title: Substandard antimalarials available in Afghanistan: a case for assessing the quality of drugs in resource poor settings.
abstract: Good-quality antimalarials are crucial for the effective treatment and control of malaria. A total of 7,740 individual and packaged tablets, ampoules, and syrups were obtained from 60 randomly selected public (N = 35) and private outlets (N = 25) in Afghanistan. Of these, 134 samples were screened using the Global Pharma Health Fund (GPHF) MiniLab® in Kabul with 33/126 (26%) samples failing the MiniLab® disintegration test. The quality of a subsample (N = 37) of cholorquine, quinine, and sulfadoxine/pyrimethamine tablets was assessed by in vitro dissolution testing following U.S. Pharmacopeia (USP) monographs at a bioanalytical laboratory in London, United Kingdom. Overall, 12/32 (32%) samples of sulfadoxine/pyrimethamine and quinine were found not to comply with the USP tolerance limits. Substandard antimalarials were available in Afghanistan demonstrating that continuous monitoring of drug quality is warranted. However, in Afghanistan as in many low-income countries, capacity to determine and monitor drug quality using methods such as dissolution testing needs to be established to empower national authorities to take appropriate action in setting up legislation and regulation.
authors.forename: Mirza
authors.initials: M
authors.lastname: Lalani
authors.forename: Harparkash
authors.initials: H
authors.lastname: Kaur
authors.forename: Nader
authors.initials: N
authors.lastname: Mohammed
authors.forename: Naiela
authors.initials: N
authors.lastname: Mailk
authors.forename: Albert van
authors.initials: AV
authors.lastname: Wyk
authors.forename: Sakhi
authors.initials: S
authors.lastname: Jan
authors.forename: Rishtya Meena
authors.initials: RM
authors.lastname: Kakar
authors.forename: Mohammed Khalid
authors.initials: MK
authors.lastname: Mojadidi
authors.forename: Toby
authors.initials: T
authors.lastname: Leslie
mesh_terms: D000346:Afghanistan; D000962:Antimalarials / Q000737:chemistry* / Q000592:standards*; D058110:Counterfeit Drugs / Q000737:chemistry*; D003906:Developing Countries; D004304:Dosage Forms; D065546:Drug Liberation; D007880:Legislation, Drug; D011203:Poverty; D011786:Quality Control
chemical_list: D000962:Antimalarials; D058110:Counterfeit Drugs; D004304:Dosage Forms