1Pharmacy, College of Medicine and Dentistry, James Cook University, Townsville, Australia.
2Division of Basic Medical Sciences, Pharmacology, University of Papua New Guinea, Port Moresby, Papua New Guinea.
Am J Trop Med Hyg. 2021 May 17;105(1):238-244. doi: 10.4269/ajtmh.20-1570.
Antibiotics are commonly reported as being substandard or falsified in low- to middle-income countries, having potential to contribute to the development of antimicrobial resistance and drug-resistant infections. Amoxicillin, used to treat a number of infections and listed by the WHO as an essential medicine, presented as a good drug candidate for this study. We aimed to measure the prevalence of substandard and falsified amoxicillin oral products (tablets, capsules, and suspensions) in the National Capital District of Papua New Guinea (PNG). These oral products were surveyed in 2018 and 2019 from retail pharmacies, private and public health facilities, and the Area Medical Store, representing more than 90% of licensed medicine outlets. The product packaging was visually inspected, and the samples were analyzed for amoxicillin content using a validated high-performance liquid chromatography method. Although no falsified products were identified, 15% of the 190 products analyzed contained substandard amounts of amoxicillin. Quality varied with the dosage form (P = 0.002), with capsules exhibiting the lowest incidence of substandard content (4% in 2019) and tablets collected in 2018 experiencing the highest failure rate (50%). Suspension (40%) quality was compromised by failure to achieve homogeneity on reconstitution. A higher incidence of substandard content (P = 0.002) was associated with one major retail group. Routine testing of medicines by resource-poor countries is often unachievable, leading to the circulation of poor quality drugs, which is a global public health concern. Our study highlighted that substandard amoxicillin oral products are indeed prevalent in the NCD of PNG.
抗生素在中低收入国家常被报道为不合规或假冒，这可能导致抗生素耐药性和耐药感染的发展。阿莫西林用于治疗多种感染，被世界卫生组织列为基本药物，是本研究的一个很好的候选药物。我们旨在测量巴布亚新几内亚（PNG）国家首都地区（NCD）不合格和假冒阿莫西林口服产品（片剂、胶囊和混悬剂）的流行率。这些口服产品于 2018 年和 2019 年从零售药店、私人和公共卫生设施以及地区医疗商店进行了调查，这些商店代表了超过 90%的有执照的药品销售点。对产品包装进行了目视检查，并使用经过验证的高效液相色谱法分析了样品中的阿莫西林含量。虽然没有发现假冒产品，但在分析的 190 种产品中有 15%的产品含有不合格的阿莫西林。质量随剂型而异（P=0.002），胶囊的不合格含量发生率最低（2019 年为 4%），而 2018 年收集的片剂失败率最高（50%）。混悬剂（40%）的质量因再配制时未能达到均一性而受损。不合格内容物的发生率较高（P=0.002）与一个主要的零售集团有关。资源匮乏国家对药品进行常规检测通常是无法实现的，导致劣质药品的流通，这是一个全球公共卫生关注的问题。我们的研究表明，不合格的阿莫西林口服产品在 PNG 的 NCD 确实很普遍。
