title: A Repeat Random Survey of the Prevalence of Falsified and Substandard Antimalarials in the Lao PDR: A Change for the Better.
abstract: In 2003, a stratified random sample survey was conducted in the Lao People's Democratic Republic (Laos) to study the availability and quality of antimalarials in the private sector. In 2012, this survey was repeated to allow a statistically valid analysis of change through time. The counterfeit detection device 3 (CD-3) was used to assess packaging quality in the field and HPLC and mass spectroscopy analysis chemical analysis performed. The availability of oral artesunate monotherapies had significantly decreased from 22.9% (22) of 96 outlets in southern Laos in 2003 to 4.8% (7) of 144 outlets in 2012 (P < 0.0001). All the samples collected in the 2012 survey contained the correct active pharmaceutical ingredients (APIs) in contrast to the 21 (84%) falsified artesunate samples found in the 2003 survey. Although none of the medicines found in 2012 survey had evidence for falsification, 25.4% (37) of the samples were outside the 90-110% pharmacopeial limits of the label claim, suggesting that they were substandard or degraded. Results obtained from this survey show that patients are still exposed to poorly manufactured drugs or to ineffective medicines such as chloroquine. The quality of artemisinin-based combination therapies (ACTs) used in Laos needs to be monitored, since falsified ACTs would have devastating consequences in public health.
authors.forename: Patricia
authors.initials: P
authors.lastname: Tabernero
authors.forename: Mayfong
authors.initials: M
authors.lastname: Mayxay
authors.forename: María Julia
authors.initials: MJ
authors.lastname: Culzoni
authors.forename: Prabha
authors.initials: P
authors.lastname: Dwivedi
authors.forename: Isabel
authors.initials: I
authors.lastname: Swamidoss
authors.forename: Elizabeth Louise
authors.initials: EL
authors.lastname: Allan
authors.forename: Maniphone
authors.initials: M
authors.lastname: Khanthavong
authors.forename: Chindaphone
authors.initials: C
authors.lastname: Phonlavong
authors.forename: Chantala
authors.initials: C
authors.lastname: Vilayhong
authors.forename: Sengchanh
authors.initials: S
authors.lastname: Yeuchaixiong
authors.forename: Chanvilay
authors.initials: C
authors.lastname: Sichanh
authors.forename: Sivong
authors.initials: S
authors.lastname: Sengaloundeth
authors.forename: Harparkash
authors.initials: H
authors.lastname: Kaur
authors.forename: Facundo M
authors.initials: FM
authors.lastname: Fernández
authors.forename: Michael D
authors.initials: MD
authors.lastname: Green
authors.forename: Paul N
authors.initials: PN
authors.lastname: Newton
mesh_terms: D000962:Antimalarials / Q000191:economics* / Q000592:standards*; D058110:Counterfeit Drugs; D003430:Cross-Sectional Studies; D004349:Drug Packaging; D007812:Laos; D007880:Legislation, Drug; D013607:Tablets
chemical_list: D000962:Antimalarials; D058110:Counterfeit Drugs; D013607:Tablets