May 12, 2022
See latest update on the situation, resources on conservation strategies
The Food and Drug Administration (FDA) continues to report shortages of GE Healthcare’s iohexol and iodixanol intravenous contrast media products for computed tomography imaging. In an April 19 letter to customers, GE Healthcare said it was rationing orders for its iohexol products after a COVID-19 lockdown temporarily shut down its production facility for iodinated contrast media in Shanghai, China.
On a call today, a GE Healthcare official said that the Shanghai facility returned to 25% production capacity as of this week and that it hopes to reach 50% capacity within the next week. GE Healthcare said that it has moved some production to a plant in Cork, Ireland and has begun sending product to the U.S. by air to speed deliveries. However, normal production is not expected to resume until late June.
GE Healthcare said it expects product supply availability to improve the week of May 23, but until then a 20% allocation level has been established. In addition, GE Healthcare said immediate production capacity and resources have been allocated to produce primarily a single stock keeping unit (SKU), its 100ml vial of iohexol. The product number is Y-542, and the NDC is 00407-1414-91. GE recommends all orders should be placed for this product in the near term. Similarly, on today’s call GE Healthcare noted that it is only producing a single SKU of iodixanol, but it did not provide the product number or NDC.
In addition, a GE official today said if a critical need exists, hospitals should reach out to their local GE representative and that allocations are being made on a case-by-case basis. For other questions on repackaging and dosing information, hospitals should contact GE’s medical affairs team.
The AHA is working closely with its Association for Health Care Resource & Materials Management professional membership group to identify conservation strategies and to ensure other stakeholders are aware of the issue and its implications. We have raised the issue with the Administration, including with the White House, FDA, the Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response and the Centers for Medicare & Medicaid Services, to ensure they are aware of the immediate problem and are including contrast media products in their work to improve the resilience of the supply chain for vital products. AHA also is sharing information with other stakeholders including national payer association leaders to ensure they are aware of the situation and the potential implications for the course of care – both in the immediate term as well as after the supply returns to more normal levels should there be a surge in scans performed as we work through the backlog of patients whose care was delayed.
This shortage once again points to the need to improve the resilience of the supply chain so that urgently needed care for patients is not interrupted. These efforts must include taking steps to encourage and strengthen domestic manufacturing and production in nearby countries, and to deepen the supply chain to enable continued availability of critical supplies and medications. We will continue to seek out and share potential temporary mitigation strategies for hospitals and health systems while also urging the government and other stakeholders to prioritize this issue.
RESOURCES ON CONSERVATION STRATEGIES
The following are links to additional information and resources that hospitals and health systems may want to consider, in consultation with their clinical teams, when thinking about conservation strategies.
- A bulletin from ASHP, which represents pharmacists who serve as patient care providers in hospitals, health systems, ambulatory clinics and other health care settings
- Guidance and information from the American College of Radiology’s Committee on Drugs and Contrast Media
- FDA drug shortage information on Iodixanol (Visipaque) Injection and Iohexol (Omnipaque) Injection
WHAT YOU CAN DO
- Please share this Member Advisory with your executive, clinical, supply chain and pharmacy leadership teams at your hospital and health system.
- Watch for updates from the AHA on this issue.