Medicine Usage in South Africa (MUSA), Faculty of Health Sciences, North-West University, Potchefstroom, South Africa.
S Afr Med J. 2023 Jun 5;113(6):26-33. doi: 10.7196/SAMJ.2023.v113i5.16522.
The South African Health Products Regulatory Authority (SAHPRA) monitors the safety of health products by collecting and evaluating adverse drug reaction (ADR) reports submitted by healthcare professionals, patients and pharmaceutical companies. The reports are shared with the World Health Organization (WHO) Programme for International Drug Monitoring. A demographic and clinical profile of ADR reports will improve our understanding of ADR reporting in South Africa to enhance training of reporters at all levels.
This study describes the demographic and clinical profile of spontaneous ADR reports received by the SAHPRA during the year 2017.
A retrospective, cross-sectional study was conducted to describe all ADR reports submitted by South Africa to VigiBase®, the WHO global database of Individual Case Safety Reports (ICSRs), during 2017. The demographic profile included patient characteristics (age and sex), type of reporter and the vigiGrade™ completeness score for each ICSR. The clinical profile included characteristics of the case, medicine(s) and reaction(s).
A total of 8 438 reports with a mean completeness score of 0.456 (SD = 0.221) were assessed. Females and males represented 61.96% and 33.05% of cases, respectively (if sex was reported). All age groups were represented; however, 76.28% involved adults (aged 19-64 years). Physicians submitted the most reports (39.66%). Consumers were the reporters in 29.39% of cases. Pharmacists submitted only 4.45% of the reports. Anti-infective medicines were the most reported Anatomical Therapeutic Class (20.08%), while Human Immunodeficiency Virus was the top indication reported (10.27%). The highest number of MedDRA preferred terms used to describe reactions belonged to the System Organ Class, general disorder and administration site conditions. In 55.87% of the reports, the cases were reported as serious and 12.47% fatal. Death was the most reported MedDRA preferred term used to describe a reaction (5.17%).
This was the first study that described ADR reports received by SAHPRA and improves our understanding of reporting in the country. The core clinical elements that are important in signal detection were often not included in reports. The findings demonstrated that patients were more active contributors to the national pharmacovigilance database than pharmacists. Reporters should be trained in pharmacovigilance and ADR reporting processes to increase the quantity and completeness of reports.
南非卫生产品监管局（SAHPRA）通过收集和评估医疗保健专业人员、患者和制药公司提交的药物不良反应（ADR）报告来监测药品的安全性。这些报告与世界卫生组织（WHO）的国际药物监测计划共享。ADR 报告的人口统计学和临床特征将有助于我们了解南非的 ADR 报告情况，从而加强对各级报告人的培训。
本研究描述了 2017 年 SAHPRA 收到的自发 ADR 报告的人口统计学和临床特征。
采用回顾性、横断面研究方法，描述 2017 年南非向世界卫生组织全球个体病例安全报告数据库（VigiBase®）提交的所有 ADR 报告。人口统计学特征包括患者特征（年龄和性别）、报告人类型和每个个体病例安全报告的 vigigrade™完整性评分。临床特征包括病例、药物和反应的特征。
共评估了 8438 份报告，平均完整性评分为 0.456（SD=0.221）。女性和男性分别占病例的 61.96%和 33.05%（如果报告了性别）。所有年龄组均有报告，但 76.28%为成年人（19-64 岁）。医生提交的报告最多（39.66%）。消费者是 29.39%病例的报告人。药剂师仅提交了 4.45%的报告。抗感染药物是报告最多的解剖治疗学类别（20.08%），而人类免疫缺陷病毒是报告最多的指征（10.27%）。用于描述反应的 MedDRA 首选术语数量最多的是系统器官类别、一般疾病和给药部位情况。在 55.87%的报告中，病例被报告为严重，12.47%为致命。死亡是用于描述反应的最常见的 MedDRA 首选术语（5.17%）。
这是第一项描述 SAHPRA 收到的 ADR 报告的研究，有助于我们了解该国的报告情况。在信号检测中很重要的核心临床要素在报告中经常没有被包括。研究结果表明，与药剂师相比，患者对国家药物警戒数据库的贡献更大。应培训报告人药物警戒和 ADR 报告程序，以提高报告的数量和完整性。
