Quality of artemisinin-based combination formulations for malaria treatment: Prevalence and risk factors for poor quality medicines in public facilities and private sector drug out...

Autores: Kaur, Harparkash; Allan, Elizabeth Louise; Mamadu, Ibrahim; Hall, Zoe; Ibe, Ogochukwu; El Sherbiny, Mohamed; Van Wyk, Albert; Yeung, Shunmay; Swamidoss, Isabel; Green, Michael D.; Dwivedi, Prabha; Culzoni, Maria Julia; Calrke, Sian; Schellenberg, David; Fernández, Facundo M.; Onwujekwe, Obina
Año de publicación: 2015
Idioma: inglés
Tipo de recurso: artículo
Estado: versión publicada
Descripción: Background Artemisinin-based combination therapies are recommended by the World Health Organisation (WHO) as first-line treatment for Plasmodium falciparum malaria, yet medication must be of good quality for efficacious treatment. A recent meta-analysis reported 35% (796/ 2,296) of antimalarial drug samples from 21 Sub-Saharan African countries, purchased from outlets predominantly using convenience sampling, failed chemical content analysis. We used three sampling strategies to purchase artemisinin-containing antimalarials (ACAs) in Enugu metropolis, Nigeria, and compared the resulting quality estimates. Methods ACAs were purchased using three sampling approaches - convenience, mystery clients and overt, within a defined area and sampling frame in Enugu metropolis. The active pharmaceutical ingredients were assessed using high-performance liquid chromatography and confirmed by mass spectrometry at three independent laboratories. Results were expressed as percentage of APIs stated on the packaging and used to categorise each sample as acceptable quality, substandard, degraded, or falsified. Results Content analysis of 3024 samples purchased from 421 outlets using convenience (n=200), mystery (n=1,919) and overt (n=905) approaches, showed overall 90.8% ACAs to be of acceptable quality, 6.8% substandard, 1.3% degraded and 1.2% falsified. Convenience sampling yielded a significantly higher prevalence of poor quality ACAs, but was not evident by the mystery and overt sampling strategies both of which yielded results that were comparable between each other. Artesunate (n=135; 4 falsified) and dihydroartemisinin (n=14) monotherapy tablets, not recommended by WHO, were also identified. Conclusion Randomised sampling identified fewer falsified ACAs than previously reported by convenience approaches. Our findings emphasise the need for specific consideration to be given to sampling frame and sampling approach if representative information on drug quality is to be obtained.This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.
Fil: Kaur, Harparkash. London School of Hygiene & Tropical Medicine; Reino Unido
Fil: Allan, Elizabeth Louise. London School of Hygiene & Tropical Medicine; Reino Unido
Fil: Mamadu, Ibrahim. London School of Hygiene & Tropical Medicine; Reino Unido
Fil: Hall, Zoe. London School of Hygiene & Tropical Medicine; Reino Unido
Fil: Ibe, Ogochukwu. University of Nigeria; Nigeria
Fil: El Sherbiny, Mohamed. London School of Hygiene & Tropical Medicine; Reino Unido
Fil: Van Wyk, Albert. London School of Hygiene & Tropical Medicine; Reino Unido
Fil: Yeung, Shunmay. London School of Hygiene & Tropical Medicine; Reino Unido
Fil: Swamidoss, Isabel. US Centers for Disease Control and Prevention; Estados Unidos
Fil: Green, Michael D.. US Centers for Disease Control and Prevention; Estados Unidos
Fil: Dwivedi, Prabha. US Centers for Disease Control and Prevention; Estados Unidos
Fil: Culzoni, Maria Julia. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Santa Fe; Argentina. Universidad Nacional del Litoral. Facultad de Bioquímica y Ciencias Biológicas; Argentina
Fil: Calrke, Sian. London School of Hygiene & Tropical Medicine; Reino Unido
Fil: Schellenberg, David. London School of Hygiene & Tropical Medicine; Reino Unido
Fil: Fernández, Facundo M.. Georgia Institute of Techology; Estados Unidos
Fil: Onwujekwe, Obina. University of Nigeria; Nigeria
Materia: Sampling approaches
Artemisinin based monotherapy
Artemisinin based combination therapy
High-performance liquid chromatography
ambient mass spectrometry
drug quality
acceptable quality
degraded drugs
substandard drugs
falsified drugs
Nivel de accesibilidad: acceso abierto
Condiciones de uso: https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
Repositorio
Institución: Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador: oai:ri.conicet.gov.ar:11336/49018

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network_name_str	CONICET Digital (CONICET)
spelling	Quality of artemisinin-based combination formulations for malaria treatment: Prevalence and risk factors for poor quality medicines in public facilities and private sector drug outlets in Enugu, NigeriaKaur, HarparkashAllan, Elizabeth LouiseMamadu, IbrahimHall, ZoeIbe, OgochukwuEl Sherbiny, MohamedVan Wyk, AlbertYeung, ShunmaySwamidoss, IsabelGreen, Michael D.Dwivedi, PrabhaCulzoni, Maria JuliaCalrke, SianSchellenberg, DavidFernández, Facundo M.Onwujekwe, ObinaSampling approachesArtemisinin based monotherapyArtemisinin based combination therapyHigh-performance liquid chromatographyambient mass spectrometrydrug qualityacceptable qualitydegraded drugssubstandard drugsfalsified drugshttps://purl.org/becyt/ford/3.3https://purl.org/becyt/ford/3Background Artemisinin-based combination therapies are recommended by the World Health Organisation (WHO) as first-line treatment for Plasmodium falciparum malaria, yet medication must be of good quality for efficacious treatment. A recent meta-analysis reported 35% (796/ 2,296) of antimalarial drug samples from 21 Sub-Saharan African countries, purchased from outlets predominantly using convenience sampling, failed chemical content analysis. We used three sampling strategies to purchase artemisinin-containing antimalarials (ACAs) in Enugu metropolis, Nigeria, and compared the resulting quality estimates. Methods ACAs were purchased using three sampling approaches - convenience, mystery clients and overt, within a defined area and sampling frame in Enugu metropolis. The active pharmaceutical ingredients were assessed using high-performance liquid chromatography and confirmed by mass spectrometry at three independent laboratories. Results were expressed as percentage of APIs stated on the packaging and used to categorise each sample as acceptable quality, substandard, degraded, or falsified. Results Content analysis of 3024 samples purchased from 421 outlets using convenience (n=200), mystery (n=1,919) and overt (n=905) approaches, showed overall 90.8% ACAs to be of acceptable quality, 6.8% substandard, 1.3% degraded and 1.2% falsified. Convenience sampling yielded a significantly higher prevalence of poor quality ACAs, but was not evident by the mystery and overt sampling strategies both of which yielded results that were comparable between each other. Artesunate (n=135; 4 falsified) and dihydroartemisinin (n=14) monotherapy tablets, not recommended by WHO, were also identified. Conclusion Randomised sampling identified fewer falsified ACAs than previously reported by convenience approaches. Our findings emphasise the need for specific consideration to be given to sampling frame and sampling approach if representative information on drug quality is to be obtained.This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.Fil: Kaur, Harparkash. London School of Hygiene & Tropical Medicine; Reino UnidoFil: Allan, Elizabeth Louise. London School of Hygiene & Tropical Medicine; Reino UnidoFil: Mamadu, Ibrahim. London School of Hygiene & Tropical Medicine; Reino UnidoFil: Hall, Zoe. London School of Hygiene & Tropical Medicine; Reino UnidoFil: Ibe, Ogochukwu. University of Nigeria; NigeriaFil: El Sherbiny, Mohamed. London School of Hygiene & Tropical Medicine; Reino UnidoFil: Van Wyk, Albert. London School of Hygiene & Tropical Medicine; Reino UnidoFil: Yeung, Shunmay. London School of Hygiene & Tropical Medicine; Reino UnidoFil: Swamidoss, Isabel. US Centers for Disease Control and Prevention; Estados UnidosFil: Green, Michael D.. US Centers for Disease Control and Prevention; Estados UnidosFil: Dwivedi, Prabha. US Centers for Disease Control and Prevention; Estados UnidosFil: Culzoni, Maria Julia. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Santa Fe; Argentina. Universidad Nacional del Litoral. Facultad de Bioquímica y Ciencias Biológicas; ArgentinaFil: Calrke, Sian. London School of Hygiene & Tropical Medicine; Reino UnidoFil: Schellenberg, David. London School of Hygiene & Tropical Medicine; Reino UnidoFil: Fernández, Facundo M.. Georgia Institute of Techology; Estados UnidosFil: Onwujekwe, Obina. University of Nigeria; NigeriaPublic Library of Science2015-05info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/49018Kaur, Harparkash; Allan, Elizabeth Louise; Mamadu, Ibrahim; Hall, Zoe; Ibe, Ogochukwu; et al.; Quality of artemisinin-based combination formulations for malaria treatment: Prevalence and risk factors for poor quality medicines in public facilities and private sector drug outlets in Enugu, Nigeria; Public Library of Science; Plos One; 10; 5; 5-2015; e01255771932-6203CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0125577info:eu-repo/semantics/altIdentifier/doi/10.1371/journal.pone.0125577info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-10-22T11:54:52Zoai:ri.conicet.gov.ar:11336/49018instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-10-22 11:54:52.989CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv	Quality of artemisinin-based combination formulations for malaria treatment: Prevalence and risk factors for poor quality medicines in public facilities and private sector drug outlets in Enugu, Nigeria
title	Quality of artemisinin-based combination formulations for malaria treatment: Prevalence and risk factors for poor quality medicines in public facilities and private sector drug outlets in Enugu, Nigeria
spellingShingle	Quality of artemisinin-based combination formulations for malaria treatment: Prevalence and risk factors for poor quality medicines in public facilities and private sector drug outlets in Enugu, Nigeria Kaur, Harparkash Sampling approaches Artemisinin based monotherapy Artemisinin based combination therapy High-performance liquid chromatography ambient mass spectrometry drug quality acceptable quality degraded drugs substandard drugs falsified drugs
title_short	Quality of artemisinin-based combination formulations for malaria treatment: Prevalence and risk factors for poor quality medicines in public facilities and private sector drug outlets in Enugu, Nigeria
title_full	Quality of artemisinin-based combination formulations for malaria treatment: Prevalence and risk factors for poor quality medicines in public facilities and private sector drug outlets in Enugu, Nigeria
title_fullStr	Quality of artemisinin-based combination formulations for malaria treatment: Prevalence and risk factors for poor quality medicines in public facilities and private sector drug outlets in Enugu, Nigeria
title_full_unstemmed	Quality of artemisinin-based combination formulations for malaria treatment: Prevalence and risk factors for poor quality medicines in public facilities and private sector drug outlets in Enugu, Nigeria
title_sort	Quality of artemisinin-based combination formulations for malaria treatment: Prevalence and risk factors for poor quality medicines in public facilities and private sector drug outlets in Enugu, Nigeria
dc.creator.none.fl_str_mv	Kaur, Harparkash Allan, Elizabeth Louise Mamadu, Ibrahim Hall, Zoe Ibe, Ogochukwu El Sherbiny, Mohamed Van Wyk, Albert Yeung, Shunmay Swamidoss, Isabel Green, Michael D. Dwivedi, Prabha Culzoni, Maria Julia Calrke, Sian Schellenberg, David Fernández, Facundo M. Onwujekwe, Obina
author	Kaur, Harparkash
author_facet	Kaur, Harparkash Allan, Elizabeth Louise Mamadu, Ibrahim Hall, Zoe Ibe, Ogochukwu El Sherbiny, Mohamed Van Wyk, Albert Yeung, Shunmay Swamidoss, Isabel Green, Michael D. Dwivedi, Prabha Culzoni, Maria Julia Calrke, Sian Schellenberg, David Fernández, Facundo M. Onwujekwe, Obina
author_role	author
author2	Allan, Elizabeth Louise Mamadu, Ibrahim Hall, Zoe Ibe, Ogochukwu El Sherbiny, Mohamed Van Wyk, Albert Yeung, Shunmay Swamidoss, Isabel Green, Michael D. Dwivedi, Prabha Culzoni, Maria Julia Calrke, Sian Schellenberg, David Fernández, Facundo M. Onwujekwe, Obina
author2_role	author author author author author author author author author author author author author author author
dc.subject.none.fl_str_mv	Sampling approaches Artemisinin based monotherapy Artemisinin based combination therapy High-performance liquid chromatography ambient mass spectrometry drug quality acceptable quality degraded drugs substandard drugs falsified drugs
topic	Sampling approaches Artemisinin based monotherapy Artemisinin based combination therapy High-performance liquid chromatography ambient mass spectrometry drug quality acceptable quality degraded drugs substandard drugs falsified drugs
purl_subject.fl_str_mv	https://purl.org/becyt/ford/3.3 https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv	Background Artemisinin-based combination therapies are recommended by the World Health Organisation (WHO) as first-line treatment for Plasmodium falciparum malaria, yet medication must be of good quality for efficacious treatment. A recent meta-analysis reported 35% (796/ 2,296) of antimalarial drug samples from 21 Sub-Saharan African countries, purchased from outlets predominantly using convenience sampling, failed chemical content analysis. We used three sampling strategies to purchase artemisinin-containing antimalarials (ACAs) in Enugu metropolis, Nigeria, and compared the resulting quality estimates. Methods ACAs were purchased using three sampling approaches - convenience, mystery clients and overt, within a defined area and sampling frame in Enugu metropolis. The active pharmaceutical ingredients were assessed using high-performance liquid chromatography and confirmed by mass spectrometry at three independent laboratories. Results were expressed as percentage of APIs stated on the packaging and used to categorise each sample as acceptable quality, substandard, degraded, or falsified. Results Content analysis of 3024 samples purchased from 421 outlets using convenience (n=200), mystery (n=1,919) and overt (n=905) approaches, showed overall 90.8% ACAs to be of acceptable quality, 6.8% substandard, 1.3% degraded and 1.2% falsified. Convenience sampling yielded a significantly higher prevalence of poor quality ACAs, but was not evident by the mystery and overt sampling strategies both of which yielded results that were comparable between each other. Artesunate (n=135; 4 falsified) and dihydroartemisinin (n=14) monotherapy tablets, not recommended by WHO, were also identified. Conclusion Randomised sampling identified fewer falsified ACAs than previously reported by convenience approaches. Our findings emphasise the need for specific consideration to be given to sampling frame and sampling approach if representative information on drug quality is to be obtained.This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication. Fil: Kaur, Harparkash. London School of Hygiene & Tropical Medicine; Reino Unido Fil: Allan, Elizabeth Louise. London School of Hygiene & Tropical Medicine; Reino Unido Fil: Mamadu, Ibrahim. London School of Hygiene & Tropical Medicine; Reino Unido Fil: Hall, Zoe. London School of Hygiene & Tropical Medicine; Reino Unido Fil: Ibe, Ogochukwu. University of Nigeria; Nigeria Fil: El Sherbiny, Mohamed. London School of Hygiene & Tropical Medicine; Reino Unido Fil: Van Wyk, Albert. London School of Hygiene & Tropical Medicine; Reino Unido Fil: Yeung, Shunmay. London School of Hygiene & Tropical Medicine; Reino Unido Fil: Swamidoss, Isabel. US Centers for Disease Control and Prevention; Estados Unidos Fil: Green, Michael D.. US Centers for Disease Control and Prevention; Estados Unidos Fil: Dwivedi, Prabha. US Centers for Disease Control and Prevention; Estados Unidos Fil: Culzoni, Maria Julia. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Santa Fe; Argentina. Universidad Nacional del Litoral. Facultad de Bioquímica y Ciencias Biológicas; Argentina Fil: Calrke, Sian. London School of Hygiene & Tropical Medicine; Reino Unido Fil: Schellenberg, David. London School of Hygiene & Tropical Medicine; Reino Unido Fil: Fernández, Facundo M.. Georgia Institute of Techology; Estados Unidos Fil: Onwujekwe, Obina. University of Nigeria; Nigeria
description	Background Artemisinin-based combination therapies are recommended by the World Health Organisation (WHO) as first-line treatment for Plasmodium falciparum malaria, yet medication must be of good quality for efficacious treatment. A recent meta-analysis reported 35% (796/ 2,296) of antimalarial drug samples from 21 Sub-Saharan African countries, purchased from outlets predominantly using convenience sampling, failed chemical content analysis. We used three sampling strategies to purchase artemisinin-containing antimalarials (ACAs) in Enugu metropolis, Nigeria, and compared the resulting quality estimates. Methods ACAs were purchased using three sampling approaches - convenience, mystery clients and overt, within a defined area and sampling frame in Enugu metropolis. The active pharmaceutical ingredients were assessed using high-performance liquid chromatography and confirmed by mass spectrometry at three independent laboratories. Results were expressed as percentage of APIs stated on the packaging and used to categorise each sample as acceptable quality, substandard, degraded, or falsified. Results Content analysis of 3024 samples purchased from 421 outlets using convenience (n=200), mystery (n=1,919) and overt (n=905) approaches, showed overall 90.8% ACAs to be of acceptable quality, 6.8% substandard, 1.3% degraded and 1.2% falsified. Convenience sampling yielded a significantly higher prevalence of poor quality ACAs, but was not evident by the mystery and overt sampling strategies both of which yielded results that were comparable between each other. Artesunate (n=135; 4 falsified) and dihydroartemisinin (n=14) monotherapy tablets, not recommended by WHO, were also identified. Conclusion Randomised sampling identified fewer falsified ACAs than previously reported by convenience approaches. Our findings emphasise the need for specific consideration to be given to sampling frame and sampling approach if representative information on drug quality is to be obtained.This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.
publishDate	2015
dc.date.none.fl_str_mv	2015-05
dc.type.none.fl_str_mv	info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion http://purl.org/coar/resource_type/c_6501 info:ar-repo/semantics/articulo
format	article
status_str	publishedVersion
dc.identifier.none.fl_str_mv	http://hdl.handle.net/11336/49018 Kaur, Harparkash; Allan, Elizabeth Louise; Mamadu, Ibrahim; Hall, Zoe; Ibe, Ogochukwu; et al.; Quality of artemisinin-based combination formulations for malaria treatment: Prevalence and risk factors for poor quality medicines in public facilities and private sector drug outlets in Enugu, Nigeria; Public Library of Science; Plos One; 10; 5; 5-2015; e0125577 1932-6203 CONICET Digital CONICET
url	http://hdl.handle.net/11336/49018
identifier_str_mv	Kaur, Harparkash; Allan, Elizabeth Louise; Mamadu, Ibrahim; Hall, Zoe; Ibe, Ogochukwu; et al.; Quality of artemisinin-based combination formulations for malaria treatment: Prevalence and risk factors for poor quality medicines in public facilities and private sector drug outlets in Enugu, Nigeria; Public Library of Science; Plos One; 10; 5; 5-2015; e0125577 1932-6203 CONICET Digital CONICET
dc.language.none.fl_str_mv	eng
language	eng
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publisher.none.fl_str_mv	Public Library of Science
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Quality of artemisinin-based combination formulations for malaria treatment: Prevalence and risk factors for poor quality medicines in public facilities and private sector drug out...

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