Error Alert
Institute for Safe Medication Practices, Horsham, PA
With the expanded EUA for patients as young as 6 months old, there are now 3 different age groups, not just two, that are eligible for Pfizer–BioNTech and Moderna COVID-19 vaccinations. Similar to the mix-ups that occurred between the Pfizer–BioNTech vaccines for children 5 through 11 years old and for individuals 12 years and older, it is predictable that we will see confusion between these 3 age groups with both the Pfizer–BioNTech and the Moderna vaccines.
In the past, some individuals 12 years and older received the Pfizer–BioNTech vaccine formulation and dose intended for children 5 to 11 years old, resulting in underdoses. Or children who were 5 to 11 years old received the formulation and dose intended for individuals 12 years and older, resulting in overdoses.
Similar errors could happen with the new vaccines for our youngest patients. Consider the following risk-reduction recommendations.
- Segregate storage. In refrigerators and freezers, store the vaccine formulations apart from one another in separate plastic bins that are properly labeled with the corresponding age group. Differentiate the bin labels with colors that align with the vial label color, keeping in mind that purple may be the label color for both the Pfizer–BioNTech vaccine for patients 12 years and older and the Moderna vaccine for children 6 years through 11 years.
- Verify identity, age, and vaccine(s) requested. When checking in a patient who is scheduled to be vaccinated, ask the parent, caregiver, or patient to provide at least two patient identifiers—for example, their full name and date of birth. Verify the patient’s actual age with the patient, parent, or caregiver, and be sure to ask which vaccine(s), including the brand, they have requested. Repeat this process immediately prior to vaccination.
- Verify the vaccine history. Prior to vaccine preparation, check the patient’s vaccine card, the patient’s medical record, and the immunization information system to confirm which COVID-19 vaccines have been administered previously and when.
- Label syringes. Clearly label all syringes. To facilitate labeling, print labels for each patient or provide practitioners who prepare the vaccines with strips of preprinted labels that differentiate the formulations and doses.
- Employ barcode technology. During preparation and administration, use barcode scanning to confirm the correct vaccine.
- Vaccinate one patient at a time. Only bring the intended and labeled vaccine syringe(s) for one patient into the vaccination area. Vaccinate one patient at a time.
- Engage the patient. Involve the parent, caregiver, or patient in verifying the vaccine, formulation, and dose by reading the label to confirm the correct vaccine.
- Document the vaccine(s). Document the lot number and date of manufacture prior to vaccine administration, and document administration afterwards in the patient’s profile, on vaccination records, and via state or other immunization information systems.
- Report vaccine errors. Report vaccine errors internally as well as to the Vaccine Adverse Event Reporting System (vaers.hhs.gov), which is mandatory for COVID-19 vaccines available under an EUA. Institute for Safe Medication Practices (ISMP) also asks providers to report vaccine errors to the ISMP National Vaccine Errors Reporting Program (www.ismp.org/report-medication-error).
Additional resources
For details on immunization schedules, review CDC’s resource, COVID-19 Vaccine Interim Immunization Schedule for 6 Months of Age and Older.
Also, Immunize.org has compiled a tool that organizes information about U.S. COVID-19 vaccines and provides links to dosing guidance, fact sheets, package inserts, storage and handling, and preparation and administration. This resource is updated at least monthly. ■