ISMP Alerts Healthcare Practitioners about Errors with New COVID-19 Vaccines

HORSHAM, PA—Since mid-December 2020, the Institute for Safe Medication Practices (ISMP) has received numerous voluntary reports of errors or hazards with the administration of COVID-19 vaccines as one of the most ambitious immunization campaigns in history has gotten underway. The free featured article in the January 14, 2021 ISMP Medication Safety Alert!^® newsletter discusses possible causes and contributing factors and outlines lessons learned for healthcare organizations administering vaccines.

Main categories of errors being reported so far with vaccines under Emergency Use Authorization (EUA) include:

• Dilution errors. Pfizer-BioNTech’s COVID-19 vaccine must be diluted with preservative-free sodium chloride injection. Multiple errors have occurred involving the addition of too little diluent, which results in administration of too much vaccine and potentially stronger adverse effects if they occur.
• Mix-Ups with look-alike products. Moderna’s COVID-19 vaccine and the new Regeneron monoclonal antibody, casirivimab, have been confused, likely due to labeling issues. Two versions of vial and carton labels for the Regeneron antibody exist, and neither version includes the name of the specific antibody, casirivimab, or has a functioning barcode.
• Waste of vaccine doses. ISMP has received reports that some of the syringes being shipped as part of the federal COVID-19 response are not efficient enough to extract a sixth dose from the Pfizer-BioNTech vaccine vials or an eleventh dose from the Moderna vaccine. Since both vaccines must be used within six hours at room temperature, some facilities are scrambling to at the end of the day to use doses or have to discard them.

Other reported errors included a misspelling in an email address that resulted in the patient not receiving information on appointment to receive a second vaccine dose, vaccination of underage patients, and serious but not life-threatening allergic responses.

Safe practice recommendations
These voluntary reports are likely the tip of the iceberg, given the massive scope of the global COVID-19 vaccination campaign. Following are actions that healthcare organizations can take to help reduce risk.

• Safely select vaccination sites. Allow enough space to assess patients prior to vaccination, observe them afterwards, and treat any who experience a reaction, while maintaining social distancing and other precautions.
• Verify competency of vaccinators. Healthcare workers involved in vaccination campaigns should be educated regarding vaccine storage, preparation, administration, and common types of errors that can occur. Provide vaccinators with an up-to-date Fact Sheet for the vaccines being administered and verify their key competencies (full list is provided in newsletter article).
• Dispense pharmacy-prepared syringes. If feasible within the timeframe for vaccine stability at room temperature, have the pharmacy confirm the number of verified appointments and dispense prefilled, labeled syringes for daily vaccination clinics. Check that the needle cap is tight on each syringe before dispensing.
• Use an independent double-check. When administering the Pfizer-BioNTech vaccine, require an independent double-check of the dilution process (if staffing permits).
• Maximize doses withdrawn from vials. Whenever possible, use low dead-volume syringes/needles to withdraw as many doses as possible of the COVID-19 vaccine from each vial to reduce waste.
• Identify/differentiate monoclonal antibodies. If Regeneron monoclonal antibodies are received in investigational drug packaging without the product name on the outer carton or vial, establish a process to be implemented immediately upon receipt to identify and differentiate from other medications, including the Moderna COVID-19 vaccine.
• Separate vaccine storage. To avoid mix-ups, do not store the Pfizer-BioNTech and Moderna vaccines together in the refrigerator while or after thawing (use separate shelves).
• Plan for leftover vaccine. Establish a standard process such as a list of readily available alternative recipients for dealing with doses remaining in vaccine vials or pharmacy-prepared syringes at the end of a vaccination clinic (still must be within six hours of storage at room temperature).
• Be prepared for allergic reactions. At all vaccination sites, make sure emergency equipment and medications are immediately available. Monitor patients for at least 15 minutes for signs of adverse reaction, and at least 30 minutes if there is a history of allergic reaction to a vaccine or injectable therapy or history of anaphylaxis. Avoid vaccinating patients with a known reaction to ingredients such as polyethylene glycol, or with a reaction of any severity to polysorbate due to cross-reactivity to polyethylene glycol.
• Verify second dose scheduling. Establish a system for setting up/confirming appointments for second dose administration, and if relying on email, check on non-responses via phone calls or other rapid communication methods. Consider establishing a “hotline” for questions and providing the number to patients at the time of their first dose.
• Report vaccine errors and adverse reactions. Report all COVID-19 vaccine errors and adverse reactions to the Vaccine Adverse Event Reporting System (VAERS) at https://vaers.hhs.gov, which is mandatory for healthcare providers. ISMP also asks providers to report vaccine errors to the ISMP National Vaccine Errors Reporting Program (ISMP VERP) at https://ismp.org/report-medication-error.

For a copy of the full ISMP newsletter article, visit: Learning from Errors with the New COVID-19 Vaccines | Institute for Safe Medication Practices (ismp.org). Access may require free registration.

About ECRI
ECRI is an independent, nonprofit organization improving the safety, quality, and cost-effectiveness of care across all healthcare settings. With a focus on patient safety, evidence-based medicine, and health technology decision solutions, ECRI is respected and trusted by healthcare leaders and agencies worldwide. Over the past fifty years, ECRI has built its reputation on integrity and disciplined rigor, with an unwavering commitment to independence and strict conflict-of-interest rules.

ECRI is the only organization worldwide to conduct independent medical device evaluations, with labs located in North America and Asia Pacific. ECRI is designated an Evidence-based Practice Center by the U.S. Agency for Healthcare Research and Quality. ECRI and the Institute for Safe Medication Practices PSO is a federally certified Patient Safety Organization as designated by the U.S. Department of Health and Human Services. The Institute for Safe Medication Practices (ISMP) formally became an ECRI Affiliate in 2020.

Visit www.ecri.org and follow @ECRI_Org to learn more.

About the Institute for Safe Medication Practices
The Institute for Safe Medication Practices (ISMP) is the only 501c (3) nonprofit organization devoted entirely to preventing medication errors. ISMP is known and respected as the gold standard for 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, and ECRI and the Institute for Safe Medication Practices PSO is a federally certified Patient Safety Organization by the U.S. Department of Health and Human Services. As a 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 @ismp1 to learn more.

For more information, contact:
Laurie Menyo, Director of Strategic Communications
(610) 825-6000, ext. 5310
lmenyo@ecri.org

Renee Brehio, ISMP Public and Media Relations
(614) 376-0212
rbrehio@ismp.org