Abstract
Background: 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. Methods: 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. Results: 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. Conclusions: 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.
Highlights
Substandard and falsified (SF) medical products are a threat to public health, and may lead to increased mortality and morbidity, as well as emerging drug resistance [1]
Myanmar is located near Cambodia, research activities were restricted until political reforms were undertaken in 2011 [5]
This study aims to examine the extent of SF medicines (SFMs) sold in Myanmar, focusing on the quality of medicines sold to patients
Summary
Substandard and falsified (SF) medical products are a threat to public health, and may lead to increased mortality and morbidity, as well as emerging drug resistance [1]. We previously investigated SF products, focusing on SF medicines (SFMs), especially in pharmacies and wholesalers in Cambodia. SFMs were detected due to unsanitary storage conditions, poor adherence to Good. Manufacturing Practice (GMP) in the pharmaceutical industries, or illegal production of medicines. We found unacceptable amoxicillin and clavulanic acid tablets during quality testing, as well as metformin extended-release tablets, which dissolved much too quickly [2,3,4]. Myanmar is located near Cambodia, research activities were restricted until political reforms were undertaken in 2011 [5]
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