USP publishes Vulnerable Medicines List to inform efforts to reduce risk and increase supply chain reliability for patients
Rockville, MD – The U.S. Pharmacopeia (USP) today published the “2024-2025 Vulnerable Medicines List for the United States: A data-based approach to identify risks and enable interventions to increase reliability of supply”. This list complements other resources, such as FDA’s essential medicines list.
Using the USP Medicine Supply Map and other resources, USP identified 100 vulnerable medicines – 49 used to manage chronic conditions and 51 for acute care – to encourage dialogue and action to bolster medicines supply chain resilience. A public list of medicines vulnerable to shortage can help stakeholders work more effectively to make the medicine supply chain more reliable for patients.
“A data-driven, vulnerability-informed approach can help inform stakeholder actions – including drug makers, purchasing entities such as hospitals and GPOs, and policymakers to effectively build a more resilient medicines supply chain,” said Anthony Lakavage, Senior Vice President for Global External Affairs at USP.
For this report, vulnerability to supply chain disruptions was measured using predicted shortage risk scores from the USP Medicine Supply Map, which estimate the likelihood of drug shortages over a 12-month period with 94% accuracy. This analysis shows:
- The most prevalent therapeutic classes for vulnerable drugs include pain management, oncology, hospital solutions, and antibacterial medications. Of the 11 oncology drugs on the list, one is a chronic condition management medicine (methotrexate injection) while 10 are acute care medicines. These drugs treat conditions including leukemia, non-Hodgkin lymphoma, and other forms of cancer.
- As of January 2025, 61% of the drugs on the list were not in shortage. Recognizing their high susceptibility to shortage can allow for proactive mitigation and prevention strategies to be enacted to mitigate vulnerability.
- Injectable drugs make up the majority of the Vulnerable Medicines List, accounting for 71% of all drugs. The five drugs identified as most vulnerable were all injectables – sodium chloride injection, dextrose injection, heparin sodium injection, propofol injectable emulsion, and lidocaine hydrochloride injection.
“Medicines should be prioritized based on their clinical impact on patient care, as well as their pre-existing supply chain vulnerability,” said Vimala Raghavendran, Vice President for Informatics Product Development at USP.
The more than 100 vulnerability factors considered in the USP shortage risk score include manufacturing complexity, geographic concentration of production, shortage history, price, and other factors.
The data-driven methodology used to produce the Vulnerable Medicines List provides a snapshot at the time of analysis. Among other limitations noted in the report, no measure exists for availability of therapeutic alternatives and for count of patients impacted by each medicine. Future analysis should also consider refinement to account for these challenges.
USP will continue to leverage insights from the Medicine Supply Map to help inform efforts to strengthen the medicine supply chain. Using these and other insights, USP publishes an annual Drug Shortage Report. Further data and insights will be released in the coming months.
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