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) reported 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.

KEYWORDS:

• pharmacovigilance
• medication safety
• adverse drug reaction
• descriptive
• Jordan

Declaration of Interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants, or patents received or pending, or royalties.

Author contributions

NM Mhaidat: conception and design, supervision, data interpretation, writing – review & editing. OY Alshogran: conception and design, funding acquisition, supervision, analysis and interpretation of data, writing original draft. SM Altawalbeh: conception and design, analysis and interpretation of data, writing original draft. JM Jaber: conception and design, writing – review & editing. HA Banat: conception and design, data curation, writing – review & editing. DA Ahmad: conception and design, writing – review & editing. W Alabsi: data curation, writing – review & editing. All authors approved the final version of the manuscript and agree to be accountable for all aspects of the work.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2023.2223957

Additional information

Funding

This work was supported by the Deanship of Scientific Research in Jordan University of Science and Technology (JUST) (grant number 583/2022).