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

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          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.

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          Most cited references29

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          Control of neglected tropical diseases.

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            Substandard medicines in resource-poor settings: a problem that can no longer be ignored.

            The circulation of substandard medicines in the developing world is a serious clinical and public health concern. Problems include under or over concentration of ingredients, contamination, poor quality ingredients, poor stability and inadequate packaging. There are multiple causes. Drugs manufactured for export are not regulated to the same standard as those for domestic use, while regulatory agencies in the less-developed world are poorly equipped to assess and address the problem. A number of recent initiatives have been established to address the problem, most notably the WHO pre-qualification programme. However, much more action is required. Donors should encourage their partners to include more explicit quality requirements in their tender mechanisms, while purchasers should insist that producers and distributors supply drugs that comply with international quality standards. Governments in rich countries should not tolerate the export of substandard pharmaceutical products to poor countries, while developing country governments should improve their ability to detect substandard medicines.
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              The drugs we have and the drugs we need against major helminth infections.

              Parasitic worms (helminths) have accompanied humans for thousands of years and, still today, they are pervasive where poverty persists, including large parts of Southeast Asia and the Western Pacific Region. The global strategy for the control of helminth infections is morbidity control and elimination as a public health problem. Regular administration of anthelminthic drugs to at-risk populations (e.g. school-aged children) serves as the backbone of interventions in areas where helminth infections are highly endemic. In this review, we focus on soil-transmitted helminthiasis (ascariasis, hookworm disease, strongyloidiasis and trichuriasis) and food-borne trematodiasis (clonorchiasis, fascioliasis, intestinal fluke infections, opisthorchiasis and paragonimiasis) and discuss the few drugs that are currently available for their treatment and control. Emphasis is placed on efficacy with new light shed on multiple dosing and combination therapy. We summarise recent advances made with anthelminthic drugs that might become the future armentarium for the control of major helminthiasis (e.g. artemisinins, cyclooctadepsipeptides, mefloquine, monepantel, nitazoxandide, synthetic peroxides and tribendimidine). Issuing from our review are current research gaps and the need for concerted efforts to discover, develop and deploy the next generation of anthelminthic drugs. Copyright 2010 Elsevier Ltd. All rights reserved.
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                Author and article information

                Contributors
                Role: Editor
                Journal
                PLoS Negl Trop Dis
                PLoS Negl Trop Dis
                plos
                plosntds
                PLoS Neglected Tropical Diseases
                Public Library of Science (San Francisco, USA )
                1935-2727
                1935-2735
                December 2014
                4 December 2014
                : 8
                : 12
                : e3345
                Affiliations
                [1 ]School of Pharmacy, Jimma University, Jimma, Ethiopia
                [2 ]Drug Quality and Registration (DruQuaR) Group, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium
                [3 ]School of Medical Laboratory Sciences, Jimma University, Jimma, Ethiopia
                [4 ]Department of Virology, Parasitology and Immunology, Faculty of Veterinary Medicine, Ghent University, Merelbeke, Belgium
                [5 ]Department of Comparative Physiology and Biometrics, Faculty of Veterinary Medicine, Ghent University, Merelbeke, Belgium
                Swiss Tropical and Public Health Institute, Switzerland
                Author notes

                The authors have declared that no competing interests exist.

                Conceived and designed the experiments: SS BDS. Performed the experiments: SS GZ HD. Analyzed the data: SS MD EW. Contributed to the writing of the manuscript: SS GZ. Critically reviewed the manuscript: ZM BL JV LD BDS.

                Article
                PNTD-D-14-00773
                10.1371/journal.pntd.0003345
                4256469
                25473966
                21304445-29a6-4bbe-aed4-0bdb68848e10
                Copyright @ 2014

                This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 7 May 2014
                : 14 October 2014
                Page count
                Pages: 16
                Funding
                This study was supported by Jimma University ( http://www.ju.edu.et). SS and ZM are supported by the Infectious Diseases and Epidemiology Project within Institutional University Cooperation Programme (Jimma University) of VLIR ( http://www.iucju.ugent.be). BL is a postdoctoral fellow of FWO (Grant number FWO12/PDO/099). MD is supported by the Institute for the Promotion of Innovation through Science and Technology in Flanders (IWT-Vlaanderen) (No. 101529) while EW is supported by the Special Research Fund of Ghent University (Grant number BOF 01J22510). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
                Categories
                Research Article
                Biology and Life Sciences
                Medicine and Health Sciences
                Custom metadata
                The authors confirm that all data underlying the findings are fully available without restriction. All relevant data are within the paper and its Supporting Information files.

                Infectious disease & Microbiology
                Infectious disease & Microbiology

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