Aug 4, 2024: A major research project has raised alarm over the prevalence of substandard or fake medicines in Africa, suggesting that this issue could be contributing to the deaths of countless patients. Researchers from Bahir Dar University in Ethiopia reviewed 27 studies, analyzing 7,508 medicine samples. They found that 1,639 of these samples failed at least one quality test, confirming them to be substandard or falsified.
Claudia Martínez, head of research at the Access to Medicine Foundation, described the findings as a significant public health concern. “If patients are receiving substandard or fake medicines, their treatment can fail, leading to preventable deaths,” she stated. Last year, estimates by the UN Office on Drugs and Crime suggested that substandard and falsified medicines might be responsible for up to 500,000 deaths annually in sub-Saharan Africa.
The term “substandard medicines” refers to those that are authorized but fail to meet quality standards, while “falsified medicines” deliberately misrepresent their identity, composition, or source. A spokesperson for the World Health Organization (WHO) noted that antibiotics and antimalarial products are the most commonly falsified medicines in Africa. These substandard products can contain incorrect dosages or wrong active ingredients, leading to ineffective treatments and promoting the survival of resistant strains, thereby exacerbating antimicrobial resistance.
According to the study, Malawi has the highest proportion of substandard and falsified medicines. Martínez identified several contributing factors, including complex, inefficient, and fragmented pharma supply chains in many low- and middle-income countries. These regions heavily rely on a limited number of suppliers for essential medicines, face significant challenges in timely procurement, and struggle to effectively police product quality in the market. The involvement of multiple middlemen in the distribution process further facilitates the infiltration of substandard or falsified medicines.
A previous WHO study estimated that one in 10 medical products in developing countries were substandard or falsified, with 42% of reports coming from Africa. Sean Cavany, a mathematical modeller at the University of Oxford’s Centre for Tropical Medicine and Global Health, cautioned against overgeneralizing these findings. He noted potential biases in such reviews and highlighted the variability of substandard and falsified medicines over time and across regions.
Martínez called for immediate action from governments, national authorities, regulators, and pharmaceutical companies to address the issue. She emphasized the need to strengthen supply chains, improve logistics, and implement better surveillance and monitoring systems. Pharmaceutical companies should report cases of substandard or falsified medical products to national health authorities and the WHO rapid alert system promptly and contribute to capacity building.
A WHO spokesperson highlighted the need for a concerted multi-stakeholder approach to prevent, detect, and respond to substandard and falsified products. Increasing public awareness of the scope, scale, and potential harm caused by these products is also crucial.