Department of Clinical Pharmacy and Pharmacy Administration, University of Ibadan, Ibadan, Nigeria.
Int J Clin Pharm. 2019 Aug;41(4):1062-1073. doi: 10.1007/s11096-019-00849-9. Epub 2019 May 28.
Background Higher incidence of adverse drug reactions (ADRs) remain a major cause of morbidity and mortality. Most targeted ADR reporting activities are mainly professional-centered with less attention to patients' knowledge, perception and selfreporting of experienced ADRs. Objectives To comprehensively evaluate patients' knowledge, awareness, perception and reporting of experienced ADRs. Setting Three public healthcare facilities in Ibadan, southwestern Nigeria. Method A questionnaire-guided cross-sectional interview of 1190 consented ambulatory adult patients consecutively recruited from various clinics of the selected hospitals between February and June 2018. The 32-item pretested questionnaire comprised open- and closed-ended questions, as well as open-ended questions with relevant prompts. Data were summarised using descriptive statistics, while Chi square was used to investigate association between relevant categorical variables at p < 0.05. Main outcome measure Knowledge, awareness, perception and reporting of experienced ADRs among patients. Results Response rate was 99.1%. Mean age was 40.6 ± 14.9 years. Forty-nine (4.1%) patients were aware of pharmacovigilance. A total of 964 (81.0%) correctly understood what can be regarded as serious adverse drug reactions (ADRs), 444 (37.3%) had previously experienced ADRs, while 77 (6.5%) experienced reactions with current medication(s). Of this, 64 (83.1%) made a report largely to physician (52; 81.3%). Summarily, reported reactions were more with antimalarials (214; 49.1%), with itching (168; 78.5%) constituting the most frequently occurring reaction. Use of text message (276; 27.2%) and filling of ADR report form (248; 24.4%) were topmost on the list of suggested methods for ADR reporting. There was a significant association between patient's age and awareness of pharmacovigilance (p = 0.015), while educational qualification (p = 0.001) significantly influenced tendency to make a report of experienced ADRs. Conclusion Approximately four percent of patients were aware of pharmacovigilance, while more than three-quarters correctly understood the concept of serious adverse drug reactions. A little above one-quarter had previously experienced one form of reaction or the other, with majority reporting such reactions to physician. Continuous education of stakeholders in pharmacovigilance activities is advocated, while patient's active involvement in spontaneous reporting of ADRs should be carefully considered.
药物不良反应(ADR)发生率较高仍是发病率和死亡率的主要原因。大多数靶向 ADR 报告活动主要以专业为中心,对患者对所经历的 ADR 的知识、感知和自我报告关注较少。
全面评估患者对所经历的 ADR 的知识、意识、感知和报告情况。
在尼日利亚西南部伊巴丹的三家公共医疗设施。
2018 年 2 月至 6 月期间,连续从选定医院的各个诊所招募了 1190 名同意的门诊成年患者,对其进行问卷调查引导的横断面访谈。经过预测试的 32 项问卷包括开放式和封闭式问题,以及带有相关提示的开放式问题。使用描述性统计数据总结数据,而卡方检验用于调查相关分类变量之间的关联,p 值<0.05。
患者对所经历的 ADR 的知识、意识、感知和报告情况。
应答率为 99.1%。平均年龄为 40.6±14.9 岁。有 49 名(4.1%)患者了解药物警戒。共有 964 名(81.0%)患者正确理解什么可被视为严重药物不良反应(ADR),444 名(37.3%)患者之前曾经历过 ADR,而 77 名(6.5%)患者目前正在服用药物时出现了反应。其中,64 名(83.1%)主要向医生报告了反应(52 名;81.3%)。总的来说,报告的反应更多地与抗疟药(214 例;49.1%)有关,其中瘙痒(168 例;78.5%)是最常发生的反应。使用短信(276 例;27.2%)和填写 ADR 报告表(248 例;24.4%)是 ADR 报告建议方法中最受欢迎的方法。患者年龄与对药物警戒的认识之间存在显著关联(p=0.015),而教育程度(p=0.001)显著影响经历 ADR 报告的倾向。
大约有 4%的患者了解药物警戒,而超过四分之三的患者正确理解严重药物不良反应的概念。超过四分之一的患者以前曾经历过一种或另一种形式的反应,大多数人向医生报告了此类反应。提倡对药物警戒活动的利益相关者进行持续教育,同时应认真考虑患者在自发报告 ADR 方面的积极参与。