Diverse pharmacovigilance jurisdiction—The right way for global drug safety?
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: Leg...
| Publicado en: | European Journal of Clinical Pharmacology Vol. 80; no. 3; pp. 305 - 316 |
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| Autores principales: | , |
| Formato: | research systematic review tables/charts Journal Article |
| Publicado: |
Springer Nature
Mar2024
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=175530168&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 175530168 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00316970 NP9 jtl: European Journal of Clinical Pharmacology issn: 00316970 maglogo: N pubinfo: dt: Mar2024 vid: 80 iid: 3 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 175530168 174365658 175530168 175530168 10.1007/s00228-023-03608-y 175530168 ppf: 305 ppct: 11 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: Diverse pharmacovigilance jurisdiction—The right way for global drug safety? aug: au: Zatovkaňuková, Petra Slíva, Jiří affil: https://ror.org/024d6js02 Department of Pharmacology, Third Faculty of Medicine, Charles University, Ruská 87, 100 00, Prague 10, Czech Republic sug: subj: Pharmacovigilance Legislation and Jurisprudence Adverse Drug Event Legislation and Jurisprudence Adverse Drug Event Risk Factors Risk Assessment Mandatory Reporting Human Czech Republic Canada Japan United Kingdom China United States Embase PubMed Medline ab: 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. pubtype: Academic Journal doctype: research systematic review tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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