黎巴嫩国家药物不良事件 (AE) 数据库的描述性分析
Rita Karam1,2,3, Sarah Reda El Sayed1, Aya Ibrahim1
1Quality Assurance of Pharmaceutical Products Department, National Pharmacovigilance Program, Lebanese, Ministry of Public Health, Beirut, Lebanon.
Journal of pharmaceutical policy and practice
|March 18, 2025
概括
黎巴嫩 黎巴嫩 黎巴嫩 黎巴嫩 黎巴嫩 黎巴嫩
科学领域:
- 药物监督 药物监督 药物监督
- 公共卫生 公共卫生
- 药品安全 药品安全
背景情况:
- 不良事件 (AE),包括药物不良反应 (ADR) 和药物错误 (ME),是全球重要的健康问题.
- 药监系统 (PV),如黎巴嫩国家药监计划 (LNPVP),对于药物上市后监测至关重要.
- 在黎巴嫩公共卫生部 (MoPH) 下,LNPVP负责监测黎巴嫩的药物.
研究的目的:
- 评估在黎巴嫩人口中检测到的不良事件 (AE) 的流行率.
- 进行LNPVP收集的AE数据的描述性分析.
- 评估LNPVP在管理安全报告方面的效率.
主要方法:
- 对2018年至2023年期间向LNPVP报告的国家AE病例的回顾性分析.
- 包括销售和预销售药物的数据.
- 由营销许可证持有人提交的个案安全报告 (ICSR) 的分析.
主要成果:
- 总共分析了17776个ICSR,代表37768个AE.
- 大多数报告的副作用与女性受访者 (55.3%) 有关.
- 报告了1961个可疑的药物错误 (5.2%的AE总量).
结论:
- 黎巴嫩成功地实施和运营了一套高效的光伏系统,尽管面临经济和健康方面的挑战.
- 传播AE数据提高了利益相关者的意识,并促进了患者,医疗保健提供者和监管机构之间的合作.
- 需要进一步的研究来确定导致黎巴嫩药物错误的因素.
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