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Reporting Antimicrobial-Related Adverse Drug Events in Jordan: An Analysis from the VigiBase Database
This study aims to assess the reporting of antimicrobial-related adverse drug events (ADEs) in Jordan between 2003 and 2022. Data regarding the antimicrobial-related ADEs were extracted from the WHO’s global database (VigiBase) by the Rational Drug Use and Pharmacovigilance Department at the Jordan...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10044927/ https://www.ncbi.nlm.nih.gov/pubmed/36978491 http://dx.doi.org/10.3390/antibiotics12030624 |
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author | Mhaidat, Nizar Mahmoud Al-Azzam, Sayer Banat, Hayaa Abdallah Jaber, Jaber Mohammad Araydah, Mohammad Alshogran, Osama Y. Aldeyab, Mamoon A. |
author_facet | Mhaidat, Nizar Mahmoud Al-Azzam, Sayer Banat, Hayaa Abdallah Jaber, Jaber Mohammad Araydah, Mohammad Alshogran, Osama Y. Aldeyab, Mamoon A. |
author_sort | Mhaidat, Nizar Mahmoud |
collection | PubMed |
description | This study aims to assess the reporting of antimicrobial-related adverse drug events (ADEs) in Jordan between 2003 and 2022. Data regarding the antimicrobial-related ADEs were extracted from the WHO’s global database (VigiBase) by the Rational Drug Use and Pharmacovigilance Department at the Jordan Food and Drug Administration (JFDA). A total of 279 Individual Case Safety Reports (ICSRs) were recorded. The number of ICSRs increased from 2019 onwards (219 out of 279 cases). This increase in the reported ADEs was influenced by the actions of the JFDA, including the introduction of electronic reporting forms, updating the national pharmacovigilance guidelines, which encouraged adverse drug reactions reporting, the implementation of the AMR-national action plan, the encouragement to report due to COVID-19 vaccine, and the continuous awareness campaigns and training programs. Skin and subcutaneous tissue disorders (n = 105; 19.48%) were the most reported antimicrobial-related ADEs. The highest number of ADEs was reported for tetracyclines (n = 101; 18.74%) followed by fluoroquinolones (n = 54; 10.02%), third-generation cephalosporines (n = 48; 8.9%), and carbapenems (n = 42; 7.79%). From the top 10 consumed antibiotics, the number of ADEs in patients who consumed Watch group antibiotics (97 ADEs) was higher than those who consumed Access group antibiotics (28 ADEs). The findings highlight the need to monitor and rationalize the use of Watch antibiotics. Enhanced reporting of antimicrobial-related adverse drug reactions is needed to inform antimicrobial stewardship and improve the pharmacovigilance system in Jordan. |
format | Online Article Text |
id | pubmed-10044927 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-100449272023-03-29 Reporting Antimicrobial-Related Adverse Drug Events in Jordan: An Analysis from the VigiBase Database Mhaidat, Nizar Mahmoud Al-Azzam, Sayer Banat, Hayaa Abdallah Jaber, Jaber Mohammad Araydah, Mohammad Alshogran, Osama Y. Aldeyab, Mamoon A. Antibiotics (Basel) Article This study aims to assess the reporting of antimicrobial-related adverse drug events (ADEs) in Jordan between 2003 and 2022. Data regarding the antimicrobial-related ADEs were extracted from the WHO’s global database (VigiBase) by the Rational Drug Use and Pharmacovigilance Department at the Jordan Food and Drug Administration (JFDA). A total of 279 Individual Case Safety Reports (ICSRs) were recorded. The number of ICSRs increased from 2019 onwards (219 out of 279 cases). This increase in the reported ADEs was influenced by the actions of the JFDA, including the introduction of electronic reporting forms, updating the national pharmacovigilance guidelines, which encouraged adverse drug reactions reporting, the implementation of the AMR-national action plan, the encouragement to report due to COVID-19 vaccine, and the continuous awareness campaigns and training programs. Skin and subcutaneous tissue disorders (n = 105; 19.48%) were the most reported antimicrobial-related ADEs. The highest number of ADEs was reported for tetracyclines (n = 101; 18.74%) followed by fluoroquinolones (n = 54; 10.02%), third-generation cephalosporines (n = 48; 8.9%), and carbapenems (n = 42; 7.79%). From the top 10 consumed antibiotics, the number of ADEs in patients who consumed Watch group antibiotics (97 ADEs) was higher than those who consumed Access group antibiotics (28 ADEs). The findings highlight the need to monitor and rationalize the use of Watch antibiotics. Enhanced reporting of antimicrobial-related adverse drug reactions is needed to inform antimicrobial stewardship and improve the pharmacovigilance system in Jordan. MDPI 2023-03-21 /pmc/articles/PMC10044927/ /pubmed/36978491 http://dx.doi.org/10.3390/antibiotics12030624 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/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 (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Mhaidat, Nizar Mahmoud Al-Azzam, Sayer Banat, Hayaa Abdallah Jaber, Jaber Mohammad Araydah, Mohammad Alshogran, Osama Y. Aldeyab, Mamoon A. Reporting Antimicrobial-Related Adverse Drug Events in Jordan: An Analysis from the VigiBase Database |
title | Reporting Antimicrobial-Related Adverse Drug Events in Jordan: An Analysis from the VigiBase Database |
title_full | Reporting Antimicrobial-Related Adverse Drug Events in Jordan: An Analysis from the VigiBase Database |
title_fullStr | Reporting Antimicrobial-Related Adverse Drug Events in Jordan: An Analysis from the VigiBase Database |
title_full_unstemmed | Reporting Antimicrobial-Related Adverse Drug Events in Jordan: An Analysis from the VigiBase Database |
title_short | Reporting Antimicrobial-Related Adverse Drug Events in Jordan: An Analysis from the VigiBase Database |
title_sort | reporting antimicrobial-related adverse drug events in jordan: an analysis from the vigibase database |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10044927/ https://www.ncbi.nlm.nih.gov/pubmed/36978491 http://dx.doi.org/10.3390/antibiotics12030624 |
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