ISMP Provides Recommendations for Avoiding COVID-19 Vaccination Administration Errors

The Institute for Safe Medication Practices (ISMP) is providing recommendations for avoiding mistakes when administering coronavirus disease 2019 (COVID-19) vaccines. Published as guidance for health care providers, the recommendations focus on dilution errors, vaccine and monoclonal antibody mix-ups, waste of doses, administering immunizations to the wrong age group, errors with scheduling the second dose, and allergic reactions.¹

According to ISMP, it has received numerous reports of errors or hazards with the administration of COVID-19 vaccines since mid-December 2020. These reports were submitted to the ISMP National Vaccine Error Reporting Program (ISMP VERP) voluntarily, but reporting to the Vaccine Adverse Event Reporting System (VAERS) is mandatory for vaccines available under the FDA’s Emergency Use Authorization (EUA).¹

Although the FDA has not approved a COVID-19 vaccine, the agency has issued an EUA to Pfizer's and BioNTech’s COVID-19 vaccine (BNT162b2) and to Moderna’s COVID-19 vaccine (mRNA-1273). These vaccines are both being administered across the United States to those who are eligible to receive them, including frontline health care workers.²

Additionally, AstraZeneca is currently conducting a large trial of its vaccine in the United States and in other countries,² and an investigational COVID-19 vaccine candidate (JNJ-78436735) is being developed Janssen Pharmaceutical Companies of Johnson & Johnson. The latter company announced this week it had collected promising results from a phase 1/2a analysis.³

The ISMP’s recommendations appear in its January 14, 2021, ISMP Medication Safety Alert! Newsletter. Possible causes and contributing factors to vaccination errors are discussed, and lessons for health care organizations that are administering vaccines are outlined.¹

Reported Errors

Main categories of errors being reported thus far with vaccines under EUAs are as follows:¹

· 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 or has a functioning barcode.

· Waste of Vaccine Doses. 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 6 hours at room temperature, some facilities are scrambling at the end of the day to use doses to avoid discarding them.

Other reported errors included a misspelling in an email address that resulted in the patient not receiving information on an appointment to receive a second vaccine dose, vaccination of underage patients, and serious but not life-threatening allergic responses.¹

Recommendations for Safe Practice

According to ISMP, the voluntary reports it has received are likely the “tip of the iceberg,” given the massive scope of the global COVID-19 vaccination campaign. Health care organizations can take actions to help reduce risk, as follows:¹

• Safely selecting vaccination sites. A location that allows 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, should be chosen.
• Verifying competency of vaccinators. Health care workers involved in vaccination campaigns should be educated regarding vaccine storage, preparation, administration, and common types of errors that can occur. Those administering vaccines should be provided with up-to-date information on COVID-19 vaccine administration and verify their key competencies.
• Dispensing pharmacy-prepared syringes. If feasible within the timeframe for vaccine stability at room temperature, the pharmacy should confirm the number of verified appointments, and dispense prefilled, labeled syringes for daily vaccination clinics. The needle cap should be checked to ensure it is tight on each syringe before dispensing.
• Using an independent double-check. When administering the Pfizer-BioNTech vaccine, an independent double-check of the dilution process should be required, if staffing permits.
• Maximizing doses withdrawn from vials. Whenever possible, low dead-volume syringes and needles should be used to withdraw as many doses as possible of the COVID-19 vaccine from each vial, in order to reduce waste.
• Identifying and differentiating monoclonal antibodies. If Regeneron monoclonal antibodies are received in investigational drug packaging without the product name on the outer carton or vial, a process should be immediately established and implemented upon receipt. Monoclonal antibodies should be identified and differentiated from other medications, including the Moderna COVID-19 vaccine.
• Separating vaccine storage. The Pfizer-BioNTech and Moderna vaccines should not be stored together in the refrigerator while or after thawing to avoid mix-ups.
• Planning for leftover vaccine. 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 should be established.
• Preparing for allergic reactions. At all vaccination sites, emergency equipment and medications should be immediately available. Patients should be monitored 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. 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, should be avoided.
• Verifying second dose scheduling. A system for setting up and confirming appointments for second dose administration should be established. If relying on email, non-responses should be checked via phone calls or other rapid communication methods. A hotline for questions and for providing the number to patients at the time of their first dose can be implemented.
• Reporting vaccine errors and adverse reactions. All COVID-19 vaccine errors and adverse reactions should be reported to the VAERS at vaers.hhs.gov, which is mandatory for health care providers. ISMP is also requesting that providers report vaccine errors to the ISMP VERP at ismp.org/report-medication-error.

In addition to the recommendations from ISMP, the American Society of Health-System Pharmacists (ASHP) recently released new guidance on the security, storage, and handling of COVID-19 vaccines. The ASHP resource guide addresses vaccine security and storage, vaccine procurement, pharmacy security and storage, transport, patient care area security, management of vaccine returns, and community pharmacy consideration, and is accessible on that organization’s website.⁴

REFERENCES

• ISMP Alerts Healthcare Practitioners about Errors with New COVID-19 Vaccines [news release]. Horsham, PA; January 14, 2021: ISMP. [email]
• Coppock K. COVID-19 Vaccine Developers Announce New Authorizations for Global Use. Pharmacy Times®. Published January 8, 2021. Accessed January 15, 2021. https://www.pharmacytimes.com/news/covid-19-vaccine-developers-announce-new-authorizations-for-global-use
• Johnson & Johnson COVID-19 Vaccine Candidate Interim Phase 1/2a Data Published in New England Journal of Medicine. [news release]. New Brunswick, NJ; January 13, 2021: Johnson & Johnson. Accessed January 15, 2021. https://www.jnj.com/johnson-johnson-covid-19-vaccine-candidate-interim-phase-1-2a-data-published-in-new-england-journal-of-medicine
• Karlovitch S. ASHP Releases New COVID-19 Vaccine Guide. Pharmacy Times®. Published January 8, 2021. Accessed January 15, 2021. https://www.pharmacytimes.com/news/ashp-releases-new-covid-19-vaccine-guide