Researchers working to improve pharmaceutical drug supply chain
We’ve all taken a generic drug to alleviate a headache, get rid of a virus, prevent an infection or reduce inflammation. But how often do we really think about where these common drugs are manufactured ― let alone their quality?
A new funded research project led by Professor John Gray seeks to address the growing concern about the quality and resilience of the U.S. drug supply, specifically generic drugs.
Gray, the dean’s distinguished professor of operations in the Department of Operations and Business Analytics at Fisher, was named the principal investigator (PI) on a $1.52 million grant focused on pharmaceutical supply chain quality and resilience.
“A key goal of this research is to study the drivers of quality issues and shortages in the pharmaceutical industry, particularly surrounding generic drugs, which is a priority for government agencies such as the Department of Defense (DOD).” Gray said.
Generic drugs and U.S. supply shortages are inextricably linked. According to testimony shared in a 2023 U.S. Senate Committee on Finance meeting regarding drug shortages, 90% of all medicines prescribed nationwide are generic drugs, and 84% of drug shortages involve generic drugs. As shortages have become more frequent, researchers have discovered that more than half (62%) of all shortages have been caused by quality issues.
“In the process of our project, we hope to develop drug-level scores for quality risk and resilience, at least for a set of drugs deemed critical by the DOD,” Gray said.
His project is part of a larger grant awarded to Uniformed Services University’s (USU’s) Center for Health Services Research entitled “Domestic Production of Pharmaceutical Products for the Military Health System.” The project’s other lines of effort are led by PIs from USU, Johns Hopkins and Brookings.
Gray, along with two post-doctoral students, two PhDs and sub-awardee Professor Rob Handfield of North Carolina State University, will contribute to the DOD research in two ways.
The initial focus will be on drugs that appear on multiple Essential Medicine Lists (EMLs) from the DOD, the U.S. Department of Health and Human Services, the Food and Drug Administration and the World Health Organization.
The EMLs contain many common drugs such as acetaminophen, aspirin, albuterol, amoxicillin, atropine, epinephrine, heparin, ibuprofen, ketamine, lorazepam, meloxicam, nitroglycerin, various types of penicillin, potassium chloride, zinc, topical alcohol-based sanitizers and seasonal vaccines for influenza and tetanus.
“From this subset of drugs, we’ll try to create valid and reliable resiliency scores and quality risk scores based on the regulatory history of the manufacturer, the drug’s adverse event history and other creative data that we hope to compile,” Gray said. “The idea is that these scores will be used by the DOD in sourcing and pricing decisions.”
The comparison of these EMLs will also help policymakers who are working to provide solutions to strengthen the U.S. pharmaceutical supply chain.
“The outcomes of this research could be good news for everyone,” Gray said. “In theory, hospitals, health insurers and other drug purchasers could also use the information we find.”
The research project draws on Gray’s extensive expertise in pharmaceutical supply chains as a researcher and thought leader. A recently published paper authored by Gray and two former Fisher PhD students shows variation in the quality risk of drugs, depending on where they are manufactured. Gray is also studying how increased transparency among drug manufacturers may affect the pharmaceutical marketplace.
Gray was recently named president of the Industry Studies Association, an organization dedicated to promoting industry studies research. He also recently concluded a prestigious appointment as a consultant in the Executive Office of the President in Washington, D.C., where he provided insights and expertise related to pharmaceutical supply chain policy to the Biden administration.
