A fifth of medicine in Africa may be substandard or fake, according to a major research project, raising the alarm about a problem that could contribute to the deaths of countless patients.
Researchers from Bahir Dar University in Ethiopia analyzed 27 studies in the review and found, of the 7,508 drug samples included, 1,639 failed at least one quality test and were confirmed to be substandard or counterfeit.
Claudia Martínez, the head of research at the Access to Medicine Foundation, an Amsterdam-based non-profit group, described the finding as a major public health concern.
“If patients are given medicines that are substandard or outright fake, it can lead to failure of their treatment or even preventable deaths,” she said.
Estimates published last year by the UN Office on Drugs and Crime puts the human cost of counterfeit and substandard medicines at up to 500,000 deaths a year in sub-Saharan Africa.
“Substandard medicines” refer to those that are authorized but do not meet quality standards, while “counterfeit medicines” are those that deliberately misrepresent their identity, composition or source.
A spokesperson for the World Health Organization (WHO) said antibiotics and antimalarial products are the most counterfeited medicines in Africa.
Substandard or counterfeit antibiotics may contain incorrect doses or the wrong active ingredients, leading to ineffective treatments and survival of resistant strains. The WHO said that such products are likely to fuel an increase in antimicrobial resistance.
According to the study, Malawi has the highest percentage of substandard and counterfeit medicines.
Martínez said several factors contributed to the problem, leaving patients without access to essential medicines.
She said: “Pharma supply chains in many low- and middle-income countries are often complex, inefficient and fragmented; the region relies heavily on a limited number of suppliers for essential medicines, and many countries face significant challenges in procuring products in a timely manner and effectively policing the quality of products in the market.”
Martínez said the role of various middlemen in the distribution of products on the continent makes it easier for substandard or counterfeit medicines to infiltrate the supply chain.
A previous study by the WHO found that an estimated one in 10 medical products in developing countries were substandard or counterfeit, with 42% of reports of substandard and counterfeit medicines coming from Africa, 21% from the Americas and 21% from Europe.
Sean Cavany, a mathematical modeler at the University of Oxford’s Center for Tropical Medicine and Global Health, cautioned against generalizing findings from the new research.
Cavany said: “There is a potential for bias in these types of reviews, for example surveys that found no substandard and falsified medicines may not be published, and some of the surveys are not randomised, so they may be that they specifically selected samples for this.
“Also, substandard medicines and counterfeit medicines will vary greatly between countries and between medicines over time, so producing an average across all these different factors has the potential to be misleading.”
Cavany said that while previous studies had shown that substandard and counterfeit medicines were highest in Africa, the few studies outside Africa and Asia made it difficult to generalize the findings.
Martínez said immediate action is needed to address the problem by governments, national authorities, regulators and pharmaceutical companies that manufacture and sell the products.
“We need to strengthen supply chains across the continent by improving infrastructure, improving logistics and implementing better surveillance monitoring systems.
“But there is also much that pharmaceutical companies can do by promptly reporting any cases of substandard or falsified medical products to national health authorities and the WHO’s rapid warning system and contributing to capacity building.”
A WHO spokesperson said: “Recent incidents of contaminated oral liquid medicines have shown that we need a joint multi-stakeholder approach to prevent, detect and respond to substandard and counterfeit products.
“Raising public awareness of the scale, scope and potential harm these products cause is a key activity in this.”
