Quality of antidiabetic medicines in 13 sub-Saharan African countries: a cross-sectional surveyResearch in context
Summary: Background: The burden of diabetes is rising dramatically in low- and middle-income countries. The menace of substandard and falsified drugs constitutes a major hazard that compromises healthcare. The DIABDAF study aimed to assess the quality of routinely used antidiabetic drugs including...
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Elsevier
2025-09-01
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| author | Marie Antignac Roland N'Guetta Philippe Henri Secretan Bernard Do Meo Stephane Ikama Jean Bruno Mipinda Ibrahim Ali Toure Jean Laurent Takombe Yves Lubenga Mouhamadoul Mounir Dia El Bou Isselmou Boukhary Ould Maxwell Dalaba Naby Moussa Balde Amadou Kake Ely Cheikh Ibrahima Sy Pauline Cavagna Marie Cécile Perier Eugène Sobngwi Pr Badara Cisse Christian Boitard J.P. Empana I. Bara Diop Maimouna Ndour Mbaye Xavier Jouven |
| author_facet | Marie Antignac Roland N'Guetta Philippe Henri Secretan Bernard Do Meo Stephane Ikama Jean Bruno Mipinda Ibrahim Ali Toure Jean Laurent Takombe Yves Lubenga Mouhamadoul Mounir Dia El Bou Isselmou Boukhary Ould Maxwell Dalaba Naby Moussa Balde Amadou Kake Ely Cheikh Ibrahima Sy Pauline Cavagna Marie Cécile Perier Eugène Sobngwi Pr Badara Cisse Christian Boitard J.P. Empana I. Bara Diop Maimouna Ndour Mbaye Xavier Jouven |
| author_sort | Marie Antignac |
| collection | DOAJ |
| description | Summary: Background: The burden of diabetes is rising dramatically in low- and middle-income countries. The menace of substandard and falsified drugs constitutes a major hazard that compromises healthcare. The DIABDAF study aimed to assess the quality of routinely used antidiabetic drugs including oral drugs and insulins in sub-Saharan Africa. Methods: Drugs were collected in 13 sub-Saharan African cities in licensed and unlicensed places of sales between February 2020 and March 2023. Chemical analyses were conducted blindly in a public laboratory following recommended good laboratory practices. Drug quality was classified based on the ratio of measured to expected active ingredient dosage: 95–105% as good (A), 85–94·99% or 105·01–115% as low (B), and below 85% or above 115% as very low (C). Impurity levels were assessed using thresholds from the United States and European Pharmacopoeias monographs. Findings: A convenient samples of 4951 antidiabetic drugs were collected from 13 sub-Saharan African countries (Seven middle-income and six low-income countries). Out of the 1673 (of 4951 collected) drug samples randomly tested, 28·0% (n: 468, 95% CI [22·3–33·0]) failed to meet standards related to the expected content of active ingredients (B: 27·2% 95% CI [21·5–32·0]; C: 0·8% 95% CI [0·2–3·5]), with more samples showing underdosage (19·31% 95% CI [14·8–24·3]) than overdosage (8·67% 95% CI [5·3–12·5]). Impurity levels were excessive in 9·68% (n: 162, 95% CI [6·0–14·8]) of samples. Overall, 32·8% (n: 548, 95% CI [26·5–38·1]) were deemed to be of poor quality according to active ingredient content or impurity level. In multivariate logistic regression, factors associated with worse quality were drugs, expired status, and country of purchase. Interpretation: In this multinational study assessing the quality of antidiabetic drugs in sub-Saharan Africa, we found a significant proportion of poor-quality drugs. National health authorities must take action to ensure access to safe, high-quality medications for diabetic patients. Funding: DIABDAF study was exclusively supported by French public grant (INSERM, AVIESAN, AP-HP, and University of Paris Cité). |
| format | Article |
| id | doaj-art-395375d1e7cc4cc9862f1052208fefa5 |
| institution | Kabale University |
| issn | 2589-5370 |
| language | English |
| publishDate | 2025-09-01 |
| publisher | Elsevier |
| record_format | Article |
| series | EClinicalMedicine |
| spelling | doaj-art-395375d1e7cc4cc9862f1052208fefa52025-08-20T03:41:26ZengElsevierEClinicalMedicine2589-53702025-09-018710340510.1016/j.eclinm.2025.103405Quality of antidiabetic medicines in 13 sub-Saharan African countries: a cross-sectional surveyResearch in contextMarie Antignac0Roland N'Guetta1Philippe Henri Secretan2Bernard Do3Meo Stephane Ikama4Jean Bruno Mipinda5Ibrahim Ali Toure6Jean Laurent Takombe7Yves Lubenga8Mouhamadoul Mounir Dia9El Bou Isselmou Boukhary Ould10Maxwell Dalaba11Naby Moussa Balde12Amadou Kake13Ely Cheikh Ibrahima Sy14Pauline Cavagna15Marie Cécile Perier16Eugène Sobngwi17Pr Badara Cisse18Christian Boitard19J.P. Empana20I. Bara Diop21Maimouna Ndour Mbaye22Xavier Jouven23Department of Pharmacy, Pitié Salpêtrière Hospital, AP-HP, Paris, France; Cluster of Research Excellence Non Communicable Disease Core-NCD ARUA (African Research Universities Alliance) - THE GUILD (The Guild of European Research Intensive Universities), Paris, France; Paris Global Health Institute, Université Paris Cité, France; Université Paris Cité, Inserm, PARCC, F-75015 Paris, France, Team Integrative Epidemiology of Cardiovascular Diseases; African Research Network (ARNcd) Consortium, Senegal; Corresponding author. Department of Pharmacy, Pitié Salpêtrière Hospital, AP-HP, Paris, France.Paris Global Health Institute, Université Paris Cité, France; African Research Network (ARNcd) Consortium, Senegal; Cardiology Department, Institut de Cardiologie d’Abidjan, Abidjan, Côte d'IvoireLaboratoire Matériaux et Santé, Université Paris-Saclay, Orsay, 91400, FrancePharmaceutical Department, Gustave Roussy Cancer Campus, Villejuif, 94805, France; Université Paris-Saclay, CNRS, Institut des Sciences Moléculaires d'Orsay, Orsay, 91405, FranceAfrican Research Network (ARNcd) Consortium, Senegal; Cardiology Department, Centre Hospitalier Universitaire de Brazzaville, Brazzaville, CongoAfrican Research Network (ARNcd) Consortium, Senegal; Cardiology Department, Centre Hospitalier Universitaire de Libreville (CHUL), Libreville, GabonAfrican Research Network (ARNcd) Consortium, Senegal; Cardiology and Internal Medicine, Centre Hospitalier Universitaire LAMORDÉ, Niamey, NigerAfrican Research Network (ARNcd) Consortium, Senegal; Cardiology and Internal Medicine, Clinique Universitaire de Kinshasa, Kinshasa, Democratic Republic of the CongoAfrican Research Network (ARNcd) Consortium, Senegal; Cardiology and Internal Medicine, Clinique Universitaire de Kinshasa, Kinshasa, Democratic Republic of the CongoService de Cardiologie du Centre médico-social de la Fonction publique, Dakar, SenegalAfrican Research Network (ARNcd) Consortium, Senegal; Coordinateur Programme National de Lutte Contre le Diabete, Centre National de cardiologie, Ministere de la Sante, Nouakchott, MauritaniaAfrican Research Network (ARNcd) Consortium, Senegal; University of Health and Allied Sciences (UHAS), Accra, GhanaAfrican Research Network (ARNcd) Consortium, Senegal; Service d'Endocrinologie Diabétologie, CHU de Donka, Conakry, Guinea; Faculté des sciences et techniques de la santé, Université Gamal Abdel Nasser de Conakry, GuineaAfrican Research Network (ARNcd) Consortium, Senegal; Service d'Endocrinologie Diabétologie, CHU de Donka, Conakry, Guinea; Faculté des sciences et techniques de la santé, Université Gamal Abdel Nasser de Conakry, GuineaAfrican Research Network (ARNcd) Consortium, Senegal; Service de Médecine et d’Endocrinologie, Hôpital du Mali, Bamako, MaliDepartment of Pharmacy, Pitié Salpêtrière Hospital, AP-HP, Paris, France; Paris Global Health Institute, Université Paris Cité, France; Université Paris Cité, Inserm, PARCC, F-75015 Paris, France, Team Integrative Epidemiology of Cardiovascular Diseases; African Research Network (ARNcd) Consortium, SenegalParis Global Health Institute, Université Paris Cité, France; Université Paris Cité, Inserm, PARCC, F-75015 Paris, France, Team Integrative Epidemiology of Cardiovascular DiseasesAfrican Research Network (ARNcd) Consortium, Senegal; Department of Internal Medicine and Specialties, University of Yaounde, Yaounde, CameroonAfrican Research Network (ARNcd) Consortium, Senegal; Institut de Recherche en Santé, de Surveillance Épidémiologique et de Formation (IRESSEF), Dakar, SenegalParis Global Health Institute, Université Paris Cité, France; Pathophysiologie, Métabolisme et Nutrition Institute, Paris Cité University, INSERM, FranceParis Global Health Institute, Université Paris Cité, France; Université Paris Cité, Inserm, PARCC, F-75015 Paris, France, Team Integrative Epidemiology of Cardiovascular DiseasesParis Global Health Institute, Université Paris Cité, France; African Research Network (ARNcd) Consortium, Senegal; Cardiology Department, Centre hospitalier de Fann, Dakar, Senegal; Université Cheikh-Anta-Diop, Dakar, SenegalAfrican Research Network (ARNcd) Consortium, Senegal; Centre de Diabétologie Marc Sankalé, Dakar, SenegalCluster of Research Excellence Non Communicable Disease Core-NCD ARUA (African Research Universities Alliance) - THE GUILD (The Guild of European Research Intensive Universities), Paris, France; Paris Global Health Institute, Université Paris Cité, France; Université Paris Cité, Inserm, PARCC, F-75015 Paris, France, Team Integrative Epidemiology of Cardiovascular Diseases; African Research Network (ARNcd) Consortium, Senegal; Université Paris Cité, Paris, France; Department of Cardiology, European G. Pompidou Hospital, AP-HP, Paris, FranceSummary: Background: The burden of diabetes is rising dramatically in low- and middle-income countries. The menace of substandard and falsified drugs constitutes a major hazard that compromises healthcare. The DIABDAF study aimed to assess the quality of routinely used antidiabetic drugs including oral drugs and insulins in sub-Saharan Africa. Methods: Drugs were collected in 13 sub-Saharan African cities in licensed and unlicensed places of sales between February 2020 and March 2023. Chemical analyses were conducted blindly in a public laboratory following recommended good laboratory practices. Drug quality was classified based on the ratio of measured to expected active ingredient dosage: 95–105% as good (A), 85–94·99% or 105·01–115% as low (B), and below 85% or above 115% as very low (C). Impurity levels were assessed using thresholds from the United States and European Pharmacopoeias monographs. Findings: A convenient samples of 4951 antidiabetic drugs were collected from 13 sub-Saharan African countries (Seven middle-income and six low-income countries). Out of the 1673 (of 4951 collected) drug samples randomly tested, 28·0% (n: 468, 95% CI [22·3–33·0]) failed to meet standards related to the expected content of active ingredients (B: 27·2% 95% CI [21·5–32·0]; C: 0·8% 95% CI [0·2–3·5]), with more samples showing underdosage (19·31% 95% CI [14·8–24·3]) than overdosage (8·67% 95% CI [5·3–12·5]). Impurity levels were excessive in 9·68% (n: 162, 95% CI [6·0–14·8]) of samples. Overall, 32·8% (n: 548, 95% CI [26·5–38·1]) were deemed to be of poor quality according to active ingredient content or impurity level. In multivariate logistic regression, factors associated with worse quality were drugs, expired status, and country of purchase. Interpretation: In this multinational study assessing the quality of antidiabetic drugs in sub-Saharan Africa, we found a significant proportion of poor-quality drugs. National health authorities must take action to ensure access to safe, high-quality medications for diabetic patients. Funding: DIABDAF study was exclusively supported by French public grant (INSERM, AVIESAN, AP-HP, and University of Paris Cité).http://www.sciencedirect.com/science/article/pii/S2589537025003372DrugsDiabetesSubstandardCounterfeit drugsFalsified drugsDrug quality |
| spellingShingle | Marie Antignac Roland N'Guetta Philippe Henri Secretan Bernard Do Meo Stephane Ikama Jean Bruno Mipinda Ibrahim Ali Toure Jean Laurent Takombe Yves Lubenga Mouhamadoul Mounir Dia El Bou Isselmou Boukhary Ould Maxwell Dalaba Naby Moussa Balde Amadou Kake Ely Cheikh Ibrahima Sy Pauline Cavagna Marie Cécile Perier Eugène Sobngwi Pr Badara Cisse Christian Boitard J.P. Empana I. Bara Diop Maimouna Ndour Mbaye Xavier Jouven Quality of antidiabetic medicines in 13 sub-Saharan African countries: a cross-sectional surveyResearch in context EClinicalMedicine Drugs Diabetes Substandard Counterfeit drugs Falsified drugs Drug quality |
| title | Quality of antidiabetic medicines in 13 sub-Saharan African countries: a cross-sectional surveyResearch in context |
| title_full | Quality of antidiabetic medicines in 13 sub-Saharan African countries: a cross-sectional surveyResearch in context |
| title_fullStr | Quality of antidiabetic medicines in 13 sub-Saharan African countries: a cross-sectional surveyResearch in context |
| title_full_unstemmed | Quality of antidiabetic medicines in 13 sub-Saharan African countries: a cross-sectional surveyResearch in context |
| title_short | Quality of antidiabetic medicines in 13 sub-Saharan African countries: a cross-sectional surveyResearch in context |
| title_sort | quality of antidiabetic medicines in 13 sub saharan african countries a cross sectional surveyresearch in context |
| topic | Drugs Diabetes Substandard Counterfeit drugs Falsified drugs Drug quality |
| url | http://www.sciencedirect.com/science/article/pii/S2589537025003372 |
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