Department of Pharmaceutical Chemistry and Pharmacognosy, School of Pharmacy, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.
Ethiopian Food and Drug Authority, Addis Ababa, Ethiopia.
Am J Trop Med Hyg. 2024 Feb 13;110(3):596-608. doi: 10.4269/ajtmh.23-0536. Print 2024 Mar 6.
The prevalence of substandard and falsified (SF) antimicrobial drugs is increasing around the globe. This poses a great concern for the healthcare system. The consumption of SF antimicrobial drugs has the potential to result in treatment failure, emergence and development of antimicrobial resistance, and ultimately a rise in mortality rate. The objective of this study was to assess the quality of four commonly used antimicrobials marketed in the cities of Dire Dawa and Jijiga and the town of Togo-Wuchale, which have high potential for illegal drug trade activities in Ethiopia because they are located near the border with Somalia. A total of 54 brands/samples of amoxicillin, amoxicillin/clavulanic acid, ciprofloxacin, and norfloxacin formulations were collected covertly from 43 facilities using a convenience sampling strategy from March 16 to March 29, 2022. The samples were first screened using Global Pharma Health Fund (GPHF)-Minilab protocols and then analyzed using U.S. Pharmacopoeial and British Pharmacopoeia official methods. The quality evaluation detected no falsified product; however, it showed that 14.3% of the samples failed the GPHF-Minilab screening test semiquantitatively. Overall, 22.2% of the products analyzed did not meet any of pharmacopoeial specifications assessed: 13%, 12.2%, and 11.1% of the products failed in assay, dissolution, and weight variation, respectively. Additionally, 56.3% of amoxicillin samples, 60% of amoxicillin/clavulanate, 20% of ciprofloxacin, and 54.5% of norfloxacin samples were found to be pharmaceutically nonequivalent with their respective comparator products regarding dissolution profiles. The study showed the presence of substandard antimicrobial medicines in the eastern Ethiopian market.
全球范围内，劣药和假药（SF）的流行率正在上升。这对医疗保健系统构成了极大的关注。使用 SF 抗菌药物有可能导致治疗失败、抗菌药物耐药性的出现和发展，最终导致死亡率上升。本研究的目的是评估在埃塞俄比亚东部城市 Dire Dawa、Jijiga 和 Togo-Wuchale 销售的四种常用抗菌药物的质量，这些城市由于靠近索马里边境，具有非法药物贸易活动的高潜力。从 2022 年 3 月 16 日至 3 月 29 日，使用便利抽样策略从 43 个设施秘密收集了 54 个品牌/样本的阿莫西林、阿莫西林/克拉维酸、环丙沙星和诺氟沙星制剂。首先使用全球制药健康基金（GPHF）-Minilab 方案对样品进行筛选，然后使用美国药典和英国药典官方方法进行分析。质量评估未发现假药，但表明 14.3%的样品未能通过 GPHF-Minilab 半定量筛选测试。总体而言，分析的产品中有 22.2%不符合任何评估的药典规格：13%、12.2%和 11.1%的产品分别在含量测定、溶出度和重量差异方面不合格。此外，56.3%的阿莫西林样品、60%的阿莫西林/克拉维酸、20%的环丙沙星和 54.5%的诺氟沙星样品在溶出度方面与各自的比较产品相比，在药学上不等效。研究表明，在埃塞俄比亚东部市场存在劣药抗菌药物。
