USP/PQM, Addis Ababa, Ethiopia.
GAMBYMedical and Business College, Addis Ababa, Ethiopia.
PLoS One. 2020 Jan 21;15(1):e0227712. doi: 10.1371/journal.pone.0227712. eCollection 2020.
Adverse drug reactions (ADRs) are global public health problems. In its severe form it may cause hospital admission, morbidity and mortality. Early reporting of suspected ADRs to regulatory authorities is known to be appropriate measure toinsure health and safety of public form such adverse drug reaction of drugs. In Addis Ababa, there is limited information on ADR reporting practices among medical doctors. Hence, this study aimed to assess ADR reporting practices and associated factors among doctors in government hospitals in Addis Ababa.
An institution based cross-sectional mixed-methods study design was used. Data werecollected from 407 doctors using self-administered questionnaire and five key informants using semi-structured questionnaire from October 01 to December 31, 2017. Binary logistic regression and thematic analysis methods for quantitative and qualitative data analysis were used respectively.
Only 94(27.4%) of doctors had ever reported ADRs to national pharmacovigilance center. The study showed that sex (AOR = 3.51, 95% CI: 1.76-7.03), level ofeducation (AOR = 5.01, 95% CI: 2.23-11.28), work experience (AOR = 4.59, 95% CI: 1.21-17.40), existence of ADR reporting form (AOR = 3.96, 95% CI: 1.07-14.61) and reporting to respective marketing authorization holders (AOR = 21.41, 95% CI: 5.89-77.88) were significantly associated with ADR reporting practices. Poor awareness and training on risk of under-reporting, feeling that reporting is minor, absence of appropriate reporting tools, delay and/or absence of feedback on reported ADRs, overly burdened doctors, negligence, fear of legal liabilityand communication gap were cited by key informants as barriers for reporting practice.
Adverse drug reaction reporting practice among doctors wasfound to be low. Sex, level of education, work experience, existence of reporting form and reporting to marketing authorization holderswere significantly associated with ADR reporting practice. In addition, there are gaps in availabilities of guidelines, reporting systems and structure, pre-service and in-service training, and awareness of doctors on impact of reporting. Hence, improving access to ADR reporting form, decentralize safety monitoring system, and conducting awareness training on ADR reporting are essential to improve the ADR reporting practice.
药物不良反应（ADR）是全球公共卫生问题。在严重的情况下，它可能导致住院、发病和死亡。向监管机构早期报告疑似 ADR 被认为是确保公众健康和安全的适当措施，以避免此类药物的不良反应。在亚的斯亚贝巴，关于医生报告 ADR 的实践知之甚少。因此，本研究旨在评估亚的斯亚贝巴政府医院医生的 ADR 报告实践和相关因素。
采用基于机构的横断面混合方法设计。2017 年 10 月 1 日至 12 月 31 日，使用自我管理问卷从 407 名医生中收集数据，并使用半结构问卷从 5 名关键信息提供者中收集数据。分别使用二元逻辑回归和主题分析方法对定量和定性数据进行分析。
只有 94（27.4%）名医生向国家药物警戒中心报告过 ADR。研究表明，性别（AOR = 3.51，95%CI：1.76-7.03）、教育水平（AOR = 5.01，95%CI：2.23-11.28）、工作经验（AOR = 4.59，95%CI：1.21-17.40）、是否有 ADR 报告表（AOR = 3.96，95%CI：1.07-14.61）和向各自的上市许可持有人报告（AOR = 21.41，95%CI：5.89-77.88）与 ADR 报告实践显著相关。关键信息提供者提到，对漏报风险的认识和培训不足、认为报告不重要、缺乏适当的报告工具、报告的 ADR 延迟和/或缺乏反馈、医生负担过重、疏忽、害怕法律责任和沟通差距是报告实践的障碍。
研究发现，医生报告 ADR 的实践情况不佳。性别、教育水平、工作经验、报告表的存在以及向上市许可持有人报告与 ADR 报告实践显著相关。此外，在指南的可获得性、报告系统和结构、职前和在职培训以及医生对报告影响的认识方面存在差距。因此，改善 ADR 报告表的获取途径、分散安全监测系统以及开展 ADR 报告意识培训对于改善 ADR 报告实践至关重要。
