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Substandard and Falsified Antibiotics and Medicines against Noncommunicable Diseases in Western Cameroon and Northeastern Democratic Republic of Congo

Falsified and substandard medicines may undermine the progress toward the Sustainable Development Goals. The present study investigated the quality of 13 essential medicines in Cameroon and the Democratic Republic of Congo (DR Congo). Five hundred six medicine samples were collected from the governm...

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Autores principales: Schäfermann, Simon, Hauk, Cathrin, Wemakor, Emmanuel, Neci, Richard, Mutombo, Georges, Ngah Ndze, Edward, Cletus, Tambo, Nyaah, Fidelis, Pattinora, Manyi, Wistuba, Dorothee, Helmle, Irina, Häfele-Abah, Christine, Gross, Harald, Heide, Lutz
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The American Society of Tropical Medicine and Hygiene 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7410427/
https://www.ncbi.nlm.nih.gov/pubmed/32394884
http://dx.doi.org/10.4269/ajtmh.20-0184
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author Schäfermann, Simon
Hauk, Cathrin
Wemakor, Emmanuel
Neci, Richard
Mutombo, Georges
Ngah Ndze, Edward
Cletus, Tambo
Nyaah, Fidelis
Pattinora, Manyi
Wistuba, Dorothee
Helmle, Irina
Häfele-Abah, Christine
Gross, Harald
Heide, Lutz
author_facet Schäfermann, Simon
Hauk, Cathrin
Wemakor, Emmanuel
Neci, Richard
Mutombo, Georges
Ngah Ndze, Edward
Cletus, Tambo
Nyaah, Fidelis
Pattinora, Manyi
Wistuba, Dorothee
Helmle, Irina
Häfele-Abah, Christine
Gross, Harald
Heide, Lutz
author_sort Schäfermann, Simon
collection PubMed
description Falsified and substandard medicines may undermine the progress toward the Sustainable Development Goals. The present study investigated the quality of 13 essential medicines in Cameroon and the Democratic Republic of Congo (DR Congo). Five hundred six medicine samples were collected from the government and faith-based health facilities, private pharmacies, and informal vendors (total 60 facilities). Collected samples were analyzed according to the U.S. Pharmacopeia (USP) for identity, content, and dissolution of their active pharmaceutical ingredients (APIs) and for uniformity of dosage units. Three samples (0.6%) were identified as falsified. Overall, 8.5% of the samples failed USP specifications for the content of the API and 11.7% failed dissolution testing. Medicines from informal vendors showed a higher out-of-specification rate (28.2%) than other types of drug outlets (12.3%; P < 0.0001). All three falsified medicines had been sold by informal vendors. The failure rate of medicines stated to be produced in Europe (5.1%) was lower than that for medicines from Asia (17.7%; P = 0.0049) and Africa (22.2%; P = 0.0042). Medicines against noncommunicable diseases showed a higher failure rate than antibiotics (25.3% versus 12.1%; P = 0.0004). Four hundred fifty-one of the samples were analyzed in Cameroon and the DR Congo with the Global Pharma Health Fund Minilab (thin-layer chromatography and disintegration testing). The three falsified medicines were readily detected in Minilab analysis. However, substandard samples were detected with low sensitivity. A well-enforced ban of medicine sales by informal vendors and increased attention to supplier qualification in the procurement process may reduce the prevalence of substandard and falsified medicines.
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spelling pubmed-74104272020-08-07 Substandard and Falsified Antibiotics and Medicines against Noncommunicable Diseases in Western Cameroon and Northeastern Democratic Republic of Congo Schäfermann, Simon Hauk, Cathrin Wemakor, Emmanuel Neci, Richard Mutombo, Georges Ngah Ndze, Edward Cletus, Tambo Nyaah, Fidelis Pattinora, Manyi Wistuba, Dorothee Helmle, Irina Häfele-Abah, Christine Gross, Harald Heide, Lutz Am J Trop Med Hyg Articles Falsified and substandard medicines may undermine the progress toward the Sustainable Development Goals. The present study investigated the quality of 13 essential medicines in Cameroon and the Democratic Republic of Congo (DR Congo). Five hundred six medicine samples were collected from the government and faith-based health facilities, private pharmacies, and informal vendors (total 60 facilities). Collected samples were analyzed according to the U.S. Pharmacopeia (USP) for identity, content, and dissolution of their active pharmaceutical ingredients (APIs) and for uniformity of dosage units. Three samples (0.6%) were identified as falsified. Overall, 8.5% of the samples failed USP specifications for the content of the API and 11.7% failed dissolution testing. Medicines from informal vendors showed a higher out-of-specification rate (28.2%) than other types of drug outlets (12.3%; P < 0.0001). All three falsified medicines had been sold by informal vendors. The failure rate of medicines stated to be produced in Europe (5.1%) was lower than that for medicines from Asia (17.7%; P = 0.0049) and Africa (22.2%; P = 0.0042). Medicines against noncommunicable diseases showed a higher failure rate than antibiotics (25.3% versus 12.1%; P = 0.0004). Four hundred fifty-one of the samples were analyzed in Cameroon and the DR Congo with the Global Pharma Health Fund Minilab (thin-layer chromatography and disintegration testing). The three falsified medicines were readily detected in Minilab analysis. However, substandard samples were detected with low sensitivity. A well-enforced ban of medicine sales by informal vendors and increased attention to supplier qualification in the procurement process may reduce the prevalence of substandard and falsified medicines. The American Society of Tropical Medicine and Hygiene 2020-08 2020-05-11 /pmc/articles/PMC7410427/ /pubmed/32394884 http://dx.doi.org/10.4269/ajtmh.20-0184 Text en © The American Society of Tropical Medicine and Hygiene This is an open-access article distributed under the terms of the Creative Commons Attribution (CC-BY) License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Articles
Schäfermann, Simon
Hauk, Cathrin
Wemakor, Emmanuel
Neci, Richard
Mutombo, Georges
Ngah Ndze, Edward
Cletus, Tambo
Nyaah, Fidelis
Pattinora, Manyi
Wistuba, Dorothee
Helmle, Irina
Häfele-Abah, Christine
Gross, Harald
Heide, Lutz
Substandard and Falsified Antibiotics and Medicines against Noncommunicable Diseases in Western Cameroon and Northeastern Democratic Republic of Congo
title Substandard and Falsified Antibiotics and Medicines against Noncommunicable Diseases in Western Cameroon and Northeastern Democratic Republic of Congo
title_full Substandard and Falsified Antibiotics and Medicines against Noncommunicable Diseases in Western Cameroon and Northeastern Democratic Republic of Congo
title_fullStr Substandard and Falsified Antibiotics and Medicines against Noncommunicable Diseases in Western Cameroon and Northeastern Democratic Republic of Congo
title_full_unstemmed Substandard and Falsified Antibiotics and Medicines against Noncommunicable Diseases in Western Cameroon and Northeastern Democratic Republic of Congo
title_short Substandard and Falsified Antibiotics and Medicines against Noncommunicable Diseases in Western Cameroon and Northeastern Democratic Republic of Congo
title_sort substandard and falsified antibiotics and medicines against noncommunicable diseases in western cameroon and northeastern democratic republic of congo
topic Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7410427/
https://www.ncbi.nlm.nih.gov/pubmed/32394884
http://dx.doi.org/10.4269/ajtmh.20-0184
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