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

Author

Kwabena Frimpong-Manso Opuni, Henry Nettey, Marvin Adjei Larbi, Salome Naa Amerley Amartey, Gifty Nti, Abraham Dzidonu, Patrick Owusu-Danso, Nicholas Amoah Owusu, and Alexander Kwadwo Nyarko

Subjects
Anti-malarial, Falsified medicines, Substandard medicines, Screening and confirmatory methods, Arctic medicine. Tropical medicine, RC955-962, Infectious and parasitic diseases, RC109-216
Abstract

Abstract Background The 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. Methods The 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). Results The 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 (

Published
2019
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2. Usefulness of combined screening methods for rapid detection of falsified and/or substandard medicines in the absence of a confirmatory method

Author

Alexander K. Nyarko, Henry Nettey, Nicholas Amoah Owusu, Salome Naa Amerley Amartey, Kwabena F.M. Opuni, Patrick Owusu-Danso, Marvin Adjei Larbi, Abraham Dzidonu, and Gifty Nti

Subjects
Quality Control, Anti malarial, lcsh:Arctic medicine. Tropical medicine, lcsh:RC955-962, Falsified medicines, 030231 tropical medicine, Lumefantrine, Ghana, Rapid detection, lcsh:Infectious and parasitic diseases, Antimalarials, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Substandard medicines, Screening and confirmatory methods, medicine, Screening method, lcsh:RC109-216, 030212 general & internal medicine, Artemether, Traditional medicine, business.industry, Quality assessment, Substandard Drugs, Research, Artemether, Lumefantrine Drug Combination, Additional research, Infectious Diseases, chemistry, Counterfeit Drugs, Minilab, Parasitology, Anti-malarial, business, Tablets, medicine.drug
Abstract

Background The 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. Methods The 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). Results The 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 ( Conclusion The 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.

Published
2019

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