Abu Hammour Khawla, El-Dahiyat Faris, Hyari Rund, Salameh Sara, Manaseer Qusai, Farha Rana Abu, Hammour Adnan Abu, Zawiah Mohammed
Department of Biopharmaceutics and Clinical Pharmacy, Faculty of Pharmacy, The University of Jordan, Amman, Jordan.
College of Pharmacy, Al Ain University, Abu Dhabi, UAE.
J Pharm Policy Pract. 2024 Jul 23;17(1):2378461. doi: 10.1080/20523211.2024.2378461. eCollection 2024.
The study aims to analyse adverse drug reaction (ADR) reporting patterns at Jordan University Hospital to enhance pharmacovigilance practices.
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.
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%).
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.
本研究旨在分析约旦大学医院的药品不良反应（ADR）报告模式，以加强药物警戒实践。
对2023年2月至8月的ADR数据进行回顾性分析。数据包括患者人口统计学信息、涉及的药物、严重程度标准以及受影响的系统器官类别。
在分析的1340份ADR报告中，女性占病例的67.4%，18岁至65岁以下的成年人占报告的95.3%。大多数ADR为非严重不良反应，只有2.1%导致住院或延长住院时间。最常报告的ADR包括腹痛（8.3%）、恶心（6.9%）、头痛（4.7%）和头晕（4.7%）。值得注意的是，心血管系统药物（16.4%）和消化道及代谢药物（16.2%）与ADR的关联最为常见，其次是肌肉骨骼系统药物（9.0%）。此外，在所有报告的药物中，99.9%被视为可疑药物，（可疑ADR病例包括在因果关系评估（2017年由世界卫生组织药物不良反应监测中心系统进行）后，与药物治疗相关可能性被评为“可能”“很可能”或“肯定”的患者治疗病例），口服给药是主要途径（89.5%）。
该研究强调，与历史数据相比，研究期间ADR报告显著增加，表明医疗保健提供者的意识和理解有所提高。加强药物警戒实践，特别是让药剂师参与其中，对于有效检测和报告ADR至关重要。有必要进一步调查导致严重ADR普遍存在的因素，以改善患者安全和健康结局。
