National Pharmacovigilance Centre, National Drug Authority, Kampala, Uganda.
Department of Pharmacology and Therapeutics, Makerere University, Kampala, Uganda.
Malar J. 2020 Feb 10;19(1):63. doi: 10.1186/s12936-020-3148-5.
Efficient testing to identify poor quality artemisinin-based combination therapy (ACT) is important to optimize efforts to control and eliminate malaria. Healthcare professionals interact with both ACT and malaria patients they treat and hence could observe, first-hand, suspect poor quality artemisinin-based combinations linked to poor malaria treatment outcomes and the factors associated with inappropriate use or treatment failure.
A cross-sectional study of 685 HCP perspectives about the efficacy of ACT between June and July 2018 at selected health facilities in Uganda. Medicine samples were obtained from the seven regions of Uganda and tested for quality using the Germany Pharma Health Fund™ minilabs.
The average age of the 685 respondents was 30 (SD = 7.4) years. There was an almost equal distribution between male and female respondents (51:49), respectively. Seventy percent (n = 480) were diploma holders and the nurses contributed to half (49%, n = 334) of the study population. Sixty-one percent of the HCPs reported having ever encountered ACT failures while treating uncomplicated malaria. Nineteen percent of HCPs thought that dihydroartemisinin/piperaquine gave the most satisfactory patient treatment outcomes, while 80% HCPs thought that artemether/lumefantrine gave the least satisfactory patient treatment outcomes, possibly due to dosing schedule and pill burden. Healthcare professionals from the Central region (OR = 3.0, CI 0.3-1.0; P = 0.0001), Eastern region (OR = 5.4, CI 2.9-9.8; P = 0.0001) and Northern region (OR = 5.3, CI 2.9-9.9; P = 0.0001) had a higher chance of encountering ACT failure in 4 weeks prior to the survey as compared to those from the western region. Healthcare professionals from private health facilities also had higher chances of encountering ACT failures in past 4 weeks as compared to those from public health facilities (OR = 2.7, CI 1.7-3.9; P = 0.0001). All 192 samples passed the quality screening tests. The random sample of 10% of all samples randomly obtained by the laboratory staff also passed the chemical content analysis and dissolution tests.
ACT medicines are widely available over-the-counter to the public and it is very difficult to report and monitor a decrease in efficacy or treatment failure. The perspectives of HCPs on treatment failure or lack of efficacy may potentially guide optimization efforts of sampling methodologies for the quality survey of ACT medicines.
高效的检测方法可以识别出青蒿素类复方药物(ACT)质量差的情况,这对于优化控制和消除疟疾的努力非常重要。医疗保健专业人员与他们治疗的 ACT 和疟疾患者都有接触,因此可以直接观察到与治疗效果不佳相关的质量差的青蒿素类复方药物,并了解与之相关的不合理使用或治疗失败的因素。
2018 年 6 月至 7 月,在乌干达选定的卫生设施,对 685 名医疗保健专业人员对 ACT 疗效的看法进行了横断面研究。从乌干达的七个地区采集了药品样本,并使用德国 Pharma Health Fund™ minilabs 进行了质量检测。
685 名受访者的平均年龄为 30 岁(标准差=7.4)。男女受访者的比例几乎相等(分别为 51%和 49%)。70%(n=480)为文凭持有者,护士占研究人群的一半(49%,n=334)。61%的医疗保健专业人员在治疗无并发症疟疾时曾遇到过 ACT 失败的情况。19%的医疗保健专业人员认为双氢青蒿素/哌喹能给患者带来最满意的治疗效果,而 80%的医疗保健专业人员认为青蒿琥酯/咯萘啶的治疗效果最不满意,这可能与用药方案和药物负担有关。与西部地区相比,来自中部地区(OR=3.0,CI 0.3-1.0;P=0.0001)、东部地区(OR=5.4,CI 2.9-9.8;P=0.0001)和北部地区(OR=5.3,CI 2.9-9.9;P=0.0001)的医疗保健专业人员在调查前 4 周内遇到 ACT 失败的几率更高。与来自公立卫生机构的医疗保健专业人员相比,来自私立卫生机构的医疗保健专业人员在过去 4 周内遇到 ACT 失败的几率更高(OR=2.7,CI 1.7-3.9;P=0.0001)。所有 192 个样本均通过质量筛选测试。实验室工作人员随机抽取的 10%的样本进行了随机抽样,也通过了化学含量分析和溶解测试。
ACT 药物在公众中广泛可获得,因此很难报告和监测疗效下降或治疗失败的情况。医疗保健专业人员对治疗失败或疗效不佳的看法可能有助于优化 ACT 药物质量调查的采样方法。