International Drug Safety Monitoring

In the 1960s, following the Thalidomide Disaster, the World Health Organization (WHO) initiated the development of an international drug safety monitoring programme. The objectives of this WHO programme are to improve the quality and safety of pharmaceuticals, and to support public health programmes...

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Main Authors: A. S. Kazakov, E. V. Shubnikova, M. A. Darmostukova, I. I. Snegireva, G. V. Kutekhova, K. E. Zatolochina, N. Yu. Velts, D. A. Kaperko, Yu. V. Olefir
Format: Article
Language:Russian
Published: Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2019-09-01
Series:Безопасность и риск фармакотерапии
Subjects:
Online Access:https://www.risksafety.ru/jour/article/view/151
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author A. S. Kazakov
E. V. Shubnikova
M. A. Darmostukova
I. I. Snegireva
G. V. Kutekhova
K. E. Zatolochina
N. Yu. Velts
D. A. Kaperko
Yu. V. Olefir
author_facet A. S. Kazakov
E. V. Shubnikova
M. A. Darmostukova
I. I. Snegireva
G. V. Kutekhova
K. E. Zatolochina
N. Yu. Velts
D. A. Kaperko
Yu. V. Olefir
author_sort A. S. Kazakov
collection DOAJ
description In the 1960s, following the Thalidomide Disaster, the World Health Organization (WHO) initiated the development of an international drug safety monitoring programme. The objectives of this WHO programme are to improve the quality and safety of pharmaceuticals, and to support public health programmes by providing information for effective assessment of the risk-benefit ratio of medicinal products. The paper outlines the main focus areas of the programme and the mechanism of interaction between the countries involved. It summarises the functions of the WHO Collaborating Centre for International Drug Monitoring located in Uppsala, namely, accumulation and assessment of data on efficacy, inefficacy and risks of medicinal products, which are communicated by the participating countries, and provision of reliable and coherent data to specialists. The paper provides a review of online resources and methods used by VigiBase — global database of adverse drug reactions — that make it possible to search and analyse the data statistically. It describes the functions of the national monitoring centres located in different regions, and their interaction with the WHO. The dissemination of objective and reliable medical information throughout the world, promotion of pharmacovigilance as a science, creation of international partnerships and pooling of expertise from different countries allow for a significant improvement in the safety of pharmacotherapy.
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spelling doaj.art-b6d8dc91215348808819a2a332b5cf2d2024-04-03T17:56:36ZrusMinistry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Безопасность и риск фармакотерапии2312-78212619-11642019-09-017312012610.30895/2312-7821-2019-7-3-120-126146International Drug Safety MonitoringA. S. Kazakov0E. V. Shubnikova1M. A. Darmostukova2I. I. Snegireva3G. V. Kutekhova4K. E. Zatolochina5N. Yu. Velts6D. A. Kaperko7Yu. V. Olefir8Peoples' Friendship University of Russia, Scientifi c Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsPeoples' Friendship University of RussiaScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsIn the 1960s, following the Thalidomide Disaster, the World Health Organization (WHO) initiated the development of an international drug safety monitoring programme. The objectives of this WHO programme are to improve the quality and safety of pharmaceuticals, and to support public health programmes by providing information for effective assessment of the risk-benefit ratio of medicinal products. The paper outlines the main focus areas of the programme and the mechanism of interaction between the countries involved. It summarises the functions of the WHO Collaborating Centre for International Drug Monitoring located in Uppsala, namely, accumulation and assessment of data on efficacy, inefficacy and risks of medicinal products, which are communicated by the participating countries, and provision of reliable and coherent data to specialists. The paper provides a review of online resources and methods used by VigiBase — global database of adverse drug reactions — that make it possible to search and analyse the data statistically. It describes the functions of the national monitoring centres located in different regions, and their interaction with the WHO. The dissemination of objective and reliable medical information throughout the world, promotion of pharmacovigilance as a science, creation of international partnerships and pooling of expertise from different countries allow for a significant improvement in the safety of pharmacotherapy.https://www.risksafety.ru/jour/article/view/151drug safety monitoringadverse drug reactionspharmacovigilanceworld health organizationvigibase
spellingShingle A. S. Kazakov
E. V. Shubnikova
M. A. Darmostukova
I. I. Snegireva
G. V. Kutekhova
K. E. Zatolochina
N. Yu. Velts
D. A. Kaperko
Yu. V. Olefir
International Drug Safety Monitoring
Безопасность и риск фармакотерапии
drug safety monitoring
adverse drug reactions
pharmacovigilance
world health organization
vigibase
title International Drug Safety Monitoring
title_full International Drug Safety Monitoring
title_fullStr International Drug Safety Monitoring
title_full_unstemmed International Drug Safety Monitoring
title_short International Drug Safety Monitoring
title_sort international drug safety monitoring
topic drug safety monitoring
adverse drug reactions
pharmacovigilance
world health organization
vigibase
url https://www.risksafety.ru/jour/article/view/151
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AT evshubnikova internationaldrugsafetymonitoring
AT madarmostukova internationaldrugsafetymonitoring
AT iisnegireva internationaldrugsafetymonitoring
AT gvkutekhova internationaldrugsafetymonitoring
AT kezatolochina internationaldrugsafetymonitoring
AT nyuvelts internationaldrugsafetymonitoring
AT dakaperko internationaldrugsafetymonitoring
AT yuvolefir internationaldrugsafetymonitoring