ISMP warns about confusion with co-packaging, labeling on monoclonal antibody products

The Institute for Safe Medication Practices (ISMP) is alerting health care providers about potential confusion over new alternative packaging for casirivimab and imdevimab. These monoclonal antibodies, administered together as REGEN-COV, are used for treating COVID-19. ISMP recently received multiple reports about these types of errors.

“Due to the high demand for monoclonal antibodies, Regeneron (manufacturer of REGEN-COV) is distributing co-packaged products of the antibodies that are manufactured by Roche Pharmaceuticals. The Roche co-packaged products are intended for distribution outside the U.Sand use labeling that differs in some ways from Regeneron’s other REGEN-COV products,” ISMP stated in a news release. These products also may not contain a barcode.

Currently, casirivimab and imdevimab are available in a co-formulated vial containing both products together, co-packaged in cartons with one vial of casirivimab and one vial of imdevimab, and in Dose Pack bags containing individual vials of casirivimab and imdevimab.

“Most of the errors are associated with preparing and administering only one component of the 2 monoclonal antibodies, or prescribing, preparing, and/or administering the wrong dose,” ISMP noted.

On September 9, 2021, HHS made its 9th amendment to the PREP Act in order to expand the authority of licensed pharmacists, as well as certain pharmacy interns and pharmacy technicians, to deliver COVID-19 therapeutics such as monoclonal antibodies.

Data show that monoclonal antibody therapy reduces COVID-19 hospital admissions, ED visits, and viral levels in the blood of infected people.

In the news release, ISMP provides the following safe-practice recommendations for health care practitioners:

• 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 subcutaneous 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 into 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. Health care 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 health care 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.