Antibiotics and antimalarial drugs are most frequently reported as substandard and falsified to the World Health Organization’s Global Surveillance and Monitoring system for such medical products, according to a WHO report released this week. The report estimates that one in ten medical products in low- and middle-income countries either fail to meet quality standards or are counterfeit, and that the market size for such products is in the order of $30 billion.
Increasing globalization and the use of e-commerce are making supply chains for medicines increasingly complex, allowing for new and multiple entry points for unethically and illegally produced products, the report says.
“Nowadays, a tablet taken in Germany may be made in Egypt from ingredients imported from India, Brazil and Spain, packaged in foil that came from China, inserted into a box designed for the United Kingdom of Great Britain and Northern Ireland, and shipped to Liverpool by way of Dubai,” the report notes. “A trader in the United Kingdom, taking advantage of fluctuations in the foreign exchange rate, might legally repackage the medicines with information written in German and ship it to Munich.”
Substandard and falsified medicines are not only a waste of money for individuals, families and health systems, the report notes; such products cause serious illness, death, and pose a substantial threat to rising antimicrobial resistance, and consequently global health security.
“Antimicrobials that do not deliver a full dose because they are badly made or degraded will kill only the most susceptible pathogens,” the report says. “That contributes to antimicrobial resistance through the development of drug-resistant mutations of the pathogen and its onward transmission.”
Antibiotics make up nearly 17 percent of all substandard and falsified products reported to the WHO monitoring system, while malaria medicines make up nearly 20 percent of all reported drugs. Substandard and falsified formulations have been reported for up to 15 percent of the drugs listed in the WHO’s Essential Medicines List, the report says.
Based on modelling exercises, the University of Edinburgh estimates that 72,000 to 169,000 children may die from pneumonia due to substandard and falsified antibiotics every year, while the London School of Hygiene and Tropical Medicine estimates substandard and falsified antimalarial drugs could kill an additional 116,000 people every year.
Since the WHO established the monitoring and surveillance system in 2013, 1,500 cases of substandard and falsified products have been reported, and reports are split evenly between generic and name-brand products. Forty-two percent of reports have come from Africa, 21 percent from the Americas, and 21 percent from Europe, the report says. The report notes that these cases most likely represent a small fraction of the overall problem.
The WHO monitoring and surveillance system has already helped prevent deaths from substandard and falsified medicines, with the report noting one case in which patients in Paraguay were saved after analysis showed they were affected by the same contaminated products that had killed patients in Pakistan months earlier. The contaminated product – in this case, cough syrup – was discovered in other countries and removed from markets.
The sale of substandard and falsified drugs is highest in places where demand for drugs is high, supply is low, and where technical capacity for ensuring good practices in manufacturing, quality control and distribution are limited, the report says.
“Substandard and falsified medicines particularly affect the most vulnerable communities,” Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, said in a statement. “Imagine a mother who gives up food or other basic needs to pay for her child’s treatment, unaware that the medicines are substandard or falsified, and then that treatment causes her child to die. This is unacceptable.”