A Repeat Random Survey of the Prevalence of Falsified and Substandard Antimalarials in the Lao PDR: A Change for the Better

Autores
Tabernero, Patricia; Mayxay, Mayfong; Culzoni, Maria Julia; Dwivedi, Prabha; Swamidoss, Isabel; Allan, Elizabeth Louise; Khanthavong, Maniphone; Phonlavong, Chindaphone; Vilayhong, Chantala; Yeuchaixiong, Sengchanh; Sichanh, Chanvilay; Sengaloundeth, Sivong; Kaur, Harparkash; Fernandez, Facundo M.; Green, Michael D.; Newton, Paul N.
Año de publicación
2015
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
In 2003, a stratified random sample survey was conducted in the Lao People's Democratic Republic (Laos) to study the availability and quality of antimalarials in the private sector. In 2012, this survey was repeated to allow a statistically valid analysis of change through time. The counterfeit detection device 3 (CD-3) was used to assess packaging quality in the field and HPLC and mass spectroscopy analysis chemical analysis performed. The availability of oral artesunate monotherapies had significantly decreased from 22.9% (22) of 96 outlets in southern Laos in 2003 to 4.8% (7) of 144 outlets in 2012 (P < 0.0001). All the samples collected in the 2012 survey contained the correct active pharmaceutical ingredients (APIs) in contrast to the 21 (84%) falsified artesunate samples found in the 2003 survey. Although none of the medicines found in 2012 survey had evidence for falsification, 25.4% (37) of the samples were outside the 90-110% pharmacopeial limits of the label claim, suggesting that they were substandard or degraded. Results obtained from this survey show that patients are still exposed to poorly manufactured drugs or to ineffective medicines such as chloroquine. The quality of artemisinin-based combination therapies (ACTs) used in Laos needs to be monitored, since falsified ACTs would have devastating consequences in public health.
Fil: Tabernero, Patricia. Lao Oxford Mahosot Hospital; China
Fil: Mayxay, Mayfong. University of Oxford; Reino Unido
Fil: Culzoni, Maria Julia. Universidad Nacional del Litoral. Facultad de Bioquímica y Ciencias Biológicas; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Santa Fe; Argentina
Fil: Dwivedi, Prabha. University Of Heath Sciences; China
Fil: Swamidoss, Isabel. U.S. Centers for Disease Control and Prevention; Estados Unidos
Fil: Allan, Elizabeth Louise. Georgia Institute of Techology; Estados Unidos
Fil: Khanthavong, Maniphone. U.S. Centers for Disease Control and Prevention; Estados Unidos
Fil: Phonlavong, Chindaphone. U.S. Centers for Disease Control and Prevention; Estados Unidos
Fil: Vilayhong, Chantala. Centre of Malariology, Parasitology and Entomology; China
Fil: Yeuchaixiong, Sengchanh. Centre of Malariology, Parasitology and Entomology; China
Fil: Sichanh, Chanvilay. Bureau of Food and Drug Inspection; China
Fil: Sengaloundeth, Sivong. Food and Drug Department; China
Fil: Kaur, Harparkash. University of London; Reino Unido
Fil: Fernandez, Facundo M.. Georgia Institute of Techology; Estados Unidos
Fil: Green, Michael D.. National Center for Infectious Diseases; Estados Unidos
Fil: Newton, Paul N.. University of Oxford; Reino Unido
Materia
RANDOM SURVEY
ANTIMALARIALS
FALSIFIED AND SUBSTANDARD MEDICINES
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/50375
Acceder
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oai_identifier_str oai:ri.conicet.gov.ar:11336/50375
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling A Repeat Random Survey of the Prevalence of Falsified and Substandard Antimalarials in the Lao PDR: A Change for the BetterTabernero, PatriciaMayxay, MayfongCulzoni, Maria JuliaDwivedi, PrabhaSwamidoss, IsabelAllan, Elizabeth LouiseKhanthavong, ManiphonePhonlavong, ChindaphoneVilayhong, ChantalaYeuchaixiong, SengchanhSichanh, ChanvilaySengaloundeth, SivongKaur, HarparkashFernandez, Facundo M.Green, Michael D.Newton, Paul N.RANDOM SURVEYANTIMALARIALSFALSIFIED AND SUBSTANDARD MEDICINEShttps://purl.org/becyt/ford/3.3https://purl.org/becyt/ford/3In 2003, a stratified random sample survey was conducted in the Lao People's Democratic Republic (Laos) to study the availability and quality of antimalarials in the private sector. In 2012, this survey was repeated to allow a statistically valid analysis of change through time. The counterfeit detection device 3 (CD-3) was used to assess packaging quality in the field and HPLC and mass spectroscopy analysis chemical analysis performed. The availability of oral artesunate monotherapies had significantly decreased from 22.9% (22) of 96 outlets in southern Laos in 2003 to 4.8% (7) of 144 outlets in 2012 (P < 0.0001). All the samples collected in the 2012 survey contained the correct active pharmaceutical ingredients (APIs) in contrast to the 21 (84%) falsified artesunate samples found in the 2003 survey. Although none of the medicines found in 2012 survey had evidence for falsification, 25.4% (37) of the samples were outside the 90-110% pharmacopeial limits of the label claim, suggesting that they were substandard or degraded. Results obtained from this survey show that patients are still exposed to poorly manufactured drugs or to ineffective medicines such as chloroquine. The quality of artemisinin-based combination therapies (ACTs) used in Laos needs to be monitored, since falsified ACTs would have devastating consequences in public health.Fil: Tabernero, Patricia. Lao Oxford Mahosot Hospital; ChinaFil: Mayxay, Mayfong. University of Oxford; Reino UnidoFil: Culzoni, Maria Julia. Universidad Nacional del Litoral. Facultad de Bioquímica y Ciencias Biológicas; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Santa Fe; ArgentinaFil: Dwivedi, Prabha. University Of Heath Sciences; ChinaFil: Swamidoss, Isabel. U.S. Centers for Disease Control and Prevention; Estados UnidosFil: Allan, Elizabeth Louise. Georgia Institute of Techology; Estados UnidosFil: Khanthavong, Maniphone. U.S. Centers for Disease Control and Prevention; Estados UnidosFil: Phonlavong, Chindaphone. U.S. Centers for Disease Control and Prevention; Estados UnidosFil: Vilayhong, Chantala. Centre of Malariology, Parasitology and Entomology; ChinaFil: Yeuchaixiong, Sengchanh. Centre of Malariology, Parasitology and Entomology; ChinaFil: Sichanh, Chanvilay. Bureau of Food and Drug Inspection; ChinaFil: Sengaloundeth, Sivong. Food and Drug Department; ChinaFil: Kaur, Harparkash. University of London; Reino UnidoFil: Fernandez, Facundo M.. Georgia Institute of Techology; Estados UnidosFil: Green, Michael D.. National Center for Infectious Diseases; Estados UnidosFil: Newton, Paul N.. University of Oxford; Reino UnidoAmerican Society of Tropical Medicine and Hygiene2015-06info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/50375Tabernero, Patricia; Mayxay, Mayfong; Culzoni, Maria Julia; Dwivedi, Prabha; Swamidoss, Isabel; et al.; A Repeat Random Survey of the Prevalence of Falsified and Substandard Antimalarials in the Lao PDR: A Change for the Better; American Society of Tropical Medicine and Hygiene; American Journal of Tropical Medicine and Hygiene; 92; 6; 6-2015; 95-1040002-96371476-1645CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/doi/10.4269/ajtmh.15-0057info:eu-repo/semantics/altIdentifier/url/https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4455074/info:eu-repo/semantics/altIdentifier/url/http://www.ajtmh.org/content/journals/10.4269/ajtmh.15-0057info:eu-repo/semantics/altIdentifier/doi/10.4269%2Fajtmh.15-0057info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-29T10:45:00Zoai:ri.conicet.gov.ar:11336/50375instacron: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 10:45:00.83CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv A Repeat Random Survey of the Prevalence of Falsified and Substandard Antimalarials in the Lao PDR: A Change for the Better
title A Repeat Random Survey of the Prevalence of Falsified and Substandard Antimalarials in the Lao PDR: A Change for the Better
spellingShingle A Repeat Random Survey of the Prevalence of Falsified and Substandard Antimalarials in the Lao PDR: A Change for the Better
Tabernero, Patricia
RANDOM SURVEY
ANTIMALARIALS
FALSIFIED AND SUBSTANDARD MEDICINES
title_short A Repeat Random Survey of the Prevalence of Falsified and Substandard Antimalarials in the Lao PDR: A Change for the Better
title_full A Repeat Random Survey of the Prevalence of Falsified and Substandard Antimalarials in the Lao PDR: A Change for the Better
title_fullStr A Repeat Random Survey of the Prevalence of Falsified and Substandard Antimalarials in the Lao PDR: A Change for the Better
title_full_unstemmed A Repeat Random Survey of the Prevalence of Falsified and Substandard Antimalarials in the Lao PDR: A Change for the Better
title_sort A Repeat Random Survey of the Prevalence of Falsified and Substandard Antimalarials in the Lao PDR: A Change for the Better
dc.creator.none.fl_str_mv Tabernero, Patricia
Mayxay, Mayfong
Culzoni, Maria Julia
Dwivedi, Prabha
Swamidoss, Isabel
Allan, Elizabeth Louise
Khanthavong, Maniphone
Phonlavong, Chindaphone
Vilayhong, Chantala
Yeuchaixiong, Sengchanh
Sichanh, Chanvilay
Sengaloundeth, Sivong
Kaur, Harparkash
Fernandez, Facundo M.
Green, Michael D.
Newton, Paul N.
author Tabernero, Patricia
author_facet Tabernero, Patricia
Mayxay, Mayfong
Culzoni, Maria Julia
Dwivedi, Prabha
Swamidoss, Isabel
Allan, Elizabeth Louise
Khanthavong, Maniphone
Phonlavong, Chindaphone
Vilayhong, Chantala
Yeuchaixiong, Sengchanh
Sichanh, Chanvilay
Sengaloundeth, Sivong
Kaur, Harparkash
Fernandez, Facundo M.
Green, Michael D.
Newton, Paul N.
author_role author
author2 Mayxay, Mayfong
Culzoni, Maria Julia
Dwivedi, Prabha
Swamidoss, Isabel
Allan, Elizabeth Louise
Khanthavong, Maniphone
Phonlavong, Chindaphone
Vilayhong, Chantala
Yeuchaixiong, Sengchanh
Sichanh, Chanvilay
Sengaloundeth, Sivong
Kaur, Harparkash
Fernandez, Facundo M.
Green, Michael D.
Newton, Paul N.
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv RANDOM SURVEY
ANTIMALARIALS
FALSIFIED AND SUBSTANDARD MEDICINES
topic RANDOM SURVEY
ANTIMALARIALS
FALSIFIED AND SUBSTANDARD MEDICINES
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.3
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv In 2003, a stratified random sample survey was conducted in the Lao People's Democratic Republic (Laos) to study the availability and quality of antimalarials in the private sector. In 2012, this survey was repeated to allow a statistically valid analysis of change through time. The counterfeit detection device 3 (CD-3) was used to assess packaging quality in the field and HPLC and mass spectroscopy analysis chemical analysis performed. The availability of oral artesunate monotherapies had significantly decreased from 22.9% (22) of 96 outlets in southern Laos in 2003 to 4.8% (7) of 144 outlets in 2012 (P < 0.0001). All the samples collected in the 2012 survey contained the correct active pharmaceutical ingredients (APIs) in contrast to the 21 (84%) falsified artesunate samples found in the 2003 survey. Although none of the medicines found in 2012 survey had evidence for falsification, 25.4% (37) of the samples were outside the 90-110% pharmacopeial limits of the label claim, suggesting that they were substandard or degraded. Results obtained from this survey show that patients are still exposed to poorly manufactured drugs or to ineffective medicines such as chloroquine. The quality of artemisinin-based combination therapies (ACTs) used in Laos needs to be monitored, since falsified ACTs would have devastating consequences in public health.
Fil: Tabernero, Patricia. Lao Oxford Mahosot Hospital; China
Fil: Mayxay, Mayfong. University of Oxford; Reino Unido
Fil: Culzoni, Maria Julia. Universidad Nacional del Litoral. Facultad de Bioquímica y Ciencias Biológicas; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Santa Fe; Argentina
Fil: Dwivedi, Prabha. University Of Heath Sciences; China
Fil: Swamidoss, Isabel. U.S. Centers for Disease Control and Prevention; Estados Unidos
Fil: Allan, Elizabeth Louise. Georgia Institute of Techology; Estados Unidos
Fil: Khanthavong, Maniphone. U.S. Centers for Disease Control and Prevention; Estados Unidos
Fil: Phonlavong, Chindaphone. U.S. Centers for Disease Control and Prevention; Estados Unidos
Fil: Vilayhong, Chantala. Centre of Malariology, Parasitology and Entomology; China
Fil: Yeuchaixiong, Sengchanh. Centre of Malariology, Parasitology and Entomology; China
Fil: Sichanh, Chanvilay. Bureau of Food and Drug Inspection; China
Fil: Sengaloundeth, Sivong. Food and Drug Department; China
Fil: Kaur, Harparkash. University of London; Reino Unido
Fil: Fernandez, Facundo M.. Georgia Institute of Techology; Estados Unidos
Fil: Green, Michael D.. National Center for Infectious Diseases; Estados Unidos
Fil: Newton, Paul N.. University of Oxford; Reino Unido
description In 2003, a stratified random sample survey was conducted in the Lao People's Democratic Republic (Laos) to study the availability and quality of antimalarials in the private sector. In 2012, this survey was repeated to allow a statistically valid analysis of change through time. The counterfeit detection device 3 (CD-3) was used to assess packaging quality in the field and HPLC and mass spectroscopy analysis chemical analysis performed. The availability of oral artesunate monotherapies had significantly decreased from 22.9% (22) of 96 outlets in southern Laos in 2003 to 4.8% (7) of 144 outlets in 2012 (P < 0.0001). All the samples collected in the 2012 survey contained the correct active pharmaceutical ingredients (APIs) in contrast to the 21 (84%) falsified artesunate samples found in the 2003 survey. Although none of the medicines found in 2012 survey had evidence for falsification, 25.4% (37) of the samples were outside the 90-110% pharmacopeial limits of the label claim, suggesting that they were substandard or degraded. Results obtained from this survey show that patients are still exposed to poorly manufactured drugs or to ineffective medicines such as chloroquine. The quality of artemisinin-based combination therapies (ACTs) used in Laos needs to be monitored, since falsified ACTs would have devastating consequences in public health.
publishDate 2015
dc.date.none.fl_str_mv 2015-06
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/11336/50375
Tabernero, Patricia; Mayxay, Mayfong; Culzoni, Maria Julia; Dwivedi, Prabha; Swamidoss, Isabel; et al.; A Repeat Random Survey of the Prevalence of Falsified and Substandard Antimalarials in the Lao PDR: A Change for the Better; American Society of Tropical Medicine and Hygiene; American Journal of Tropical Medicine and Hygiene; 92; 6; 6-2015; 95-104
0002-9637
1476-1645
CONICET Digital
CONICET
url http://hdl.handle.net/11336/50375
identifier_str_mv Tabernero, Patricia; Mayxay, Mayfong; Culzoni, Maria Julia; Dwivedi, Prabha; Swamidoss, Isabel; et al.; A Repeat Random Survey of the Prevalence of Falsified and Substandard Antimalarials in the Lao PDR: A Change for the Better; American Society of Tropical Medicine and Hygiene; American Journal of Tropical Medicine and Hygiene; 92; 6; 6-2015; 95-104
0002-9637
1476-1645
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/doi/10.4269/ajtmh.15-0057
info:eu-repo/semantics/altIdentifier/url/https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4455074/
info:eu-repo/semantics/altIdentifier/url/http://www.ajtmh.org/content/journals/10.4269/ajtmh.15-0057
info:eu-repo/semantics/altIdentifier/doi/10.4269%2Fajtmh.15-0057
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv American Society of Tropical Medicine and Hygiene
publisher.none.fl_str_mv American Society of Tropical Medicine and Hygiene
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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score 13.070432

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