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.
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
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
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