Bin Yousef Nora, Yenugadhati Nagarajkumar, Alqahtani Nasser, Alshahrani Ali, Alshahrani Mubarak, Al Jeraisy Majed, Badri Motasim
Department of Epidemiology and Biostatistics, College of Public Health and Health Informatics, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Kingdom of Saudi Arabia.
Drug Sector, Saudi Food and Drug Authority, Riyadh, Kingdom of Saudi Arabia.
Saudi Pharm J. 2022 Jan;30(1):8-13. doi: 10.1016/j.jsps.2021.08.014. Epub 2021 Aug 4.
Pharmacovigilance enhances post-market drug safety. However, analytical reports of a pattern of adverse drug reactions (ADRs) experienced by patients in Saudi Arabia are demanded.
To describe patterns of ADRs submitted to the Saudi Central National Pharmacovigilance and Drug Safety Center (NPC), Saudi Food and Drug Administration (SFDA), from its inception in 2015 until the end of 2017 to understand the pattern of ADR reporting in Saudi Arabia.
In this retrospective study, data from cases reported to the NPC were used to determine ADRs and identify the most common associated drug classes based on anatomical therapeutic chemical (ATC) classification system.
A total of 17,730 ADR cases were reported during study period. An annual increase in ADRs was clearly evident. Approximately 54% of the total ADRs reported were serious. Most commonly reported ATC drug classes were anti-infective agents for systemic use (22.27%), antineoplastic and immunomodulating agents (21.49%), alimentary tract and metabolism (15.48 %), cardiovascular system (11.11%) and nervous system (10.23%). Vancomycin (2.7%), ceftiraxone (1.8%), fingolimod (1.4%) and paracetamol (1.4%) were the most common drugs associated with serious ADRs.
This study provide valuable insights in hypothesis generation for future studies on drug-event interactions and amplification studies. The NPC educational programs and awareness campaigns to promote systematic reporting of ADRs among healthcare professionals and general public should be continued.
药物警戒可提高上市后药品的安全性。然而，需要有关沙特阿拉伯患者所经历的药物不良反应（ADR）模式的分析报告。
描述自2015年成立至2017年底提交给沙特食品药品管理局（SFDA）下属的沙特国家药物警戒和药品安全中心（NPC）的ADR模式，以了解沙特阿拉伯的ADR报告模式。
在这项回顾性研究中，使用向NPC报告的病例数据来确定ADR，并根据解剖学治疗学化学（ATC）分类系统确定最常见的相关药物类别。
在研究期间共报告了17730例ADR病例。ADR呈明显的年度增长。报告的ADR中约54%为严重不良反应。报告最多的ATC药物类别为全身用抗感染药（22.27%）、抗肿瘤和免疫调节药（21.49%）、消化道及代谢药（15.48%）、心血管系统药（11.11%）和神经系统药（10.23%）。万古霉素（2.7%）、头孢曲松（1.8%）、芬戈莫德（1.4%）和对乙酰氨基酚（1.4%）是与严重ADR相关最常见的药物。
本研究为未来关于药物-事件相互作用和放大研究的假设生成提供了有价值的见解。应继续开展NPC教育项目和宣传活动，以促进医疗专业人员和公众对ADR进行系统报告。
