Substandard and Falsified Medicines in Myanmar

<b>Background:</b> 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 o...

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Main Authors: Mirai Sakuda, Naoko Yoshida, Takashi Takaoka, Tomoko Sanada, Mohammad Sofiqur Rahman, Tsuyoshi Tanimoto, Theingi Zin, Kazuko Kimura, Hirohito Tsuboi
Format: Article
Language:English
Published: MDPI AG 2020-03-01
Series:Pharmacy
Subjects:
Online Access:https://www.mdpi.com/2226-4787/8/1/45
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spelling doaj-585b58e7e3bc46f5b3aaa6d50a8f8d152020-11-25T02:07:58ZengMDPI AGPharmacy2226-47872020-03-01814510.3390/pharmacy8010045pharmacy8010045Substandard and Falsified Medicines in MyanmarMirai Sakuda0Naoko Yoshida1Takashi Takaoka2Tomoko Sanada3Mohammad Sofiqur Rahman4Tsuyoshi Tanimoto5Theingi Zin6Kazuko Kimura7Hirohito Tsuboi8Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa 920-1192, JapanInstitute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa 920-1192, JapanInstitute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa 920-1192, JapanInstitute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa 920-1192, JapanMedi-Quality Security Institute, Graduate School of Medical Sciences, Kanazawa University, Kakuma-machi, Kanazawa 920-1192, JapanPharmaceutical and Medical Device Regulatory Science Society of Japan, Osaka 150-0002, JapanDepartment of Food and Drug Administration, Naypyidaw 15000, MyanmarMedi-Quality Security Institute, Graduate School of Medical Sciences, Kanazawa University, Kakuma-machi, Kanazawa 920-1192, JapanInstitute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa 920-1192, Japan<b>Background:</b> 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. <b>Methods:</b> 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. <b>Results:</b> 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. <b>Conclusions:</b> 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.https://www.mdpi.com/2226-4787/8/1/45falsified medicinessubstandard medicinesmyanmarauthenticitydistribution
collection DOAJ
language English
format Article
sources DOAJ
author Mirai Sakuda
Naoko Yoshida
Takashi Takaoka
Tomoko Sanada
Mohammad Sofiqur Rahman
Tsuyoshi Tanimoto
Theingi Zin
Kazuko Kimura
Hirohito Tsuboi
spellingShingle Mirai Sakuda
Naoko Yoshida
Takashi Takaoka
Tomoko Sanada
Mohammad Sofiqur Rahman
Tsuyoshi Tanimoto
Theingi Zin
Kazuko Kimura
Hirohito Tsuboi
Substandard and Falsified Medicines in Myanmar
Pharmacy
falsified medicines
substandard medicines
myanmar
authenticity
distribution
author_facet Mirai Sakuda
Naoko Yoshida
Takashi Takaoka
Tomoko Sanada
Mohammad Sofiqur Rahman
Tsuyoshi Tanimoto
Theingi Zin
Kazuko Kimura
Hirohito Tsuboi
author_sort Mirai Sakuda
title Substandard and Falsified Medicines in Myanmar
title_short Substandard and Falsified Medicines in Myanmar
title_full Substandard and Falsified Medicines in Myanmar
title_fullStr Substandard and Falsified Medicines in Myanmar
title_full_unstemmed Substandard and Falsified Medicines in Myanmar
title_sort substandard and falsified medicines in myanmar
publisher MDPI AG
series Pharmacy
issn 2226-4787
publishDate 2020-03-01
description <b>Background:</b> 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. <b>Methods:</b> 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. <b>Results:</b> 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. <b>Conclusions:</b> 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.
topic falsified medicines
substandard medicines
myanmar
authenticity
distribution
url https://www.mdpi.com/2226-4787/8/1/45
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