The Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota has announced preliminary findings from its Resilient Drug Supply Project to address shortages of life-saving drugs in the U.S.
The Resilient Drug Supply Project focuses on the supply chains and global disruptions for the most critical drugs for life-saving and life-sustaining treatment. As part of this work, CIDRAP is developing a detailed mapping of the entire supply chain for critical U.S. drug products, from key starting materials to patients.
Outcomes of this research will improve the health care supply system’s ability to maintain a steady and adequate supply of critical medicines and supplies worldwide.
For the past 18 months, CIDRAP, supported by Christy Walton through the Walton Family Foundation, and in partnership with the New Zealand Medicines & Medical Devices Safety Authority, has been investigating the vulnerability of the U.S. healthcare system to shortages of drugs and their active pharmaceutical ingredients (API) and especially those made in other countries, principally China and India.
This critical drug supply chain is likely to be significantly disrupted by the COVID-19 pandemic.
Preliminary findings include:
- 156 critical drugs have been identified that are needed for acute care within a few hours to days or patient mortality rises;
- many of these drugs are made, formulated, packaged, or have an API made in China, India, Italy or other severely affected countries;
- the precise health risk of drug shortage to the U.S. healthcare system is difficult to determine due to the lack of structural transparency and available supply chain data about drugs, which may be known by pharmaceutical companies, wholesalers, suppliers, and contract manufacturers, but not shared with the Food and Drug Administration or the public;
- if pharmaceutical companies, their suppliers, and contract manufacturers do not disclose supply chain information on critical drugs, including their current inventory and relative dependency on any China/India-based supply chain, it is assumed that some of the 156 critical drugs will be in short supply within the next 90 days.
Albuterol (asthma inhalers), epinephrine (EpiPens), heparin, ketamine, prednisone, vasopressin, verapamil and warfarin are included on the list, as well as several antibiotics.
The full Critical Acute Drug List for Resilient Drug Supply Project is available here.
“With the COVID-19 pandemic expected to last many more months and with more patients in need of life-saving drugs, we call upon the pharmaceutical companies and their partners to publicly come forward with current inventory levels and information on the status and relative resiliency of their critical drug supply chains,” said Michael T. Osterholm, Co-Principal Investigator of the project and University of Minnesota Regents Professor, McKnight Presidential Endowed Chair in Public Health, and director of CIDRAP. Osterholm added information on supply chains is essential to healthcare systems, nursing homes, pharmacies, and public health agencies as they plan and prepare in the event a shortage of drugs arises.
“This is life and death, and the public needs to know where their drugs come from and be assured they will always be available in a timely manner,” according to Stephen W. Schondelmeyer, Co-Principal Investigator of the project and Professor in the College of Pharmacy at the University of Minnesota, Century Mortar Club Endowed Chair in Pharmaceutical Management & Economics, and Director of the PRIME Institute.