Substandard and falsified drugs increasingly affect people in all corners of the world, and they disproportionately impact those living in low- and middle-income countries. According to the World Health Organization, at least 10 percent of drugs worldwide may be substandard or falsified, and medicines used to treat common bacterial infections and malaria are particularly affected.
A new fellowship, sponsored by the US Pharmacopeial Convention (USP) Quality Institute and administered by Boston University, will fund a study of the potential consequences of antimicrobial resistance (AMR) resulting from repeated use of poor-quality pharmaceutical drugs. Such resistance occurs when drug concentrations are insufficient to quickly eradicate the infection, but high enough to create a reproductive advantage for resistant mutants by killing susceptible pathogens.
“These medicines may not contain the correct substance or dose and may include harmful impurities or degraded products,” explains Muhammad Zaman, a College of Engineering professor of biomedical engineering and of materials science and engineering and a Howard Hughes Medical Institute Professor of Biomedical Engineering and International Health, who is a mentor in the fellowship program. “Differentiating genuine medicines from substandard or falsified versions is difficult and usually requires laboratory tests to confirm authenticity. This raises risks both of adverse events and of not properly treating the disease or condition for which they were intended, with potentially serious consequences, including accelerating the rise of antimicrobial resistance,” he says.
It is well known that the widespread use of substandard or falsified antimicrobials contributes to these treatments becoming less effective, but to what extent the poor-quality medicines drive AMR has yet to be determined. Governments and health policymakers around the world need more data about the benefits of quality medicine so they can make strategic decisions about where to invest scarce resources. Zaman says the new fellowship will pair the fellow with expert mentors from BU and USP.
“We are delighted to partner with Boston University and Dr. Zaman to develop evidence about the impact of poor-quality medicines on the rise of AMR,” said Erin Wilhelm, USP Quality Institute director. “Access to safe and effective quality-assured medicines is critical worldwide. This research will heighten awareness of this important public health issue.”
The University will recruit a fellow for the Fellowship in Quality of Medical Products at BU to conduct mentored research on evidentiary gaps in demonstrating the value of medicine quality. The Quality Institute, a research program within USP, develops research and data through partnerships with academic institutions; the BU program is the second fellowship to be established. The fellow, who will be based in Boston, will have the unique opportunity to engage in real-world training experiences, as well as interactions with USP and other stakeholders.
Qualified candidates with advanced degrees interested in conducting research and receiving specialized training in quality of medical products can view the request for application here or email Muhammad Zaman with questions.
Katie Clifford can be reached at firstname.lastname@example.org.