Reporting Antimicrobial-Related Adverse Drug Events in Jordan: An Analysis from the VigiBase Database

Abstract

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.

Pharmacovigilance Strategies to Address Resistance to Antibiotics and Inappropriate Use—A Narrative Review

“…In 279 reports, it was possible to characterize the AEs, and the "drug ineffective" MedDRA PT (n = 28; 5.19%) was most often related to carbapenems (n = 9; 32%), followed by tetracyclines (n = 8; 28%). The study also found "off-label" reports (n = 13; 2.41%), "incorrect route of administration" (n = 10; 1.89%), and "unapproved indication" (n = 6; 1.11%) [111].…”

Pharmacovigilance Strategies to Address Resistance to Antibiotics and Inappropriate Use—A Narrative Review

“…In 279 reports, it was possible to characterise the AEs, and the "drug ineffective" MedDRA PT (n = 28; 5.19%) was most often related to carbapenems (n = 9; 32%), followed by tetracyclines (n = 8; 28%). The study also found "off-label" reports (n = 13; 2.41%), "incorrect route of administration" (n = 10; 1.89%), and "unapproved indication" (n = 6; 1.11%) [111].…”

Antibiotics-Related Adverse Drug Reaction in a Tertiary Hospital in Saudi Arabia: A Cohort, Retrospective Study

“…Likewise, in a study done by Junk et al in South Korea, the most common antibiotic-associated ADR is cephalosporins (both first and second generation) in 26.1% followed by Penicillin and Quinolone in 16% of the patients [ 10 ]. In a study conducted in Jordan based on the data extracted from WHO global database (VigiBase), 48 patients are recorded for third-generation cephalosporins-mediated ADR, and the commonest antibiotic for the cause of ADR is tetracyclines (n=101), followed by fluoroquinolones (n=54) [ 17 ]. Meanwhile, in a Malaysia study, the second most common cause of ADR is a cephalosporin (20.6%) and the primary cause of ADR is mainly due to penicillins (32%) [ 18 ].…”

“…In Mhaidat et al's study, the most common organ affected as a result of ADR is skin and subcutaneous tissue disorders in 19.48% of patients. Further, they also reported that in ADR related to skin, rashes are the most commonly observed reaction in 58 cases (10.76%) and the incidence of rashes is higher in patients consuming third-generation cephalosporins (n=11, 18.97% out of 58) [ 17 ]. In Jung et al's study, cutaneous and skin-related toxicities are the most common ADR event in 45.1% of cases and cephalosporin accounts for 46.25% of skin-related manifestations [ 10 ].…”