Quality of antidiabetic medicines in 13 sub-Saharan African countries: a cross-sectional survey.

IF 10 1区医学 Q1 MEDICINE, GENERAL & INTERNAL

EClinicalMedicine Pub Date : 2025-08-07 eCollection Date: 2025-09-01 DOI:10.1016/j.eclinm.2025.103405

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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引用次数: 0

Abstract

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).

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13个撒哈拉以南非洲国家的抗糖尿病药物质量：横断面调查。

背景：在低收入和中等收入国家，糖尿病负担正在急剧上升。伪劣药品的威胁构成了危及医疗保健的主要危害。DIABDAF研究旨在评估撒哈拉以南非洲地区常规使用的降糖药的质量，包括口服药物和胰岛素。方法：在2020年2月至2023年3月期间，在撒哈拉以南非洲13个城市的有证和无证销售场所收集药物。化学分析是按照推荐的良好实验室规范在公共实验室盲目进行的。根据实际有效成分用量与预期有效成分用量之比对药品质量进行分类：95-105%为良好(A), 85- 94.99%或105.01 -115%为低(B)，低于85%或高于115%为极低(C)。使用美国和欧洲药典专著的阈值评估杂质水平。结果：从13个撒哈拉以南非洲国家（7个中等收入国家和6个低收入国家）收集了4951种抗糖尿病药物。随机检测的1673份（共收集4951份）药物样品中，28.0% （n: 468份，95% CI[22.3 ~ 33.0]）的有效成分预期含量不符合标准（B: 27.2% 95% CI [21.5 ~ 32.0]; C: 0.8% 95% CI[0.2 ~ 3.5]），剂量不足（19.31% 95% CI[14.8 ~ 24.3]）的样品多于过量（8.67% 95% CI[5.3 ~ 12.5]）。9·68% （n: 162, 95% CI[6·0 ~ 14·8]）的样品杂质含量超标。总体而言，根据活性成分含量或杂质水平，32.8% （n: 548, 95% CI[26.5 - 38.1]）被认为质量差。在多元logistic回归中，与质量较差相关的因素是药品、过期状态和购买国家。解释：在这项评估撒哈拉以南非洲地区抗糖尿病药物质量的跨国研究中，我们发现了相当大比例的劣质药物。国家卫生当局必须采取行动，确保糖尿病患者获得安全、高质量的药物。资助：DIABDAF研究由法国公共基金（INSERM， AVIESAN， AP-HP和巴黎城市大学）独家支持。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

EClinicalMedicine Medicine-Medicine (all)

CiteScore

18.90

自引率

1.30%

发文量

506

审稿时长

22 days

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.