title: Poor quality vital anti-malarials in Africa - an urgent neglected public health priority.
abstract: BACKGROUND
  Plasmodium falciparum malaria remains a major public health problem. A vital component of malaria control rests on the availability of good quality artemisinin-derivative based combination therapy (ACT) at the correct dose. However, there are increasing reports of poor quality anti-malarials in Africa.
  
  
  METHODS
  Seven collections of artemisinin derivative monotherapies, ACT and halofantrine anti-malarials of suspicious quality were collected in 2002/10 in eleven African countries and in Asia en route to Africa. Packaging, chemical composition (high performance liquid chromatography, direct ionization mass spectrometry, X-ray diffractometry, stable isotope analysis) and botanical investigations were performed.
  
  
  RESULTS
  Counterfeit artesunate containing chloroquine, counterfeit dihydroartemisinin (DHA) containing paracetamol (acetaminophen), counterfeit DHA-piperaquine containing sildenafil, counterfeit artemether-lumefantrine containing pyrimethamine, counterfeit halofantrine containing artemisinin, and substandard/counterfeit or degraded artesunate and artesunate+amodiaquine in eight countries are described. Pollen analysis was consistent with manufacture of counterfeits in eastern Asia. These data do not allow estimation of the frequency of poor quality anti-malarials in Africa.
  
  
  CONCLUSIONS
  Criminals are producing diverse harmful anti-malarial counterfeits with important public health consequences. The presence of artesunate monotherapy, substandard and/or degraded and counterfeit medicines containing sub-therapeutic amounts of unexpected anti-malarials will engender drug resistance. With the threatening spread of artemisinin resistance to Africa, much greater investment is required to ensure the quality of ACTs and removal of artemisinin monotherapies. The International Health Regulations may need to be invoked to counter these serious public health problems.
authors.affiliation: Wellcome Trust-Mahosot Hospital-Oxford University Tropical Medicine Research Collaboration, Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao PDR. paul@tropmedres.ac
authors.forename: Paul N
authors.initials: PN
authors.lastname: Newton
authors.forename: Michael D
authors.initials: MD
authors.lastname: Green
authors.forename: Dallas C
authors.initials: DC
authors.lastname: Mildenhall
authors.forename: Aline
authors.initials: A
authors.lastname: Plançon
authors.forename: Henry
authors.initials: H
authors.lastname: Nettey
authors.forename: Leonard
authors.initials: L
authors.lastname: Nyadong
authors.forename: Dana M
authors.initials: DM
authors.lastname: Hostetler
authors.forename: Isabel
authors.initials: I
authors.lastname: Swamidoss
authors.forename: Glenn A
authors.initials: GA
authors.lastname: Harris
authors.forename: Kristen
authors.initials: K
authors.lastname: Powell
authors.forename: Ans E
authors.initials: AE
authors.lastname: Timmermans
authors.forename: Abdinasir A
authors.initials: AA
authors.lastname: Amin
authors.forename: Stephen K
authors.initials: SK
authors.lastname: Opuni
authors.forename: Serge
authors.initials: S
authors.lastname: Barbereau
authors.forename: Claude
authors.initials: C
authors.lastname: Faurant
authors.forename: Ray C W
authors.initials: RC
authors.lastname: Soong
authors.forename: Kevin
authors.initials: K
authors.lastname: Faure
authors.forename: Jonarthan
authors.initials: J
authors.lastname: Thevanayagam
authors.forename: Peter
authors.initials: P
authors.lastname: Fernandes
authors.forename: Harparkash
authors.initials: H
authors.lastname: Kaur
authors.forename: Brian
authors.initials: B
authors.lastname: Angus
authors.forename: Kasia
authors.initials: K
authors.lastname: Stepniewska
authors.forename: Philippe J
authors.initials: PJ
authors.lastname: Guerin
authors.forename: Facundo M
authors.initials: FM
authors.lastname: Fernández
mesh_terms: D000349:Africa; D000962:Antimalarials / Q000737:chemistry* / Q000600:supply & distribution*; D037621:Artemisinins / Q000737:chemistry* / Q000600:supply & distribution*; D001208:Asia; D002623:Chemistry Techniques, Analytical / Q000379:methods; D058110:Counterfeit Drugs / Q000737:chemistry* / Q000600:supply & distribution*; D004349:Drug Packaging / Q000706:statistics & numerical data; D006801:Humans; D007783:Lactones / Q000737:chemistry* / Q000600:supply & distribution*; D011787:Quality of Health Care / Q000706:statistics & numerical data*
chemical_list: D000962:Antimalarials; D037621:Artemisinins; D058110:Counterfeit Drugs; D007783:Lactones; C075875:artemisin