An Investigation into the Quality of Medicines in Yangon, Myanmar

Mr, Islam; Yoshida, Naoko; Kimura, Kazuko; Uwatoko, Chisana; Rahman, Mohammad Sofiqur; Kumada, Sayako; K, Ito; Tanimoto, Tsuyoshi; T, Zin; Tsuboi, Hirohito

doi:10.3390/pharmacy6030096

Cited by 8 publications

(6 citation statements)

References 14 publications

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“…Sampling was carried out in Mandalay, the second most populous city of Myanmar after Yangon with a population of nearly 1.2 million; it is the major trading and communications center for northern and central Myanmar. We selected this city after the 2013' investigation in Yangon [9]. The sampling sites were private hospitals, clinical pharmacies, community pharmacies and wholesalers in Chan-Aye-Thar-San Township, Pyi-Gyi-Tagon Township, Aung-Myay-Thar-San Township, Mahar-Aung-Myay Township of Mandalay District, Pyin-Oo-Lwin Township of Pyin-Oo-Lwin District, and Mite-Htee-Lar Township of Mite-Htee-Lar District in the Mandalay region.…”

Section: Sampling Areasmentioning

confidence: 99%

“…Further, there were sporadic reports concerning Myanmar in 2001 and 2008 [7,8]. Therefore, we started a survey in Myanmar in 2014 [9,10], and followed that with the present in 2015. Because the number of patients with long-term diseases in developing countries is increasing [11], not only on anti-microbials, but also on medicines against chronic or life-style related diseases are important.…”

Section: Introductionmentioning

confidence: 99%

“…In our previous survey [9], pharmaceutical shops in Yangon were equipped with awnings to protect medicines from direct sunlight, and 39.2% were equipped with air conditioning. The average temperature and the humidity in air-conditioning equipped/non-equipped locations were 30.8 ± 2.16 • C/28.6 ± 2.64 • C, and 69.3 ± 8.70%/67.9 ± 12.37%, respectively.…”

Section: Introductionmentioning

confidence: 99%

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Substandard and Falsified Medicines in Myanmar

et al. 2020

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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.

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Section: Sampling Areasmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Substandard and Falsified Medicines in Myanmar

et al. 2020

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“…Recent studies of some established medicines have shown that the incidence of substandard products in Cambodia has declined in recent years, which can be attributed to the strong action of the government of Cambodia, with international cooperation. 25 However, substandard and falsified medicines remain on sale in Cambodia, 26,27 and the status of antimicrobials as well as other essential medicines for communicable and NCDs remains to be fully investigated. 27,28 Therefore, the aim of this project was to investigate the status of selected medicines for NCDs in the private market in Cambodia, to provide data for guiding further actions and countermeasures to reduce the prevalence of SFs among these medicines.…”

Section: Introductionmentioning

confidence: 99%

A Cross-Sectional Investigation of the Quality of Selected Medicines for Noncommunicable Diseases in Private Community Drug Outlets in Cambodia during 2011–2013

Rahman

Yoshida

Tsuboi

et al. 2019

The American Journal of Tropical Medicine and Hygiene

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Although the issue of substandard and falsified medicines is quite well known, most research has focused on medicines used to treat communicable diseases, and relatively little research has been carried out on the quality of medicines for noncommunicable diseases (NCDs). This study was designed to assess the quality of seven widely used medicines for NCDs in Cambodia during 2011-2013. Medicines were collected from private community drug outlets in Phnom Penh (urban area), by stratified random sampling and in Battambang, Kandal, Kampong Speu, and Takeo (rural areas) by convenience sampling. Samples were subsequently analyzed by visual inspection, authenticity investigation, and pharmacopoeial analysis by high-performance liquid chromatography. Various discrepancies were observed in visual inspection of packages and medicines. Of 372 tablet/capsule samples from 64 manufacturers in 16 countries, the manufacturers confirmed 107 (28.8%) as authentic; the authenticity of other samples could not be verified. Three hundred sixty-four (97.8%) samples were registered in Cambodia. Among all samples, 23.4% (95% CI 19.2-28.0) were noncompliant in one or more of the quality tests: 12.9% (95% CI 9.7-16.7) contained an amount of active pharmaceutical ingredient outside the permitted range, including some showing extreme deviations, 14% (95% CI 10.6-17.9) failed because of content variation, and 10.8% (95% CI 7.8-14.4) failed to meet pharmacopoeial reference ranges in dissolution tests. Pharmaceutical quality appeared to be unrelated to storage conditions. Although no sample was obviously falsified, there is a high prevalence of substandard medicines for NCDs in Cambodia, indicating the need for focused regulatory action, including collaborative initiatives with manufacturers.

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“…Besides the global efforts and directive regulations against SF medical products, local laboratories also need efficient analytical methods to survey the (illegal) drug market. The majority of papers related to SF antimicrobials deal with the determination of APIs using liquid chromatography‐ultra violet (LC−UV) and/or liquid chromatography−mass spectrometry (LC–MS) . However, other parameters may also have a tremendous influence on drug efficacy and toxicity.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of impurities and dissolution profiles of illegal antimicrobial drugs encountered in Belgium

Tie

Loock

Deconinck

et al. 2019

Drug Testing and Analysis

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Substandard and falsified (SF) antimicrobials are gaining popularity in both developing and developed countries, posing a growing threat to public health. In general, the evaluation of SF antimicrobial drugs mainly focuses on the identification and quantification of the pharmaceutical active ingredients, ignoring other parameters of drug quality control. This study performed an in‐depth characterization and hazard identification of suspected SF antimicrobial medicinal products encountered in Belgium. In this comprehensive evaluation, impurity tests and dissolution studies were carried out. The dissolution profiles of illegal SF antimicrobials were mathematically compared to their genuine counterparts using the f1 and f2‐factor. The results indicated that 17 out of 57 illegal samples contained higher than permitted amounts of impurities and clearly demonstrated low equivalences of dissolution profiles between SF antimicrobials and genuine products. The variations between tablets at the different time points of the dissolution curves were also higher for the SF medicines. Moreover, 11 out of 19 illegal samples failed to meet the dissolution criteria prescribed by the United States Pharmacopeia. As impurities may induce adverse reactions and improper dissolution patterns may be the cause of insufficient drug efficacy, aggravation of illness and even promotion of antimicrobial resistance can be expected.

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An Investigation into the Quality of Medicines in Yangon, Myanmar

Cited by 8 publications

References 14 publications

Substandard and Falsified Medicines in Myanmar

Substandard and Falsified Medicines in Myanmar

A Cross-Sectional Investigation of the Quality of Selected Medicines for Noncommunicable Diseases in Private Community Drug Outlets in Cambodia during 2011–2013

Evaluation of impurities and dissolution profiles of illegal antimicrobial drugs encountered in Belgium

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