,
Songuigama Coulibaly,
Alain Kacou,
Avi Tanguy Kouao,
Amelanh Sica Diakité,
Jean-Fabrice Konan Koffi,
Melissa Eunice Apleheni Adouko,
Mahama Ouattara
Background: Counterfeit and substandard medicines represent a severe public health issue, particularly in developing nations where their prevalence exacerbates disease resistance and economic challenges. In addition, many deaths in Côte d'Ivoire could be avoided each year if the drugs prescribed against malaria were compliant with regulations and able to effectively treat the disease. Objective: This study aimed to evaluate the quality of artemether-lumefantrine antimalarial combination on the Ivorian illicit market using the GPHF-Minilab® kit. Methods: A total of 15 samples were analyzed through visual inspection, disintegration testing, and TLC for qualitative and semi-quantitative assessments. Results: The findings reveal significant non-conformities, including 20% of samples lacking manufacturer information, 7% without accompanying instructions, and 20% with physical degradation. 93% of samples disintegrated within 30 minutes, meeting pharmacopoeial standards. One sample exceeded the recommended time, indicating substandard manufacturing. Most samples (67%) met active ingredient quantity requirements, but 26% were underdosed, and 7% were overdosed, highlighting manufacturing and storage deficiencies. In view of these results, it appears that the Artemether-lumefantrine drugs seized on the illegal market in Côte d'Ivoire are not of good quality. Conclusion: The GPHF-Minilab® proves a reliable tool for identifying substandard and counterfeit drugs in resource-limited settings, though further validation is required for broader applications. These results underscore the need for stringent regulatory frameworks, public education, and expanded quality control initiatives.
| Published in | International Journal of Pharmacy and Chemistry (Volume 11, Issue 1) |
| DOI | 10.11648/j.ijpc.20251101.14 |
| Page(s) | 22-30 |
| Creative Commons |
This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited. |
| Copyright |
Copyright © The Author(s), 2025. Published by Science Publishing Group |
Antimalarials, Artemether, Counterfeit Drugs, Lumefantrine, Minilab, Quality Control
| [1] |
World Health Organization (WHO). Substandard and falsified medical products: Impact on public health. Geneva, 2017. Available from:
https://www.who.int/fr/news/item/28-11-2017-1-in-10-medical-products-in-developing-countries-issubstandard-or-falsified (accessed 09 January 2024). |
| [2] | Ozawa, S., Evans, D. R., Bessias, S., Haynie, D. G., Yemeke, T. T., Laing, S. K., and Herrington, J. E. Prevalence and estimated economic burden of substandard and falsified medicines in low- and middle-income countries: A systematic review and meta-analysis. JAMA Netw Open. 2018, 1(4), e181662. |
| [3] | Cavany, S., Nanyonga, S., Hauk, C., et al. The uncertain role of substandard and falsified medicines in the emergence and spread of antimicrobial resistance. Nat Commun. 2023, 14(1), 6153. |
| [4] | Ozawa, S., Higgins, C. R., Yemeke, T. T., Nwokike, J. I., Evans, L., Hajjou, M., and Pribluda, V. S. Importance of medicine quality in achieving universal health coverage. PLoS One. 2020, 15(7), e0232966. |
| [5] | Bittar Araujo Lima, M., and Yonamine, M. Counterfeit medicines: relevance, consequences and strategies to combat the global crisis. Brazilian Journal of Pharmaceutical Sciences. 2023, 59, e20402. |
| [6] | Attinsounon, C. A., Sissinto, Y., Avokpaho, E., Alassani, A., Sanni, M., and Zannou, M. Self-medication practice against malaria and associated factors in the city of Parakou in Northern Benin: Results of a population survey in 2017. Advances in Infectious Diseases. 2019, 9, 263–275. |
| [7] | Oga, A. S. S., Attia-Konan, A. R., Vehi, F., et al. Diabetic and cardiovascular patients’ willingness to pay for upcoming national health insurance scheme in Côte d’Ivoire. Health Econ Rev. 2019, 9, 8. |
| [8] |
Kanavos, P., Das, P., Durairaj, V., Laing, R., and Abegunde, D. O. Options for financing and optimizing medicines in resource-poor countries. World Health Report (2010) Background Paper, 34. HSS/HSF Discussion Paper, 7: 57p. Available from:
https://www.researchgate.net/publication/234058035_Options_for_financing_and_optimizing_medicines_in_resource-poor_countries (accessed 30 December 2024). |
| [9] | Thellier, M., Gemegah, A. A. J., Tantaoui, I. Global fight against malaria: Goals and achievements 1900–2022. Journal of Clinical Medicine 2024, 13(19), 5680. |
| [10] | Bédia-Tanoh, A. V., Kassi, K. F., Touré, O. A., et al. Meta-analysis of data from four clinical trials in the Ivory Coast assessing the efficacy of two artemisinin-based combination therapies (Artesunate-Amodiaquine and Artemether-Lumefantrine) between 2009 and 2016. Trop. Med. Infect. Dis. 2024, 9(1), 10. |
| [11] | Bhatt, S., Weiss, D., Cameron, E., et al. The effect of malaria control on Plasmodium falciparum in Africa between 2000 and 2015. Nature 2015, 526, 207–211. |
| [12] | Dhorda, M., Amaratunga, C., Dondorp, A. M. Artemisinin and multidrug-resistant Plasmodium falciparum – a threat for malaria control and elimination. Curr Opin Infect Dis 2021, 34(5), 432–439. |
| [13] | Nguyen, T. D., Gao, B., Amaratunga, C., Dhorda, M., Tran, T. N., White, N. J., Dondorp, A. M., Boni, M. F., Aguas, R. Preventing antimalarial drug resistance with triple artemisinin-based combination therapies. Nat Commun 2023, 14(1), 4568. |
| [14] | Dondorp, A. M., Nosten, F., Yi, P., Das, D., Phyo, A. P., Tarning, J., et al. Artemisinin resistance in Plasmodium falciparum malaria. N Engl J Med. 2009, 361, 455–467. |
| [15] | Sevene, E., González, R., and Menéndez, C. Current knowledge and challenges of antimalarial drugs for treatment and prevention in pregnancy. Expert Opin Pharmacother. 2010, 11(8), 1277–1293. |
| [16] | Richard, J., Gabrielle, K., and Klaus, F. Low-cost quality assurance of medicines using the GPHF-Minilab®. Drug Information Journal. 2001, 35(3), 941–945. |
| [17] |
Jähnke, R. W. O., and Dwornik, K. GPHF-Minilab® Manual: A Concise Quality Control Guide on Essential Drugs and Other Medicines. 2021, 12p. Available from:
https://www.gphf.org/en/minilab/manuals.htm (accessed 30 December 2024). |
| [18] | Salako, K. S., Adepoju-Bello, A. A., & Silva, B. O. Quality assessment of fifteen brands of artemether-lumefantrine tablets in Lagos metropolis, Nigeria. West African Journal of Pharmacy 2023, 31(1), 143–154. |
| [19] | Wilson, J., Fenoff, R. The health and economic effects of counterfeit pharmaceuticals in Africa. Global Edge Business Review 2011, 5(6), 1–2. |
| [20] | Commons, R. J., Simpson, J. A., Thriemer, K., Abreha, T., Adam, I., Anstey, N. M., Assefa, A., Awab, G. R., Baird, J. K., Barber, B. E., Chu, C. S., Dahal, P., Daher, A., Davis, T. M. E., Dondorp, A. M., Grigg, M. J., Humphreys, G. S., Hwang, J., Karunajeewa, H., Laman, M., Lidia, K., Moore, B. R., Mueller, I., Nosten, F., Pasaribu, A. P., Pereira, D. B., Phyo, A. P., Poespoprodjo, J. R., Sibley, C. H., Stepniewska, K., Sutanto, I., Thwaites, G., Hien, T. T., White, N. J., William, T., Woodrow, C. J., Guerin, P. J., Price, R. N. The efficacy of dihydroartemisinin-piperaquine and artemether-lumefantrine with and without primaquine on Plasmodium vivax recurrence: A systematic review and individual patient data meta-analysis. PLoS Medicine 2019, 16(10), e1002928. |
APA Style
N'guessan, D. U. J., Coulibaly, S., Kacou, A., Kouao, A. T., Diakité, A. S., et al. (2025). Evaluation of the Quality of Artemether-Lumefantrine-based Antimalarials from the Illicit Ivorian Market in West Africa. International Journal of Pharmacy and Chemistry, 11(1), 22-30. https://doi.org/10.11648/j.ijpc.20251101.14
ACS Style
N'guessan, D. U. J.; Coulibaly, S.; Kacou, A.; Kouao, A. T.; Diakité, A. S., et al. Evaluation of the Quality of Artemether-Lumefantrine-based Antimalarials from the Illicit Ivorian Market in West Africa. Int. J. Pharm. Chem. 2025, 11(1), 22-30. doi: 10.11648/j.ijpc.20251101.14
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author = {Déto Ursul Jean-Paul N'guessan and Songuigama Coulibaly and Alain Kacou and Avi Tanguy Kouao and Amelanh Sica Diakité and Jean-Fabrice Konan Koffi and Melissa Eunice Apleheni Adouko and Mahama Ouattara},
title = {Evaluation of the Quality of Artemether-Lumefantrine-based Antimalarials from the Illicit Ivorian Market in West Africa
},
journal = {International Journal of Pharmacy and Chemistry},
volume = {11},
number = {1},
pages = {22-30},
doi = {10.11648/j.ijpc.20251101.14},
url = {https://doi.org/10.11648/j.ijpc.20251101.14},
eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijpc.20251101.14},
abstract = {Background: Counterfeit and substandard medicines represent a severe public health issue, particularly in developing nations where their prevalence exacerbates disease resistance and economic challenges. In addition, many deaths in Côte d'Ivoire could be avoided each year if the drugs prescribed against malaria were compliant with regulations and able to effectively treat the disease. Objective: This study aimed to evaluate the quality of artemether-lumefantrine antimalarial combination on the Ivorian illicit market using the GPHF-Minilab® kit. Methods: A total of 15 samples were analyzed through visual inspection, disintegration testing, and TLC for qualitative and semi-quantitative assessments. Results: The findings reveal significant non-conformities, including 20% of samples lacking manufacturer information, 7% without accompanying instructions, and 20% with physical degradation. 93% of samples disintegrated within 30 minutes, meeting pharmacopoeial standards. One sample exceeded the recommended time, indicating substandard manufacturing. Most samples (67%) met active ingredient quantity requirements, but 26% were underdosed, and 7% were overdosed, highlighting manufacturing and storage deficiencies. In view of these results, it appears that the Artemether-lumefantrine drugs seized on the illegal market in Côte d'Ivoire are not of good quality. Conclusion: The GPHF-Minilab® proves a reliable tool for identifying substandard and counterfeit drugs in resource-limited settings, though further validation is required for broader applications. These results underscore the need for stringent regulatory frameworks, public education, and expanded quality control initiatives.
},
year = {2025}
}
TY - JOUR T1 - Evaluation of the Quality of Artemether-Lumefantrine-based Antimalarials from the Illicit Ivorian Market in West Africa AU - Déto Ursul Jean-Paul N'guessan AU - Songuigama Coulibaly AU - Alain Kacou AU - Avi Tanguy Kouao AU - Amelanh Sica Diakité AU - Jean-Fabrice Konan Koffi AU - Melissa Eunice Apleheni Adouko AU - Mahama Ouattara Y1 - 2025/01/24 PY - 2025 N1 - https://doi.org/10.11648/j.ijpc.20251101.14 DO - 10.11648/j.ijpc.20251101.14 T2 - International Journal of Pharmacy and Chemistry JF - International Journal of Pharmacy and Chemistry JO - International Journal of Pharmacy and Chemistry SP - 22 EP - 30 PB - Science Publishing Group SN - 2575-5749 UR - https://doi.org/10.11648/j.ijpc.20251101.14 AB - Background: Counterfeit and substandard medicines represent a severe public health issue, particularly in developing nations where their prevalence exacerbates disease resistance and economic challenges. In addition, many deaths in Côte d'Ivoire could be avoided each year if the drugs prescribed against malaria were compliant with regulations and able to effectively treat the disease. Objective: This study aimed to evaluate the quality of artemether-lumefantrine antimalarial combination on the Ivorian illicit market using the GPHF-Minilab® kit. Methods: A total of 15 samples were analyzed through visual inspection, disintegration testing, and TLC for qualitative and semi-quantitative assessments. Results: The findings reveal significant non-conformities, including 20% of samples lacking manufacturer information, 7% without accompanying instructions, and 20% with physical degradation. 93% of samples disintegrated within 30 minutes, meeting pharmacopoeial standards. One sample exceeded the recommended time, indicating substandard manufacturing. Most samples (67%) met active ingredient quantity requirements, but 26% were underdosed, and 7% were overdosed, highlighting manufacturing and storage deficiencies. In view of these results, it appears that the Artemether-lumefantrine drugs seized on the illegal market in Côte d'Ivoire are not of good quality. Conclusion: The GPHF-Minilab® proves a reliable tool for identifying substandard and counterfeit drugs in resource-limited settings, though further validation is required for broader applications. These results underscore the need for stringent regulatory frameworks, public education, and expanded quality control initiatives. VL - 11 IS - 1 ER -
Department of Pharmaceutical Sciences of the UFR Pharmaceutical and Biological Sciences, Felix Houphouet-Boigny University, Abidjan, Côte d'Ivoire
Department of Pharmaceutical Sciences of the UFR Pharmaceutical and Biological Sciences, Felix Houphouet-Boigny University, Abidjan, Côte d'Ivoire
Department of Pharmaceutical Sciences of the UFR Pharmaceutical and Biological Sciences, Felix Houphouet-Boigny University, Abidjan, Côte d'Ivoire
Department of Pharmaceutical Sciences of the UFR Pharmaceutical and Biological Sciences, Felix Houphouet-Boigny University, Abidjan, Côte d'Ivoire
Department of Pharmaceutical Sciences of the UFR Pharmaceutical and Biological Sciences, Felix Houphouet-Boigny University, Abidjan, Côte d'Ivoire
Department of Pharmaceutical Sciences of the UFR Pharmaceutical and Biological Sciences, Felix Houphouet-Boigny University, Abidjan, Côte d'Ivoire
Department of Pharmaceutical Sciences of the UFR Pharmaceutical and Biological Sciences, Felix Houphouet-Boigny University, Abidjan, Côte d'Ivoire
Department of Pharmaceutical Sciences of the UFR Pharmaceutical and Biological Sciences, Felix Houphouet-Boigny University, Abidjan, Côte d'Ivoire
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