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马拉维布兰太尔市区药店中阿莫西林的质量和销售情况。

Amoxicillin Quality and Selling Practices in Urban Pharmacies and Drug Stores of Blantyre, Malawi.

机构信息

Biomedical Sciences and Pharmacy Departments, College of Medicine, University of Malawi, Blantyre, Malawi.

Department of Chemistry and Biochemistry, University of Notre Dame, Notre Dame, Indiana.

出版信息

Am J Trop Med Hyg. 2018 Jul;99(1):233-238. doi: 10.4269/ajtmh.18-0003. Epub 2018 Apr 19.

Abstract

This study evaluated a newly developed paper analytical device (PAD) for screening amoxicillin samples in Blantyre urban townships. Covert shoppers attempted to buy amoxicillin from a geographically stratified selection of private pharmacies ( = 22 out of 26) and drug stores ( = 23 out of 103) in the township area. According to the PAD results, all 42 samples obtained by the shoppers contained amoxicillin and none contained suspicious filler materials. Next, the products were assayed using high-performance liquid chromatography. Consistent with the PAD results, all samples contained the correct amount of amoxicillin with no unexpected ingredients. However, one sample was purchased as amoxicillin and contained that ingredient, but was packaged in capsules that are normally used to package ampicillin. Almost every sample failed a simple packaging analysis. Nine in 10 samples were missing their original packaging and/or inserts (52.4% repackaged capsules and 35.7% repackaged blister packs). Only 33.3% of the packages had expiry dates, 16.7% had batch numbers, and 47.6% had the manufacturer's name. Dispensing practices were likewise unsatisfactory. Ninety-five percentage of the sellers sold the amoxicillin without a prescription, even though this medicine is regulated as prescription-only in Malawi. Although the chemical analysis showed that amoxicillin quality was good, our market survey revealed poor adherence to prescription-only medicine dispensing of antibiotics, which threatens antimicrobial stewardship efforts. Furthermore, the wide prevalence of repackaging deprives medicines of important information needed during patient's use, regulatory investigations, and pharmacovigilance reporting.

摘要

本研究评估了一种新开发的纸质分析设备(PAD),用于筛查布兰太尔市区乡镇的阿莫西林样本。秘密购物者试图从乡镇地区按地理位置分层选择的私人药店(= 26 家药店中的 22 家)和药店(= 103 家药店中的 23 家)购买阿莫西林。根据 PAD 的结果,购物者获得的所有 42 个样本均含有阿莫西林,且均不含可疑的填充材料。然后,使用高效液相色谱法对这些产品进行了检测。与 PAD 的结果一致,所有样本均含有正确剂量的阿莫西林,且无意外成分。然而,有一个样本被购买为阿莫西林,且含有该成分,但包装在通常用于包装氨苄西林的胶囊中。几乎每个样本的包装分析都不合格。十分之九的样本缺少原始包装和/或插页(52.4%的胶囊重新包装,35.7%的泡罩包装重新包装)。只有 33.3%的包装有有效期,16.7%有批次号,47.6%有制造商名称。配药做法同样不尽人意。95%的卖家在没有处方的情况下销售阿莫西林,尽管这种药物在马拉维被规定为凭处方销售。尽管化学分析显示阿莫西林质量良好,但我们的市场调查显示,对抗生素的凭处方销售规定执行不力,这威胁到抗菌药物管理工作。此外,广泛的重新包装使药品在患者使用、监管调查和药物警戒报告中失去了重要信息。

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