Frequently asked questions about creating a resilient drug supply chain.
Last updated: January, 2022
The project team convened an expert working group and led a workshop on Dec 11 and 12, 2018, to create a critical acute drug list. Critical acute drugs were defined as those "needed in acute care, whose absence—or the lack of availability of an effective substitute—will lead to serious health outcomes, including death or the inability to provide humane care." Participating experts came from government, academia, and the private sector and represented the fields of pharmacy, clinical healthcare, medical and pharmaceutical supply chains, public health, preparedness and response, emergency medical services, and drug distribution.
Critical acute drugs are drugs that "when medically needed in acute care must be available and used within hours or days of the need or the patient will suffer serious outcomes that may include disability or death." Also, the "absence of a critical acute drug, or even the lack of availability of an effective substitute, may also lead to serious health outcomes or limited ability to provide humane care."
The Resilient Drug Supply Project (RDSP) is working on the drug supply chain for the whole Critical Acute Drug List. For 18 of 21 critical antibiotics (all generics) that may be used to treat secondary infections to COVID-19, the US drug supply depends heavily on foreign sources. For those 18 antibiotics, more than 80% of the drug products (identified by a National Drug Code [NDC]) marketed in the United States are made in China, India, and/or Italy.
RDSP also found that the US supply of 19 of the 20 top-selling brand-name drugs in 2019 was made entirely outside of the United States. The US Food and Drug Administration (FDA) has reported that 72% of API manufacturers supplying the country with drugs were overseas.
“The upstream drug supply chain in the US is heavily dependent upon foreign sources for both brand name and generic drug products,” said Stephen W. Schondelmeyer, PharmD, PhD, co-principal investigator of RDSP and professor in the College of Pharmacy at the University of Minnesota. “The US drug supply chain has been seriously stressed and is at risk of shortages for several critical drugs in the very near future.”
CIDRAP is calling for pharmaceutical companies to work with federal and state government and public health officials to identify and track the upstream drug supply chain so that potential disruptions can be identified and alternatives found as quickly as possible.
“With the COVID-19 pandemic expected to last several 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 Osterholm, PhD, MPH, co-principal investigator of RDSP and director of CIDRAP. Osterholm added that information on supply chains is essential to healthcare systems, nursing homes, pharmacies, and public health agencies as they plan and prepare in the event of a drug shortage.
“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,” Schondelmeyer said.
RDSP was developed to identify the reasons for drug shortages in the US healthcare system and to develop a systematic approach for predicting, preventing, and mitigating drug shortages from any cause for any reason. Fortunately, the RDSP team designed the project in 2018 and 2019 and developed methods to track the upstream supply chain of all drug products in the United States. Although this project and its drug supply database are not complete, they have progressed sufficiently to allow identification of upstream drug supply chain issues arising because of the COVID-19 pandemic. This project is positioned to help predict, prevent, and mitigate drug shortages from the stresses of COVID-19 on the critical drug supply chain.