Alshabi Ali Mohamed, Shaikh Mohammed Ashique K, Shaikh Ibrahim Ahmed, Alkahtani Saad Ahmed, Aljadaan Adel
Department of Clinical Pharmacy, College of Pharmacy, Najran University, Najran, Saudi Arabia.
Pharmacy Services Division, Najran University Hospital, Najran, Saudi Arabia.
Saudi Pharm J. 2022 Jul;30(7):1018-1026. doi: 10.1016/j.jsps.2022.04.014. Epub 2022 Apr 30.
Pharmacovigilance (PV) is critical in determining the risk-benefit ratio of medicines and encouraging their safe, rational, and effective use, hence enhancing patient safety and care. Pharmacists, as drug experts, share responsibility for ensuring that medicines remain safe.
The study aimed to assess the knowledge, attitude, and practice of hospital pharmacists towards PV and adverse drug reaction (ADR) reporting and to know factors that discourage them from reporting ADRs in Najran, Saudi Arabia.
A pre-tested self-administered questionnaire was distributed to all the pharmacists working in government hospitals who consented to participate in the study. Data was collected over three months, from 01 June 2018 to 31 Aug 2018. Data were analyzed using Statistical Package for Social Science (SPSS) software for Windows, version 23. Descriptive statistics such as frequency and percentages, mean ± standard deviation (SD) were calculated, and the Pearson's Chi-square test was used to examine the relationship between different variables.
A total of 145 questionnaires were distributed, and the response rate obtained was 70.3%. The definition of PV and ADR were correctly identified by 42% and 68.3% of participants, respectively. A noteworthy finding is that 95% of participants were aware of the existence of the ADR reporting system, and 88.9% knew the responsible regulatory agency. Participants showed a positive attitude towards PV and ADR reporting; 90.1% considered ADR reporting a part of professional obligation, and 94.1% believed that there should be collaboration between pharmacists and other healthcare professionals. A majority of participants (86.1%) had identified an ADR during their practice, and 71.3% had reported an ADR. The unavailability of a professional environment to discuss ADR and insufficient pharmacotherapy/clinical knowledge was cited as the main factors discouraging from reporting ADRs.
Overall, the pharmacists had an average to good knowledge of and positive attitude towards PV and ADR reporting and a good ADR reporting practice. The concept of PV and ADR reporting should be further strengthened, and there is a vast potential for the same.
药物警戒（PV）对于确定药物的风险效益比以及促进其安全、合理和有效使用至关重要，从而提高患者安全和护理水平。药剂师作为药物专家，对确保药物安全负有共同责任。
本研究旨在评估沙特阿拉伯纳季兰地区医院药剂师对药物警戒和药品不良反应（ADR）报告的知识、态度和实践，并了解阻碍他们报告ADR的因素。
向所有同意参与研究的政府医院药剂师发放一份经过预测试的自填式问卷。数据收集期为三个月，从2018年6月1日至2018年8月31日。使用适用于Windows的社会科学统计软件包（SPSS）23版进行数据分析。计算频率和百分比、均值±标准差（SD）等描述性统计量，并使用Pearson卡方检验来检验不同变量之间的关系。
共发放145份问卷，获得的回复率为70.3%。分别有42%和68.3%的参与者正确识别了药物警戒和药品不良反应的定义。一个值得注意的发现是，95%的参与者知晓药品不良反应报告系统的存在，88.9%的人知道负责的监管机构。参与者对药物警戒和药品不良反应报告表现出积极态度；90.1%的人认为药品不良反应报告是职业义务的一部分，94.1%的人认为药剂师与其他医疗专业人员之间应该开展合作。大多数参与者（86.1%）在实践中识别出了药品不良反应，71.3%的人报告过药品不良反应。缺乏讨论药品不良反应的专业环境以及药物治疗/临床知识不足被认为是阻碍报告药品不良反应的主要因素。
总体而言，药剂师对药物警戒和药品不良反应报告有中等至良好的知识水平和积极态度，且有良好的药品不良反应报告实践。药物警戒和药品不良反应报告的概念应进一步强化，并且有很大的潜力。
