Anti-infective medicine quality: analysis of basic product quality by approval status and country of manufacture
Roger Bate,1 Lorraine Mooney,2 Kimberly Hess,3 Julissa Milligan,1 Amir Attaran41American Enterprise Institute, Washington DC, USA; 2Africa Fighting Malaria, London, UK; 3Africa Fighting Malaria, Washington DC, USA; 4Faculty of Law and Medicine, University of Ottawa, Ottawa, CanadaBackground: Some me...
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ftdoajarticles:oai:doaj.org/article:68cd12bfe5064d3399006081bd8b9e75 2023-05-15T15:14:54+02:00 Anti-infective medicine quality: analysis of basic product quality by approval status and country of manufacture Bate R Mooney L Hess K Milligan J Attaran A 2012-07-01T00:00:00Z https://doaj.org/article/68cd12bfe5064d3399006081bd8b9e75 EN eng Dove Medical Press http://www.dovepress.com/anti-infective-medicine-quality-analysis-of-basic-product-quality-by-a-a10412 https://doaj.org/toc/1179-7282 1179-7282 https://doaj.org/article/68cd12bfe5064d3399006081bd8b9e75 Research and Reports in Tropical Medicine, Vol 2012, Iss default, Pp 57-61 (2012) Arctic medicine. Tropical medicine RC955-962 article 2012 ftdoajarticles 2022-12-31T13:52:39Z Roger Bate,1 Lorraine Mooney,2 Kimberly Hess,3 Julissa Milligan,1 Amir Attaran41American Enterprise Institute, Washington DC, USA; 2Africa Fighting Malaria, London, UK; 3Africa Fighting Malaria, Washington DC, USA; 4Faculty of Law and Medicine, University of Ottawa, Ottawa, CanadaBackground: Some medicines for sale in developing countries are approved by a stringent regulatory authority (SRA) or the World Health Organization (WHO) prequalification program; many of these are global brands. This study ascertains whether medicines approved by SRAs or the WHO perform better in simple quality tests than those that have not been approved by either.Methods: Over the past 4 years, 2652 essential drugs (products to treat malaria, tuberculosis, and bacterial infections) were procured by covert shoppers from eleven African cities and eight cities in a variety of mid-income nations. All samples were assessed using the Global Pharma Health Fund eV Minilab® protocol to identify whether they were substandard, degraded, or counterfeit.Results: The failure rate among SRA-approved products was 1.01%, among WHO-approved products was 6.80%, and 13.01% among products that were not approved by either. African cities had a greater proportion of SRA- or WHO-approved products (31.50%) than Indian cities (26.57%), but they also experienced a higher failure rate (14.21%) than Indian cities (7.83%). The remainder of cities tested had both the highest proportion of approved products at 34.46% and the lowest failure rate at 2.70%. Products made in Africa had the highest failure rate at 25.77%, followed by Chinese products at 15.74%, Indian products at 3.70%, and European/US products, which failed least often, at 1.70%. Most worrying is that 17.65% of Chinese products approved by the WHO failed.Conclusion: The results strongly indicate that approval by either an SRA or the WHO is correlated with higher medicine quality at a statistically significant level. The comparatively high failure rates among WHO-approved products suggest there may be ... Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic Indian Hess ENVELOPE(-65.133,-65.133,-67.200,-67.200) Mooney ENVELOPE(-145.800,-145.800,-86.567,-86.567) |
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Directory of Open Access Journals: DOAJ Articles |
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English |
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Arctic medicine. Tropical medicine RC955-962 |
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Arctic medicine. Tropical medicine RC955-962 Bate R Mooney L Hess K Milligan J Attaran A Anti-infective medicine quality: analysis of basic product quality by approval status and country of manufacture |
topic_facet |
Arctic medicine. Tropical medicine RC955-962 |
description |
Roger Bate,1 Lorraine Mooney,2 Kimberly Hess,3 Julissa Milligan,1 Amir Attaran41American Enterprise Institute, Washington DC, USA; 2Africa Fighting Malaria, London, UK; 3Africa Fighting Malaria, Washington DC, USA; 4Faculty of Law and Medicine, University of Ottawa, Ottawa, CanadaBackground: Some medicines for sale in developing countries are approved by a stringent regulatory authority (SRA) or the World Health Organization (WHO) prequalification program; many of these are global brands. This study ascertains whether medicines approved by SRAs or the WHO perform better in simple quality tests than those that have not been approved by either.Methods: Over the past 4 years, 2652 essential drugs (products to treat malaria, tuberculosis, and bacterial infections) were procured by covert shoppers from eleven African cities and eight cities in a variety of mid-income nations. All samples were assessed using the Global Pharma Health Fund eV Minilab® protocol to identify whether they were substandard, degraded, or counterfeit.Results: The failure rate among SRA-approved products was 1.01%, among WHO-approved products was 6.80%, and 13.01% among products that were not approved by either. African cities had a greater proportion of SRA- or WHO-approved products (31.50%) than Indian cities (26.57%), but they also experienced a higher failure rate (14.21%) than Indian cities (7.83%). The remainder of cities tested had both the highest proportion of approved products at 34.46% and the lowest failure rate at 2.70%. Products made in Africa had the highest failure rate at 25.77%, followed by Chinese products at 15.74%, Indian products at 3.70%, and European/US products, which failed least often, at 1.70%. Most worrying is that 17.65% of Chinese products approved by the WHO failed.Conclusion: The results strongly indicate that approval by either an SRA or the WHO is correlated with higher medicine quality at a statistically significant level. The comparatively high failure rates among WHO-approved products suggest there may be ... |
format |
Article in Journal/Newspaper |
author |
Bate R Mooney L Hess K Milligan J Attaran A |
author_facet |
Bate R Mooney L Hess K Milligan J Attaran A |
author_sort |
Bate R |
title |
Anti-infective medicine quality: analysis of basic product quality by approval status and country of manufacture |
title_short |
Anti-infective medicine quality: analysis of basic product quality by approval status and country of manufacture |
title_full |
Anti-infective medicine quality: analysis of basic product quality by approval status and country of manufacture |
title_fullStr |
Anti-infective medicine quality: analysis of basic product quality by approval status and country of manufacture |
title_full_unstemmed |
Anti-infective medicine quality: analysis of basic product quality by approval status and country of manufacture |
title_sort |
anti-infective medicine quality: analysis of basic product quality by approval status and country of manufacture |
publisher |
Dove Medical Press |
publishDate |
2012 |
url |
https://doaj.org/article/68cd12bfe5064d3399006081bd8b9e75 |
long_lat |
ENVELOPE(-65.133,-65.133,-67.200,-67.200) ENVELOPE(-145.800,-145.800,-86.567,-86.567) |
geographic |
Arctic Indian Hess Mooney |
geographic_facet |
Arctic Indian Hess Mooney |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
Research and Reports in Tropical Medicine, Vol 2012, Iss default, Pp 57-61 (2012) |
op_relation |
http://www.dovepress.com/anti-infective-medicine-quality-analysis-of-basic-product-quality-by-a-a10412 https://doaj.org/toc/1179-7282 1179-7282 https://doaj.org/article/68cd12bfe5064d3399006081bd8b9e75 |
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1766345302614212608 |