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

The American Society of Tropical Medicine and Hygiene., 2015; 15: 0057
Authors:
Tabernero P, Mayxay M, Culzoni MJ, Dwivedi P, Swamidoss I, Allan EL, Khanthavong M, Phonlavong C, Vilayhong C, Yeuchaixiong S, Sichanh C, Sengaloundeth S, Kaur H, Fernández FM, Green MD, Newton PN.
Doi: 10.4269/ajtmh.15-0057  PMID: 25897062

In 2003, a stratified random sample survey was conducted in the Lao People's Democratic Republic (Laos) to study the availability and quality ofantimalarials 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. 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 2012survey contained the correct active pharmaceutical ingredients (APIs) in contrast to the 21 (84%) falsified artesunate samples found in the 2003survey. 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.