Prevalence of substandard and falsified artemisinin-based combination antimalarial medicines on Bioko Island, Equatorial Guinea

Autores
Kaur, Harparkash; Allan, Elizabeth Louise; Mamadu, Ibrahim; Hall, Zoe; Green, Michael D; Swamidos, Isabel; Dwivedi, Prabha; Culzoni, Maria Julia; Fernandez, Facundo M.; Garcia, Guillermo; Hergott, Dianna; Monti, Feliciano
Año de publicación
2017
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Introduction Poor-quality artemisinin-containingantimalarials (ACAs), including falsified and substandardformulations, pose serious health concerns in malariaendemic countries. They can harm patients, contributeto the rise in drug resistance and increase the public?smistrust of health systems. Systematic assessment of drugquality is needed to gain knowledge on the prevalence ofthe problem, to provide Ministries of Health with evidenceon which local regulators can take action.Methods We used three sampling approaches topurchase 677 ACAs from 278 outlets on Bioko Island,Equatorial Guinea as follows: convenience surveyusing mystery client (n=16 outlets, 31 samples), fullisland-wide survey using mystery client (n=174 outlets,368 samples) and randomised survey using an overtsampling approach (n=88 outlets, 278 samples). Thestated active pharmaceutical ingredients (SAPIs) wereassessed using high-performance liquid chromatographyand confirmed by mass spectrometry at threeindependent laboratories.Results Content analysis showed 91.0% of ACAs wereof acceptable quality, 1.6% were substandard and7.4% falsified. No degraded medicines were detected.The prevalence of medicines without the SAPIs washigher for ACAs purchased in the convenience surveycompared with the estimates obtained using the fullisland-wide survey-mystery client and randomised-overtsampling approaches. Comparable results were obtainedfor full island survey-mystery client and randomisedovert. However, the availability of purchased artesunatemonotherapies differed substantially according to thesampling approach used (convenience, 45.2%; fullisland-wide survey-mystery client, 32.6%; random-overtsampling approach, 21.9%). Of concern is that 37.1%(n=62) of these were falsified.Conclusion Falsified ACAs were found on Bioko Island,with the prevalence ranging between 6.1% and 16.1%,depending on the sampling method used. These findingsunderscore the vital need for national authorities to trackthe scale of ineffective medicines that jeopardise treatmentof life-threatening diseases and value of a representativesampling approach to obtain/measure the true prevalenceof poor-quality medicines.
Fil: Kaur, Harparkash. London School of Hygiene and Tropical Medicine; Reino Unido
Fil: Allan, Elizabeth Louise. London School of Hygiene and Tropical Medicine; Reino Unido
Fil: Mamadu, Ibrahim. London School of Hygiene and Tropical Medicine; Reino Unido
Fil: Hall, Zoe. London School of Hygiene and Tropical Medicine; Reino Unido
Fil: Green, Michael D. US Centers for Disease Control and Prevention; Estados Unidos
Fil: Swamidos, Isabel. US Centers for Disease Control and Prevention; Estados Unidos
Fil: Dwivedi, Prabha. Centers for Disease Control and Prevention; Estados Unidos
Fil: Culzoni, Maria Julia. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional del Litoral. Facultad de Bioquímica y Ciencias Biológicas; Argentina
Fil: Fernandez, Facundo M.. Georgia Institute of Technology; Estados Unidos
Fil: Garcia, Guillermo. Bioko Island Malaria Control Project, Medical Care Development International; Guinea Ecuatorial
Fil: Hergott, Dianna. Bioko Island Malaria Control Project, Medical Care Development International; Guinea Ecuatorial
Fil: Monti, Feliciano. Bioko Island Malaria Control Project, Medical Care Development International; Guinea Ecuatorial
Materia
Substandard Medicine
Falsified Medicine
Antimalarials
Artemisinin
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/58693

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oai_identifier_str oai:ri.conicet.gov.ar:11336/58693
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Prevalence of substandard and falsified artemisinin-based combination antimalarial medicines on Bioko Island, Equatorial GuineaKaur, HarparkashAllan, Elizabeth LouiseMamadu, IbrahimHall, ZoeGreen, Michael DSwamidos, IsabelDwivedi, PrabhaCulzoni, Maria JuliaFernandez, Facundo M.Garcia, GuillermoHergott, DiannaMonti, FelicianoSubstandard MedicineFalsified MedicineAntimalarialsArtemisininhttps://purl.org/becyt/ford/1.4https://purl.org/becyt/ford/1Introduction Poor-quality artemisinin-containingantimalarials (ACAs), including falsified and substandardformulations, pose serious health concerns in malariaendemic countries. They can harm patients, contributeto the rise in drug resistance and increase the public?smistrust of health systems. Systematic assessment of drugquality is needed to gain knowledge on the prevalence ofthe problem, to provide Ministries of Health with evidenceon which local regulators can take action.Methods We used three sampling approaches topurchase 677 ACAs from 278 outlets on Bioko Island,Equatorial Guinea as follows: convenience surveyusing mystery client (n=16 outlets, 31 samples), fullisland-wide survey using mystery client (n=174 outlets,368 samples) and randomised survey using an overtsampling approach (n=88 outlets, 278 samples). Thestated active pharmaceutical ingredients (SAPIs) wereassessed using high-performance liquid chromatographyand confirmed by mass spectrometry at threeindependent laboratories.Results Content analysis showed 91.0% of ACAs wereof acceptable quality, 1.6% were substandard and7.4% falsified. No degraded medicines were detected.The prevalence of medicines without the SAPIs washigher for ACAs purchased in the convenience surveycompared with the estimates obtained using the fullisland-wide survey-mystery client and randomised-overtsampling approaches. Comparable results were obtainedfor full island survey-mystery client and randomisedovert. However, the availability of purchased artesunatemonotherapies differed substantially according to thesampling approach used (convenience, 45.2%; fullisland-wide survey-mystery client, 32.6%; random-overtsampling approach, 21.9%). Of concern is that 37.1%(n=62) of these were falsified.Conclusion Falsified ACAs were found on Bioko Island,with the prevalence ranging between 6.1% and 16.1%,depending on the sampling method used. These findingsunderscore the vital need for national authorities to trackthe scale of ineffective medicines that jeopardise treatmentof life-threatening diseases and value of a representativesampling approach to obtain/measure the true prevalenceof poor-quality medicines.Fil: Kaur, Harparkash. London School of Hygiene and Tropical Medicine; Reino UnidoFil: Allan, Elizabeth Louise. London School of Hygiene and Tropical Medicine; Reino UnidoFil: Mamadu, Ibrahim. London School of Hygiene and Tropical Medicine; Reino UnidoFil: Hall, Zoe. London School of Hygiene and Tropical Medicine; Reino UnidoFil: Green, Michael D. US Centers for Disease Control and Prevention; Estados UnidosFil: Swamidos, Isabel. US Centers for Disease Control and Prevention; Estados UnidosFil: Dwivedi, Prabha. Centers for Disease Control and Prevention; Estados UnidosFil: Culzoni, Maria Julia. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional del Litoral. Facultad de Bioquímica y Ciencias Biológicas; ArgentinaFil: Fernandez, Facundo M.. Georgia Institute of Technology; Estados UnidosFil: Garcia, Guillermo. Bioko Island Malaria Control Project, Medical Care Development International; Guinea EcuatorialFil: Hergott, Dianna. Bioko Island Malaria Control Project, Medical Care Development International; Guinea EcuatorialFil: Monti, Feliciano. Bioko Island Malaria Control Project, Medical Care Development International; Guinea EcuatorialBMJ Publishing Group2017-10info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/58693Kaur, Harparkash; Allan, Elizabeth Louise; Mamadu, Ibrahim; Hall, Zoe; Green, Michael D; et al.; Prevalence of substandard and falsified artemisinin-based combination antimalarial medicines on Bioko Island, Equatorial Guinea; BMJ Publishing Group; BMJ Global Health; 2; 4; 10-2017; 1-122059-7908CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/doi/10.1136/bmjgh-2017-000409info:eu-repo/semantics/altIdentifier/url/https://gh.bmj.com/content/2/4/e000409info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-nd/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-29T10:01:07Zoai:ri.conicet.gov.ar:11336/58693instacron: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:34982025-09-29 10:01:08.246CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Prevalence of substandard and falsified artemisinin-based combination antimalarial medicines on Bioko Island, Equatorial Guinea
title Prevalence of substandard and falsified artemisinin-based combination antimalarial medicines on Bioko Island, Equatorial Guinea
spellingShingle Prevalence of substandard and falsified artemisinin-based combination antimalarial medicines on Bioko Island, Equatorial Guinea
Kaur, Harparkash
Substandard Medicine
Falsified Medicine
Antimalarials
Artemisinin
title_short Prevalence of substandard and falsified artemisinin-based combination antimalarial medicines on Bioko Island, Equatorial Guinea
title_full Prevalence of substandard and falsified artemisinin-based combination antimalarial medicines on Bioko Island, Equatorial Guinea
title_fullStr Prevalence of substandard and falsified artemisinin-based combination antimalarial medicines on Bioko Island, Equatorial Guinea
title_full_unstemmed Prevalence of substandard and falsified artemisinin-based combination antimalarial medicines on Bioko Island, Equatorial Guinea
title_sort Prevalence of substandard and falsified artemisinin-based combination antimalarial medicines on Bioko Island, Equatorial Guinea
dc.creator.none.fl_str_mv Kaur, Harparkash
Allan, Elizabeth Louise
Mamadu, Ibrahim
Hall, Zoe
Green, Michael D
Swamidos, Isabel
Dwivedi, Prabha
Culzoni, Maria Julia
Fernandez, Facundo M.
Garcia, Guillermo
Hergott, Dianna
Monti, Feliciano
author Kaur, Harparkash
author_facet Kaur, Harparkash
Allan, Elizabeth Louise
Mamadu, Ibrahim
Hall, Zoe
Green, Michael D
Swamidos, Isabel
Dwivedi, Prabha
Culzoni, Maria Julia
Fernandez, Facundo M.
Garcia, Guillermo
Hergott, Dianna
Monti, Feliciano
author_role author
author2 Allan, Elizabeth Louise
Mamadu, Ibrahim
Hall, Zoe
Green, Michael D
Swamidos, Isabel
Dwivedi, Prabha
Culzoni, Maria Julia
Fernandez, Facundo M.
Garcia, Guillermo
Hergott, Dianna
Monti, Feliciano
author2_role author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Substandard Medicine
Falsified Medicine
Antimalarials
Artemisinin
topic Substandard Medicine
Falsified Medicine
Antimalarials
Artemisinin
purl_subject.fl_str_mv https://purl.org/becyt/ford/1.4
https://purl.org/becyt/ford/1
dc.description.none.fl_txt_mv Introduction Poor-quality artemisinin-containingantimalarials (ACAs), including falsified and substandardformulations, pose serious health concerns in malariaendemic countries. They can harm patients, contributeto the rise in drug resistance and increase the public?smistrust of health systems. Systematic assessment of drugquality is needed to gain knowledge on the prevalence ofthe problem, to provide Ministries of Health with evidenceon which local regulators can take action.Methods We used three sampling approaches topurchase 677 ACAs from 278 outlets on Bioko Island,Equatorial Guinea as follows: convenience surveyusing mystery client (n=16 outlets, 31 samples), fullisland-wide survey using mystery client (n=174 outlets,368 samples) and randomised survey using an overtsampling approach (n=88 outlets, 278 samples). Thestated active pharmaceutical ingredients (SAPIs) wereassessed using high-performance liquid chromatographyand confirmed by mass spectrometry at threeindependent laboratories.Results Content analysis showed 91.0% of ACAs wereof acceptable quality, 1.6% were substandard and7.4% falsified. No degraded medicines were detected.The prevalence of medicines without the SAPIs washigher for ACAs purchased in the convenience surveycompared with the estimates obtained using the fullisland-wide survey-mystery client and randomised-overtsampling approaches. Comparable results were obtainedfor full island survey-mystery client and randomisedovert. However, the availability of purchased artesunatemonotherapies differed substantially according to thesampling approach used (convenience, 45.2%; fullisland-wide survey-mystery client, 32.6%; random-overtsampling approach, 21.9%). Of concern is that 37.1%(n=62) of these were falsified.Conclusion Falsified ACAs were found on Bioko Island,with the prevalence ranging between 6.1% and 16.1%,depending on the sampling method used. These findingsunderscore the vital need for national authorities to trackthe scale of ineffective medicines that jeopardise treatmentof life-threatening diseases and value of a representativesampling approach to obtain/measure the true prevalenceof poor-quality medicines.
Fil: Kaur, Harparkash. London School of Hygiene and Tropical Medicine; Reino Unido
Fil: Allan, Elizabeth Louise. London School of Hygiene and Tropical Medicine; Reino Unido
Fil: Mamadu, Ibrahim. London School of Hygiene and Tropical Medicine; Reino Unido
Fil: Hall, Zoe. London School of Hygiene and Tropical Medicine; Reino Unido
Fil: Green, Michael D. US Centers for Disease Control and Prevention; Estados Unidos
Fil: Swamidos, Isabel. US Centers for Disease Control and Prevention; Estados Unidos
Fil: Dwivedi, Prabha. Centers for Disease Control and Prevention; Estados Unidos
Fil: Culzoni, Maria Julia. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional del Litoral. Facultad de Bioquímica y Ciencias Biológicas; Argentina
Fil: Fernandez, Facundo M.. Georgia Institute of Technology; Estados Unidos
Fil: Garcia, Guillermo. Bioko Island Malaria Control Project, Medical Care Development International; Guinea Ecuatorial
Fil: Hergott, Dianna. Bioko Island Malaria Control Project, Medical Care Development International; Guinea Ecuatorial
Fil: Monti, Feliciano. Bioko Island Malaria Control Project, Medical Care Development International; Guinea Ecuatorial
description Introduction Poor-quality artemisinin-containingantimalarials (ACAs), including falsified and substandardformulations, pose serious health concerns in malariaendemic countries. They can harm patients, contributeto the rise in drug resistance and increase the public?smistrust of health systems. Systematic assessment of drugquality is needed to gain knowledge on the prevalence ofthe problem, to provide Ministries of Health with evidenceon which local regulators can take action.Methods We used three sampling approaches topurchase 677 ACAs from 278 outlets on Bioko Island,Equatorial Guinea as follows: convenience surveyusing mystery client (n=16 outlets, 31 samples), fullisland-wide survey using mystery client (n=174 outlets,368 samples) and randomised survey using an overtsampling approach (n=88 outlets, 278 samples). Thestated active pharmaceutical ingredients (SAPIs) wereassessed using high-performance liquid chromatographyand confirmed by mass spectrometry at threeindependent laboratories.Results Content analysis showed 91.0% of ACAs wereof acceptable quality, 1.6% were substandard and7.4% falsified. No degraded medicines were detected.The prevalence of medicines without the SAPIs washigher for ACAs purchased in the convenience surveycompared with the estimates obtained using the fullisland-wide survey-mystery client and randomised-overtsampling approaches. Comparable results were obtainedfor full island survey-mystery client and randomisedovert. However, the availability of purchased artesunatemonotherapies differed substantially according to thesampling approach used (convenience, 45.2%; fullisland-wide survey-mystery client, 32.6%; random-overtsampling approach, 21.9%). Of concern is that 37.1%(n=62) of these were falsified.Conclusion Falsified ACAs were found on Bioko Island,with the prevalence ranging between 6.1% and 16.1%,depending on the sampling method used. These findingsunderscore the vital need for national authorities to trackthe scale of ineffective medicines that jeopardise treatmentof life-threatening diseases and value of a representativesampling approach to obtain/measure the true prevalenceof poor-quality medicines.
publishDate 2017
dc.date.none.fl_str_mv 2017-10
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/11336/58693
Kaur, Harparkash; Allan, Elizabeth Louise; Mamadu, Ibrahim; Hall, Zoe; Green, Michael D; et al.; Prevalence of substandard and falsified artemisinin-based combination antimalarial medicines on Bioko Island, Equatorial Guinea; BMJ Publishing Group; BMJ Global Health; 2; 4; 10-2017; 1-12
2059-7908
CONICET Digital
CONICET
url http://hdl.handle.net/11336/58693
identifier_str_mv Kaur, Harparkash; Allan, Elizabeth Louise; Mamadu, Ibrahim; Hall, Zoe; Green, Michael D; et al.; Prevalence of substandard and falsified artemisinin-based combination antimalarial medicines on Bioko Island, Equatorial Guinea; BMJ Publishing Group; BMJ Global Health; 2; 4; 10-2017; 1-12
2059-7908
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/doi/10.1136/bmjgh-2017-000409
info:eu-repo/semantics/altIdentifier/url/https://gh.bmj.com/content/2/4/e000409
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv BMJ Publishing Group
publisher.none.fl_str_mv BMJ Publishing Group
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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