A.E. Krasheninnikov, Cand. farm. Sci., General Director of ANO «National Scientific pharmacovigilance center «, Moscow, anatoly.krasheninnikov@drugsafety.ru
The spontaneous reporting method is the basis for the existence of the entire pharmacovigilance system both in the world and in a single country. The procedure for organizing pharmacovigilance involves receiving and registering messages. Improving the efficiency and quality of messages are becoming key objectives. Therefore, the central problem of the spontaneous reporting method in the national pharmacovigilance system as a complex of state and public institutions authorized or interested in ensuring the safety of drug circulation on the territory of the Russian Federation is primarily the number of spontaneous messages. The latter, in turn, is determined by the activity of the subjects obliged, on the basis of Article 73 of the Federal Law «On the Fundamentals of Health Protection of Citizens in the Russian Federation», to inform the authorized official of the organization about incidents related to the use of medicinal products. These key reporting cohorts of subjects are medical and pharmaceutical professionals. Therefore, the effectiveness of identifying drug safety problems depends primarily on them. Meanwhile, according to the published results of studies of pharmacovigilance activity of medical and pharmaceutical workers, key subjects are not distinguished by high activity in reporting about adverse reactions, although they mostly face them. Thus, there is a subject-oriented problem of the presence of a factor that reduces the effectiveness of the spontaneous reporting method in the Russian pharmacovigilance system, and an appropriate approach is required to solve it. It is a subject-oriented approach, which implies the possibility of polysubject control based on a preliminary study of the orientation of subjects to the manifestation of activity and the study of their subject position, its role in the implementation of activities. In accordance with the identified problem, the goal of this study was to study the subject-oriented problems of the spontaneous reporting method in the Russian pharmacovigilance system and develop ways to solve them.
MATERIALS AND METHODS
The methods of achieving the goal were: questioning 102 medical workers, as well as 100 pharmaceutical workers using specially developed questionnaires on the problems of practical pharmacovigilance; abstract modeling of interactive training in practical pharmacovigilance of medical and pharmaceutical workers; pedagogical experiment on the implementation of the developed model into practice. In the course of the experiment, the initial knowledge of 100 healthcare workers, including 50 medical and 50 pharmaceutical workers, about the nature and procedure of pharmacovigilance in the Russian Federation was diagnosed on the basis of a developed test containing 20 questions.
RESULTS AND DISCUSSION
The results of the survey of medical and pharmaceutical workers made it possible to identify a number of subject-oriented problems of the spontaneous reporting method in the Russian pharmacovigilance system. One of the subject-oriented problems is the phenomenon of a specialist’s confusion under the pressure of internal doubts. The data obtained showed that, although 65.35% of medical workers and 58.00% of pharmaceutical workers noted that they observed adverse reactions in a patient after taking a drug, the respondents often have internal doubts when recognizing an adverse reaction or establishing a causal relationship between it. and taking a drug (16.48% of doctors and 35.76% of pharmacists).
CONCLUSIONS
1. In the Russian pharmacovigilance system, there are a number of subject-oriented problems that affect the efficiency of the spontaneous reporting method, although the procedure for organizing pharmacovigilance involves receiving and registering messages. Subject-oriented problems were identified by questioning medical and pharmaceutical workers and consist in the fact that the further development of the effectiveness of the method of spontaneous messages on the part of such subjects as doctors and pharmacists who implement it are hindered by: the phenomenon of confusion of a specialist under the pressure of internal doubts; avoiding reporting a drug incident; low level of professional competence of specialists in the field of pharmacovigilance; conscientious delusion of medical and pharmaceutical workers regarding their obligation to inform the authorized person for pharmacovigilance of their own organization about adverse reactions when using medicinal products; awareness of the discreditedness of additional education on the basis of treatment-and-prophylactic and pharmacy organizations.
2. The subject-oriented approach to solving the problems of the spontaneous reporting method in the Russian pharmacovigilance system is to use the proven interactive technology for teaching medical and pharmaceutical workers to form their professional competence in the field of pharmacovigilance.
3. The subject-oriented approach to solving the problems of the method of spontaneous messages has received confirmation of the high efficiency of the subject-oriented model of the development of professional competence of medical and pharmaceutical workers in the field of pharmacovigilance during the implementation of a pedagogical experiment to test the developed model of interactive learning, based on the use of the master class form and a complex of private methods of interactive teaching technology: dramatization, «everyone teaches everyone», situation analysis, working with documents, round table, case study and situational tasks. The introduction of the approach will improve the organization of pharmacovigilance in terms of the implementation of spontaneous messages to increase the number of the latter by an order of magnitude.