Development of a pharmacovigilance safety monitoring tool for the rollout of single low-dose primaquine and artemether-lumefantrine to treat Plasmodium falciparum infections in Swaziland: a pilot study
Development of a pharmacovigilance safety monitoring tool for the rollout of single low-dose primaquine and artemether-lumefantrine to treat Plasmodium falciparum infections in Swaziland: a pilot study
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DOI：
10.1186/s12936-016-1410-7
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发表时间：
2016-07-22
期刊：
影响因子：
3
通讯作者：
Gosling, Roland
中科院分区：
文献类型：
--
作者：
Poirot, Eugenie;Soble, Adam;Gosling, Roland
背景：各国仍不愿采用2012年世界卫生组织关于阻断恶性疟原虫传播的单次低剂量（0.25 mg/kg）伯氨喹（SLD PQ）的建议，原因是担心药物相关的溶血风险，特别是在葡萄糖-6-磷酸脱氢酶缺陷（G6PDd）人群中，而且没有证据表明它可以安全地在其环境中使用。药物警戒方法提供了一种收集安全性数据的系统方法，并支持SLD PQ的推广。方法：伯氨喹推出监测药物警戒工具（PROMPT），包括：(1)支持SLD PQ治疗后可能不良事件监测的标准化表格；(2)制作患者信息卡，提高患者对使用SLD PQ的已知不良反应的认识；(3)建立了记录信息数据库，并进行了试点。收集有关患者特征、疟疾诊断和治疗的数据。血液样本被用来测量血红蛋白（Hb）和测试G6PD缺乏症。积极随访包括在第7天或接近第7天重复Hb测量和不良事件监测。在斯威士兰的两家医院进行了为期13个月的前瞻性试点研究，同时引入了SLD PQ，产生了关于PROMPT的可行性和可接受性的初步证据。结果：PROMPT作为一种简单、实用的主动监测SLD PQ安全数据的方法，受到护士的好评。在102名入组并给予SLD PQ治疗的患者中，没有人患有G6PDd。93例（91.2%）在第7天或接近第7天返回随访。4例（4.6%）患者Hb >较基线下降25%，均未出现贫血的体征或症状。没有患者的Hb低于7 g/dL，也没有患者需要输血。在研究期间报告不良事件的11例（11%）患者中，3例被认为是严重的，包括2例死亡和1例住院；与SLD PQ均无因果关系。四种非严重不良事件被认为肯定、可能或可能与SLD PQ相关。结论：需要改进药物警戒以监测和促进世卫组织建议的安全性。PROMPT的成功应用证明了它作为一种重要工具的潜力，可以快速生成本地获取的安全数据，并在资源有限的情况下支持药物警戒。
Background: Countries remain reluctant to adopt the 2012 World Health Organization recommendation for single low-dose (0.25 mg/kg) primaquine (SLD PQ) for Plasmodium falciparum transmission-blocking due to concerns over drug-related haemolysis risk, especially among glucose-6-phosphate dehydrogenase-deficient (G6PDd) people, without evidence demonstrating that it can be safely deployed in their settings. Pharmacovigilance methods provide a systematic way of collecting safety data and supporting the rollout of SLD PQ.Methods: The Primaquine Roll Out Monitoring Pharmacovigilance Tool (PROMPT), comprising: (1) a standardized form to support the surveillance of possible adverse events following SLD PQ treatment; (2) a patient information card to enhance awareness of known adverse drug reactions of SLD PQ use; and (3) a database compiling recorded information, was developed and piloted. Data on patient characteristics, malaria diagnosis and treatment are collected. Blood samples are taken to measure haemoglobin (Hb) and test for G6PD deficiency. Active follow-up includes a repeat Hb measurement and adverse event monitoring on or near day 7. A 13-month prospective pilot study in two hospital facilities in Swaziland alongside the introduction of SLD PQ generated preliminary evidence on the feasibility and acceptability of PROMPT.Results: PROMPT was well received by nurses as a simple, pragmatic approach to active surveillance of SLD PQ safety data. Of the 102 patients enrolled and administered SLD PQ, none were G6PDd. 93 (91.2 %) returned on or near day 7 for follow-up. Four (4.6 %) patients had falls in Hb >= 25 % from baseline, none of whom presented with signs or symptoms of anaemia. No patient's Hb fell below 7 g/dL and none required a blood transfusion. Of the 11 (11 %) patients who reported an adverse event over the study period, three were considered serious and included two deaths and one hospitalization; none were causally related to SLD PQ. Four non-serious adverse events were considered definitely, probably, or possibly related to SLD PQ.Conclusion: Improved pharmacovigilance to monitor and promote the safety of the WHO recommendation is needed. The successful application of PROMPT demonstrates its potential as an important tool to rapidly generate locally acquired safety data and support pharmacovigilance in resource-limited settings.