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Examining the Quality of Medicines at Kenyan Healthcare Facilities: A Validation of an Alternative Post-Market Surveillance Model That Uses Standardized Patients. 检查肯尼亚医疗机构的药品质量:使用标准化患者的另一种上市后监督模式的验证》。
IF 2 Pub Date : 2017-03-01 DOI: 10.1007/s40801-016-0100-7
Francis Wafula, Amy Dolinger, Benjamin Daniels, Njeri Mwaura, Guadalupe Bedoya, Khama Rogo, Ana Goicoechea, Jishnu Das, Bernard Olayo

Background: Promoting access to medicines requires concurrent efforts to strengthen quality assurance for sustained impact. Although problems of substandard and falsified medicines have been documented in low- and middle-income countries, reliable information on quality is rarely available.

Objective: The aim of this study was to validate an alternative post-market surveillance model to complement existing models.

Methods: The study used standardized patients or mystery clients (people recruited from the local community and trained to pose as real patients) to collect medicine samples after presenting a pre-specified condition. The patients presented four standardized conditions to 42 blinded facilities in Nairobi, Kenya, resulting in 166 patient-clinician interactions and dispensing of 300 medicines at facilities or nearby retail pharmacies. The medicine samples obtained thus resemble those that would be given to real patients.

Results: Sixty samples were selected from the 300, and sent for analysis at the Kenya National Quality Control Laboratory. Of these, ten (17%) did not comply with monograph specifications (three ibuprofen, two cetirizine, two amoxicillin/clavulanic acid combinations, and one each for prednisone, salbutamol and zinc). Five of the ten samples that failed had been inappropriately prescribed to patients who had presented symptoms of unstable angina. There was no association between medicine quality and ownership, size or location of the facilities.

Conclusion: The study shows that the standardized patient model can provide insights into multiple dimensions of care, thus helping to link primary care encounters with medicine quality. Furthermore, it makes it possible to obtain medicines from blinded sellers, thus minimizing the risk of obtaining biased samples.

背景:要促进药品的可及性,就必须同时努力加强质量保证,以取得持续的效果。虽然中低收入国家存在假冒伪劣药品问题,但却很少有可靠的质量信息:本研究旨在验证另一种上市后监督模式,以补充现有模式:研究使用标准化病人或神秘客户(从当地社区招募并经过培训的人,冒充真正的病人),在病人陈述预先指定的病情后收集药品样本。这些患者向肯尼亚内罗毕的 42 家盲人医疗机构提出了四种标准化病情,共进行了 166 次患者与医生的互动,并在医疗机构或附近的零售药店配发了 300 种药品。因此,所获得的药品样本与实际患者获得的样本相似:从 300 份样本中选取了 60 份样本,送往肯尼亚国家质量控制实验室进行分析。其中有 10 个样品(17%)不符合各论规定(布洛芬 3 个、西替利嗪 2 个、阿莫西林/克拉维酸复方 2 个、泼尼松、沙丁胺醇和锌各 1 个)。在不合格的 10 个样本中,有 5 个样本是不恰当地开给出现不稳定型心绞痛症状的患者的。药品质量与医疗机构的所有权、规模或地点没有关系:这项研究表明,标准化患者模型可以深入了解医疗服务的多个方面,从而有助于将初级医疗服务与药品质量联系起来。此外,该模式还能从盲目的销售者那里获得药品,从而最大限度地降低获得偏差样本的风险。
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引用次数: 0
Everywhere I Go: Affirming Our Rootedness in Zion and the Earth 我所到之处:肯定我们在锡安和地球上的根基
Pub Date : 2015-05-04 DOI: 10.1353/coj.2014.0020
B. Artson
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引用次数: 0
A Religious Perspective on the Place of Religion in the Public Square 从宗教视角看宗教在公共广场上的地位
Pub Date : 2015-05-04 DOI: 10.1353/COJ.2014.0022
David E. Greenstein
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引用次数: 0
The Religious Turn: A Review Essay 宗教转向:一篇评论文章
Pub Date : 2015-05-04 DOI: 10.1353/coj.2014.0025
Edward Feld
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引用次数: 0
Bracketing Belief: Giyyur for the Godless 信仰:为不信神的人祈祷
Pub Date : 2015-05-04 DOI: 10.1353/COJ.2014.0017
Shai Cherry
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引用次数: 0
A Strange, Familiar City 陌生而熟悉的城市
Pub Date : 2015-05-04 DOI: 10.1353/coj.2014.0021
J. Seltzer
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引用次数: 0
Agnon’s Yamim Nora⋅im: Then and Now 诺拉·伊姆:过去和现在
Pub Date : 2015-05-04 DOI: 10.1353/COJ.2014.0024
James S. Diamond
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引用次数: 0
Emil Fackenheim, Tikkun, and the Possibility of Response 埃米尔·法肯海姆:《Tikkun和回应的可能性》
Pub Date : 2015-05-04 DOI: 10.1353/COJ.2014.0026
J. Gordon
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引用次数: 1
Theological Responses to Natural Disasters 神学对自然灾害的反应
Pub Date : 2015-05-04 DOI: 10.1353/coj.2014.0016
Micah Peltz
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引用次数: 0
“My Father, The Rabbi”: Images of the Pre-Geonic Rabbinate’s Paternal Authority “我的父亲,拉比”:前犹太祭司拉比的父权形象
Pub Date : 2015-05-04 DOI: 10.1353/COJ.2014.0019
J. Rank
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引用次数: 0
期刊
Conservative Judaism
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