Kampichit Sirinya, Pratipanawatr Thongchai, Jarernsiripornkul Narumol
Division of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen, Thailand.
Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.
Int J Clin Pharm. 2018 Dec;40(6):1559-1567. doi: 10.1007/s11096-018-0732-7. Epub 2018 Oct 26.
Background Patient reporting of adverse drug reactions (ADRs) could supplement the existing reporting system and contribute to early detection of ADRs. The confidence in ADR identification and their attribution of ADRs were limited to outpatients. Objective To determine the type and frequency of ADRs reported by outpatients, to evaluate confidence and accuracy in ADR identification as well as contributing factors. Setting University hospital in northeastern Thailand Method Cross-sectional study using questionnaires distributed to 500 outpatients who claimed to have experienced an ADR. Confidence in identifying ADRs was measured by visual analogue score (VAS), while accuracy of reported ADRs was determined using Naranjo algorithm and WHO criteria. Main outcome measure Number and type of ADRs, confidence rating and accuracy category. Results In total, 390 outpatients completed the questionnaire (response rate = 78.0%). Rash (19.0%), nausea/vomiting (7.4%), and dizziness (5.8%) were the top three reported ADRs. Sixty-one percent of respondents rated their level of confidence in identifying ADRs as high (VAS 9.2 ± 0.95), which was associated with having underlying diseases (OR 1.93), low number of reported symptoms (OR 0.38) and severe ADRs (OR 1.33). Causality assessment was classified as true ADRs in 90.0% and 88.9% of cases, using Naranjo algorithm and WHO criteria, respectively. Respondents with low number of reported symptoms (OR 0.27) and high level of confidence had greater accuracy in ADR identification (OR 1.11). Conclusion The outpatients reported a high proportion of potential ADRs with high confidence and accuracy. Patient reporting of ADRs has potential to support the pharmacovigilance system.
背景 患者报告药物不良反应（ADR）可补充现有报告系统，并有助于早期发现ADR。门诊患者对ADR识别及其归因的信心有限。目的 确定门诊患者报告的ADR类型和频率，评估ADR识别的信心和准确性以及相关因素。地点 泰国东北部的大学医院 方法 采用横断面研究，向500名自称经历过ADR的门诊患者发放问卷。通过视觉模拟评分（VAS）测量识别ADR的信心，同时使用Naranjo算法和WHO标准确定报告的ADR的准确性。主要观察指标 ADR的数量和类型、信心评级和准确性类别。结果 共有390名门诊患者完成了问卷（回复率 = 78.0%）。皮疹（19.0%）、恶心/呕吐（7.4%）和头晕（5.8%）是报告最多的前三种ADR。61%的受访者将其识别ADR的信心水平评为高（VAS 9.2±0.95），这与患有基础疾病（OR 1.93）、报告症状数量少（OR 0.38）和严重ADR（OR 1.33）有关。分别使用Naranjo算法和WHO标准，因果关系评估在90.0%和88.9%的病例中被分类为真正的ADR。报告症状数量少（OR 0.27）且信心水平高的受访者在ADR识别方面具有更高的准确性（OR 1.11）。结论 门诊患者报告了高比例的潜在ADR，且信心和准确性较高。患者报告ADR有可能支持药物警戒系统。
