Sakuda Mirai, Yoshida Naoko, Takaoka Takashi, Sanada Tomoko, Rahman Mohammad Sofiqur, Tanimoto Tsuyoshi, Zin Theingi, Kimura Kazuko, Tsuboi Hirohito
Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa 920-1192, Japan.
Medi-Quality Security Institute, Graduate School of Medical Sciences, Kanazawa University, Kakuma-machi, Kanazawa 920-1192, Japan.
Pharmacy (Basel). 2020 Mar 19;8(1):45. doi: 10.3390/pharmacy8010045.
substandard and falsified medicines (SFMs) are a threat to public health. The availability of SFMs in Myanmar was reported by the World Health Organization (WHO) in 1999, but there have been few systematic surveys on falsified medicines in Myanmar since then. The aim of this study is to examine the extent of SFMs for sale in Myanmar. target medicines were tablets of candesartan, metformin, and pioglitazone, and infusions of ciprofloxacin and levofloxacin. Samples were collected from hospitals, pharmacies, and wholesalers located in the Mandalay region in 2015. We carried out observation testing, authenticity investigation, and quality testing to search for SFMs, and analyzed the relationship between SFMs and the price and store type. There were no falsified medicines found in the authenticity check, though there remained a problem due to low response rates from manufacturers and regulatory authorities. In the quality test, some tablets of metformin and pioglitazone made in India failed the dissolution test. although no serious problems were found, some substandard medicines were detected. Regular surveys to monitor SFMs are therefore recommended, together with further regulatory guidance to improve conditions in all medicine manufacturers, distributors, and pharmacies.
不合格和伪造药品（SFMs）对公众健康构成威胁。1999年世界卫生组织（WHO）报告了缅甸存在SFMs，但自那时起，缅甸对伪造药品的系统性调查很少。本研究的目的是调查缅甸在售SFMs的程度。目标药品为坎地沙坦、二甲双胍和吡格列酮片剂，以及环丙沙星和左氧氟沙星注射液。2015年从曼德勒地区的医院、药店和批发商处收集样本。我们进行了观察测试、真伪调查和质量检测以寻找SFMs，并分析了SFMs与价格和店铺类型之间的关系。在真伪检查中未发现伪造药品，不过由于制造商和监管当局的回应率较低，问题仍然存在。在质量检测中，一些印度产的二甲双胍和吡格列酮片剂溶出度测试不合格。虽然未发现严重问题，但检测到了一些不合格药品。因此，建议定期进行调查以监测SFMs，并提供进一步的监管指导以改善所有药品制造商、经销商和药店的状况。
