UN Human Rights, Office of the High Commissioner Access to Medicines and the Right to Health. Available at: https://www.ohchr.org/en/development/access-medicines-fundamental-element-right-health. Accessed May 3, 2022.
Bassat Q, Tanner M, Guerin PJ, Stricker K, Hamed K, 2016. Combating poor-quality anti-malarial medicines: a call to action. Malar J 15: 302.
Green MD, Hostetler DM, Nettey H, Swamidoss I, Ranieri N, Newton PN, 2015. Integration of novel low-cost colorimetric, laser photometric, and visual fluorescent techniques for rapid identification of falsified medicines in resource-poor areas: application to artemether–lumefantrine. Am J Trop Med Hyg 92 (Suppl 6): 8–16.
World Health Organization , 2013. Global Action Plan for the Prevention and Control of Noncommunicable Diseases 2013–2020. Available at: https://www.who.int/publications/i/item/9789241506236. Accessed April 20, 2022.
World Health Organization , 2017. A Study on the Public Health and Socioeconomic Impact of Substandard and Falsified Medical Products. Available at: https://www.who.int/publications/i/item/9789241513432. Accessed May 3, 2022.
Schiavetti B et al., 2018. The quality of medicines used in children and supplied by private pharmaceutical wholesalers in Kinshasa, Democratic Republic of Congo: a prospective survey. Am J Trop Med Hyg 98: 894–903
Schiavetti B, Wynendaele E, Melotte V, Van Der Elst J, De Spiegeleer B, Ravinetto R, 2020. A simplified checklist for the visual inspection of finished pharmaceutical products: a way to empower frontline health workers in the fight against poor-quality medicines. J Pharm Policy Pract 13: 9.
Newton PN, Bond KC; on behalf of the Oxford Statement signatories , 2019. Global access to quality-assured medical products: the Oxford Statement and call to action. Lancet Glob Health 7: e1609–e1611.
Schneider M, Ho Tu Nam N, 2020. Africa and counterfeit pharmaceuticals in the times of COVID-19. J Intellect Prop Law Pract. 15: 417–418.
Alerte produit médical N°5/2021 Vaccin COVISHIELD falsifié (mise à jour) Available at: https://www.who.int/fr/news/item/31-08-2021-medical-product-alert-n-5-2021-falsified-covishield-vaccine. Accessed September 20, 2021.
Waffo Tchounga CA, Sacre PY, Ciza P, Ngono R, Ziemons E, Hubert P, Marini R, 2021. Composition analysis of falsified chloroquine phosphate samples seized during the COVID-19 pandemic. J Pharm Biomed Anal 194: 113761.
World Health Organization , 2017, WHO Member State Mechanism On Substandard/Spurious/Falselylabelled/Falsified/Counterfeit (SSFFC) Medical Products Working Definitions, Appendix 3. Geneva, Switzerland. Available at: https://apps.who.int/gb/ebwha/pdf_files/WHA70/A70_23-en.pdf. Accessed October 8, 2021.
Organisation Mondiale de la Santé , 2017. Dans les pays en développement, 1 médicament sur 10 est de qualité inférieure ou falsifié. Available at: https://www.who.int/fr/news/item/28-11-2017-1-in-10-medical-products-in-developing-countries-is-substandard-or-falsified. Accessed October 8, 2021.
Ozawa S, Evans DR, Bessias S, Haynie DG, Yemeke TT, Laing SK, Herrington JE, 2018. 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 1: e181662.
Khuluza F, Kigera S, Heide L, 2017. Low prevalence of substandard and falsified antimalarial and antibiotic medicines in public and faith-based health facilities of southern Malawi. Am J Trop Med Hyg 96: 1124–1135
Waffo Tchounga C, Sacré P-Y, Hamuli PC, Mballa RN, Nga NE, Hubert P, Marini R, 2021. Poor-quality medicines in Cameroon: a critical review. Am J Trop Med Hyg 105: 284–294.
World Health Organization , 2020. Global Antimicrobial Resistance and Use Surveillance System (GLASS). Geneva, Switzerland: WHO. Available at: https://www.who.int/publications/i/item/9789240027336. Accessed May 25, 2021.
Schaeffer AJ, 2003. The expanding role of fluoroquinolones. Am J Med 49: 129–147.
Sakira AK, Mees C, De Braekeleer K, Delporte C, Yameogo J, Yabre M, Some TI, Van Antwerpen P, Mertens D, Kauffmann JM, 2021. Determination of the quality of metronidazole formulations by near-infrared spectrophotometric analysis. Talanta Open 3: 100027.
Ministère de la santé publique, Direction de la pharmacie, du médicament et des laboratoires Liste nationale des médicaments essentiels du Cameroun 2017. Available at: https://dpml.cm/index.php/fr/catalogue/medicaments-essentiels. Accessed August 18, 2021.
Schäfermann S, Wemakor E, Hauk C, Heide LI, 2018. Quality of medicines in southern Togo: investigation of antibiotics and of medicines for non-communicable diseases from pharmacies and informal vendors. PLoS One 13: e0207911.
Schäfermann S, Neci R, Ngah Ndze E, Nyaah F, Basolanduma Pondo V, Heide LI, 2020. Availability, prices and affordability of selected antibiotics and medicines against non-communicable diseases in western Cameroon and northeast DR Congo. PLoS One 15: e0227515.
Coic L, Sacré P-Y, Dispas A, Karim Sakira A, Fillet M, Marini RD, Hubert P, Ziemons E, 2019. Comparison of hyperspectral imaging techniques for the elucidation of falsified medicines composition. Talanta 198: 457–463.
World Health Organization Good Pharmacopoeial Practices , 2016. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. WHO Technical Fiftieth Report Series 996, Geneva, Switzerland. Available at: https://cdn.who.int/media/docs/default-source/medicines/norms-and-standards/guidelines/distribution/trs966-annex7-who-guidelines-on-the-conduct-of-surveys-of-the-quality-of-medicines.pdf?sfvrsn=4dbb5519_2. Accessed June 17, 2022.
Newton PN et al., 2009. Guidelines and guidance guidelines for field surveys of the quality of medicines: a proposal. PLoS One 6: e1000052.
Ministère de la santé publique, Direction de la pharmacie, du médicament et des laboratoires Politique pharmaceutique nationale du Cameroun, 2013. Available at: https://dpml.cm/index.php/fr/s-informer/actualite/annee-2018/546-politique-pharmaceutique-nationale-du-cameroun-ppn-2013 Accessed October 8, 2021.
Nickerson B, Kong A, Gerst P, Kao S, 2018. Correlation of dissolution and disintegration results for an immediate-release tablet. J Pharm Biomed Anal 150: 333–340.
U.S. Pharmacopeia , 2021. USP NF online, Issue 2. Available at: https://online.uspnf.com/uspnf. Accessed June 2, 2022.
Ministère de la santé publique, Direction de la pharmacie, du médicament et des laboratoires Repertoire des médicaments homologués. Available at: https://dpml.cm/repertoireDesAmm/index.php. Accessed October 8, 2021.
World Health Organization , 2011. Survey of the Quality of Selected Antimalarial Medicines Circulating in Six Countries of Sub-Saharan Africa. Available at: https://www.afro.who.int/sites/default/files/2017-06/WHO_QAMSA_report.pdf. Accessed April 25, 2020.
Hauk C, Hagen N, Heide L, 2021. Identification of substandard and falsified medicines: influence of different tolerance limits and use of authenticity inquiries. Am J Trop Med Hyg 104: 1936–1945.
Schäfermann S et al., 2020. Substandard and falsified antibiotics and medicines against noncommunicable diseases in Western Cameroon and Northeastern Democratic Republic of Congo. Am J Trop Med Hyg 103: 894–908.
Petersen A, Held N, Heide L, 2017. Surveillance for falsified and substandard medicines in Africa and Asia by local organizations using the low-cost GPHF Minilab. PLoS One 12: e0184165.
Rahman MS, Yoshida N, Tsuboi H, Karmoker JR, Kabir N, Schaefermann S, Akimoto Y, Bhuiyan MA, Reza MS, Kimura K, 2022. A comprehensive analysis of select medicines collected from private drug outlets of Dhaka City, Bangladesh in a simple random survey. Sci Rep 12: 234.
OMS , 2020, Résistance aux antibiotiques. Available at: https://www.who.int/fr/news-room/fact-sheets/detail/antibiotic-resistance. Accessed September 21, 2021.
Tulkens PM, Van Bambeke F, Zinner SH, 2019. Profile of a novel anionic fluoroquinolone-delafloxacin. Clin Infect Dis 68: S213–S222.
Ching C, Zaman MH, 2021. Impact of ciprofloxacin impurities on bacterial growth, antibiotic resistance development and content assays. Lett Appl Microbiol 73: 220–228.
Ching C, Zaman MH, 2021. Identification of multiple low-level resistance determinants and coselection of motility impairment upon sub-MIC ceftriaxone exposure in Escherichia coli. MSphere 6: e0077821.
Fasugba O, Gardner A, Mitchell BG, Mnatzaganian G, 2015. Ciprofloxacin resistance in community-and hospital-acquired Escherichia coli urinary tract infections: a systematic review and meta-analysis of observational studies. BMC Inf Dis 15: 545.
Lalani M, Kaur H, Mohammed N, Mailk N, Van Wyk A, Jan S, Kakar RM, Mojadidi KM, Tobie L, 2015. Substandard antimalarials available in Afghanistan: a case for assessing the quality of drugs in resource poor settings. Am J Trop Med Hyg 92: 51–58.
Organization for Economic Cooperation and Development/EU Intellectual Property Office , 2020. Trade in Counterfeit Pharmaceutical Products, Illicit Trade. Paris, France: OECD Publ, 94.
Lehmann A, Katerere DR, Dressman J, 2018. Drug quality in South Africa: a field test. J Pharm Sci 107: 2720–2730.
Essomba N, Adiogo D, Essome MJ, Lehman L, Coppieters Y, 2014. Habitudes d’approvisionnement en médicaments par les populations d’une ville semi-rurale au Cameroun. Health Sci Dis 15. Available at: https://www.hsd-fmsb.org/index.php/hsd/article/view/438. Accessed October 5, 2021.
Ekambi GAE, Ebongue CO, Penda C, Nga EN, Mpondo EM, Moukokoid CEE, 2019. Knowledge, practices and attitudes on antibiotics use in Cameroon: self-medication and prescription survey among children, adolescents and adults in private pharmacies. PLoS One 14: e0212875.
Chikowe I, Bliese SL, Lucas S, Lieberman M, 2018. Amoxicillin quality and selling practices in urban pharmacies and drug stores of Blantyre, Malawi. Am J Trop Med Hyg 99: 233–238.
|Past two years||Past Year||Past 30 Days|
|Full Text Views||41||41||15|
Quality is one of the essential components of medicines and needs to be ensured to preserve the population’s health. This can be achieved through post-marketing quality control of medicines and is one of the most important duties of national regulatory authorities. In collaboration with the Cameroonian National Drug Quality Control and Valuation Laboratory, the decision was made to initiate a prevalence study to assess the quality of antiinfective medicines in Cameroon. A total of 150 samples of ciprofloxacin tablets and 142 samples of metronidazole tablets were collected from 76 licensed pharmacies and 75 informal vendors in three cities in Cameroon using a random strategy wherever possible and a mystery shopper approach. Three tests were carried out on each of the samples. Visual inspection allowed to find two falsified samples (0.7%) due to lack of information about the manufacturing company, and five more samples (1.7%) were deemed to be substandard due to flaws in the product. An additional 13 samples (4.5%) failed disintegration testing, and six (2.1%) others failed high-performance liquid chromatography assay testing due to insufficient active pharmaceutical ingredient (API) content. All samples were found to contain some API. A prevalence of 7.9% substandard or falsified (SF) medicines was found. Moreover, the prevalence of outlets selling SF medicines was greater in the informal sector (26.7%) than in the formal sector (2.6%). Although the prevalence of SF medicines found was low, efforts need to be made by national regulatory authorities to monitor the pharmaceutical market more closely.
Financial support: Research grants from Academy of Research and Higher Education is the federation of French-speaking higher education institutions in Belgium (ARES-CCD) to Christelle WAFFO and Patient CIZA are gratefully acknowledged. LANACOME’ staff is thanked for the precious collaboration in this study. Anonymous reviewers are also kindly acknowledged for their useful comments.
Authors’ addresses: Christelle Ange Waffo Tchounga, Laboratory of Pharmaceutical Analytical Chemistry, Department of Pharmacy, University of Liege, CIRM, Vibra-Santé Hub, Liège, Belgium, and Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon, E-mail: email@example.com. Pierre-Yves Sacre, Charlotte De Bleye, Eric Ziemons, Philippe Hubert, and Roland Marini Djang’eing’a, Laboratory of Pharmaceutical Analytical Chemistry, Department of Pharmacy, University of Liege, CIRM, Vibra-Santé Hub, Liège, Belgium, E-mails: firstname.lastname@example.org, email@example.com, firstname.lastname@example.org, email@example.com, and firstname.lastname@example.org. Patient Ciza Hamuli, Laboratory of Pharmaceutical Analytical Chemistry, Department of Pharmacy, University of Liege, CIRM, Vibra-Santé Hub, Liège, Belgium, and Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa, Democratic Republic of Congo, E-mail: email@example.com. Rose Ngono Mballa, Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon, and Laboratoire National de Contrôle des Médicaments et Expertise, Yaoundé, Cameroon, E-mail: firstname.lastname@example.org.