Abstract
Many poor-quality medicines are supplied to patients mainly in developing countries. No systematic survey on counterfeit medicines has been conducted in Myanmar since 1999. The purpose of this study was to investigate the current situation of substandard or counterfeit medicines in Myanmar. Samples of oral medicines, cefuroxime axetil (CXM), donepezil hydrochloride (DN) and omeprazole (OM), and injections, ceftriaxone sodium (CTRX), and gentamicin sulfate (GM), were collected from pharmacies, hospitals, and wholesalers in Yangon, Myanmar in 2014. Authenticity and quality were verified. There were 221 (94%) foreign medicines among 235 collected samples. Five samples of GM and 1 DN sample were not registered with the Food and Drug Administration, Myanmar. In quality analysis, 36 samples out of 177 (20.3%) did not pass quantity tests, 27 samples out of 176 (15.3%) did not pass content uniformity tests, and 23 out of 128 samples (18.0%) did not pass dissolution tests. Three of the unregistered GM samples failed in both identification and microbial assay tests. Counterfeit GM is being sold in Yangon. Also, the quality of OM is a matter of concern. Poor-quality medicines were frequently found among the products of a few manufacturers. Regular surveys to monitor counterfeit and substandard medicines in Myanmar are recommended.
Highlights
Medicines are essential for human health, but many substandard or counterfeit medicines are supplied to patients [1,2], and in this vast sector it is very difficult to identify these products and develop effective preventive measures
The aim of this study is to investigate the current situation of substandard or counterfeit medicine in Myanmar to provide baseline data for preventing the spread of such medicines in the future
Samples were collected from a government hospital and a private hospital designated by the MFDA, as well as community pharmacies, clinical pharmacies, and wholesalers nearby
Summary
Medicines are essential for human health, but many substandard or counterfeit medicines are supplied to patients [1,2], and in this vast sector it is very difficult to identify these products and develop effective preventive measures. Health Organization (WHO) reported that the proportion of substandard or counterfeit drugs supplied in developed countries was approximately 1% [3], the risks appear to be increasing according to the development of the Internet and the progress of globalization [4]. WHO reported that the proportion of such poor-quality drugs supplied in developing countries was about 10% [3]. It is significant to investigate the conditions of substandard or counterfeit medicines in developing countries for preventing health damages by poor-quality medicines.
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