title: Assessing the quality of anti-malarial drugs from Gabonese pharmacies using the MiniLab®: a field study.
abstract: BACKGROUND
  Recent studies alluded to the alarming scale of poor anti-malarial drug quality in malaria-endemic countries, but also illustrated the major geographical gaps in data on anti-malarial drug quality from endemic countries. Data are particularly scarce from Central Africa, although it carries the highest burden of malaria. The aim of this medicine quality field survey was to determine the prevalence of poor-quality anti-malarial drugs in Gabon.
  
  
  METHODS
  A field survey of the quality of anti-malarial drugs in Gabonese pharmacies was conducted using the Global Pharma Health Fund Minilab(®) tests, following the Medicine Quality Assessment Reporting Guidelines. Anti-malarial drugs were purchased randomly from selected pharmacies in Gabon. Semi-quantitative thin-layer chromatography (TLC) and disintegration testing were carried out to measure the concentration of active pharmaceutical ingredients (APIs). The samples failing the TLC test were analysed by high-performance liquid chromatography. Following the collection of anti-malarial drugs, a street survey was conducted to understand where people purchase their anti-malarial drugs.
  
  
  RESULTS
  A total of 432 samples were purchased from 41 pharmacies in 11 cities/towns in Gabon. The prevalence of poor-quality anti-malarial drugs was 0.5% (95% CI 0.08-1.84%). Two out of 432 samples failed the MiniLab(®) semi-quantitative TLC test, of which a suspected artemether-lumefantrine (AL) sample was classified as falsified and one sulfadoxine-pyrimethamine (SP) sample as substandard. High performance liquid chromatography with ultraviolet photo diode array detection analysis confirmed the absence of APIs in the AL sample, and showed that the SP sample did contain the stated APIs but the amount was half the stated dose. Of the people interviewed, 92% (187/203) purchased their anti-malarial drugs at a pharmacy.
  
  
  CONCLUSIONS
  Using the GPHF Minilab(®), the prevalence of poor-quality anti-malarial drugs is far lower than anticipated. The findings emphasize the need for randomized and robust sampling methods in order to collect representative data on anti-malarial drug quality.
  
  
  BACKGROUND
  NTR4341 (Dutch Trial Registry).
authors.affiliation: Division of Internal Medicine, Department of Infectious Diseases, Center of Tropical Medicine and Travel Medicine, Academic Medical Center, University of Amsterdam, Meibergdreef 9, PO Box 22700, 1100 DE, Amsterdam, The Netherlands. b.j.visser@amc.uva.nl.|Centre de Recherches de Médicales de Lambaréné (CERMEL), Albert Schweitzer Hospital, Lambaréné, Gabon. b.j.visser@amc.uva.nl.|Institute of Tropical Medicine, University of Tübingen, Tübingen, Germany. b.j.visser@amc.uva.nl.
authors.forename: Benjamin J
authors.initials: BJ
authors.lastname: Visser
authors.affiliation: Division of Internal Medicine, Department of Infectious Diseases, Center of Tropical Medicine and Travel Medicine, Academic Medical Center, University of Amsterdam, Meibergdreef 9, PO Box 22700, 1100 DE, Amsterdam, The Netherlands. j.gerrits1@students.uu.nl.|Department of Pharmaceutical Technology and Biopharmacy, Utrecht University, Utrecht, The Netherlands. j.gerrits1@students.uu.nl.
authors.forename: Janneke
authors.initials: J
authors.lastname: Meerveld-Gerrits
authors.affiliation: Division of Internal Medicine, Department of Infectious Diseases, Center of Tropical Medicine and Travel Medicine, Academic Medical Center, University of Amsterdam, Meibergdreef 9, PO Box 22700, 1100 DE, Amsterdam, The Netherlands. d.kroon@amc.uva.nl.|Centre de Recherches de Médicales de Lambaréné (CERMEL), Albert Schweitzer Hospital, Lambaréné, Gabon. d.kroon@amc.uva.nl.
authors.forename: Daniëlle
authors.initials: D
authors.lastname: Kroon
authors.affiliation: Centre de Recherches de Médicales de Lambaréné (CERMEL), Albert Schweitzer Hospital, Lambaréné, Gabon. judechrist1978@gmail.com.
authors.forename: Judith
authors.initials: J
authors.lastname: Mougoula
authors.affiliation: Division of Internal Medicine, Department of Infectious Diseases, Center of Tropical Medicine and Travel Medicine, Academic Medical Center, University of Amsterdam, Meibergdreef 9, PO Box 22700, 1100 DE, Amsterdam, The Netherlands. m.l.vingerling@amc.uva.nl.|Centre de Recherches de Médicales de Lambaréné (CERMEL), Albert Schweitzer Hospital, Lambaréné, Gabon. m.l.vingerling@amc.uva.nl.
authors.forename: Rieke
authors.initials: R
authors.lastname: Vingerling
authors.affiliation: Centre de Recherches de Médicales de Lambaréné (CERMEL), Albert Schweitzer Hospital, Lambaréné, Gabon. emmanuel.bache@lambarene.org.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Bache
authors.affiliation: Division of Internal Medicine, Department of Infectious Diseases, Center of Tropical Medicine and Travel Medicine, Academic Medical Center, University of Amsterdam, Meibergdreef 9, PO Box 22700, 1100 DE, Amsterdam, The Netherlands. jimmyboersma@gmail.com.
authors.forename: Jimmy
authors.initials: J
authors.lastname: Boersma
authors.affiliation: Division of Internal Medicine, Department of Infectious Diseases, Center of Tropical Medicine and Travel Medicine, Academic Medical Center, University of Amsterdam, Meibergdreef 9, PO Box 22700, 1100 DE, Amsterdam, The Netherlands. m.vanvugt@amc.uva.nl.
authors.forename: Michèle
authors.initials: M
authors.lastname: van Vugt
authors.affiliation: Centre de Recherches de Médicales de Lambaréné (CERMEL), Albert Schweitzer Hospital, Lambaréné, Gabon. agnandjis@lambarene.org.|Institute of Tropical Medicine, University of Tübingen, Tübingen, Germany. agnandjis@lambarene.org.
authors.forename: Selidji T
authors.initials: ST
authors.lastname: Agnandji
authors.affiliation: Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, UK. harparkash.kaur@lshtm.ac.uk.
authors.forename: Harparkash
authors.initials: H
authors.lastname: Kaur
authors.affiliation: Division of Internal Medicine, Department of Infectious Diseases, Center of Tropical Medicine and Travel Medicine, Academic Medical Center, University of Amsterdam, Meibergdreef 9, PO Box 22700, 1100 DE, Amsterdam, The Netherlands. m.p.grobusch@amc.uva.nl.|Centre de Recherches de Médicales de Lambaréné (CERMEL), Albert Schweitzer Hospital, Lambaréné, Gabon. m.p.grobusch@amc.uva.nl.|Institute of Tropical Medicine, University of Tübingen, Tübingen, Germany. m.p.grobusch@amc.uva.nl.
authors.forename: Martin P
authors.initials: MP
authors.lastname: Grobusch
mesh_terms: D000962:Antimalarials / Q000032:analysis* / Q000592:standards; D002851:Chromatography, High Pressure Liquid; D002855:Chromatography, Thin Layer; D005681:Gabon; D010594:Pharmacies; D011786:Quality Control
chemical_list: D000962:Antimalarials