Georgetown, USP Launch Training Program to Examine Substandard, Falsified Medicines

Posted in GUMC Stories

July 18, 2017 – A new fellowship offered by Georgetown University Medical Center (GUMC) and USP, a global health organization that works to develop independent, transparent standards for quality in medicines and other health products, will help address a serious global health threat: substandard and falsified medicines. 

Through the Fellowship in Quality of Medical Products at GUMC, two fellows will receive specialized training to conduct mentored research on important evidentiary gaps in demonstrating the value of improving medicine quality with a special focus on antimicrobial resistance (AMR).

The program, beginning this fall, comes at a time when substandard and falsified medicines are increasingly affecting people in all corners of the world. For example, poor quality medicines drive AMR by exposing patients to ineffective doses of medicine, thereby enabling the development of resistant pathogens.

Scope and Scale Unknown

A recent literature review found that up to 10 percent of medicines worldwide may be falsified. Anti-infectives, anti-malarials and genito-urinary/sex hormones are particularly affected, according to the World Health Organization (WHO). 

Substandard or falsified medicines are often designed to appear identical to the genuine product. While they don’t always cause an obvious or immediate adverse reaction, they may be altered in a variety of ways, ranging from containing other unsuspected medicines or contaminants to having no or reduced amounts of the desired drug.

Falsified or substandard medicines raise 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.  

“When subpotent medicines are given to a child with malaria or pneumonia, for example, they not only pose great risk to that individual, but also can help induce resistance in the infecting organisms to the antimalarial or antibiotic used, affecting others,” explains Jesse Goodman, MD, MPH, director of Georgetown’s Center on Medical Product Access, Safety and Stewardship, and a mentor in the fellowship program. Goodman is also the current volunteer president of the USP convention and a member of USP’s board.

Over time, widespread use of substandard or falsified anti-infective medicines contributes to resistance to treatment, adding to the growing global crisis of antimicrobial resistance. Conversely, access to safe and effective quality-assured medicines is critical worldwide. 

Real-World Training

The new GUMC Fellowship is sponsored by the USP’s Quality Institute, a new research institute within USP dedicated to developing and disseminating research and data on the impact of improving medicine quality.

The fellows, who will be based at Georgetown, will have the unique opportunity to engage in real-world training experiences, as well as interactions with USP and other stakeholders.

“Quality Institute brings a wealth of policy, scientific and technical expertise to this fellowship program,” says Michael Levy, vice president and leader of the Quality Institute. “It is critical to identify holes in our understanding of the value of quality medicines and then develop the evidence to fill those gaps as a foundation to enable fact-based discussions and decisions by policy makers. Ultimately, the aim is to improve medicine quality globally and help to ensure access to quality-assured medicines for people around the world.”

“This fellowship program expands upon existing efforts at Georgetown to provide mentored, real-world training in specialized areas of research,” says Erin Wilhelm, MPH, director of the fellowship program. “We are delighted to partner with USP to shine a light on a very specific area of global public health concern. Having access to experts and dedicated time to devote to research will not only enhance the careers of the fellows, but also lead to meaningful outcomes in the quality of medicines.”

This opportunity is for qualified candidates with advanced degrees who wish to conduct and receive specialized training in research related to quality of medical products. For more information, download the RFA , and direct any questions via email to Erin Wilhelm.