A Repeat Random Survey of the Prevalence of Falsified and Substandard Antimalarials in the Lao PDR: A Change for the Better

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. Fil: Tabernero, Patricia. Lao Oxford Mahosot Hospital; China Fil: Mayxay, Mayfong. University of Oxford; Reino Unido Fil: Culzoni, Maria Julia. Universidad Nacional del Litoral. Facultad de Bioquímica y Ciencias Biológicas; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Santa Fe; Argentina Fil: Dwivedi, Prabha. University Of Heath Sciences; China Fil: Swamidoss, Isabel. U.S. Centers for Disease Control and Prevention; Estados Unidos Fil: Allan, Elizabeth Louise. Georgia Institute of Techology; Estados Unidos Fil: Khanthavong, Maniphone. U.S. Centers for Disease Control and Prevention; Estados Unidos Fil: Phonlavong, Chindaphone. U.S. Centers for Disease Control and Prevention; Estados Unidos Fil: Vilayhong, Chantala. Centre of Malariology, Parasitology and Entomology; China Fil: Yeuchaixiong, Sengchanh. Centre of Malariology, Parasitology and Entomology; China Fil: Sichanh, Chanvilay. Bureau of Food and Drug Inspection; China Fil: Sengaloundeth, Sivong. Food and Drug Department; China Fil: Kaur, Harparkash. University of London; Reino Unido Fil: Fernandez, Facundo M.. Georgia Institute of Techology; Estados Unidos Fil: Green, Michael D.. National Center for Infectious Diseases; Estados Unidos Fil: Newton, Paul N.. University of Oxford; Reino Unido