute to the formation of both Periodic Safety Update Reports and Form No. 682 for registration of medicinal products.