article · American Journal of Tropical Medicine and Hygiene
A cross-sectional survey evaluated the quality of essential paediatric medicines distributed by private pharmaceutical wholesalers in Kinshasa, Democratic Republic of Congo. Researchers covertly sampled 417 products, comprising amoxicillin powders, artemether and lumefantrine powders, and paracetamol tablets. A representative subset of 239 samples underwent visual checks locally and chemical analysis in accredited European laboratories against international pharmacopoeial standards. Visual assessments revealed labelling deficiencies and flaws in antimalarial powders. Chemical assays demonstrated that 27.2 percent of samples failed quality standards, with 59.5 percent of artemether and lumefantrine formulations underdosed in artemether. Products manufactured locally displayed significantly higher failure rates. These defects risk compromising patient recovery and accelerating antimalarial drug resistance, providing critical data to support targeted regulatory interventions.
Substandard paediatric medications severely undermine child health by failing to cure life-threatening infections such as malaria. Furthermore, distributing underdosed treatments fosters the spread of antimicrobial resistance across populations. By uncovering high failure rates among private wholesalers, this evidence alerts healthcare providers and equips regulatory bodies with the specific data required to enforce quality controls across medicine supply chains.
The work provides immediate utility for post-market surveillance programmes, regulatory enforcement, and pharmaceutical supply chain auditing. National medicine regulators and private wholesale distributors can apply the findings immediately to identify vulnerable product categories and monitor local manufacturers. While not representing a proprietary product, the study offers an applied testing framework for quality assurance operations seeking to eliminate substandard pharmaceuticals from regional markets.
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Poor-quality medicines are a threat to public health in many low- and middle-income countries, and prospective surveys are needed to inform corrective actions. Therefore, we conducted a cross-sectional survey on a sample of products used for children and available in the private market in Kinshasa, Democratic Republic Congo: amoxicillin (AX) and artemether/lumefantrine (AL), powders for suspension, and paracetamol (PC) tablets 500 mg. Overall, 417 products were covertly purchased from 61 wholesalers. To obtain a representative sample, the products were weighted on their market shares and a subset of 239 samples was randomly extracted to undergo in-depth visual inspection locally, and they were chemically assessed at two accredited laboratories in Belgium. Samples were defined of "poor-quality" if they failed to comply with at least one specification of the International Pharmacopoeia (for AL) or United States Pharmacopoeia 37 (for AX and PC). Results are reported according to the Medicine Quality Assessment Reporting Guideline. The visual inspection detected nonconformities in the aspects of antimalarial powders for suspension, and poor-quality labels across all medicine types. According to chemical analysis, 27.2% samples were of poor quality and 59.5% of AL samples were underdosed in artemether. Poor quality was more frequent for locally manufactured antimalarials (83.3%, <i>P</i> = 0.021; 86.4%, <i>P</i> = 0.022) and PC (4.8%, <i>P</i> = 0.000). The poor quality of the surveyed products may decrease the treatment's efficacy and favor the development of resistances to antimalarials. It is hoped that these findings may guide the corrective actions of the Democratic Republic of Congo Regulatory Authority, which was the main partner in the research.
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DOI: 10.4269/ajtmh.17-0732
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