New research published in the JAMA Network Open journal has found that 13.6 percent of medicines in low- and middle-income countries are falsified or substandard — a higher figure than the 10 percent figure reported in a 2017 study by the World Health Organization. In practice, that means people who believe they are being treated for malaria and children who are taking antibiotics to fight pneumonia are actually taking poor-quality medicines that may put them at risk of prolonged illness, poisoning, adverse drug reactions, and even death.
The article “Prevalence and Estimated Economic Burden of Substandard and Falsified Medicines in Low- and Middle-Income Countries,” found that the problem is greatest in Africa, where 18.7 percent of medicines are poor quality. It also addressed the enormous economic costs to patients, who may drain their personal savings and assets to purchase these drugs, and society as a whole, which must deal with the increased health care costs, decreased economic productivity, and reduced sales and tax revenue. In calculating the problem’s economic burden, study estimates range from $10 billion-$200 billion, depending on the size of the market.
The discrepancy between the findings from the JAMA and WHO reports highlights the fact that there is not enough research being done to understand the scope of this issue. More research is needed to address this critical public health challenge appropriately on a global scale.
The threat of poor-quality medicines to global health
Both studies point out that the pervasiveness of falsified and substandard medicines is a significant impediment to progress to-date in global disease prevention and treatment — and requires much greater attention by health program planners. To illustrate the gravity of the problem, WHO noted that treatment failures due to substandard and falsified antimalarials in sub-Saharan Africa alone cost health providers and patients $38.5 million annually. Worse still, up to 169,000 children with pneumonia may be dying each year due to treatment with poor-quality antibiotics.
“More research is needed so this critical public health challenge can be addressed appropriately on a global scale.”— Emily Kaine, senior vice president of global health, USP
Increasingly complex global supply chains — along with sophisticated criminal networks — make the problem more challenging. Counterfeiters create almost indistinguishable copies of legitimate medicines that may have little or no therapeutic value, or may contain harmful substances. WHO also claims offshore foreign companies and bank accounts are used to facilitate the sale of falsified medicines.
The adage “what is measured is managed” is particularly relevant here. We need more research like the JAMA and the WHO studies to track the level of poor-quality medicines and better data sharing from countries around the world. Above all, this is an urgent call to ministries of health as well as donors — from traditional players such as the Global Fund to Fight AIDS, Tuberculosis and Malaria to private-sector drug companies — to invest in building sustainable systems to ensure that quality, life-saving medicines reach patients.
How can this be solved?
The good news is that we know how to solve this problem. It starts with strong local country infrastructure in the form of medicines regulatory authorities, or MRAs. With the right regulations in place, MRAs can watch medicines circulating in the market and remove poor-quality ones. But many developing countries lack a strong MRA, thus enabling substandard and falsified medicines to flourish.
The Promoting the Quality of Medicines program — or PQM program, financed by the United States Agency for International Development and implemented by USP — is applying a risk-based approach to surveillance in developing countries. We’re helping to implement medicines sampling and testing where the risk to the population is greatest. This approach maximizes the use of available resources and helps support countries to transition from donor-supported sampling and testing to locally funded and sustainable medicine surveillance.
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In 2009 for example, the Liberian government partnered with PQM to establish an MRA and began surveillance on the proliferation of poor-quality medicines. The results were staggering. Surveillance showed that nearly half of all antimalarial medicine samples were poor quality. With malaria a leading cause of death, this highlighted the public health emergency. It was akin to fighting a fire with a faulty extinguisher.
Equipped with new surveillance data and a strong MRA, Liberia is addressing the problem and cracking down on poor-quality medicines. Last year alone, Liberian officials removed nearly 30,000 packages of poor-quality antimalarials from the market.
People around the world should be able to trust that the medicines they use to treat their illnesses won’t make them sicker. We need more data and more donors to invest in quality assurance for medicines, including medicines surveillance. This will ensure quality medicines are reaching patients and saving lives.