A retrospective analysis of the pharmacovigilance data registry in a tertiary teaching hospital in Jordan

Abstract

Objectives The study aims to analyse adverse drug reaction (ADR) reporting patterns at Jordan University Hospital to enhance pharmacovigilance practices.Methods Retrospective analysis of ADR data from February to August 2023 was conducted. Data included patient demographics, drugs implicated, seriousness criteria, and system organ classes affected.Results Among 1340 ADR reports analysed, females accounted for 67.4% of cases, with adults aged 18 to less than 65 years comprising 95.3% of reports. The majority of ADRs were non-serious, with only 2.1% resulting in hospitalisation or prolonged hospital stay. The most frequently reported ADRs included abdominal pain (8.3%), nausea (6.9%), headache (4.7%), and dizziness (4.7%). Notably, cardiovascular system drugs (16.4%) and alimentary tract and metabolism drugs (16.2%) were commonly associated with ADRs, followed by musculoskeletal system drugs (9.0%). Additionally, among all reported drugs, 99.9% were considered suspects, (suspected ADR cases include patient treatment cases for which a likelihood of being related to a drug therapy was scored as ‘possible’, ‘probable’, or ‘certain’ after causality assessment (by the WHO-UMC system in 2017), with oral administration being the predominant route (89.5%).Conclusion The study highlights a notable increase in ADR reporting during the study period compared to historical data, indicating heightened awareness and understanding among healthcare providers. Enhanced pharmacovigilance practices, particularly involving pharmacists, are essential for detecting and reporting ADRs effectively. Further investigation into factors contributing to prevalent serious ADRs is warranted to improve patient safety and health outcomes.

Keywords

• Adverse drug reactions
• Pharmacovigilance
• Drug safety
• ADR reporting patterns
• Jordan