Nyame Linda, Xue Hui, Yu Jinxia, Fiagbey Emmanuel D K, Thomford Kwesi Prah, Du Wei
School of Public Health, Southeast University, Nanjing, China.
School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing, China.
Naunyn Schmiedebergs Arch Pharmacol. 2025 Jan;398(1):657-672. doi: 10.1007/s00210-024-03302-5. Epub 2024 Jul 23.
Adverse drug reaction (ADR) monitoring is crucial in ensuring patient and pharmaceutical safety. However, there is a lack of evidence regarding ADR reporting trend pattern in Ghana. This study, therefore, aimed to analyse and characterise trends in ADRs reported in Ghana over 16 years.
We retrospectively analysed individual case safety retorts (ICSRs) received by the Ghana National Pharmacovigilance Centre from 2005 to 2021. Jointpoint regression was used to estimate age-adjusted ADR rates, stratified by sex and patient characteristics, suspected medication groups, clinical indications, and the manifestation of ADRs. To evaluate trends over time, the percentage annualised estimator was used.
We identified a total of 6853 ICSRs from 2005 to 2021. The age-adjusted ICSR rates increased significantly from 2005 to 2019, with an annual increase of 18.6%; however, there was a downward trend from 2019 to 2021, although not statistically significant. Males accounted for the majority (64.3%) of ICSRs compared to females (35.7%). The suspected medication group most frequently associated with ADRs were antiprotozoals accounting for 35.6% of all ICSRs, while vascular disorders (21.0%) were the most commonly observed clinical indication in relation to ADRs. An increase in ICSR rates was noted for gastrointestinal disorders with an annual increase of 32.5% (95% CI, 20.6-45.6%; p < 0.001). Amodiaquine was the most commonly suspected medication (8.9%) associated with ADRs, while pruritus (7.2%) was the most frequently reported preferred term.
The study provides a detailed overview of ICSRs received by the Ghana National Pharmacovigilance Centre over the past 16 years and demonstrates an increasing trend of ADR-related medication use as well as clinical indications over time. The findings of this study call for multifaceted strategies aimed at reducing the risks associated with inappropriate drug use, and enhancing knowledge of medication safety, thus improving healthcare service delivery and patient safety.
药物不良反应（ADR）监测对于确保患者和药品安全至关重要。然而，加纳缺乏关于ADR报告趋势模式的证据。因此，本研究旨在分析和描述加纳16年来报告的ADR趋势。
我们回顾性分析了加纳国家药物警戒中心在2005年至2021年期间收到的个体病例安全报告（ICSR）。采用Joinpoint回归法估计按性别、患者特征、可疑药物组、临床适应症和ADR表现分层的年龄调整后的ADR发生率。为了评估随时间的趋势，使用了年化百分比估计值。
我们在2005年至2021年期间共识别出6853份ICSR。年龄调整后的ICSR发生率从2005年到2019年显著增加，年增长率为18.6%；然而，从2019年到2021年呈下降趋势，尽管无统计学意义。男性占ICSR的大多数（64.3%），而女性占35.7%。与ADR最常相关的可疑药物组是抗原虫药，占所有ICSR的35.6%，而血管疾病（21.0%）是与ADR相关最常观察到的临床适应症。胃肠道疾病的ICSR发生率有所增加，年增长率为32.5%（95%CI，20.6-45.6%；p<0.001）。阿莫地喹是与ADR最常相关的可疑药物（8.9%），而瘙痒（7.2%）是最常报告的首选术语。
本研究详细概述了加纳国家药物警戒中心在过去16年收到的ICSR，并表明随着时间的推移，与ADR相关的药物使用以及临床适应症呈增加趋势。本研究结果呼吁采取多方面策略，以降低与不当药物使用相关的风险，并增强药物安全知识，从而改善医疗服务提供和患者安全。
