Medicines Information Centre, Division of Clinical Pharmacology, Department of Medicine, Faculty of Health Sciences, University of Cape Town, South Africa.
S Afr Med J. 2020 Nov 27;110(12):1226-1230. doi: 10.7196/SAMJ.2020.v110i12.14721.
There are limited data in South Africa (SA) on adverse drug reaction (ADR) patterns and common causative medicines, outside of HIV and tuberculosis treatment programmes. In SA, Western Cape Province has a pharmacovigilance programme that collects spontaneous reports of suspected ADRs from public sector healthcare facilities.
To describe reports received by the pharmacovigilance programme over a 4-year period (excluding those ascribed to medicines used to treat HIV and tuberculosis), as well as challenges faced in the implementation of such a system.
Reports of suspected ADRs and deaths possibly related to ADRs received between January 2015 and December 2018 were reviewed. Causality was assessed by a pharmacist, with multidisciplinary team involvement for all deaths and complicated cases. Causality was categorised according to the World Health Organization-Uppsala Monitoring Centre system. Preventability was assessed using Schumock and Thornton criteria. Observations on preventability and challenges faced in the operation of a spontaneous reporting system were also noted.
We received 5 346 reports containing 6 023 suspected ADRs. There were 5 486 ADRs confirmed after causality assessment, in 5 103 reports. Cough, angio-oedema, movement disorders and uterine bleeding disorders were the most common ADRs. Enalapril, etonogestrel, amlodipine and hydrochlorothiazide were the most commonly implicated drugs. Seven deaths were reported; 3 of these reports of deaths had confirmed ADRs, and these ADRs were assessed as contributing to the deaths. Approximately 3.8% of commonly reported ADRs were preventable.
Enalapril and etonogestrel were responsible for a significant proportion of ADRs reported to this provincial programme. Future work should include quantification of preventability aspects to better inform gaps in healthcare worker knowledge that can be addressed in order to improve patient care.
在南非（SA），除了艾滋病毒和结核病治疗方案外，关于药物不良反应（ADR）模式和常见致病药物的数据有限。在南非，西开普省拥有一个药物警戒计划，该计划从公共部门医疗设施中收集疑似 ADR 的自发报告。
描述在 4 年期间（不包括用于治疗艾滋病毒和结核病的药物）该药物警戒计划收到的报告，以及在实施该系统时面临的挑战。
审查了 2015 年 1 月至 2018 年 12 月期间收到的疑似 ADR 报告和可能与 ADR 相关的死亡报告。由药剂师评估因果关系，所有死亡和复杂病例均由多学科团队参与。根据世界卫生组织-乌普萨拉监测中心系统对因果关系进行分类。使用 Schumock 和 Thornton 标准评估可预防性。还注意到与操作自发报告系统相关的可预防性和面临的挑战的观察结果。
我们收到了 5346 份报告，其中包含 6023 例疑似 ADR。在因果关系评估后，5103 份报告中有 5486 例 ADR 得到确认。咳嗽、血管性水肿、运动障碍和子宫出血障碍是最常见的 ADR。依那普利、依托孕烯、氨氯地平和氢氯噻嗪是最常涉及的药物。报告了 7 例死亡；其中 3 例死亡报告确认了 ADR，这些 ADR 被评估为导致死亡。约 3.8%的常见报告 ADR 是可预防的。
依那普利和依托孕烯是该省级计划报告的 ADR 的主要原因。未来的工作应包括量化可预防性方面，以便更好地了解医护人员知识方面的差距，从而可以改善患者护理。
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