AlShammari Thamir M, Almoslem Mohammed J
Department of Clinical Pharmacy, College of Pharmacy, University of Hail, Hail, Saudi Arabia.
Medication Safety Research Chair, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.
Saudi Pharm J. 2018 Nov;26(7):925-931. doi: 10.1016/j.jsps.2018.04.012. Epub 2018 Apr 26.
Adverse drug reactions ADRs) are a major global clinical problem, causing substantial mortality and morbidity especially in hospitals. Healthcare professionals (HCPs) knowledges', attitude and practices are crucial points to evaluate the hospital safety environment. Objective of the study was to investigate the knowledge, attitudes, and practices of HCPs regarding the ADRs reporting system.
A cross-sectional survey was conducted between January and February of 2013 in nine tertiary care hospitals (governmental and private) that provide highly specialized medical services in Riyadh, Qassim, and the Eastern region of the Kingdom of Saudi Arabia. A validated questionnaire was used to assess the knowledge, attitudes, and practices of HCPs regarding the ADR reporting system. All statistical analyses were performed using SAS version 9.2.
In total, 480 questionnaires were distributed, and the response rate was 70% (n = 336). Only 33% of the participants were aware of the National Pharmacovigilance Centre (NPC). Of those HCPs who were familiar with the NPC and their responsibility to report ADRs, most (50%) were pharmacists, followed by physicians (24%) and nurses (16%), and these differences were statistically significant (p < 0.01). Twenty-seven percent of the participants were involved in reporting ADRs; among these HCPs, 62% were pharmacists, 26% were nurses, and 6% were physicians. Most participants (95%) favoured reporting ADRs caused by antibiotics and new/old drugs. The prominent factors discouraging ADR reporting included fear that the report might be incorrect (46%) and lack of time (44%).
A significant lack of knowledge, positive attitudes, and practices regarding ADRs and reporting was observed in hospital HCPs. This finding represents an international concern, and urgent action is needed to promote drug safety and pharmacovigilance in this region.
药物不良反应（ADRs）是一个全球性的重大临床问题，尤其在医院中会导致大量的死亡率和发病率。医疗保健专业人员（HCPs）的知识、态度和做法是评估医院安全环境的关键点。本研究的目的是调查HCPs关于ADR报告系统的知识、态度和做法。
2013年1月至2月间，在沙特阿拉伯王国利雅得、卡西姆和东部地区提供高度专业化医疗服务的9家三级护理医院（政府和私立）进行了一项横断面调查。使用经过验证的问卷来评估HCPs关于ADR报告系统的知识、态度和做法。所有统计分析均使用SAS 9.2版进行。
共发放问卷480份，回复率为70%（n = 336）。只有33%的参与者知晓国家药物警戒中心（NPC）。在那些熟悉NPC及其报告ADR责任的HCPs中，大多数（50%）是药剂师，其次是医生（24%）和护士（16%），这些差异具有统计学意义（p < 0.01）。27%的参与者参与了ADR报告；在这些HCPs中，62%是药剂师，26%是护士，6%是医生。大多数参与者（95%）赞成报告由抗生素和新/旧药物引起的ADR。阻碍ADR报告的突出因素包括担心报告可能不正确（46%）和缺乏时间（44%）。
在医院HCPs中观察到对ADR及报告存在显著的知识缺乏、积极态度和做法不足。这一发现是一个国际关注的问题，需要采取紧急行动来促进该地区的药物安全和药物警戒。
