COVID-19 TREATMENT
New packaging for REGEN-COV may add confusion
Regeneron has announced the creation of a new temporary alternative packaging for casirivimab and imdevimab (REGEN-COV). The new packaging contains separate vials of each antibody solution that are copackaged in a carton labeled as "casirivimab and imdevimab 120 mg/mL concentrate for solution for infusion." The copackaged cartons were manufactured by Regeneron's development partner, Roche Pharmaceuticals, for distribution outside the US. However, the product will also be distributed by Regeneron in the US under an Emergency Use Authorization (EUA) to increase the availability of casirivimab and imdevimab and to help combat the ongoing COVID-19 public health emergency.
To help meet demand, the new copackaged product will be distributed in addition to the current presentations of coformulated REGEN-COV (casirivimab and imdevimab in a vial together) and dose packs of cartons containing individual vials of casirivimab and imdevimab. Importantly, because the coformulated product is also being distributed, the copackaged carton labeling may cause some users to mistakenly believe the vials inside the carton each contain the coformulated product, although once the carton is opened, each vial is clearly marked, identifying the individual monoclonal antibody by its nonproprietary name.
Also, while the copackaged cartons contain the same monoclonal antibodies that are approved for use in the US under an EUA, the carton and vial labels do not include a National Drug Code (NDC) number. The cartons say, "For Pandemic Use" instead of "For EUA Use." Additionally, the bar code on the carton label may not be functional, and bar codes are not provided on the vial labels.
Organizations will need to manually input the product information into their systems to confirm the bar codes do not provide incorrect information when the product is scanned. The NDC number is only provided in the quick reference guide that is shipped with the product. This reference guide also provides a QR code that leads to the current US Fact Sheet (http://www.ismp.org/ext/779), which should be used by US healthcare providers, as the package leaflet in the carton is not approved for US use and should be discarded. According to Regeneron, the vials in the copackaged carton may be used to prepare and administer I.V. infusions as well as subcutaneous injections, despite containing statements such as "Concentrate for solution for infusion" or "For intravenous infusion after dilution."
LIQUID PHENOL
Eliminate bottles of phenol 80%
The National Health Service in England (NHS England) issued a National Patient Safety Alert calling for the elimination of bottles of liquid, high-strength (80%) phenol (also known as carbolic acid), a caustic compound that has often been used for chemical ablation of the nail matrix during a matricectomy (a process used to destroy all or part of the base portion of the nail matrix to treat an ingrown toenail). Data also suggest it has been used in other clinical areas where it is no longer recommended.
High-strength phenol is rapidly absorbed through the skin and can cause burns, severe tissue injury, and systemic toxicity. The Safety Alert describes a review of more than 30 reported events during a 5-year period, including a report of phenol 80% that was administered to a child instead of the prescribed paraldehyde rectal enema to treat status epilepticus. The child required hospital admission and treatment to minimize the corrosive effects of phenol on the intestinal tissue. Another case published in the ISMP SAFETY brief on April 5, 2018, was of a teen who experienced significant dermal changes to his foot after high-strength phenol in an unlabeled bowl, thought to be saline, was used for cleansing his foot during a matricectomy. He required hospitalization at a burn center.
The NHS Safety Alert encourages hospitals and outpatient clinics to take the following actions by February 25, 2022, to avoid penalties:
* Identify where phenol 80% is used and update procedures/guidelines to substitute its use with a safer, suitable alternative.
* Ensure clinical areas have stock of safer alternatives and then remove bottles of phenol 80%.
* Amend electronic prescribing systems and purchasing systems to ensure that phenol 80% cannot be inadvertently prescribed or purchased.