Substandard and Falsified Medicines in Myanmar

Sakuda, Mirai; Yoshida, Naoko; Takaoka, Takashi; Sanada, T.; Rahman, Mohammad Sofiqur; Tanimoto, Tsuyoshi; Zin, Theingi; Kimura, Kazuko; Tsuboi, Hirohito

doi:10.3390/pharmacy8010045

Cited by 12 publications

(15 citation statements)

References 12 publications

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“…Four recent studies by Kimura and coworkers reported that authenticity responses were received from the manufacturers for 0%, 8.7%, 9.5%, and 28.8% of the investigated samples, respectively. 40 – 43 In comparison, the response rate of 49.5% obtained in the present study is reasonably high, despite interference by the COVID-19 pandemic. Higher response rates were reported from two earlier studies of the Kimura group.…”

Section: Discussionsupporting

confidence: 65%

Identification of Substandard and Falsified Medicines: Influence of Different Tolerance Limits and Use of Authenticity Inquiries

Hauk

Hagen

Heide

2021

The American Journal of Tropical Medicine and Hygiene

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Substandard and falsified medicines have severe public health and socioeconomic effects, especially in low- and middle-income countries. The WHO has emphasized the need for reliable estimates of the prevalence of such medicines to efficiently respond to this problem. In the present study, we used 601 medicine samples collected in Cameroon, the DR Congo, and Malawi to assess the rates of substandard and falsified medicines based on different criteria. Based on the specifications of the U.S. Pharmacopoeia for the amount of the active pharmaceutical ingredients, the rate of out-of-specification medicines was 9.3%. By contrast, this rate ranged from 3.3% up to 35.0% if the tolerance limits of other pharmacopoeias or recently published medicine quality studies were used. This shows an urgent need for harmonization. Principal methods to assess the rate of falsified medicines are packaging analysis, chemical analysis, and authenticity inquiries. In the present study, we carried out an authenticity inquiry for the aforementioned medicine samples, contacting 126 manufacturers and 42 distributors. Response rates were higher for samples stated to be manufactured in Asia (52.4%) or Europe (53.8%) than for samples manufactured in Africa (27.4%; P < 0.001). One sample had been identified as falsified by packaging analysis by the local researchers and two additional ones by chemical analysis. Notably, seven additional falsified samples were identified by the authenticity inquiries. The total rate of falsified medicines resulted as 1.7%. Considerations are discussed for assessing the rates of “substandard” and “falsified” medicines in future medicine quality studies.

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Section: Discussionsupporting

confidence: 65%

Identification of Substandard and Falsified Medicines: Influence of Different Tolerance Limits and Use of Authenticity Inquiries

Hauk

Hagen

Heide

2021

The American Journal of Tropical Medicine and Hygiene

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“…It is sold in the market as a single product under the brand name Actos or in combination with metformin (Actoplus Met, Actoplus Met XR) and glimepiride (Duetact) [19,20]. A few reports on the quality of pioglitazone and other medicines from China or Myanmar have appeared [21][22][23], and provide useful data for comparison with the findings of this study. Additionally, recent reports on the nitrosamine impurities detected in ranitidine and pioglitazone products suggest the presence of scarce quality pioglitazone products in the market [24,25].…”

Section: Introductionmentioning

confidence: 89%

Patient safety and public health concerns: poor dissolution rate of pioglitazone tablets obtained from China, Myanmar and internet sites

Rahman

Yoshida

Tsuboi

et al. 2021

BMC Pharmacol Toxicol

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Background Poor quality medicines have serious implications for public health. The aim of this study was to explore the quality of the antidiabetic pioglitazone, using samples collected in China and Myanmar, and samples purchased online. Methods In this cross-sectional study, we examined samples (n = 163) collected from hospitals in Shanghai, China in 2012 (n = 44), products purchased via the internet and imported into Japan in 2013 (n = 59), and samples purchased in shops in Yangon, Myanmar in 2015 (n = 60). Collected samples were subjected to visual inspection, authenticity investigation and quality testing (potency, content uniformity and dissolution test) by high-performance liquid chromatography. Samples were rated as compliant or non-compliant based on the relevant pharmacopoeial acceptance criteria. Results Visual inspection of all samples revealed compliant products. However, responses from manufacturers during authenticity investigation were poor. Among the n = 44 samples from China, one was non-compliant in the potency test. Among the n = 59 samples personally imported into Japan, 38% of generic samples were found to be non-compliant. In Myanmar, 13.3% of samples were non-compliant. Non-compliant samples predominantly failed in the dissolution test. All non-compliant samples were generic. Conclusions Despite the apparent satisfactory outcome on the samples from China, pioglitazone samples collected in Myanmar and purchased online for personal import into Japan included many substandard products, which failed quality assessment predominantly because of poor dissolution. Internet providers did not comply with Japanese regulations in various respects.

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“…The production and distribution of substandard and falsified medicines (SFs) are increasing throughout the world 1 – 3 . Lower and middle-income countries (LMICs) are most affected, but developed countries are not immune 4 – 6 .…”

Section: Introductionmentioning

confidence: 99%

Small-scale dissolution test screening tool to select potentially substandard and falsified (SF) medicines requiring full pharmacopoeial analysis

Rahman

Yoshida

Tsuboi

et al. 2021

Sci Rep

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The purpose of this study was to design a convenient, small-scale dissolution test for extracting potential substandard and falsified (SF) medicines that require full pharmacopoeial analysis. The probability of metronidazole samples complying with the US Pharmacopoeia (USP) dissolution test for immediate-release tablet formulations was predicted from small-scale dissolution test results using the following criteria: (1) 95% confidence interval lower limit (95% CIlow) of the average dissolution rate of any n = 3 of n = 24 units of each sample, and (2) average and minimum dissolution rates for any n = 3 of n = 24 units. Criteria values were optimized via bootstrap sampling with Thinkeye data-mining software. Compliant metronidazole samples in the USP first-stage and second-stage dissolution test showed complying probabilities of 99.7% and 81.0%, respectively, if the average dissolution rate of n = 3 units is equal to or greater than the monograph-specified amount of dissolved drug (Q; 85% of labeled content for metronidazole). The complying probabilities were 100.0% and 79.0%, respectively, if the average dissolution rate of n = 3 units is 91% or higher and the minimum dissolution rate is 87% or higher. Suitable compliance criteria for the small-scale dissolution test are: average dissolution rate of n = 3 units is Q + 6% or more and minimum dissolution rate is Q + 2% or more.

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Substandard and Falsified Medicines in Myanmar

Cited by 12 publications

References 12 publications

Identification of Substandard and Falsified Medicines: Influence of Different Tolerance Limits and Use of Authenticity Inquiries

Identification of Substandard and Falsified Medicines: Influence of Different Tolerance Limits and Use of Authenticity Inquiries

Patient safety and public health concerns: poor dissolution rate of pioglitazone tablets obtained from China, Myanmar and internet sites

Small-scale dissolution test screening tool to select potentially substandard and falsified (SF) medicines requiring full pharmacopoeial analysis

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