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
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The DIABDAF study aimed to assess the quality of routinely used antidiabetic drugs including oral drugs and insulins in sub-Saharan Africa.</p><p><strong>Methods: </strong>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.</p><p><strong>Findings: </strong>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% (<i>n</i>: 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% (<i>n</i>: 162, 95% CI [6·0-14·8]) of samples. Overall, 32·8% (<i>n</i>: 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.</p><p><strong>Interpretation: </strong>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.</p><p><strong>Funding: </strong>DIABDAF study was exclusively supported by French public grant (INSERM, AVIESAN, AP-HP, and University of Paris Cité).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"87 ","pages":"103405"},"PeriodicalIF":10.0000,"publicationDate":"2025-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12355408/pdf/","citationCount":"0","resultStr":"{\"title\":\"Quality of antidiabetic medicines in 13 sub-Saharan African countries: a cross-sectional survey.\",\"authors\":\"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\",\"doi\":\"10.1016/j.eclinm.2025.103405\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Findings: </strong>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% (<i>n</i>: 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% (<i>n</i>: 162, 95% CI [6·0-14·8]) of samples. Overall, 32·8% (<i>n</i>: 548, 95% CI [26·5-38·1]) were deemed to be of poor quality according to active ingredient content or impurity level. 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National health authorities must take action to ensure access to safe, high-quality medications for diabetic patients.</p><p><strong>Funding: </strong>DIABDAF study was exclusively supported by French public grant (INSERM, AVIESAN, AP-HP, and University of Paris Cité).</p>\",\"PeriodicalId\":11393,\"journal\":{\"name\":\"EClinicalMedicine\",\"volume\":\"87 \",\"pages\":\"103405\"},\"PeriodicalIF\":10.0000,\"publicationDate\":\"2025-08-07\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12355408/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"EClinicalMedicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.eclinm.2025.103405\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/9/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"EClinicalMedicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.eclinm.2025.103405","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/9/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
Quality of antidiabetic medicines in 13 sub-Saharan African countries: a cross-sectional survey.
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).
期刊介绍：
eClinicalMedicine is a gold open-access clinical journal designed to support frontline health professionals in addressing the complex and rapid health transitions affecting societies globally. The journal aims to assist practitioners in overcoming healthcare challenges across diverse communities, spanning diagnosis, treatment, prevention, and health promotion. Integrating disciplines from various specialties and life stages, it seeks to enhance health systems as fundamental institutions within societies. With a forward-thinking approach, eClinicalMedicine aims to redefine the future of healthcare.
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