Fake anti-malarials: start with the facts.
Identifieur interne : 000883 ( PubMed/Corpus ); précédent : 000882; suivant : 000884Fake anti-malarials: start with the facts.
Auteurs : Harparkash Kaur ; Si N Clarke ; Mirza Lalani ; Souly Phanouvong ; Philippe Guérin ; Andrew Mcloughlin ; Benjamin K. Wilson ; Michael Deats ; Aline Plançon ; Heidi Hopkins ; Debora Miranda ; David SchellenbergSource :
- Malaria journal [ 1475-2875 ] ; 2016.
English descriptors
- KwdEn :
- MESH :
- chemical , standards : Antimalarials, Artemisinins.
- chemical , therapeutic use : Antimalarials, Artemisinins.
- drug therapy : Malaria.
- Drug Therapy, Combination, Humans.
Abstract
This meeting report presents the key findings and discussion points of a 1-day meeting entitled 'Fake anti-malarials: start with the facts' held on 28th May 2015, in Geneva, Switzerland, to disseminate the findings of the artemisinin combination therapy consortium's drug quality programme. The teams purchased over 10,000 samples, using representative sampling approaches, from six malaria endemic countries: Equatorial Guinea (Bioko Island), Cambodia, Ghana, Nigeria, Rwanda and Tanzania. Laboratory analyses of these samples showed that falsified anti-malarials (<8 %) were found in just two of the countries, whilst substandard artemisinin-based combinations were present in all six countries and, artemisinin-based monotherapy tablets are still available in some places despite the fact that the WHO has urged regulatory authorities in malaria-endemic countries to take measures to halt the production and marketing of these oral monotherapies since 2007. This report summarizes the presentations that reviewed the public health impact of falsified and substandard drugs, sampling strategies, techniques for drug quality analysis, approaches to strengthen health systems capacity for the surveillance of drug quality, and the ensuing discussion points from the dissemination meeting.
DOI: 10.1186/s12936-016-1096-x
PubMed: 26873700
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pubmed:26873700Le document en format XML
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Sian.Clarke@lshtm.ac.uk.</nlm:affiliation></affiliation></author><author><name sortKey="Lalani, Mirza" sort="Lalani, Mirza" uniqKey="Lalani M" first="Mirza" last="Lalani">Mirza Lalani</name><affiliation><nlm:affiliation>London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK. mirza.lalani@lshtm.ac.uk.</nlm:affiliation></affiliation></author><author><name sortKey="Phanouvong, Souly" sort="Phanouvong, Souly" uniqKey="Phanouvong S" first="Souly" last="Phanouvong">Souly Phanouvong</name><affiliation><nlm:affiliation>Promoting the Quality of Medicines Program, U.S. Pharmacopeial Convention, Rockville, MD, USA. sxp@usp.org.</nlm:affiliation></affiliation></author><author><name sortKey="Guerin, Philippe" sort="Guerin, Philippe" uniqKey="Guerin P" first="Philippe" last="Guérin">Philippe Guérin</name><affiliation><nlm:affiliation>Worldwide Antimalarial Resistance Network (WWARN), University of Oxford, Oxford, UK. Philippe.Guerin@wwarn.org.</nlm:affiliation></affiliation></author><author><name sortKey="Mcloughlin, Andrew" sort="Mcloughlin, Andrew" uniqKey="Mcloughlin A" first="Andrew" last="Mcloughlin">Andrew Mcloughlin</name><affiliation><nlm:affiliation>The Global Fund to Fight Aids, Tuberculosis and Malaria, Geneva, Switzerland. Andrew.McLoughlin@theglobalfund.org.</nlm:affiliation></affiliation></author><author><name sortKey="Wilson, Benjamin K" sort="Wilson, Benjamin K" uniqKey="Wilson B" first="Benjamin K" last="Wilson">Benjamin K. 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David.Schellenberg@lshtm.ac.uk.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2016">2016</date><idno type="RBID">pubmed:26873700</idno><idno type="pmid">26873700</idno><idno type="doi">10.1186/s12936-016-1096-x</idno><idno type="wicri:Area/PubMed/Corpus">000883</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000883</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Fake anti-malarials: start with the facts.</title><author><name sortKey="Kaur, Harparkash" sort="Kaur, Harparkash" uniqKey="Kaur H" first="Harparkash" last="Kaur">Harparkash Kaur</name><affiliation><nlm:affiliation>London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK. Harparkash.kaur@lshtm.ac.uk.</nlm:affiliation></affiliation></author><author><name sortKey="Clarke, Si N" sort="Clarke, Si N" uniqKey="Clarke S" first="Si N" last="Clarke">Si N Clarke</name><affiliation><nlm:affiliation>London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK. Sian.Clarke@lshtm.ac.uk.</nlm:affiliation></affiliation></author><author><name sortKey="Lalani, Mirza" sort="Lalani, Mirza" uniqKey="Lalani M" first="Mirza" last="Lalani">Mirza Lalani</name><affiliation><nlm:affiliation>London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK. mirza.lalani@lshtm.ac.uk.</nlm:affiliation></affiliation></author><author><name sortKey="Phanouvong, Souly" sort="Phanouvong, Souly" uniqKey="Phanouvong S" first="Souly" last="Phanouvong">Souly Phanouvong</name><affiliation><nlm:affiliation>Promoting the Quality of Medicines Program, U.S. Pharmacopeial Convention, Rockville, MD, USA. sxp@usp.org.</nlm:affiliation></affiliation></author><author><name sortKey="Guerin, Philippe" sort="Guerin, Philippe" uniqKey="Guerin P" first="Philippe" last="Guérin">Philippe Guérin</name><affiliation><nlm:affiliation>Worldwide Antimalarial Resistance Network (WWARN), University of Oxford, Oxford, UK. Philippe.Guerin@wwarn.org.</nlm:affiliation></affiliation></author><author><name sortKey="Mcloughlin, Andrew" sort="Mcloughlin, Andrew" uniqKey="Mcloughlin A" first="Andrew" last="Mcloughlin">Andrew Mcloughlin</name><affiliation><nlm:affiliation>The Global Fund to Fight Aids, Tuberculosis and Malaria, Geneva, Switzerland. Andrew.McLoughlin@theglobalfund.org.</nlm:affiliation></affiliation></author><author><name sortKey="Wilson, Benjamin K" sort="Wilson, Benjamin K" uniqKey="Wilson B" first="Benjamin K" last="Wilson">Benjamin K. Wilson</name><affiliation><nlm:affiliation>Intellectual Ventures Laboratory, Bellevue, WA, USA. bwilson@intven.com.</nlm:affiliation></affiliation></author><author><name sortKey="Deats, Michael" sort="Deats, Michael" uniqKey="Deats M" first="Michael" last="Deats">Michael Deats</name><affiliation><nlm:affiliation>SSFFC Surveillance and Monitoring, Safety and Vigilance, Essential Medicines and Health Products, World Health Organization, Geneva, Switzerland. deatsm@who.int.</nlm:affiliation></affiliation></author><author><name sortKey="Plancon, Aline" sort="Plancon, Aline" uniqKey="Plancon A" first="Aline" last="Plançon">Aline Plançon</name><affiliation><nlm:affiliation>Medical Product Counterfeiting and Pharmaceutical Crime Sub-Directorate, INTERPOL, Lyon, France. a.plancon@interpol.int.</nlm:affiliation></affiliation></author><author><name sortKey="Hopkins, Heidi" sort="Hopkins, Heidi" uniqKey="Hopkins H" first="Heidi" last="Hopkins">Heidi Hopkins</name><affiliation><nlm:affiliation>London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK. Heidi.Hopkins@lshtm.ac.uk.</nlm:affiliation></affiliation></author><author><name sortKey="Miranda, Debora" sort="Miranda, Debora" uniqKey="Miranda D" first="Debora" last="Miranda">Debora Miranda</name><affiliation><nlm:affiliation>London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK. Debora.Miranda@lshtm.ac.uk.</nlm:affiliation></affiliation></author><author><name sortKey="Schellenberg, David" sort="Schellenberg, David" uniqKey="Schellenberg D" first="David" last="Schellenberg">David Schellenberg</name><affiliation><nlm:affiliation>London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK. David.Schellenberg@lshtm.ac.uk.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Malaria journal</title><idno type="eISSN">1475-2875</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antimalarials (standards)</term><term>Antimalarials (therapeutic use)</term><term>Artemisinins (standards)</term><term>Artemisinins (therapeutic use)</term><term>Drug Therapy, Combination</term><term>Humans</term><term>Malaria (drug therapy)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="standards" xml:lang="en"><term>Antimalarials</term><term>Artemisinins</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antimalarials</term><term>Artemisinins</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Malaria</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Drug Therapy, Combination</term><term>Humans</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">This meeting report presents the key findings and discussion points of a 1-day meeting entitled 'Fake anti-malarials: start with the facts' held on 28th May 2015, in Geneva, Switzerland, to disseminate the findings of the artemisinin combination therapy consortium's drug quality programme. The teams purchased over 10,000 samples, using representative sampling approaches, from six malaria endemic countries: Equatorial Guinea (Bioko Island), Cambodia, Ghana, Nigeria, Rwanda and Tanzania. Laboratory analyses of these samples showed that falsified anti-malarials (<8 %) were found in just two of the countries, whilst substandard artemisinin-based combinations were present in all six countries and, artemisinin-based monotherapy tablets are still available in some places despite the fact that the WHO has urged regulatory authorities in malaria-endemic countries to take measures to halt the production and marketing of these oral monotherapies since 2007. This report summarizes the presentations that reviewed the public health impact of falsified and substandard drugs, sampling strategies, techniques for drug quality analysis, approaches to strengthen health systems capacity for the surveillance of drug quality, and the ensuing discussion points from the dissemination meeting.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26873700</PMID><DateCreated><Year>2016</Year><Month>02</Month><Day>13</Day></DateCreated><DateCompleted><Year>2016</Year><Month>12</Month><Day>13</Day></DateCompleted><DateRevised><Year>2017</Year><Month>09</Month><Day>02</Day></DateRevised><Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">1475-2875</ISSN><JournalIssue CitedMedium="Internet"><Volume>15</Volume><PubDate><Year>2016</Year><Month>Feb</Month><Day>13</Day></PubDate></JournalIssue><Title>Malaria journal</Title><ISOAbbreviation>Malar. J.</ISOAbbreviation></Journal><ArticleTitle>Fake anti-malarials: start with the facts.</ArticleTitle><Pagination><MedlinePgn>86</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1186/s12936-016-1096-x</ELocationID><Abstract><AbstractText>This meeting report presents the key findings and discussion points of a 1-day meeting entitled 'Fake anti-malarials: start with the facts' held on 28th May 2015, in Geneva, Switzerland, to disseminate the findings of the artemisinin combination therapy consortium's drug quality programme. The teams purchased over 10,000 samples, using representative sampling approaches, from six malaria endemic countries: Equatorial Guinea (Bioko Island), Cambodia, Ghana, Nigeria, Rwanda and Tanzania. Laboratory analyses of these samples showed that falsified anti-malarials (<8 %) were found in just two of the countries, whilst substandard artemisinin-based combinations were present in all six countries and, artemisinin-based monotherapy tablets are still available in some places despite the fact that the WHO has urged regulatory authorities in malaria-endemic countries to take measures to halt the production and marketing of these oral monotherapies since 2007. This report summarizes the presentations that reviewed the public health impact of falsified and substandard drugs, sampling strategies, techniques for drug quality analysis, approaches to strengthen health systems capacity for the surveillance of drug quality, and the ensuing discussion points from the dissemination meeting.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Kaur</LastName><ForeName>Harparkash</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK. Harparkash.kaur@lshtm.ac.uk.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Clarke</LastName><ForeName>Siȃn</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK. Sian.Clarke@lshtm.ac.uk.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lalani</LastName><ForeName>Mirza</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK. mirza.lalani@lshtm.ac.uk.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Phanouvong</LastName><ForeName>Souly</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Promoting the Quality of Medicines Program, U.S. Pharmacopeial Convention, Rockville, MD, USA. sxp@usp.org.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Guérin</LastName><ForeName>Philippe</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Worldwide Antimalarial Resistance Network (WWARN), University of Oxford, Oxford, UK. Philippe.Guerin@wwarn.org.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK. Philippe.Guerin@wwarn.org.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>McLoughlin</LastName><ForeName>Andrew</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>The Global Fund to Fight Aids, Tuberculosis and Malaria, Geneva, Switzerland. Andrew.McLoughlin@theglobalfund.org.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wilson</LastName><ForeName>Benjamin K</ForeName><Initials>BK</Initials><AffiliationInfo><Affiliation>Intellectual Ventures Laboratory, Bellevue, WA, USA. bwilson@intven.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Deats</LastName><ForeName>Michael</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>SSFFC Surveillance and Monitoring, Safety and Vigilance, Essential Medicines and Health Products, World Health Organization, Geneva, Switzerland. deatsm@who.int.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Plançon</LastName><ForeName>Aline</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Medical Product Counterfeiting and Pharmaceutical Crime Sub-Directorate, INTERPOL, Lyon, France. a.plancon@interpol.int.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hopkins</LastName><ForeName>Heidi</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK. Heidi.Hopkins@lshtm.ac.uk.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Miranda</LastName><ForeName>Debora</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK. Debora.Miranda@lshtm.ac.uk.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Schellenberg</LastName><ForeName>David</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>London School of Hygiene and Tropical Medicine, London, WC1E 7HT, UK. David.Schellenberg@lshtm.ac.uk.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><GrantList CompleteYN="Y"><Grant><GrantID>WHO_001</GrantID><Agency>World Health Organization</Agency><Country>International</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2016</Year><Month>02</Month><Day>13</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Malar J</MedlineTA><NlmUniqueID>101139802</NlmUniqueID><ISSNLinking>1475-2875</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000962">Antimalarials</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D037621">Artemisinins</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>Am J Trop Med Hyg. 2015 Jun;92(6 Suppl):75-86</RefSource><PMID Version="1">25897065</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Lancet. 2001 Jun 16;357(9272):1948-50</RefSource><PMID Version="1">11425421</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Pharm World Sci. 2004 Dec;26(6):333-8</RefSource><PMID Version="1">15683103</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Anal Chim Acta. 2008 Aug 15;623(2):178-86</RefSource><PMID Version="1">18620922</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>PLoS Med. 2009 Mar 24;6(3):e52</RefSource><PMID Version="1">19320538</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Postgrad Med J. 2009 May;85(1003):251-6</RefSource><PMID Version="1">19520877</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Soc Sci Med. 2001 Feb;52(3):393-404</RefSource><PMID Version="1">11330774</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Anal Bioanal Chem. 2010 Sep;398(1):77-92</RefSource><PMID Version="1">20437031</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Lancet Infect Dis. 2012 Jun;12(6):488-96</RefSource><PMID Version="1">22632187</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>BMJ. 2012;345:e7381</RefSource><PMID Version="1">23149211</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Malar J. 2014;13:139</RefSource><PMID Version="1">24712972</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>PLoS One. 2015;10(5):e0125577</RefSource><PMID Version="1">26018221</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Am J Trop Med Hyg. 2015 Jun;92(6 Suppl):39-50</RefSource><PMID Version="1">25897063</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Nat Rev Microbiol. 2010 Apr;8(4):272-80</RefSource><PMID Version="1">20208550</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName UI="D000962" MajorTopicYN="N">Antimalarials</DescriptorName><QualifierName UI="Q000592" MajorTopicYN="Y">standards</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D037621" MajorTopicYN="N">Artemisinins</DescriptorName><QualifierName UI="Q000592" MajorTopicYN="N">standards</QualifierName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004359" MajorTopicYN="N">Drug Therapy, Combination</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" 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