Quality of medicines commonly used in the treatment of soil transmitted helminths and giardia in ethiopia: a nationwide survey.
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)]...
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ftdoajarticles:oai:doaj.org/article:bad2474077c4433a8318255ed41e884f 2023-05-15T15:15:53+02:00 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 Bart De Spiegeleer 2014-12-01T00:00:00Z https://doi.org/10.1371/journal.pntd.0003345 https://doaj.org/article/bad2474077c4433a8318255ed41e884f EN eng Public Library of Science (PLoS) http://europepmc.org/articles/PMC4256469?pdf=render https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0003345 https://doaj.org/article/bad2474077c4433a8318255ed41e884f PLoS Neglected Tropical Diseases, Vol 8, Iss 12, p e3345 (2014) Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 article 2014 ftdoajarticles https://doi.org/10.1371/journal.pntd.0003345 2022-12-31T00:11:29Z 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 ... Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic PLoS Neglected Tropical Diseases 8 12 e3345 |
institution |
Open Polar |
collection |
Directory of Open Access Journals: DOAJ Articles |
op_collection_id |
ftdoajarticles |
language |
English |
topic |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
spellingShingle |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 Sultan Suleman Gemechu Zeleke Habtewold Deti Zeleke Mekonnen Luc Duchateau Bruno Levecke Jozef Vercruysse Matthias D'Hondt Evelien Wynendaele Bart De Spiegeleer Quality of medicines commonly used in the treatment of soil transmitted helminths and giardia in ethiopia: a nationwide survey. |
topic_facet |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
description |
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 ... |
format |
Article in Journal/Newspaper |
author |
Sultan Suleman Gemechu Zeleke Habtewold Deti Zeleke Mekonnen Luc Duchateau Bruno Levecke Jozef Vercruysse Matthias D'Hondt Evelien Wynendaele Bart De Spiegeleer |
author_facet |
Sultan Suleman Gemechu Zeleke Habtewold Deti Zeleke Mekonnen Luc Duchateau Bruno Levecke Jozef Vercruysse Matthias D'Hondt Evelien Wynendaele Bart De Spiegeleer |
author_sort |
Sultan Suleman |
title |
Quality of medicines commonly used in the treatment of soil transmitted helminths and giardia in ethiopia: a nationwide survey. |
title_short |
Quality of medicines commonly used in the treatment of soil transmitted helminths and giardia in ethiopia: a nationwide survey. |
title_full |
Quality of medicines commonly used in the treatment of soil transmitted helminths and giardia in ethiopia: a nationwide survey. |
title_fullStr |
Quality of medicines commonly used in the treatment of soil transmitted helminths and giardia in ethiopia: a nationwide survey. |
title_full_unstemmed |
Quality of medicines commonly used in the treatment of soil transmitted helminths and giardia in ethiopia: a nationwide survey. |
title_sort |
quality of medicines commonly used in the treatment of soil transmitted helminths and giardia in ethiopia: a nationwide survey. |
publisher |
Public Library of Science (PLoS) |
publishDate |
2014 |
url |
https://doi.org/10.1371/journal.pntd.0003345 https://doaj.org/article/bad2474077c4433a8318255ed41e884f |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
PLoS Neglected Tropical Diseases, Vol 8, Iss 12, p e3345 (2014) |
op_relation |
http://europepmc.org/articles/PMC4256469?pdf=render https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0003345 https://doaj.org/article/bad2474077c4433a8318255ed41e884f |
op_doi |
https://doi.org/10.1371/journal.pntd.0003345 |
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PLoS Neglected Tropical Diseases |
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8 |
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12 |
container_start_page |
e3345 |
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