For the past two years, the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota has been investigating the vulnerability of the U.S. drug supply chain to shortages of drugs and their active pharmaceutical ingredients, and especially those made in other countries, principally China and India. The emergence of the COVID-19 pandemic in early 2020 has exposed many of these vulnerabilities.
Drug shortages can be a matter of life and death, and some shortages mean that a life-saving drug is not available to U.S. patients at any price.
Already, there are growing shortages in the U.S. and Europe for COVID-19-related drugs. Twenty-nine (73%) out of the 40 COVID-19 treatment drugs and 67 (43%) of the 156 critical acute drugs are in shortage status before the new case surge occurs. Drug production is further compromised with the growing case-related manufacturing shutdowns occurring in Italy and India.
According to a new report from CIDRAP, there is an urgent need for new, more effective policy with robust transparency to solve the persistent drug shortage issues plaguing the U.S. healthcare system.
“Ensuring a Resilient US Prescription Drug Supply,” the sixth report in a multipart series titled, "COVID-19: The CIDRAP Viewpoint," identifies the pressing issues facing the U.S. drug supply chain. It also proposes several recommendations, which if implemented, will provide a new national entity focused on better understanding the complex reasons for drug shortages and will establish a systematic approach for analyzing, predicting, preventing and mitigating drug shortages.
In the U.S., the lack of visibility into the upstream drug supply chain severely hampers the ability of the market and of policymakers to monitor and address drug quality issues. It also facilitates market conditions that lead to drug shortages. Additionally, a number of serious threats to the U.S. drug supply chain could precipitate a major shortage, intentionally or through natural causes, and such disruptions could lead to major healthcare consequences and costs.
In the report, CIDRAP recommends:
- The United States should have a national process and infrastructure for analyzing, predicting, managing and preventing shortages of critical medications.
- An in-depth map of the U.S. drug supply chain is needed to identify where each drug product in the U.S. market was made, including where the starting materials, active pharmaceutical ingredients, and finished drug product were produced.
- Congress should authorize and fund a national entity to build the map noted above, publish information on each drug’s supply chain, acquire and analyze prescription drug expenditure data, estimate the consequences of failing to address drug shortages, and coordinate the development of related national policy.
- This national entity could be an existing agency such as the Food and Drug Administration (FDA), National Institutes of Health (NIH), National Library of Medicine, or U.S. Pharmacopeia Convention. Alternatively, a new federal entity may be established.
- Prescription drug profiles for each drug product (at the National Drug Code level) should be made publicly available on a consumer-friendly website, with information as noted in the text.
- An ongoing research program on the resilience of the U.S. drug supply chain should be conducted and include the development of a sentinel system that can detect signals that may precede a supply chain disruption or drug shortage.
- The country should develop and regularly update lists of essential or critical drugs to be used for ensuring a high-quality and resilient drug supply for the military, triage during natural disasters, and the general public’s need for critical drugs for both acute and chronic conditions.
- Congress should authorize a federal agency (such as the FDA or Department of Health and Human Services) to prepare a response plan for managing and mitigating drug shortages and other supply chain disruptions.
- Congress should authorize and fund a federal agency to monitor the changing landscape of pharmaceutical manufacturing and the supply chain for prescription drugs.
“The urgency with the drug shortage supply issue is related directly to the major increase in COVID-19 cases that we will experience in the coming months,” said Michael Osterholm, PhD, MPH, CIDRAP director, University of Minnesota Regents Professor, McKnight Presidential Endowed Chair in Public Health, and co-principal investigator of the CIDRAP Resilient Drug Supply Project. “This, in turn, will dramatically increase the need for specific COVID-19 treatment drugs, while at the same, COVID-19 is having a major impact on two of the three key drug manufacturing areas of the world, India and Italy.”
“What makes the drug shortage such a challenging crisis is that no one organization or agency oversees this situation and responds accordingly, not even the FDA,” added Stephen W. Schondelmeyer, PharmD, PhD, co-principal investigator of the CIDRAP Resilient Drug Supply Project, director of the PRIME Institute at the University of Minnesota and the Century Mortar Club Endowed Chair in Pharmaceutical Management & Economics in the College of Pharmacy. “And no one area of the country is specifically hit with this problem as drugs will be allocated to those areas most in need, that is until everyone is in shortage status. Then we will have a national crisis.”
CIDRAP’s Resilient Drug Supply Project, which produced the new report, is supported by the Walton Family Foundation at the recommendation of Christy Walton.
About the Center for Infectious Disease Research and Policy
The Center for Infectious Disease Research and Policy is a global leader in addressing public health preparedness and emerging infectious disease response. Founded in 2001, CIDRAP is part of the Office of the Vice President for Research at the University of Minnesota.