The American Society of Health-System Pharmacists (ASHP) released some management and conservation strategies regarding the imaging contrast shortage being currently experienced. Iohexol injection is currently unavailable or available in limited supply due to the shutdown of a production facility in Shanghai, China during a COVID-19 lockdown. While the factory has been reopened and production resumed, the shortage is expected to continue until late June 2022. Organizations should develop a policy or protocol to guide clinicians in selecting and prioritizing imaging scans. Organizations must consider the clinical appropriateness of each individual patient’s needs, but may consider: (1) using alternative imaging techniques (e.g., ultrasound, MRI), (2) performing scans without the use of contrast, (3) delaying scans that are not clinically urgent, or (4) using alternative contrast agents. Organizations may consider prioritizing patients for imaging scans requiring contrast based on clinical acuity and the nature of the imaging procedure (i.e., interventional vs. diagnostic). [1]
In regards to repackaging iohexol from bulk packages, ASHP warns of the risk of inappropriate use of pharmacy bulk packages and single-dose vials. The Institute for Safe Medication Practices (ISMP) cites a 2012 Centers for Disease Control and Prevention (CDC) report of bacterial infections following the use of a single container of contrast used for multiple patients. The ISMP reinforces the need for repackaging or multiple uses of a container, other than through the use of a contrast injection system, to be handled in a pharmacy’s cleanroom according to USP Chapter 797. Pharmacy bulk packages contain an “in-use” time of 8 hours, defined as the “time within which the opened product is to be used. This is important because the Food and Drug Administration (FDA) repackaging guidance for state-licensed pharmacies or federal facilities establishes the beyond-use date (BUD) of a repackaged product may not exceed the in-use time of the product labeling. Per the FDA guidance, the BUD of a repackaged pharmacy bulk package of iohexol should not exceed 8 hours. [1]
For single-dose vials, repackaging is considered medium-risk compounding under the current version of USP Chapter <797>. The maximum BUD that can be assigned to iohexol or iodixanol repackaged in a fully compliant pharmacy cleanroom suite is 30 hours at controlled room temperature or 9 days when stored in a refrigerator. However, draft guidance from USP during the COVID-19 pandemic (in April 2020) allows a BUD of 4 days for medium-risk preparations stored at room temperature or 10 days stored in a refrigerator. This draft guidance supports risk-based enforcement discretion related to USP compounding standards and reflects options developed by the expert committee based on their expertise. [1]
The Greater New York Hospital Association (GNYHA) released a statement on May 4, 2022, listing some potential conservation strategies to consider in light of the temporary shortage of GE Healthcare’s iodinated contrast media. Potential conservation strategies include: (1) Evaluate the amount of on-hand inventory, (2) Seek other means of securing contrast media including alternate wholesalers and distributors, (3) Evaluate incoming CT and x-ray orders to determine if an alternate imaging modality can be utilized, (4) Discuss protocol options with radiology leadership, radiology staff, and ordering physicians including Emergency Department physicians, cardiologists, and outpatient imaging providers to ensure protocols are evaluated for the appropriate use of contrast media, (5) Where appropriate, consider adjusting scanning protocols to scan without contrast and injector protocols to reduce the amount of contrast dose, (6) Communicate opportunities for conservation and awareness of wasted contrast media to CT, x-ray, interventional, and catheterization lab technologists, and (7) Develop a communication plan for referring physicians and all imaging departments; leverage appropriate use criteria for when to utilize contrast-based CT examinations. The list may be updated as the shortage of GE contrast media is ongoing. [2]