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.
ABSTRACT
In this randomized, double-blind, multicenter study, H. pylori-positive patients with an active duodenal ulcer (DU) received esomeprazole, 20 mg twice daily (bid), or omeprazole, 20 mg bid, with amoxicillin, 1000 mg bid, and clarithromycin, 500 mg bid, for 1 week (EAC and OAC, respectively). Patients received an additional 3 weeks of either placebo or omeprazole, 20 mg once daily (od), in the EAC and OAC groups, respectively. The intent-to-treat population included 374 patients (EAC, 186; OAC, 188). Four-week DU healing rates were similar in the EAC+placebo and OAC+omeprazole groups: 74% and 76%, respectively. DU healing rates at 8 weeks were 87% for EAC+placebo and 88% for OAC+omeprazole. H. pylori eradication rates were 75% and 79% for EAC and OAC, respectively. Both regimens were well tolerated. A 1-week regimen of esomeprazole-based H. pylori eradication triple therapy was as effective for DU healing and eradication of H. pylori as omeprazole-based triple therapy followed by an additional 3 weeks of monotherapy.