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Adverse Drug Reaction Reporting by Patients in 12 European Countries

Patients who report suspected adverse drug reactions (ADRs) help minimize drug safety risks and bolster the pharmacovigilance system. The aim of this study was to examine the contribution of patients to pharmacovigilance and compare the tools used to promote patient reporting in European countries t...

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Autores principales: Valinciute-Jankauskiene, Agne, Kubiliene, Loreta
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7915689/
https://www.ncbi.nlm.nih.gov/pubmed/33562536
http://dx.doi.org/10.3390/ijerph18041507
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author Valinciute-Jankauskiene, Agne
Kubiliene, Loreta
author_facet Valinciute-Jankauskiene, Agne
Kubiliene, Loreta
author_sort Valinciute-Jankauskiene, Agne
collection PubMed
description Patients who report suspected adverse drug reactions (ADRs) help minimize drug safety risks and bolster the pharmacovigilance system. The aim of this study was to examine the contribution of patients to pharmacovigilance and compare the tools used to promote patient reporting in European countries that implemented this reporting type in 2012–2013. A web-based questionnaire was sent to the national competent authorities (NCAs) of the European countries. The received answers were systematized and compared using statistical analysis. The performed statistical analysis demonstrated that changes in the number of received ADR reports increased significantly in each country during the analyzed period. These changes were significantly different in Ireland and Finland from those in the other reviewed countries. The common source of information on direct patient reporting was the country’s NCA website. Other sources used were social media pages, leaflets, and posters. This is the first study on patient reporting schemes implemented after the significant reform of the European regulatory system for pharmacovigilance. However, some countries did not actively promote their patient reporting schemes. Our findings indicate that countries with minimal experience in pharmacovigilance systems that include direct patient reporting should organize comprehensive campaigns on ADR reporting.
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spelling pubmed-79156892021-03-01 Adverse Drug Reaction Reporting by Patients in 12 European Countries Valinciute-Jankauskiene, Agne Kubiliene, Loreta Int J Environ Res Public Health Article Patients who report suspected adverse drug reactions (ADRs) help minimize drug safety risks and bolster the pharmacovigilance system. The aim of this study was to examine the contribution of patients to pharmacovigilance and compare the tools used to promote patient reporting in European countries that implemented this reporting type in 2012–2013. A web-based questionnaire was sent to the national competent authorities (NCAs) of the European countries. The received answers were systematized and compared using statistical analysis. The performed statistical analysis demonstrated that changes in the number of received ADR reports increased significantly in each country during the analyzed period. These changes were significantly different in Ireland and Finland from those in the other reviewed countries. The common source of information on direct patient reporting was the country’s NCA website. Other sources used were social media pages, leaflets, and posters. This is the first study on patient reporting schemes implemented after the significant reform of the European regulatory system for pharmacovigilance. However, some countries did not actively promote their patient reporting schemes. Our findings indicate that countries with minimal experience in pharmacovigilance systems that include direct patient reporting should organize comprehensive campaigns on ADR reporting. MDPI 2021-02-05 2021-02 /pmc/articles/PMC7915689/ /pubmed/33562536 http://dx.doi.org/10.3390/ijerph18041507 Text en © 2021 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Valinciute-Jankauskiene, Agne
Kubiliene, Loreta
Adverse Drug Reaction Reporting by Patients in 12 European Countries
title Adverse Drug Reaction Reporting by Patients in 12 European Countries
title_full Adverse Drug Reaction Reporting by Patients in 12 European Countries
title_fullStr Adverse Drug Reaction Reporting by Patients in 12 European Countries
title_full_unstemmed Adverse Drug Reaction Reporting by Patients in 12 European Countries
title_short Adverse Drug Reaction Reporting by Patients in 12 European Countries
title_sort adverse drug reaction reporting by patients in 12 european countries
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7915689/
https://www.ncbi.nlm.nih.gov/pubmed/33562536
http://dx.doi.org/10.3390/ijerph18041507
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