We summarize some questions about the project in the frequently asked questions (FAQs).
Resilient Drug Supply Project Frequenly Asked Questions (last updated June 1, 2020)
- How exactly did the Resilient Drug Supply Project come up with the 156 drugs on the Critical Acute Drug List?
- What are the Critical Acute Drugs and their therapeutic categories?
- Now that 156 Critical Acute Drugs have been identified, what do you mean when you say that these drugs are needed for acute care within a few hours to days or patient mortality rises?
- How many of the 156 Critical Acute Drugs are made, formulated, packaged, or have an active pharmaceutical ingredient (API) made in China, India, Italy or other severely affected countries?
- Is CIDRAP issuing a plea for pharmaceutical companies to disclose their supply information to FDA or some other entity, or are you just issuing this release?
- Why did CIDRAP start this project?
How exactly did the Resilient Drug Supply Project come up with the 156 drugs on the Critical Acute Drug List?
The project team convened an expert working group and led a workshop on December 11 and 12, 2018, focused on creating a critical acute drug list. Critical 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 (Appendix A).
What are the Critical Acute Drugs and their therapeutic categories?
The Critical Acute Drug List are available as a PDF .
Now that 156 Critical Acute Drugs have been identified, what do you mean when you say that these drugs are needed for acute care within a few hours to days or patient mortality rises?
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."
How many of the 156 Critical Acute Drugs are made, formulated, packaged, or have an active pharmaceutical ingredient (API) made in China, India, Italy or other severely affected countries?
The Resilient Drug Supply Project (RDS) is still 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 (which are identified by a National Drug Code, or NDC) marketed in the United States are made in China, India, and/or Italy. (See Excel file with Figure and data set.)
Additionally, the Resilient Drug Supply Project found that the US drug supply for 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.
[Testimony of Janet Woodcock, M.D., Director of the Center for Drug Evaluation and Research, Before the House Committee on Energy and Commerce, Subcommittee on Health, October 30, 2019. (https://energycommerce.house.gov/subcommittees/health-116th-congress)]
“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 the RDS 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. He added, “The US drug supply chain has been seriously stressed and is at risk of shortages for several critical drugs in the very near future.”
Is CIDRAP issuing a plea for pharmaceutical companies to disclose their supply information to FDA or some other entity, or are you just issuing this release?
CIDRAP is calling for pharmaceutical companies to work with federal and state government and public health officials to identify and track the up-stream drug supply chain so that potential disruptions can be identified and alternatives found as quickly as is 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 T. Osterholm, PhD, MPH, co-principal investigator of the RDS project and University of Minnesota Regents Professor, McKnight Presidential Endowed Chair in Public Health, 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 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,” Schondelmeyer said.
Why did CIDRAP start this project?
The RDS project 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 RDS team designed the project in 2018 and 2019 and developed methods to begin tracking 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 identifying upstream drug supply chain issues that are arising because of the COVID-19 pandemic. COVID-19 is a real challenge to the world right now, and this project is positioned to help predict, prevent, and mitigate drug shortages from the stresses that COVID-19 has placed on the critical drug supply chain.