Comment citer
Résumé
Introduction
Substandard and falsified (SF) medical products continue to threaten public health worldwide, particularly in developing countries. Unfortunately, the available literature primarily focuses on anti-infective drugs.
Purpose
The aim of this study is to review data on the quality of medical products to contribute to the development of future field studies.
Methods
A ten-year retrospective study in Kinshasa, DRC, analyzed data on poor-quality medical products from 2012 to 2021. The study identified international non-proprietary names, pharmaceutical forms, countries of origin, causes of non-compliance, therapeutic classes, batch numbers, and labeling.
Results
Although the descriptive statistics derived from these data show a rate of non-compliance ranging from 0.45% to 1.34%, well below recent World Health Organization estimates, the current study reveals that quality problems with medical products also affect therapeutic classes other than antimalarials and antibiotics.
Conclusion
This study aimed to analyze data on the quality of medical products in Kinshasa to contribute to future studies. The study involved 59,961 samples analyzed over a decade, with 258 non-compliant samples in the first laboratory, 670 in the second laboratory, and 7,681 in the third laboratory. Factors such as the country and continent of manufacture, therapeutic classes, non-compliant drugs, and pharmacological forms were considered. These results highlight the need for regulatory authorities to implement effective surveillance and monitoring policies for all establishments involved in the quality control of medicines and health products. Such efforts are essential for ensuring consumer safety and reflecting the quality of regulatory activities, which must encompass all parameters that contribute to the development of an exemplary quality model.
Références
Akiny, O. (2013). Counterfeit drugs in Nigeria: A threat to public health. African Journal of Pharmacy and Pharmacology, 7(36), 2571 2576. https://doi.org/10.5897/AJPP12.343
Bakker-’t Hart, I. M. E., Ohana, D., & Venhuis, B. J. (2021). Current challenges in the detection and analysis of falsified medicines. Journal of Pharmaceutical and Biomedical Analysis, 197, 113948. https://doi.org/10.1016/j.jpba.2021.113948
Brower, V. (2017). Falsified and substandard malaria drugs in Africa. The Lancet Infectious Diseases, 17(10), 1026 1027. https://doi.org/10.1016/S1473-3099(17)30528-5
Caudron, J.-M., Ford, N., Henkens, M., Macé, C., Kiddle-Monroe, R., & Pinel, J. (2008). Substandard medicines in resource-poor settings: A problem that can no longer be ignored. Tropical Medicine & International Health, 13(8), 1062 1072. https://doi.org/10.1111/j.1365-3156.2008.02106.x
Ciza, P. H., Sacre, P.-Y., Waffo, C., Coïc, L., Avohou, H., Mbinze, J. K., Ngono, R., Marini, R. D., Hubert, P., & Ziemons, E. (2019). Comparing the qualitative performances of handheld NIR and Raman spectrophotometers for the detection of falsified pharmaceutical products. Talanta, 202, 469 478. https://doi.org/10.1016/j.talanta.2019.04.049
Contrôle de la qualité de quelques molécules antibiotiques utilisées au Sénégal | Semantic Scholar. (n.d.). Retrieved January 29, 2025, from https://www.semanticscholar.org/paper/Contr%C3%B4le-de-la-qualit%C3%A9-de-quelques-mol%C3%A9cules-au-Diop-Sarr/b64b570c1798e07821b61fdcf3f65464d6dc9d09
Dégardin, K., Roggo, Y., & Margot, P. (2014). Understanding and fighting the medicine counterfeit market. Journal of Pharmaceutical and Biomedical Analysis, 87, 167 175. https://doi.org/10.1016/j.jpba.2013.01.009
Dicko, M. (2007). Etude comparative de la qualité des médicaments en spécialités et des génériques soumis pour l’obtention d’Autorisation de Mise sur le Marché malien de 2002 à 2005. [Thesis, Université de Bamako]. https://www.bibliosante.ml/handle/123456789/6963
Djim-Madjim, M. (2008). Contrôle de la qualité des médicaments: Cas des antipaludéens au Burkina Faso [Thesis, Université de Bamako]. https://www.bibliosante.ml/handle/123456789/7042
Hamilton, W. L., Doyle, C., Halliwell-Ewen, M., & Lambert, G. (2016). Public health interventions to protect against falsified medicines: A systematic review of international, national and local policies. Health Policy and Planning, 31(10), 1448 1466. https://doi.org/10.1093/heapol/czw062
Konaté, A. (2013). Contribution au contrôle de qualité des médicaments au laboratoire national de la santé: Analyse rétrospective de 1997 à 2011. https://www.bibliosante.ml/handle/123456789/1902
Koumaré, J. L. (2018). Etudes des médicaments non conformes au Laboratoire national de la Santé de Bamako du 1er janvier au 31 décembre 2016 selon l’origine de la fabrication [Thesis, Université des Sciences, des Techniques et des Technologies de Bamako]. https://www.bibliosante.ml/handle/123456789/13218
Kouonang Komguep, S. (2005). Controle de qualité de trois antipaludiques dérivés de l’artémisine (Arthemether, artesunate, dihydroartemisinine) laboratoire national de santé [Thesis, Université de Bamako]. https://www.bibliosante.ml/handle/123456789/6836
Mackey, T. K., & Liang, B. A. (2011). The global counterfeit drug trade: Patient safety and public health risks. Journal of Pharmaceutical Sciences, 100(11), 4571 4579. https://doi.org/10.1002/jps.22679
Mayer, J. (n.d.). Discussion Paper No. 2001/39.
Mbadinga, M., & Géralde, C. (2005). Controle de qualité de l’amodiaquine et de la quinine [Thesis, Université de Bamako]. https://www.bibliosante.ml/handle/123456789/6824
Mbinze, J. K., Sacré, P.-Y., Yemoa, A., Mavar Tayey Mbay, J., Habyalimana, V., Kalenda, N., Hubert, P., Marini, R. D., & Ziemons, E. (2015). Development, validation and comparison of NIR and Raman methods for the identification and assay of poor-quality oral quinine drops. Journal of Pharmaceutical and Biomedical Analysis, 111, 21 27. https://doi.org/10.1016/j.jpba.2015.02.049
Nayyar, G. M. L., Breman, J. G., & Herrington, J. E. (2015). The Global Pandemic of Falsified Medicines: Laboratory and Field Innovations and Policy Perspectives. https://doi.org/10.4269/ajtmh.15-0221
Newton, P. N., Green, M. D., & Fernández, F. M. (2010). Impact of poor-quality medicines in the ‘developing’ world. Trends in Pharmacological Sciences, 31(3), 99 101. https://doi.org/10.1016/j.tips.2009.11.005
Newton, P. N., Green, M. D., Fernández, F. M., Day, N. P., & White, N. J. (2006). Counterfeit anti-infective drugs. The Lancet Infectious Diseases, 6(9), 602 613. https://doi.org/10.1016/S1473-3099(06)70581-3
Organization, W. H. (1999). Counterfeit drugs: Guidelines for the development of measures to combat counterfeit drugs (No. WHO/EDM/QSM/99.1). Article WHO/EDM/QSM/99.1. https://iris.who.int/handle/10665/65892
Peltier-Rivest, D., & Pacini, C. (2019). Detecting counterfeit pharmaceutical drugs: A multi-stakeholder forensic accounting strategy. Journal of Financial Crime, 26(4), 1027 1047. https://doi.org/10.1108/JFC-06-2018-0057
Praussello, F. (2006). Globalization and Incomplete Technology Transfer to Developing Countries. In B. N. Ghosh & H. M. Guven (Eds.), Globalization and the Third World (pp. 200 216). Palgrave Macmillan UK. https://doi.org/10.1057/9780230502567_12
Rahman, M. S., Yoshida, N., Tsuboi, H., Tomizu, N., Endo, J., Miyu, O., Akimoto, Y., & Kimura, K. (2018). The health consequences of falsified medicines‐ A study of the published literature. Tropical Medicine & International Health, 23(12), 1294 1303. https://doi.org/10.1111/tmi.13161
République, P. de la. (2000, October 22). Message adressé par M. Jacques Chirac au Professeur Marc Gentilin, Président de la Croix-Rouge française, à l’occasion de la 56e assemblée générale. http://www.jacqueschirac-asso.fr/archives-elysee.fr/elysee/elysee.fr/francais/interventions/lettres_et_messages/2000/octobre/fi002477.html
Sess.: 2015-2016), U. G. A. (70th. (2015). Transforming our world: The 2030 Agenda for Sustainable Development: resolution /: adopted by the General Assembly. https://digitallibrary.un.org/record/3923923
Substandard and falsified medical products. (n.d.). Retrieved January 17, 2025, from https://www.who.int/news-room/fact-sheets/detail/substandard-and-falsified-medical-products
The Sustainable Development Goals Report 2017 | DESA Publications. (2017, July 17). https://desapublications.un.org/publications/sustainable-development-goals-report-2017
Tie, Y., Vanhee, C., Deconinck, E., & Adams, E. (2019). Development and validation of chromatographic methods for screening and subsequent quantification of suspected illegal antimicrobial drugs encountered on the Belgian market. Talanta, 194, 876 887. https://doi.org/10.1016/j.talanta.2018.10.078
Waffo Tchounga, C. A., Sacré, P.-Y., Ravinetto, R., Lieberman, M., Hamuli Ciza, P., Ngono Mballa, R., Ziemons, E., Hubert, P., & Djang’eing’a Marini, R. (2023). Usefulness of medicine screening tools in the frame of pharmaceutical post-marketing surveillance. PLOS ONE, 18(8), e0289865. https://doi.org/10.1371/journal.pone.0289865
Wirtz, V. J., Hogerzeil, H. V., Gray, A. L., Bigdeli, M., De Joncheere, C. P., Ewen, M. A., Gyansa-Lutterodt, M., Jing, S., Luiza, V. L., Mbindyo, R. M., Möller, H., Moucheraud, C., Pécoul, B., Rägo, L., Rashidian, A., Ross-Degnan, D., Stephens, P. N., Teerawattananon, Y., ’T Hoen, E. F. M., … Reich, M. R. (2017). Essential medicines for universal health coverage. The Lancet, 389(10067), 403 476. https://doi.org/10.1016/S0140-6736(16)31599-9
World Health Organization. (2011). Local production and access to medicines in low- and middle-income countries: A literature review and critical analysis
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