Hayaa Abdallah Banat
Jordan Food and Drug Administration, Jordan
Title: Patterns of adverse drug reactions in Jordan: A retrospective analysis of the national pharmacovigilance data registry (2015-2021)
Biography
Biography: Hayaa Abdallah Banat
Abstract
Background: Post-marketing surveillance of drugs is a cornerstone of pharmacovigilance. This study was conducted to characterize patterns of Adverse Drug Reactions (ADRs) reporting in Jordan.
Research design and methods: ADR reports submitted to the pharmacovigilance database of the Jordan Food and Drug Administration during 2015-2021 were retrospectively analyzed. The most commonly reported drugs, drug classes, ADRs and ADRs consequences were explored. Logistic regression identified possible predictors of reporting serious ADRs.
Results: A total of 2744 ADR reports were included, among which 28.4% were classified as serious. An annual increase in ADR reporting was observed. The most commonly implicated drug classes were antineoplastic and immunomodulating agents (24.0%), anti-infective for systemic use (14.2%) and alimentary tract and metabolism (12.1%). COVID-19 vaccination was the most reported drug (22.8%). Fatigue (6.3%), injection site pain (6.1%) and headache (6.0%) were the top three common ADRs. Among ADRs with outcome information, 4.7% were fatal. Patient’s age and intravenous medication use largely predicted reporting serious ADRs.
Conclusions: This study provides contemporary insights into the post-marketing surveillance of drugs in Jordan. The findings are foundational for future studies exploring drug-ADRs causality relationships. Efforts that promote pharmacovigilance concepts should be sustained and enhanced at the national level.