Quality of Medicines Commonly Used in the Treatment of Soil Transmitted Helminths and Giardia in Ethiopia: A Nationwide Survey

Sultan Suleman, Gemechu Zeleke, Habtewold Deti, Zeleke Mekonnen, Luc Duchateau, Bruno Levecke, Jozef Vercruysse, Matthias D'Hondt, Evelien Wynendaele and Bart De Spiegeleer

PLOS Neglected Tropical Diseases, 2014, vol. 8, issue 12, 1-16

Abstract: Background: The presence of poor quality medicines in the market is a global threat on public health, especially in developing countries. Therefore, we assessed the quality of two commonly used anthelminthic drugs [mebendazole (MEB) and albendazole (ALB)] and one antiprotozoal drug [tinidazole (TNZ)] in Ethiopia. Methods/Principal Findings: A multilevel stratified random sampling, with as strata the different levels of supply chain system in Ethiopia, geographic areas and government/privately owned medicines outlets, was used to collect the drug samples using mystery shoppers. The three drugs (106 samples) were collected from 38 drug outlets (government/privately owned) in 7 major cities in Ethiopia between January and March 2012. All samples underwent visual and physical inspection for labeling and packaging before physico-chemical quality testing and evaluated based on individual monographs in Pharmacopoeias for identification, assay/content, dosage uniformity, dissolution, disintegration and friability. In addition, quality risk was analyzed using failure mode effect analysis (FMEA) and a risk priority number (RPN) was assigned to each quality attribute. A clinically rationalized desirability function was applied in quantification of the overall quality of each medicine. Overall, 45.3% (48/106) of the tested samples were substandard, i.e. not meeting the pharmacopoeial quality specifications claimed by their manufacturers. Assay was the quality attribute most often out-of-specification, with 29.2% (31/106) failure of the total samples. The highest failure was observed for MEB (19/42, 45.2%), followed by TNZ (10/39, 25.6%) and ALB (2/25, 8.0%). The risk analysis showed that assay (RPN = 512) is the most critical quality attribute, followed by dissolution (RPN = 336). Based on Derringer's desirability function, samples were classified into excellent (14/106,13%), good (24/106, 23%), acceptable (38/106, 36%%), low (29/106, 27%) and bad (1/106,1%) quality. Conclusions/Significance: This study evidenced that there is a relatively high prevalence of poor quality MEB, ALB and TNZ in Ethiopia: up to 45% if pharmacopoeial acceptance criteria are used in the traditional, dichotomous approach, and 28% if the new risk-based desirability approach was applied. The study identified assay as the most critical quality attributes. The country of origin was the most significant factor determining poor quality status of the investigated medicines in Ethiopia. Author Summary: Access to medicines of good quality improves the chances of successful treatment for individual patients and promotes better outcomes for public health in general. At present, the prevailing strategy for improving access to medicines for neglected tropical diseases (NTDs) is drug donation programs. However, the presence of poor quality medicines in the market is a global threat on public health, especially in developing countries by critically risking efforts of treatment and control of diseases in general and the NTDs in particular. Conventionally, medicine quality has been ignored in NTDs, though scattered reports show that serious problems exist. Therefore, we assessed the quality of two commonly used anthelminthic drugs (MEB and ALB) and one antiprotozoal drug (TNZ) in Ethiopia. The analytical results were converted into conclusions using two systems: the traditional dichotomous pharmacopoeial specification-compliance based approach and the risk-based Taguchi quantitative desirability approach. Overall, the results showed high prevalence of poor quality of the three medicines, mainly determined by the country of origin. We conclude that risk-based regulatory quality control procedures should be based on identification of the most critical quality attribute and apply desirability functions to quantify and classify the quality of medicines.

Date: 2014
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DOI: 10.1371/journal.pntd.0003345

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