Analysis of reports of adverse reactions (AD) and cases of lack of effectiveness in the use of drugs (MP), which form the basis of pharmacovigilance, expert assessment and prediction of potential risks of drug use in clinical practice are among the tasks of the effective functioning of the pharmacovigilance system (FP).
To ensure the possibility of monitoring information on the safety of the medicinal products used, vaccines, medical devices, medicinal herbs and biologically active additives, adaptation and use by different groups of users (ULF, pharmacovigilance contacts of distributors, healthcare professionals, medicinal product consumers), providing additional opportunities for use in order to implementation of drug safety (conducting surveillance programs, monitoring patients’ conditions, promptly informing the target audience of users on safety issues in the form of notifications, sending safety information letters from regulatory authorities to drug manufacturers, hospitals, pharmacies), a mobile application was created. As part of its testing, an expert assessment, a hall test and content analysis of the approbation data of the developed and patented mobile application “Medicinal Vigilance” were carried out in 5 (five) groups of subjects of the drug market (doctors of hospitals, employees of pharmacy organizations, medical representatives of manufacturing companies Medicinal product, authorized persons for PH of medicinal product manufacturers, population). The evaluation criteria determined the characteristics that are significant for the implementation of the effectiveness of the pharmacovigilance system and the formation of the pharmacovigilance base. The assessment was carried out on a 5-point scale.
The respondents noted the demand, accessibility and ease of filling out the mobile notification form, the ergonomics of the application, which makes it possible to use it in the routine practice of pharmacovigilance by each of the subjects of drug circulation in order to increase the number of messages about IU sent to regulatory authorities. In addition, the use of a mobile application helps to solve a number of problems with reporting security data, such as limited time resources, the difficulty of filling out a voluminous standardized notification form, and a shortage of specialized information on FN among application users. Content analysis of the time of filling out the paper form of the card-notification about the HP of the drug and the notification in the form of the mobile application “Medicinal Vigilance” showed that the time spent by the majority of respondents to enter information about the HP through the mobile application was from 3 to 10 minutes, which 2 times less time spent on filling out a standard notification card with similar information about HP. The results obtained determined the relevance of the use of mobile technologies in the field of pharmacovigilance and the prospect of using measures to minimize the risks of drug use in the implementation of measures.
The use of information technologies in the field of pharmacovigilance is becoming an integral element of the development and improvement of the drug safety system at the level of all participants in the pharmaceutical market. Effective organization and development of modern information channels in the pharmacovigilance system of drug manufacturers, the pharmacovigilance base is the key to the sufficiency of data for early diagnosis of safety signals. The introduction of mobile technologies into the system for monitoring data on HP and cases of lack of effectiveness of developed and produced drugs is relevant for all subjects of the national drug safety system (manufacturers, distributors, medical institutions, pharmacy organizations, consumers). Considering the significant responsibility and scope of work on pharmacovigilance of drug manufacturers, the use of mobile applications will provide new opportunities for the qualitative and quantitative collection and analysis of information about drug products, timely and resource-efficient informing healthcare professionals and consumers on the safety and effectiveness of drug use and effective implementation. routine and additional measures to minimize the risk of drug use.