Authors:
, , , , , , , , , , , , , , , , , and
ProCite
RefWorks
Reference Manager
BibTeX
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-
1.
WHO , 2011. The World Medicines Situation 2011. Medicines Prices, Availability and Affordability. Geneva, Switzerland: World Health Organization. Available at: https://www.who.int/medicines/areas/policy/world_medicines_situation/WMS_ch6_wPricing_v6.pdf.
-
2.
WHO , 2017. Global Surveillance and Monitoring System for Substandard and Falsifed Medical Products. Geneva, Switzerland: World Health Organization. Available at: https://www.who.int/publications/i/item/WHO-MVP-EMP-SAV-2019.04.
-
3.
Delepierre A, Gayot A, Carpentier A, 2012. Update on counterfeit antibiotics worldwide; public health risks. Med Mal Infect 42: 247–255.
-
4.
Ebrahim GJ, 1993. The Bamako initiative. J Trop Pediatr 39: 66–67.
-
5.
Nayyar GML et al., 2019. Falsified and substandard drugs: stopping the pandemic. Am J Trop Med Hyg 100: 1058–1065.
-
6.
Ozawa S et al., 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. https://doi.org/10.1001/jamanetworkopen.2018.1662.
-
7.
Peyraud N et al., 2017. An epidemic of dystonic reactions in central Africa. Lancet Glob Health 1: e181662.
-
8.
Rahman M. S. et al.2018. The health consequences of falsified medicines—a study of the published literature. Trop. Med. Int. Health 23: 1294–1303.
-
9.
Sengaloundeth S et al., 2009. A stratified random survey of the proportion of poor quality oral artesunate sold at medicine outlets in the Lao PDR - implications for therapeutic failure and drug resistance. Malar J 8: 172.
-
10.
WHO , 2006. The Safety of Medicines in Public Health Programmes: Pharmacovigilance an Essential Tool. Geneva, Switzerland: World Health Organization. Available at: https://www.who.int/medicines/areas/quality_safety/safety_efficacy/Pharmacovigilance_B.pdf.
-
11.
Schafermann 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.
-
12.
Nickerson JW, Attaran A, Westerberg B, Curtis S, Overton S, Mayer PM, 2016. Fatal bacterial meningitis possibly associated with substandard ceftriaxone. MMWR Morb Mortal Wkly Rep 64: 1375–1377.
-
13.
Bliese SL, Maina MW, Were PM, Lieberman M, 2019. Detection of degraded, adulterated, and falsified ceftriaxone using paper analytical devices. Anal Methods 11: 4727–4732.
-
14.
United Nations Department of Economic and Social Affairs , 2017. Sustainable Development Goal 3. Ensure Healthy Lives and Promote Well-Being for All at All Ages. Available at: https://www.un.org/sustainabledevelopment/health/.
-
15.
Rothe C, Schlaich C, Thompson S, 2013. Healthcare-associated infections in sub-Saharan Africa. J Hosp Infect 85: 257–267.
-
16.
WHO , 2019. Minimum Requirements for Infection Prevention and Control. Geneva, Switzerland: World Health Organization. Available at: https://www.who.int/publications/i/item/9789241516945.
-
17.
Ministere de la Santé Bénin , 2009. Plan National de Développement Sanitaire 2009–2018. Available at: https://www.prb.org/wp-content/uploads/2018/05/Plan-National-de-De%CC%81veloppement-Sanitaire-2009-2018.-Be%CC%81nin.pdf.
-
18.
Yemoa A et al., 2017. Detection of poor quality artemisinin-based combination therapy (ACT) medicines marketed in Benin using simple and advanced analytical techniques. Curr Drug Saf 12: 178–186.
-
19.
Baba-moussa F. et al., 2015. Quality control of selected antimalarials sold in the illicit market: an investigation conducted in Porto-Novo City (Republic of Benin). Adv Biosci Biotech 6: 637–644.
-
20.
Habyalimana V. et al., 2015. Analytical tools and strategic approach to detect poor quality medicines, identify unknown components, and timely alerts for appropriate measures: case study of antimalarial medicines. Am J Anal Chem 06: 977–994.
-
21.
European Centre for Disease Prevention and Control , 2013. Systematic Review and Evidence-based Guidance on Perioperative Antibiotic Prophylaxis. Available at: https://www.ecdc.europa.eu/en/publications-data/systematic-review-and-evidence-based-guidance-peri-operative-antibiotic.
-
22.
Yehouenou CL et al., 2020. Antimicrobial resistance in hospitalized surgical patients: a silently emerging public health concern in Benin. Ann Clin Microbiol Antimicrob 19: 1–10.
-
23.
World Health Organization , 1999. Counterfeit Drugs: Guidelines for the Development of Measures to Combat Counterfeit Drugs. Geneva, Switzerland: World Health Organization. Available at: http://apps.who.int/medicinedocs/pdf/h1456e/h1456e.pdf.
-
24.
US Pharmacopeia , 2019. USP 42-NF37. Available at: https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/USP42-NF37%202S%20Annotated.pdf.
-
25.
Mahamba AM, 2019. Analyse physico-chimique et microbiologique de la ceftriaxone commercialisée sur le marché de la ville de Butembo, province du Nord-Kivu/RDC. Universite de Kinshasa, Faculté des Sciences Pharmaceutiques.
-
26.
Tippa DMR, Singh N, 2010. Development and validation of stability indicating HPLC method for simultaneous estimation of amoxicillin and clavulanic acid in injection. Am J Anal Chem 01: 95–101.
-
27.
Grunwald N, Vigneron J, Blaise N, Perrin A, May I, Hoffman MA, 1997 . Determination of aminoglycosids concentration in injectable solutions by conductimetric method. J Pharm Clin 16: 189–192.
-
28.
Harron DWG, 2013. Technical requirements for registration of pharmaceuticals for human use: the ICH process. Textb Pharm Med 1994: 447–460.
-
29.
WHO , 2012. Test for Sterility. Geneva, Switzerland: World Health Organization, 571–572.
-
30.
U.S. Food and Drug Administration , 2020. Code of Federal Regulations. Title 21, Volume 8. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=820.3.
-
31.
Diop A et al., 2009. Contrôle de la qualité de quelques molécules antibiotiques utilisées au Sénégal. Med Trop (Mars) 69: 251–254.
-
32.
Kelesidis T, Falagas E, 2015. Substandard/counterfeit antimicrobial drugs. Med Mal Infect 28: 443–464.
-
33.
Boulanger B, Rozet E, Rudaz S, Hubert P, 2009. A risk-based analysis of the AAPS conference report on quantitative bioanalytical methods validation and implementation. J Chromatogr B 877: 2235–2243.
-
34.
Caudron JM et al., 2008. Substandard medicines in resource-poor settings: a problem that can no longer be ignored. Trop Med Int Health 13: 1062–1072.
-
35.
Adandé GF, 2017. 84 Tonnes de Faux Médicaments Saisis au Bénin. Available at: https://www.voaafrique.com/a/i-84-tonnes-de-feux-medicaments-saisis-au-benin-dans-la-lutte-contre-la-vente-illegale/3746807.html.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 5190 | 1957 | 261 |
| Full Text Views | 179 | 11 | 1 |
| PDF Downloads | 131 | 11 | 0 |
Assessment of the Quality of Injectable Antibiotics in Benin
Angèle Modupè Dohou
Angèle Modupè Dohou
Louvain Drug Research Institute, Clinical Pharmacy, Université Catholique de Louvain (UCLouvain), Belgium;
Laboratoire de Chimie Analytique et Analyse des Médicaments, Université d’Abomey Calavi, Bénin;
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Laboratoire de Chimie Analytique et Analyse des Médicaments, Université d’Abomey Calavi, Bénin;
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Achille Loconon Yémoa
Achille Loconon Yémoa
Laboratoire de Chimie Analytique et Analyse des Médicaments, Université d’Abomey Calavi, Bénin;
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Dodji Boris Aurel Guidan
Dodji Boris Aurel Guidan
Laboratoire de Chimie Analytique et Analyse des Médicaments, Université d’Abomey Calavi, Bénin;
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Seyive Hélène Solange Ahouandjinou
Seyive Hélène Solange Ahouandjinou
Agence Nationale de Contrôle de Qualité des produits de santé et de l’eau, Ministère de la Santé, Benin;
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Ahmed Amoussa
Ahmed Amoussa
Laboratoire de Chimie Analytique et Analyse des Médicaments, Université d’Abomey Calavi, Bénin;
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Francis Moïse Dossou
Francis Moïse Dossou
Service de Chirurgie Générale, Centre Hospitalo-Universitaire Départemental Ouémé-Plateau, Bénin;
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Roland Marini Djang’eing’a
Roland Marini Djang’eing’a
Department of Pharmacy, CIRM, Laboratory of Analytical Pharmaceutical Chemistry, University of Liege, Belgium;
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Olivia Dalleur
Olivia Dalleur
Louvain Drug Research Institute, Clinical Pharmacy, Université Catholique de Louvain (UCLouvain), Belgium;
Pharmacy Department, Cliniques Universitaires Saint-Luc, UCLouvain, Belgium
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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.
- Supplemental Materials (PDF 77 KB)
Author Notes
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.
ProCite
RefWorks
Reference Manager
BibTeX
Zotero
EndNote
-
1.
WHO , 2011. The World Medicines Situation 2011. Medicines Prices, Availability and Affordability. Geneva, Switzerland: World Health Organization. Available at: https://www.who.int/medicines/areas/policy/world_medicines_situation/WMS_ch6_wPricing_v6.pdf.
-
2.
WHO , 2017. Global Surveillance and Monitoring System for Substandard and Falsifed Medical Products. Geneva, Switzerland: World Health Organization. Available at: https://www.who.int/publications/i/item/WHO-MVP-EMP-SAV-2019.04.
-
3.
Delepierre A, Gayot A, Carpentier A, 2012. Update on counterfeit antibiotics worldwide; public health risks. Med Mal Infect 42: 247–255.
-
4.
Ebrahim GJ, 1993. The Bamako initiative. J Trop Pediatr 39: 66–67.
-
5.
Nayyar GML et al., 2019. Falsified and substandard drugs: stopping the pandemic. Am J Trop Med Hyg 100: 1058–1065.
-
6.
Ozawa S et al., 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. https://doi.org/10.1001/jamanetworkopen.2018.1662.
-
7.
Peyraud N et al., 2017. An epidemic of dystonic reactions in central Africa. Lancet Glob Health 1: e181662.
-
8.
Rahman M. S. et al.2018. The health consequences of falsified medicines—a study of the published literature. Trop. Med. Int. Health 23: 1294–1303.
-
9.
Sengaloundeth S et al., 2009. A stratified random survey of the proportion of poor quality oral artesunate sold at medicine outlets in the Lao PDR - implications for therapeutic failure and drug resistance. Malar J 8: 172.
-
10.
WHO , 2006. The Safety of Medicines in Public Health Programmes: Pharmacovigilance an Essential Tool. Geneva, Switzerland: World Health Organization. Available at: https://www.who.int/medicines/areas/quality_safety/safety_efficacy/Pharmacovigilance_B.pdf.
-
11.
Schafermann 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.
-
12.
Nickerson JW, Attaran A, Westerberg B, Curtis S, Overton S, Mayer PM, 2016. Fatal bacterial meningitis possibly associated with substandard ceftriaxone. MMWR Morb Mortal Wkly Rep 64: 1375–1377.
-
13.
Bliese SL, Maina MW, Were PM, Lieberman M, 2019. Detection of degraded, adulterated, and falsified ceftriaxone using paper analytical devices. Anal Methods 11: 4727–4732.
-
14.
United Nations Department of Economic and Social Affairs , 2017. Sustainable Development Goal 3. Ensure Healthy Lives and Promote Well-Being for All at All Ages. Available at: https://www.un.org/sustainabledevelopment/health/.
-
15.
Rothe C, Schlaich C, Thompson S, 2013. Healthcare-associated infections in sub-Saharan Africa. J Hosp Infect 85: 257–267.
-
16.
WHO , 2019. Minimum Requirements for Infection Prevention and Control. Geneva, Switzerland: World Health Organization. Available at: https://www.who.int/publications/i/item/9789241516945.
-
17.
Ministere de la Santé Bénin , 2009. Plan National de Développement Sanitaire 2009–2018. Available at: https://www.prb.org/wp-content/uploads/2018/05/Plan-National-de-De%CC%81veloppement-Sanitaire-2009-2018.-Be%CC%81nin.pdf.
-
18.
Yemoa A et al., 2017. Detection of poor quality artemisinin-based combination therapy (ACT) medicines marketed in Benin using simple and advanced analytical techniques. Curr Drug Saf 12: 178–186.
-
19.
Baba-moussa F. et al., 2015. Quality control of selected antimalarials sold in the illicit market: an investigation conducted in Porto-Novo City (Republic of Benin). Adv Biosci Biotech 6: 637–644.
-
20.
Habyalimana V. et al., 2015. Analytical tools and strategic approach to detect poor quality medicines, identify unknown components, and timely alerts for appropriate measures: case study of antimalarial medicines. Am J Anal Chem 06: 977–994.
-
21.
European Centre for Disease Prevention and Control , 2013. Systematic Review and Evidence-based Guidance on Perioperative Antibiotic Prophylaxis. Available at: https://www.ecdc.europa.eu/en/publications-data/systematic-review-and-evidence-based-guidance-peri-operative-antibiotic.
-
22.
Yehouenou CL et al., 2020. Antimicrobial resistance in hospitalized surgical patients: a silently emerging public health concern in Benin. Ann Clin Microbiol Antimicrob 19: 1–10.
-
23.
World Health Organization , 1999. Counterfeit Drugs: Guidelines for the Development of Measures to Combat Counterfeit Drugs. Geneva, Switzerland: World Health Organization. Available at: http://apps.who.int/medicinedocs/pdf/h1456e/h1456e.pdf.
-
24.
US Pharmacopeia , 2019. USP 42-NF37. Available at: https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/USP42-NF37%202S%20Annotated.pdf.
-
25.
Mahamba AM, 2019. Analyse physico-chimique et microbiologique de la ceftriaxone commercialisée sur le marché de la ville de Butembo, province du Nord-Kivu/RDC. Universite de Kinshasa, Faculté des Sciences Pharmaceutiques.
-
26.
Tippa DMR, Singh N, 2010. Development and validation of stability indicating HPLC method for simultaneous estimation of amoxicillin and clavulanic acid in injection. Am J Anal Chem 01: 95–101.
-
27.
Grunwald N, Vigneron J, Blaise N, Perrin A, May I, Hoffman MA, 1997 . Determination of aminoglycosids concentration in injectable solutions by conductimetric method. J Pharm Clin 16: 189–192.
-
28.
Harron DWG, 2013. Technical requirements for registration of pharmaceuticals for human use: the ICH process. Textb Pharm Med 1994: 447–460.
-
29.
WHO , 2012. Test for Sterility. Geneva, Switzerland: World Health Organization, 571–572.
-
30.
U.S. Food and Drug Administration , 2020. Code of Federal Regulations. Title 21, Volume 8. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=820.3.
-
31.
Diop A et al., 2009. Contrôle de la qualité de quelques molécules antibiotiques utilisées au Sénégal. Med Trop (Mars) 69: 251–254.
-
32.
Kelesidis T, Falagas E, 2015. Substandard/counterfeit antimicrobial drugs. Med Mal Infect 28: 443–464.
-
33.
Boulanger B, Rozet E, Rudaz S, Hubert P, 2009. A risk-based analysis of the AAPS conference report on quantitative bioanalytical methods validation and implementation. J Chromatogr B 877: 2235–2243.
-
34.
Caudron JM et al., 2008. Substandard medicines in resource-poor settings: a problem that can no longer be ignored. Trop Med Int Health 13: 1062–1072.
-
35.
Adandé GF, 2017. 84 Tonnes de Faux Médicaments Saisis au Bénin. Available at: https://www.voaafrique.com/a/i-84-tonnes-de-feux-medicaments-saisis-au-benin-dans-la-lutte-contre-la-vente-illegale/3746807.html.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 5190 | 1957 | 261 |
| Full Text Views | 179 | 11 | 1 |
| PDF Downloads | 131 | 11 | 0 |