EClinicalMedicine · 2025
Quality of antidiabetic medicines in 13 sub-Saharan African countries: a cross-sectional survey.
СтатьяНазвание и аннотация: Перевод в очереди
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Antignac Marie, N'Guetta Roland, Secretan Philippe Henri, Do Bernard, Ikama Meo Stephane, Mipinda Jean Bruno, Toure Ibrahim Ali, Takombe Jean Laurent, Lubenga Yves, Dia Mouhamadoul Mounir, Isselmou Boukhary Ould El Bou, Dalaba Maxwell, Balde Naby Moussa, Kake Amadou, Sy Ely Cheikh Ibrahima, Cavagna Pauline, Perier Marie Cécile, Sobngwi Eugène, Cisse Pr Badara, Boitard Christian, Empana J P, Diop I Bara, Mbaye Maimouna Ndour, Jouven Xavier
Аннотация
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).
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).