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
- Institución
- Consejo Nacional de Investigaciones Científicas y Técnicas
- OAI Identificador
- oai:ri.conicet.gov.ar:11336/58693
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oai:ri.conicet.gov.ar:11336/58693 |
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3498 |
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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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1844613801888972800 |
score |
13.070432 |