title: Strengthening of national capacity in implementation of antimalarial drug quality assurance in Thailand.
abstract: Substandard and counterfeit pharmaceutical products, including antimalarial drugs, appear to be widespread internationally and affect both the developing and developed countries. The aim of the study was to investigate the quality of antimalarial drugs, ie, artesunate (ART), chloroquine (CHL), mefloquine (MEF), quinine (QUI), sulfadoxine/pyrimethamine (S/P) and tetracycline (TT) obtained from the government sector and private pharmacies in 4 Thai provinces: Mae Hong Son, Kanchanaburi, Ranong, and Chanthaburi. Three hundred sixty-nine samples of 6 antimalarial drugs from 27 government hospitals, 27 malaria clinics, and 53 drugstores, were collected. Drug quality was assessed by simple disintegration test and semi-quantitative thin-layer chromatography in each province; 10% passed, 100% failed and doubtful samples were sent to be verified by high performance liquid chromatography (HPLC) at the Thai National Drug Analysis Laboratory, (NL). Fifteen point four percent of ART, 11.1% of CHL and 29.4% of QUI were substandard. Based on the finding, drug regulatory authorities in the country took appropriate action against violators to ensure that antimalarial drugs consumed by malaria patients are of good quality.
authors.affiliation: Department of Disease Control, Ministry of Public Health, Thailand. saowanit@health.moph.go.th
authors.forename: Saowanit
authors.initials: S
authors.lastname: Vijaykadga
authors.forename: Sawat
authors.initials: S
authors.lastname: Cholpol
authors.forename: Saipin
authors.initials: S
authors.lastname: Sitthimongkol
authors.forename: Anusorn
authors.initials: A
authors.lastname: Pawaphutanan
authors.forename: Arunya
authors.initials: A
authors.lastname: Pinyoratanachot
authors.forename: Chaiporn
authors.initials: C
authors.lastname: Rojanawatsirivet
authors.forename: Rojana
authors.initials: R
authors.lastname: Kovithvattanapong
authors.forename: Krongthong
authors.initials: K
authors.lastname: Thimasarn
mesh_terms: D000962:Antimalarials / Q000592:standards*; D005607:Fraud; D006801:Humans; D008288:Malaria / Q000188:drug therapy*; D011358:Product Surveillance, Postmarketing; D011786:Quality Control; D012449:Safety; D013785:Thailand
chemical_list: D000962:Antimalarials