Faculty of Medicine Novi Sad, Department of Pharmacology, Toxicology and Clinical Pharmacology, University of Novi Sad, Novi Sad, Serbia.
Faculty of Pharmacy, University Business Academy in Novi Sad, Novi Sad, Serbia.
Curr Med Res Opin. 2022 Jul;38(7):1229-1236. doi: 10.1080/03007995.2022.2070380. Epub 2022 May 6.
The effectiveness of the national drug safety monitoring program directly depends on the active participation of healthcare professionals in reporting suspected adverse drug reactions (ADRs). The aim of the study was to explore community pharmacists' comprehension of pharmacovigilance, their perspectives toward reporting ADRs and investigate the current practice of ADR reporting among pharmacists in Serbia.
This descriptive cross-sectional study was performed on a sample of pharmacists in Serbia between November 2019 and March 2020 using a pre-tested questionnaire distributed online. Eligible participants were community pharmacists in Serbia who were willing to participate in the study during the data collection period. Non-parametric statistical tests were performed in the analysis of knowledge, perspectives and ADR reporting. The validity and reliability of the survey were measured by exploratory factor analysis.
The median knowledge score was 6 out of 10 (interquartile range 5-7, range 2-10). No significant differences in the knowledge scores of pharmacists were found based on weekly working hours ( = 24,805, = .374), working experience ( = 4.011, DF = 2, = .135), being a member of a professional organization ( = 24,312, = .209), or highest level of pharmacy qualification obtained ( = 3.233, DF = 3, = .506). Only 28.8% of pharmacists reported ADR at least once a year, while the majority of them have never reported any ADRs.
Despite the community pharmacists' positive attitude toward adverse drug reporting and their role in the process, they show limited knowledge regarding the issue and highly prevalent under-reporting of ADRs. Educational programs are necessary to increase ADRs reporting.
国家药物安全监测计划的有效性直接取决于医疗保健专业人员积极参与报告疑似药物不良反应(ADR)。本研究旨在探讨社区药剂师对药物警戒的理解、他们对报告 ADR 的看法,并调查塞尔维亚药剂师目前报告 ADR 的情况。
本研究采用描述性横断面研究,于 2019 年 11 月至 2020 年 3 月期间在塞尔维亚的药剂师样本中进行,使用在线分发的预先测试问卷。合格的参与者是塞尔维亚的社区药剂师,他们愿意在数据收集期间参加研究。在知识、观点和 ADR 报告的分析中采用非参数统计检验。通过探索性因子分析测量调查的有效性和可靠性。
知识评分中位数为 10 分中的 6 分(四分位距 5-7,范围 2-10)。药剂师的知识评分没有因每周工作时间(U = 24805,Z = 0.374)、工作经验(U = 4.011,DF = 2,Z = 0.135)、是否为专业组织成员(U = 24312,Z = 0.209)或获得的最高药房资格水平(U = 3.233,DF = 3,Z = 0.506)而存在显著差异。只有 28.8%的药剂师每年至少报告一次 ADR,而大多数药剂师从未报告过任何 ADR。
尽管社区药剂师对不良药物报告持积极态度,并在该过程中发挥作用,但他们对该问题的知识有限,且 ADR 报告的漏报率很高。需要开展教育计划以提高 ADR 报告率。