Prevalence estimates of substandard drugs in Mongolia using a random sample survey.

Daariimaa Khurelbat,Gereltuya Dorj,Katharine Morley,Michael Morley,Takeshi Morimoto,Munkhdelger Chimedsuren,Enkhtuul Bayarsaikhan,Tsetsegmaa Sanjjav

doi:10.1186/2193-1801-3-709

Abstract

To determine the prevalence of substandard drugs in urban (Ulaanbaatar) and rural (selected provinces) areas of Mongolia, samples of 9 common, therapeutically important drugs were collected from randomly selected drug outlets in Ulaanbaatar and 4 rural provinces by “mystery shoppers”. Samples were analyzed by visual inspection, registration status, and biochemical analysis. Samples failing to meet all Pharmacopeia quality tests were considered substandard.In the rural provinces, 69 out of 388 samples were substandard, giving an estimated prevalence of substandard drugs of 17.8% (95% CI: 14.1-22.0). There were 85 unregistered samples, giving a prevalence estimate of unregistered drugs of 21.9%. (95% CI: 17.9-26.3). In the urban Ulaanbaatar districts, 112 out of 848 samples were substandard, giving an estimated prevalence of substandard drugs of 13.2% (95% CI: 11.0-15.7). There were 150 unregistered samples, giving a prevalence estimate of unregistered drugs of 17.7% (95% CI: 15.2-20.4).In the rural provinces, 35 out of 85 (41.2%) unregistered samples were substandard; whereas 34 out of 303 (11.2%) registered samples were substandard. (p < 0.0001) In the urban districts, 18 out of 150 (12.0%) unregistered samples were substandard, whereas 94 out of 698 registered were substandard. (13.5%) (p = 0.6).The prevalence of substandard and unregistered drugs is higher in rural provinces. There is a significant association between substandard and unregistered drugs in the provinces but not in the urban districts. The underlying causes for substandard drugs need to be further investigated in order to help formulate strategies to improve pharmacovigilance and the drug supply quality in Mongolia.

Highlights

Poor quality drugs have been increasingly recognized as a global public health threat because they have the potential to result in inadequate treatment, cause adverse effects from toxic ingredients, and promote drug resistance
The true extent of the problem is difficult to ascertain. Reasons for this include the difficulty and expense in performing a methodologically sound study, reluctance of governments to disclose information and the fact that many of the effects on patients are difficult to detect and hidden in other public health statistics (Cockburn et al 2005). In his 2010 article, Newton states there is an urgent need for data of sufficient sample size, with random sampling design to reliably estimate the prevalence of poor quality medicines (Newton, et al 2010) Literature reviews of prevalence studies on falsified/substandard drugs report that the percentage of substandard drugs in various Asian and African countries range from 8-46% (Caudron et al 2008), and the median prevalence of substandard/falsified medicines was 28.5% (Almuzaini et al 2013)
Our results provide prevalence estimates for substandard drugs in Mongolia of 17.8% in the rural provinces and 13.2% in the urban districts of Ulaanbaatar, based on failure to meet the threshold quality standards established in the selected Pharmacopeia

Summary

Introduction

Poor quality drugs have been increasingly recognized as a global public health threat because they have the potential to result in inadequate treatment, cause adverse effects from toxic ingredients, and promote drug resistance. Reasons for this include the difficulty and expense in performing a methodologically sound study, reluctance of governments to disclose information and the fact that many of the effects on patients are difficult to detect and hidden in other public health statistics (Cockburn et al 2005) In his 2010 article, Newton states there is an urgent need for data of sufficient sample size, with random sampling design to reliably estimate the prevalence of poor quality medicines (Newton, et al 2010) Literature reviews of prevalence studies on falsified/substandard drugs report that the percentage of substandard drugs in various Asian and African countries range from 8-46% (Caudron et al 2008), and the median prevalence of substandard/falsified medicines was 28.5% (range 11–48%) (Almuzaini et al 2013). In 1999, WHO conducted a survey of drug quality in Myanmar and Vietnam, and found that 16% of the samples did not meet all specifications of testing (Wondemagegnehu 1999)

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Results

Discussion

Conclusion