Multiple Error Pathways Possible with Monoclonal Antibody Products for COVID-19
ISMP Warns about Confusion Due to Co-Packaging and Labeling Issues
November 22, 2021
HORSHAM, PA—The Institute for Safe Medication Practices (ISMP) has received multiple reports of errors related to confusion over new alternative packaging for casirivimab and imdevimab, monoclonal antibodies used for treating COVID-19. Due to the high demand for monoclonal antibodies, Regeneron is distributing co-packaged products that are manufactured by Roche Pharmaceuticals. The co-packaged products are intended for distribution outside the U.S., have slightly different labeling, and may not contain a barcode.
The November 18, 2021 issue of the ISMP Medication Safety Alert!® Acute Care newsletter presents an analysis of available product presentations for monoclonal antibodies and some of the common causes of confusion and errors. Currently, casirivimab and imdevimab are available in a co-formulated vial containing both products together, co-packaged in cartons containing one vial of casirivimab and one vial of imdevimab, and in Dose Pack bags containing individual vials of casirivimab and imdevimab. Many of the mistakes being reported are associated with preparing and administering only one component of the two monoclonal antibodies, or prescribing, preparing, and/or administering the wrong dose.
ISMP also provides safe practice recommendations for healthcare practitioners, including:
- Clarify dosing during order entry. In order entry systems and on standardized order sets, make it clear that 600 mg (or 300 mg under certain conditions) of each antibody is required for appropriate dosing.
- Require pharmacy preparation. Wherever possible, outside of emergencies, have the pharmacy prepare and label patient-specific doses and IV infusions of monoclonal antibodies, rather than have practitioners select vials from automated dispensing cabinets and prepare them in busy patient care areas.
- Update health record with current information from the Fact Sheet. Assign an individual to regularly check the Fact Sheets for monoclonal antibodies to ensure the most current information is readily available to all frontline practitioners. Dosing and administration information on the one-page sheet included in Dose Packs is not necessarily current.
- Create separate storage. Separate the different presentations of the monoclonal antibodies in sequestered storage containers in the refrigerator and other storage locations, and clearly label them.
- Use auxiliary warnings. Include bold, colorful warnings on the product storage containers and on electronic screens or menus where these products are listed, based on the type of errors that have been reported. For example, “Dose pack of casirivimab and imdevimab (must be administered together).”
- Reduce confusion with the Roche co-packaged product. Healthcare organizations that receive this product should educate staff about the label differences. Before product use, place (if absent) or replace the barcode on the product with a pharmacy-prepared barcode, or test any available barcodes on the product and manually input the product information into the electronic healthcare record system to ensure they provide correct information when scanned.
- Educate staff. Educate practitioners handling the monoclonal antibodies, with a particular focus on the various presentations available, possible label confusion, types of errors being reported nationwide, and preparation and/or administration instructions from the most current Fact Sheet.
For a copy of ISMP’s newsletter article with more details about errors and confusion regarding monoclonal antibodies used to treat COVID-19, click here.
About the Institute for Safe Medication Practices
The Institute for Safe Medication Practices (ISMP) is the nation’s first 501c (3) nonprofit organization devoted entirely to preventing medication errors. ISMP is known and respected for its medication safety information. For more than 25 years, it also has served as a vital force for progress. ISMP’s advocacy work alone has resulted in numerous necessary changes in clinical practice, public policy, and drug labeling and packaging. Among its many initiatives, ISMP runs the only national voluntary practitioner medication error reporting program, publishes newsletters with real-time error information read and trusted throughout the global healthcare community, and offers a wide range of unique educational programs, tools, and guidelines. In 2020, ISMP formally affiliated with ECRI to create one of the largest healthcare quality and safety entities in the world, and ECRI and the ISMP PSO is a federally certified patient safety organization by the U.S. Department of Health and Human Services. As an independent watchdog organization, ISMP receives no advertising revenue and depends entirely on charitable donations, educational grants, newsletter subscriptions, and volunteer efforts to pursue its life-saving work. Visit www.ismp.org and follow @ismp_org to learn more.
For more information, contact:
Laurie Menyo, Director of Strategic Communications
610.825.6000 ext. 5310