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Assessment of the Quality of Injectable Antibiotics in Benin

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  • 1 Louvain Drug Research Institute, Clinical Pharmacy, Université Catholique de Louvain (UCLouvain), Belgium;
  • | 2 Laboratoire de Chimie Analytique et Analyse des Médicaments, Université d’Abomey Calavi, Bénin;
  • | 3 Agence Nationale de Contrôle de Qualité des produits de santé et de l’eau, Ministère de la Santé, Benin;
  • | 4 Service de Chirurgie Générale, Centre Hospitalo-Universitaire Départemental Ouémé-Plateau, Bénin;
  • | 5 Department of Pharmacy, CIRM, Laboratory of Analytical Pharmaceutical Chemistry, University of Liege, Belgium;
  • | 6 Pharmacy Department, Cliniques Universitaires Saint-Luc, UCLouvain, Belgium
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ABSTRACT.

Substandard and falsified medicines are an enormous threat to global health. Poor quality antibiotic preparations contribute to the development of antimicrobial resistance. In surgery, where the occurrence of healthcare-associated infections is high, healthcare teams need to rely on the quality of antibiotic prophylaxis to prevent infections. We assessed the quality of antibiotics used for surgical infection prophylaxis in Benin. Thirty-three samples were collected from six hospitals located in various departments in Benin. The antibiotics (powders for injection: amoxicillin + clavulanic acid, ampicillin, ceftriaxone; solutions for injection: ciprofloxacin, gentamicin, metronidazole) were assessed using visual inspection, pharmacotechnical tests (including uniformity of mass, pH measure, sterility test, and active pharmaceutical ingredient identification), and assay tests (including a simple analytical method thin layer chromatography) and complex analytical techniques (ultraviolet-visible spectrophotometry, high-performance liquid chromatography—diode-array detection, conductometry). Because the material needed for the methods recommended by the pharmacopeias to assess the dosage of gentamicin was not available, we developed and validated a conductometry method. Results showed that 97% (n = 32) of the samples passed visual inspection; 100% (n = 33) of the samples passed the pharmacotechnical tests, identification of active ingredients, and sterility test; 88% (n = 29) passed the test for percentage of active pharmaceutical ingredients. Overall, 15% of the samples did not pass the quality test (3% on visual inspection and 12% for excess active ingredients). Although most of the samples passed the quality tests, it appears important to perform routine quality control for intravenous medicines.

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Author Notes

Address correspondence to Angèle Modupè Dohou, Louvain Drug Research Institute, Clinical pharmacy, Université catholique de Louvain (UCLouvain), Belgium, Place de l’Université 1, 1348 Louvain-la-Neuve, Belgique. E-mail: angele.dohou@uclouvain.be

Financial support: This research was support by funding from l’Académie de Recherche de l’Enseignement Supérieur, Belgium.

Authors’ addresses: Angèle Modupè Dohou, Louvain Drug Research Institute, Clinical Pharmacy, Université Catholique de Louvain (UCLouvain), Belgium, Place de l’Université 1, 1348 Louvain-la-Neuve, Belgique, and Laboratoire de Chimie Analytique et Analyse des Médicaments, Faculté des Sciences de la Santé (LCAM, FSS) Université d’Abomey Calavi, 01 BP 526 Cotonou, Bénin, E-mail: angele.dohou@uclouvain.be. Achille Loconon Yémoa, Dodji Boris Aurel Guidan, and Ahmed Amoussa, Laboratoire de Chimie Analytique et Analyse des Médicaments, Faculté des Sciences de la Santé (LCAM, FSS) Université d’Abomey Calavi, 01 BP 526 Cotonou, Bénin, E-mails: ayemoa@yahoo.fr, dodjiborisaurel@gmail.com, and amord10@yahoo.fr. Seyive Hélène Solange Ahouandjinou, Agence Nationale de Contrôle de Qualité des produits de santé et de l’eau (ANCQ), 06 BP 139 Cotonou, Ministère de la Santé, Benin, E-mail: sohelene1@gmail.com. Francis Moïse Dossou, Service de Chirurgie Générale, Centre Hospitalo-Universitaire Départemental Ouémé-Plateau, Rue de l’inspection Porto-Novo, Bénin, E-mail: dosfm@yahoo.fr. Roland Marini Djang’eing’a, Department of Pharmacy, CIRM, Laboratory of Analytical Pharmaceutical Chemistry, University of Liege, Avenue de l’hôpital 1, B36 4000 Liège, Belgium, E-mail: rmarini@uliege.be. Olivia Dalleur, Pharmacy Department, Cliniques Universitaires Saint-Luc, Avenue Hippocrate 10,1200 Bruxelles, Belgium, E-mail: olivia.dalleur@uclouvain.be.

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