Following the rules of good practice for pharmacovigilance of the Eurasian Economic Union, one of the processes for documenting the critical process of working with HP at the manufacturer of medicinal products, which should be reflected in the Master File of the FN System (MFSF) – the main document of the pharmacovigilance system, is the availability and maintenance of an up-to-date and validated manufacturer’s safety databases in paper and / or electronic form. This is the main form of pharmacovigilance reporting.
Pharmacovigilance reporting – the basis for the formation of the completeness of the data of the information system on the safety of the drug manufacturer is made up of messages about HP and cases of lack of effectiveness obtained from a sufficient number of sources (consumers, healthcare professionals, company employees, etc.). The main sources of information on HP remain the data received from healthcare professionals and drug users (over 40%). However, the effective implementation of this mechanism of the pharmacovigilance reporting system is hampered by constraints at the levels of each of the participants. One of the reasons hindering the activity in the reporting of safety data by experts from medical institutions (MPI) and pharmacy organizations is the limited time and human resources, difficulties in working with HP due to a lack of information on pharmacovigilance, and the laboriousness of filling out formalized HP notification forms.
The analysis of the citizens’ position of consumers in terms of pharmacovigilance reporting showed that the main limiting factor is the lack of channels and structured information on the safety of drugs used in healthcare organizations and the media. Improvement of the formats of timely notification and receipt of feedback from drug consumers on PH issues, as well as the development of mobile technologies, will allow to adapt and increase the number of collected HP in order to form a sufficient pool of spontaneous messages and early detection of safety signals. One of the solutions to the problem of ensuring the efficiency of the tool of “spontaneous messages” by specialists is called the introduction of mobile applications as a modern tool of information technology in the work of the healthcare system and subjects of circulation of the drug market. In the world practice of pharmacovigilance, there is a positive experience of using mobile developments to ensure monitoring of data on drug exposure to drugs from consumers, doctors, employees of pharmacies, etc. Examples of such developments are applications developed by regulatory agencies and hospitals in the US, UK and other countries. The results of the inclusion of these IT solutions into the practice of FN show an increase in the number of submitted messages about HP and cases of lack of efficiency, ensuring the ease of use of this product by end users, the efficiency of information exchange and the possibility of using this tool in the implementation of routine and additional measures to minimize the risk of drug use and reporting pharmacovigilance.
Currently, for Russian users of similar mobile applications in the field of pharmacovigilance have not been presented, in connection with which the National Scientific Center for Pharmacovigilance conducted a scientific study, developed and tested a mobile application for monitoring HP “Medicinal Vigilance”, available for installation in the Play Market and App Store on Android and IOS mobile platforms.