Diverse pharmacovigilance jurisdiction - The right way for global drug safety?
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11120%2F24%3A43926308" target="_blank" >RIV/00216208:11120/24:43926308 - isvavai.cz</a>
Result on the web
<a href="https://doi.org/10.1007/s00228-023-03608-y" target="_blank" >https://doi.org/10.1007/s00228-023-03608-y</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1007/s00228-023-03608-y" target="_blank" >10.1007/s00228-023-03608-y</a>
Alternative languages
Result language
angličtina
Original language name
Diverse pharmacovigilance jurisdiction - The right way for global drug safety?
Original language description
PURPOSE: The purpose of this narrative review is to provide a comparison of several countries with different legislation and approaches to pharmacovigilance and to point out how these impact the number of adverse drug reactions (ADRs) that are reported to national competent authorities. METHODS: Legislative and statistical data regarding ADR reporting from various national competent authorities' websites, databases, and pharmacovigilance centers were used. In combination with the WHO pharmacovigilance quantitative indicator that was applied to evaluate the effectiveness of particular national pharmacovigilance systems in our scope. RESULTS: The study compared pharmacovigilance systems in six countries, focusing on ADR reporting from 2010 onwards. All countries required MAHs to report ADRs, while healthcare professionals' obligations varied. Per-capita ADR reports increased in all countries with available data, with the United States having a significantly higher reporting rate, possibly due to FDA campaigns. Despite starting later, China's per-capita reporting rate surpassed that of the Czech Republic and Japan. The study highlighted various measures taken by countries to enhance ADR reporting systems since the inception of their programs, contributing to the overall increase in reporting rates. CONCLUSIONS: ADR reporting is a global priority, with efforts made by different countries to strengthen their pharmacovigilance systems. Some success can be seen in gradually improving per-capita ADR reporting rates. The varying reporting rates and measures taken by each country may serve as a basis for further research and exchange of best practices to improve drug safety monitoring worldwide.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30104 - Pharmacology and pharmacy
Result continuities
Project
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Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2024
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
European Journal of Clinical Pharmacology
ISSN
0031-6970
e-ISSN
1432-1041
Volume of the periodical
80
Issue of the periodical within the volume
3
Country of publishing house
DE - GERMANY
Number of pages
11
Pages from-to
305-315
UT code for WoS article
001129697800001
EID of the result in the Scopus database
2-s2.0-85180261648