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.

Fingerprinting of falsified artemisinin combination therapies via direct analysis in real time coupled to a compact single quadrupole mass spectrometer

“…[4][5][6] This is especially a problem in developing regions, where there is a profound disease burden but little to no oversight in the monitoring of medical products. [7][8][9][10][11] For example, many of the treatment problems are centered in sub-Saharan Africa, which in 2015 was the location of 88% of all malaria cases and 90% of malaria deaths. 1 In most of Africa, the commonly distributed ACT is co-formulated oral artemether and lumefantrine, which has been the latest target of criminal counterfeiters.…”

Anti-malarial medicine quality field studies and surveys: a systematic review of screening technologies used and reporting of findings

“…Nevertheless, reporting of storage conditions after collection was generally poor; only 4/39 (10%) studies stated maintaining appropriate storage conditions during transit from the outlet to the laboratory and less than half (15/39 (39%)) reported storage conditions in the laboratory prior to analysis [30, 65, 67, 69]. The scale of the surveys and number of samples analysed varied substantially between studies.…”

“…Of the included studies, only 7/39 (18%) [36, 50, 51, 65, 67, 69, 72] undertook a statistical analysis presenting their results with p values or confidence intervals.…”

“…Of the remaining 24 studies, 10 provided an account of limitations specifically relevant to the type of screening test used, of which, five studies included a discussion of the disparity between results from screening and confirmatory tests [5, 28, 29, 34, 65, 67, 69, 71, 74, 75]. …”

Tackling Substandard and Falsified Medicines in the Mekong: National Responses and Regional Prospects

“…Recent studies suggest that the prevalence of falsified medicines in the Mekong has decreased; however, the circulation of substandard medicines persists and key challenges remain (Tabernero et al. ; Yeung et al. ).…”