USP publishes list of vulnerable medicines susceptible to shortages
The United States Pharmacopeia (USP) has released its inaugural Vulnerable Medicines List (VML), which identifies 100 drugs that may be at risk of shortages. The list aims to help manufacturers, purchasing organizations, and policymakers recognize medications that have a higher risk for shortages so they can take appropriate action to before shortages occur.Medications for pain management, oncology, hospital care, and antibiotics top the list of drugs most vulnerable to shortages.
The impetus for the report was USP’s 2023 global public policy position, which recommended the establishment of a vulnerable medicines list to identify those medicines that are at risk of shortage.
Anthony Lakavage, senior vice president for global external affairs at USP, told Focus that the list aims to serve as a preemptive measure against drug shortages. “We developed this because we saw a gap in the resources where there was no analysis available to stakeholders” until after a shortage occurred.
As of January 2025, the USP reported that 61% of the drugs on their list were not in shortage. The organization emphasizes that acknowledging the high susceptibility of certain drugs to shortages can enable proactive strategies to be implemented, helping to prevent and mitigate these vulnerabilities.
The process for determining the VML involved two main steps: identifying essential medicines and evaluating vulnerabilities in the supply chain.
For the first step, USP references the essential medicines lists from the World Health Organization (WHO) and the drug shortage list from the US Food and Drug Administration (FDA) to determine the medications that are widely used in the United States. The VML list can also include drugs that may not be listed by WHO or FDA but are commonly used in the US.
The next step is measuring vulnerability using the shortage risk scores from the USP Medicine Supply Map, which estimates the likelihood of drug shortages over a 12-month period. Drugs that have a shortage risk score above 50% are classified as highly vulnerable, while those with a score below 50% are excluded from the analysis. (RELATED: USP supply chain map provides ‘early warning’ of possible drug shortages, Regulatory Focus 22 March 20222).
The shortage risk score evaluates over 100 vulnerability factors, including manufacturing complexity, geographic concentration of production, history of shortages, and pricing.
Injectable drugs constitute the majority of medicines on the list, representing 71% of all listed medications. The five injectables that are the most vulnerable include sodium chloride injection, dextrose injection, heparin sodium injection, propofol injectable emulsion, and lidocaine hydrochloride injection.
USP vulnerable medicines list
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