The report released this morning by the Institute Of Medicine portrays a global and growing danger that is both deadly and resource draining, brings the highest risks in the poorest countries, and threatens affluent countries as well. Still, coordinated efforts to tackle the proliferation of fake and substandard medicines lag far behind other efforts to respond to the diseases and epidemics some of those medicines are intended to treat, the report, Countering the Problem of Falsified and Substandard Drugs, shows.
The impacts of underpowered, unsafe, and sometimes toxic medicines affect patients who are harmed and inadequately treated, but also societies that bear the burden of the results, which include drug resistance fostered by incomplete treatment and the need then to develop new drugs, said Professor Lawrence Gostin, chair of the committee on Understanding the Global Public Health Implications of Substandard, Falsified and Counterfeit Medical Products, which produced the report. But the lack of a coordinated system to track and trace drugs, deficits in resources and capacities in countries most affected by substandard drugs, and even a failure to find a common vocabulary to define the problem have hampered efforts to respond to it, Gostin said. While substandard drugs are ones that don’t meet national specifications for disease treatment, fake drugs are ones bearing false representation of their contents or intended use. The report cautions against misusing the word counterfeit — a term that applies to trademark infringement, a legal rather than public health issue.
The report includes among its recommendations that the United States Congress authorize and fund the establishment of a mandatory system through the Food and Drug Administration to track and trace medicines.
“In the interim, because we know the wheels of Congress can grind slowly,” Gostin said, “the FDA should establish a voluntary track and trace system.”
The committee also called on international agencies to help low and middle income countries that do not have the personnel, training or technologies to enforce pharmaceutical regulations to develop those capacities.
The launch of the report follows on the release of a widely reported study examining the scope and implications of fake and substandard drugs on tuberculosis treatment. That study, Substandard and falsified anti-tuberculosis drugs: a preliminary field analysis, found that inadequate versions of the two medicines most commonly used to treat tuberculosis were widely distributed in countries across Africa, Asia, South America and Europe where TB rates are high, with one in six pills collected from neighborhood pharmacies and markets in Africa inadequate for treatment — poorly made, deteriorated, or falsely labelled. Patients were exposed to these drugs because the cost of traveling to government clinics for supervised treatments and quality medicines was prohibitive, study author Roger Bate wrote in a New York Times Op-ed column about the study. The cost of taking inadequate or toxic medicine was higher, death for some patients, and for others the development of drug-resistant strains that would become more expensive to treat, and which also are then transmitted to others. In the column, Bate called for the U.S. Centers for Disease Control and Prevention to lead the fight against substandard drugs and work with the new Office of Global Health Diplomacy as well as the World Bank to help foreign governments to respond.
Paul Jensen, a coauthor of tuberculosis drug study attended the launch of the IOM report this morning. In addition to the resources the of the FDA and the CDC, international agencies, and global health donors are already working in the countries where rates of substandard drug proliferation are highest, he told Science Speaks.
“It’s a matter of marshalling the resources that are there,” he said. “In the case of tuberculosis, I think that’s something that hasn’t been on the radar.”
Some solutions might vary by country, he said, “but from a strategic viewpoint we need to elevate quality to the same level as access on the global tuberculosis agenda. We need to ensure the quality of the TB drug supply, and we need be more innovative in providing access to it–whether it’s providing incentives and enablers for patients to go to quality-assured treatment sites, deploying community health workers to deliver treatment to people where they live and work, or adopting mHealth strategies where drug quality at local pharmacies can be verified and treatment can be monitored all via mobile phone.”