title: A New Handheld Device for the Detection of Falsified Medicines: Demonstration on Falsified Artemisinin-Based Therapies from the Field.
abstract: AbstractPoor-quality medicines are a major problem for health-care systems in resource-poor settings as identifying falsified medicines requires a complex laboratory infrastructure such as a Medicines Quality Control Laboratory. We report here an evaluation of a low-cost, handheld near-infrared spectrometer (NIRS) device by analyzing a library of artemisinin-based combination therapy (ACT) medicines to determine its usefulness as a drug-screening tool. The "SCiO" research prototype device was used to collect NIR spectra of a library of ACT and artesunate monotherapy medicine samples previously collected in Bioko Island and Equatorial Guinea and Kintampo, Ghana. The quality of these samples had been categorized as falsified, substandard, and quality assured based on the amount of stated active pharmaceutical ingredients detected using high-performance liquid chromatography photodiode array. Numerical analyses were performed on the NIR spectra to assess the usefulness of NIR to identify falsified and substandard medicines. The NIRS device was successful at detecting falsified medicines in all cases where the library contained both quality assured and falsified medicines of the same stated brand of medicines. The NIRS device was successful at identifying substandard amounts of artesunate but not amodiaquine in the ACT samples (N= 15) of artesunate-amodiaquine. This work reveals that this low-cost, portable NIRS device is promising for screening ACTs for falsified samples and could enable widespread drug screening at all points of the health system.
authors.affiliation: Intellectual Ventures Laboratory, Bellevue, Washington.
authors.forename: Benjamin K
authors.initials: BK
authors.lastname: Wilson
authors.affiliation: London School of Hygiene and Tropical Medicine, London, United Kingdom.
authors.forename: Harparkash
authors.initials: H
authors.lastname: Kaur
authors.affiliation: London School of Hygiene and Tropical Medicine, London, United Kingdom.
authors.forename: Elizabeth Louise
authors.initials: EL
authors.lastname: Allan
authors.affiliation: Intellectual Ventures Laboratory, Bellevue, Washington.
authors.forename: Anthony
authors.initials: A
authors.lastname: Lozama
authors.affiliation: Intellectual Ventures Laboratory, Bellevue, Washington.
authors.forename: David
authors.initials: D
authors.lastname: Bell
mesh_terms: D000655:Amodiaquine / Q000032:analysis*; D000962:Antimalarials / Q000032:analysis*; D037621:Artemisinins / Q000032:analysis*; D000077332:Artesunate; D002851:Chromatography, High Pressure Liquid; D034201:Computers, Handheld; D058110:Counterfeit Drugs / Q000032:analysis*; D004338:Drug Combinations; D004340:Drug Contamination / Q000517:prevention & control; D016703:Equatorial Guinea; D005869:Ghana; D006801:Humans; D063731:Mobile Applications; D011786:Quality Control; D012680:Sensitivity and Specificity; D013055:Spectrophotometry, Infrared / Q000295:instrumentation / Q000379:methods
chemical_list: D000962:Antimalarials; D037621:Artemisinins; D058110:Counterfeit Drugs; D004338:Drug Combinations; C515299:amodiaquine, artesunate drug combination; D000655:Amodiaquine; D000077332:Artesunate; C031327:artemisinin