Classification of existing problems in the Russian pharmacovigilance system
The pharmacovigilance system currently represents as a complex of interstate, state, departmental and public institutions. This system provides the receipt and processing of information about facts and circumstances that pose a threat to life or health for person who using drugs at all stages of lif...
| Main Authors: | , |
|---|---|
| Format: | Article |
| Language: | Russian |
| Published: |
Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)
2018-09-01
|
| Series: | Сеченовский вестник |
| Subjects: | |
| Online Access: | https://www.sechenovmedj.com/jour/article/view/74 |
| _version_ | 1797873636552474624 |
|---|---|
| author | B. K. Romanov A. E. Krasheninnikov |
| author_facet | B. K. Romanov A. E. Krasheninnikov |
| author_sort | B. K. Romanov |
| collection | DOAJ |
| description | The pharmacovigilance system currently represents as a complex of interstate, state, departmental and public institutions. This system provides the receipt and processing of information about facts and circumstances that pose a threat to life or health for person who using drugs at all stages of life cycle of drugs. In addition, in the framework of pharmacovigilance activities, a continuous evaluation benefit and risk of the use of registered and developed drugs. On the way to its formation, the Russian pharmacovigilance system is face a challenge with a spectrum of problems, including the fragmentation of the conclusions formulated and the identification of polymorphic "targets" for the subsequent appropriate managerial decisions at pharmacovigilance field. Classification of existing problems at the field of pharmacovigilance is the technique of integration variety of studied objects to several systematized groups for the subsequent high-level review of the way for optimization and the possibilities for increasing its effectiveness. The results of the studies using methods of content analysis of publications of pharmacovigilance, statistical analysis of spontaneous reports and a sociological survey made it possible to identify a number of problems in the Russian pharmacovigilance system that were grouped of five types: political, organizational, information, cultural and personal. These analyzes allow us to determine the way for further research of the possibilities for increasing the effectiveness of the pharmacovigilance system based on the integrated development of ways for optimize the activity of the leading pharmacovigilance subjects in five problem areas. |
| first_indexed | 2024-04-10T01:19:27Z |
| format | Article |
| id | doaj.art-437ae33610704e7990a5ed7daa84e1c1 |
| institution | Directory Open Access Journal |
| issn | 2218-7332 2658-3348 |
| language | Russian |
| last_indexed | 2024-04-10T01:19:27Z |
| publishDate | 2018-09-01 |
| publisher | Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University) |
| record_format | Article |
| series | Сеченовский вестник |
| spelling | doaj.art-437ae33610704e7990a5ed7daa84e1c12023-03-13T09:51:33ZrusFederal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)Сеченовский вестник2218-73322658-33482018-09-0103596310.47093/2218-7332_2018.3.59-6373Classification of existing problems in the Russian pharmacovigilance systemB. K. Romanov0A. E. Krasheninnikov1N.I. Pirogov Russian National Research Medical University; Scientific Center of Expertise of Medical ApplicationsNational Pharmacovigilance Research CenterThe pharmacovigilance system currently represents as a complex of interstate, state, departmental and public institutions. This system provides the receipt and processing of information about facts and circumstances that pose a threat to life or health for person who using drugs at all stages of life cycle of drugs. In addition, in the framework of pharmacovigilance activities, a continuous evaluation benefit and risk of the use of registered and developed drugs. On the way to its formation, the Russian pharmacovigilance system is face a challenge with a spectrum of problems, including the fragmentation of the conclusions formulated and the identification of polymorphic "targets" for the subsequent appropriate managerial decisions at pharmacovigilance field. Classification of existing problems at the field of pharmacovigilance is the technique of integration variety of studied objects to several systematized groups for the subsequent high-level review of the way for optimization and the possibilities for increasing its effectiveness. The results of the studies using methods of content analysis of publications of pharmacovigilance, statistical analysis of spontaneous reports and a sociological survey made it possible to identify a number of problems in the Russian pharmacovigilance system that were grouped of five types: political, organizational, information, cultural and personal. These analyzes allow us to determine the way for further research of the possibilities for increasing the effectiveness of the pharmacovigilance system based on the integrated development of ways for optimize the activity of the leading pharmacovigilance subjects in five problem areas.https://www.sechenovmedj.com/jour/article/view/74pharmacovigilancespontaneous reportstypes of problemsquestionnairescontent analysis |
| spellingShingle | B. K. Romanov A. E. Krasheninnikov Classification of existing problems in the Russian pharmacovigilance system Сеченовский вестник pharmacovigilance spontaneous reports types of problems questionnaires content analysis |
| title | Classification of existing problems in the Russian pharmacovigilance system |
| title_full | Classification of existing problems in the Russian pharmacovigilance system |
| title_fullStr | Classification of existing problems in the Russian pharmacovigilance system |
| title_full_unstemmed | Classification of existing problems in the Russian pharmacovigilance system |
| title_short | Classification of existing problems in the Russian pharmacovigilance system |
| title_sort | classification of existing problems in the russian pharmacovigilance system |
| topic | pharmacovigilance spontaneous reports types of problems questionnaires content analysis |
| url | https://www.sechenovmedj.com/jour/article/view/74 |
| work_keys_str_mv | AT bkromanov classificationofexistingproblemsintherussianpharmacovigilancesystem AT aekrasheninnikov classificationofexistingproblemsintherussianpharmacovigilancesystem |