Quality of Antimalarials at the Epicenter of Antimalarial Drug Resistance: Results from an Overt and Mystery Client Survey in Cambodia

Abstract

Widespread availability of monotherapies and falsified antimalarials is thought to have contributed to the historical development of multidrug-resistant malaria in Cambodia. This study aimed to document the quality of artemisinin-containing antimalarials (ACAs) and to compare two methods of collecting antimalarials from drug outlets: through open surveyors and mystery clients (MCs). Few oral artemisinin-based monotherapies and no suspected falsified medicines were found. All 291 samples contained the stated active pharmaceutical ingredient (API) of which 69% were considered good quality by chemical analysis. Overall, medicine quality did not differ by collection method, although open surveyors were less likely to obtain oral artemisinin-based monotherapies than MCs. The results are an encouraging indication of the positive impact of the country's efforts to tackle falsified antimalarials and artemisinin-based monotherapies. However, poor-quality medicines remain an ongoing challenge that demands sustained political will and investment of human and financial resources.

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 the Problems Associated with Antimalarial Medicines of Poor Quality

“…One recent study used mystery shoppers and overt surveys to identify the quality of antimalarials in Cambodia [12]. Of 291 samples tested, 31.3% did not contain an appropriate amount of the "PI, i.e., the "PI content was not within the 85 115% range when measured by high performance liquid chromatography, and the samples were therefore considered to be of poor quality.…”

“…In many developing countries, for example, irst-line artemisinin-based combination therapy "CT) cannot be aforded by many patients [4,5]. Consequently, patients tend to procure cheaper alternatives that may be falsiied or substandard and that may contain subtherapeutic amounts of the active pharmaceutical ingredients "PIs) or only one of the two active ingredients of the "CT [2,12]. Thus, the use of such poor-quality antimalarial agents leads to increases in morbidity and mortality [19].…”