Usefulness of combined screening methods for rapid detection of falsified and/or substandard medicines in the absence of a confirmatory method

Abstract

BackgroundThe influx of substandard and falsified medicines is a global public health challenge and its rapid detection is a key solution to the menace. This study used three screening methods and one confirmatory method for the quality assessment of 25 batches of artemether/lumefantrine dosage forms from the Ghanaian market to test that combined screening methods only can rapidly detect substandard and/or falsified medicines in areas where confirmatory methods may not be available.MethodsThe quality of artemether/lumefantrine tablet products obtained from pharmacies and licensed chemical seller shops within the Accra metropolis in Ghana were analysed using three screening methods (GPHF Minilab, Colorimetry and Counterfeit Drug Indicator) and one confirmatory method (high-performance liquid chromatography).ResultsThe results showed that 18/25 batches of the artemether/lumefantrine samples passed using the combined screening and confirmatory methods and 5/25 batches of the artemether/lumefantrine samples failed using the combined screening and confirmatory methods. However, 1/25 batch of the artemether/lumefantrine samples failed using the combined screening methods but passed using the confirmatory method. Also, 1/25 batch of the artemether/lumefantrine samples passed using the combined screening methods but failed using the confirmatory method. This notwithstanding, the combined screening methods and the confirmatory method provided equivalent quality assessment profiles for 23/25 (92%) batches of the artemether/lumefantrine tablet products. Out of the 6 samples that failed the confirmatory test, 1/6, 2/6, and 3/6 failed on the high (> 110%), low (< 90%), and no active ingredient (0%), respectively. The sensitivity of Minilab, colorimetric, CoDI, and the combined screening methods at 95% confidence level were 0.5 ± 0.57, 0.83 ± 0.33, 0.75 ± 0.49, and 0.83 ± 0.33, respectively. Also, the specificity of Minilab, colorimetric, CoDI, and the combined screening methods at 95% confidence level were 1.00, 0.95 ± 0.10, 1.00, and 0.95 ± 0.10, respectively.ConclusionThe combined screening methods may be used for rapid detection of falsified and/or substandard medicines without using a confirmatory method. However, additional research on the best combinations of screening devices/methods to rapidly detect the quality of medicines is recommended.

Comparing the return on investment of technologies to detect substandard and falsified amoxicillin: A Kenya case study

“…Using a combination of these screening devices could also be an effective strategy. A recent study conducted in Ghana demonstrated the usefulness of combining three low cost (<USD $10,000) screening methods (GPHF-Minilab, colorimetry, and Counterfeit Drug Indicator) to quickly detect substandard and falsified artemether/lumefantrine products [ 36 ].…”

Usefulness of medicine screening tools in the frame of pharmaceutical post-marketing surveillance

“…Due to the wide variety of ways that pharmaceutical products can fail quality standards, the combination of several techniques is highly recommended to detect substandard or falsified medicines and to obtain an accurate final answer [8,16,17]. Several authors have combined screening and confirmation methods for the detection of SF medicines [1,[18][19][20][21][22][23][24] and recently, others attempted to evaluate the practical use of different handheld screening tools on the field [25][26][27][28].…”

Small-scale dissolution test screening tool to select potentially substandard and falsified (SF) medicines requiring full pharmacopoeial analysis

“…In this context, convenient methods to detect SF medicines are still urgently required 9 – 13 . Ensuring the quality of pharmaceuticals in the supply chain requires studies to establish the prevalence of SFs, as well as the development of effective analytical systems to identify and characterize SFs, and effective implementation of regulatory systems 14 .…”