Title: Patterns of Adverse Drug Reactions in Jordan: A Retrospective Analysis of the National Pharmacovigilance Data Registry (2015-2021)

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-infectives 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.

Biography:

Hayaa Banat Senior pharmacovigilance specialist and the Head of Pharmacovigilance Section in JFDA. Clinical Pharmacist Hayaa Banat received her Pharm.D. Degree from Jordan University of Science and Technology and is currently working at Jordan food and Drug Administration (JFDA) as the head of pharmacovigilance section. A strong advocate of increasing awareness of the importance of rational drug use, Pharmacovigilance and drug safety. Hayaa participated in several national and international meetings and conferences regarding Pharmacovigilance, quality use of medicines, effective communication. She has an active role in risk management plan (RMP) evaluation, risk minimization measures (RMM) implementation, patient leaflet updates. Hayaa is anxious in encouraging health care providers to build a culture based on patient safety. Has a good experience in clinical practice mainly in critical care units (ICU, CCU) as she worked as a clinical pharmacist in two of the biggest hospitals in Jordan, King Hussein Cancer Center and Jordan university Hospital.