Pharmaceutical Institute, Eberhard Karls University Tuebingen, Tuebingen, Germany.
German Institute for Medical Mission (Difäm), Tübingen, Germany.
Sci Rep. 2022 Jul 30;12(1):13095. doi: 10.1038/s41598-022-17123-0.
This study evaluates the use of the Global Pharma Health Fund (GPHF) Minilab for medicine quality screening by 16 faith-based drug supply organizations located in 13 low- and middle-income countries. The study period included the year before the COVID-19 pandemic (2019) and the first year of the pandemic (2020). In total 1,919 medicine samples were screened using the GPHF Minilab, and samples showing serious quality deficiencies were subjected to compendial analysis in fully equipped laboratories. Thirty-four (1.8%) of the samples were found not to contain the declared active pharmaceutical ingredient (API), or less than 50% of the declared API, or undeclared APIs, and probably represented falsified products. Fifty-four (2.8%) of the samples were reported as substandard, although the true number of substandard medicines may have been higher due to the limited sensitivity of the GPHF Minilab. The number of probably falsified products increased during the COVID-19 pandemic, especially due to falsified preparations of chloroquine; chloroquine had been incorrectly advocated as treatment for COVID-19. The reports from this project resulted in four international WHO Medical Product Alerts and several national alerts. Within this project, the costs for GPHF Minilab analysis resulted as 25.85 € per sample. Medicine quality screening with the GPHF Minilab is a cost-effective way to contribute to the global surveillance for substandard and falsified medical products.
本研究评估了全球制药健康基金(GPHF)Minilab 在 13 个中低收入国家的 16 个信仰型药物供应组织中用于药品质量筛选的情况。研究期间包括 COVID-19 大流行前一年(2019 年)和大流行第一年(2020 年)。共使用 GPHF Minilab 筛选了 1919 个药品样本,对显示严重质量缺陷的样本在设备齐全的实验室进行了药典分析。发现 34 个(1.8%)样本未包含申报的活性药物成分(API),或 API 含量低于 50%,或含有未申报的 API,可能代表假冒产品。54 个(2.8%)样本报告为劣药,尽管由于 GPHF Minilab 的灵敏度有限,劣药的真实数量可能更高。在 COVID-19 大流行期间,可能假冒产品的数量有所增加,尤其是由于氯喹的假冒制剂;氯喹曾被错误地倡导为 COVID-19 的治疗方法。该项目的报告导致了四个国际世卫组织药品警报和几个国家警报。在该项目中,GPHF Minilab 分析的成本为每个样本 25.85 欧元。使用 GPHF Minilab 进行药品质量筛选是一种具有成本效益的方法,可以有助于对劣药和假药进行全球监测。