Alert: Errors in Monoclonal Antibody Therapy for COVID Treatment and Prophylaxis

Recently, Curi became aware that errors have occurred in dosing patients for both prophylactic and treatment with Regen-COV Monoclonal Antibody therapy. Variable manufacturer packaging is a contributing factor affecting the dosing formulation. This Regen-COV fact sheet (linked) was revised in September 2021 to include important updates related to dosage and administration that included varying packaging and dosing, (section 2.4, page 24). Vials can be shipped with the following two different formulations and the latter packaged three different ways:

• Casirivimab and imdevimab co-formulated solution containing two antibodies in a 1:1 ratio in a vial.
• Casirivimab and imdevimab available as individual antibody solutions in separate vials supplied as follows:
  • Individual vials in individual cartons, or
  • Together in a single carton (also referred to as a co-packaged carton), or
  • In a dose pack; the dose pack contains individual vials of casirivimab and imdevimab, configurations that may vary in vial size, strength, and appearance and are available in dose pack configurations that include 2, 5, and 8 cartons [see Full EUA Prescribing Information, How Supplied/Storage and Handling (19)], page 49.

This has proven to be confusing in determining what equaled a complete dose, thereby leading to administration errors ranging from administering half to twice the recommended dose.

Steps to take to minimize risk:

• Be certain all involved clinicians have been properly trained in administering monoclonal antibody treatments or vaccines, including any temporary or new staff.
• Read all instructions for each new shipment of monoclonal antibody treatments to clearly identify what dose packaging you have received.
• Refer to provider fact sheets for instructions on how to administer.
• Verify with a second clinician that proper dosing has been prepared prior to administering.
  • If there are any questions remaining on the correct dose, have a physician review with clinical staff. If necessary, contact manufacturer for clarification. Some Curi practices have reported confusion and contradictions in some of the manufacturer’s instructions.
• Any syringes where medication has been pre-drawn, if not administered immediately to the patient, should be labeled appropriately with the name, dose of the medication in the syringe and time of expiration. Establish a protocol as to how syringes are to be labeled to prevent confusion, i.e., time created versus time it expires. This is important since many COVID medications and vaccines are very time-sensitive.
• Pause, take a time out, to verify what you are administering to the patient. This helps ensure the clinician and the patient are both in agreement with what the patient is receiving and what has been ordered by the physician.
  • This process will help alleviate other medical errors of administering the wrong medication to the wrong patient. There have been cases reported where patients received monoclonal antibody instead of the Moderna vaccine and COVID vaccines instead of the flu shot (including children under the age of five).

Steps to take if an error occurs:

• Immediately contact the manufacturer for advice on what action needs to be taken for patients.
• Report monoclonal antibody treatment errors to FDA MedWatch.
  • Per the Regen-COV fact sheet (pg. 34 ): Completion of an FDA MedWatch Form to report all medication errors and serious adverse events is mandatory and must be done by the prescribing healthcare provider and/or the provider’s designee, using one of the following methods:
    • Complete and submit the report online at fda.gov/medwatch/report.htm, or;
    • Complete and submit a postage-paid FDA Form 3500 at https://www.fda.gov/media/76299/download and return by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787, or fax to (1-800-FDA-0178), or call 1-800-FDA-1088 to request a reporting form.
  • In addition, Regeneron Pharmaceuticals requests you provide a copy to them of all FDA MedWatch forms using one of the following methods:
    • Fax: 1-888-876-2736;
    • E-mail: information@regeneron.com;
    • Call Regeneron Pharmaceuticals at 1-844-734-6643 to report adverse events.
• Report all vaccine errors to Vaccine Adverse Event Reporting System (VAERS).
• Notify affected patients of the error and any follow-up action/treatment that is needed.
  • For monoclonal treatments, prioritize patients based on risk and window of opportunity for receiving additional treatments. In the cases of underdosing (patients receiving half the recommended dose), the manufacturer for one practice recommended bringing patients in, who were still within the window time frame to be eligible for treatment, to administer the remaining half dose. This is especially important for patients who have not improved.
• Notify Curi for further advice: riskoncall@curi.com.

Documentation tips:

• Patient medical record:
  • Time and date of contact, and with whom you spoke.
  • Explain to patient what happened in simple terms, (stick to facts of what you know without placing blame). Be honest with patient, reassuring as much as possible, and sharing what the manufacturer advised.
  • Document how patient is doing, including any side effects/issues since treatment.
  • Document information provided and any advice/instructions given.
• In a separate incident file/note (do not place this information in the patient chart):
  • Document the facts of what occurred,
  • Action taken,
  • Any discussions and advice provided by the manufacturer including who you spoke with, and
  • Any reports submitted by you to any source.

Click the following link to read our other recent alert on Errors Related to Vaccine Administration.