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Prevalence of Poor Quality Ciprofloxacin and Metronidazole Tablets in Three Cities in Cameroon
ABSTRACT.
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.
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Author Notes
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: christellewaffo@yahoo.fr. 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: pysacre@uliege.be, cdebleye@uliege.be, eziemons@uliege.be, ph.hubert@uliege.be, and rmarini@uliege.be. 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: cizapatient@yahoo.fr. 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: rngono2002@yahoo.fr.