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Patient Safety Tip
of the Week
October
19, 2021
COVID-19
Vaccine/ Flu Vaccine Mixups
On
October 15, 2021 a headline read that 2 children in Indiana, aged 4- and
5-years old, were mistakenly administered the coronavirus vaccine rather than
the intended flu vaccines (Genovese 2021). On the same day, ISMP (Institute for Safe
Medication Practices) issued a NAN (National Alert Network) alert regarding
mix-ups between the influenza (flu) vaccine and COVID-19 vaccines (ISMP 2021).
It
was probably inevitable – COVID-19 vaccines get mistaken for influenza vaccines
and vice versa. We’ve entered the time period where annual influenza vaccines
are being administered at the same time we are seeing
more patients receiving a COVID-19 vaccine or booster.
The
ISMP NAN alert (ISMP 2021) notes that ISMP received reports of 16
cases of accidental influenza and coronavirus disease 2019 (COVID-19) vaccine mixups. All the events occurred in community/ambulatory
care pharmacies. The alert goes on to describe multiple contributing factors:
- Increased demand and coadministration of
the vaccines
- Syringes near each other
- Unlabeled syringes
- Distractions
- Staffing shortages
The
problem is not unique to the COVID-19 vaccine. Our November 19, 2019 Patient
Safety Tip of the Week “An Astonishing Gap in Medication Safety” was all about mistakes made in community
vaccination programs. We gave examples of patients being administered insulin
instead of flu vaccines and neuromuscular blocking agents (NMBA’s) instead of
measles or hepatitis vaccines.
In
hospitals and many clinic sites or physician offices we use a variety of tools
to improve medication safety. These include barcoding, CPOE with clinical
decision support, double checks, segregation of LASA (look-alike sound-alike)
drugs in storage, ADC’s (automated dispensing cabinets) with alerts, “Do Not
Disturb” vests to minimize distractions and interruptions during nurse
medication rounds, smart pumps, and others. But those valuable tools are not
used in many of the other healthcare venues where vaccines are administered,
such as community pharmacies and “drive-thru” vaccination sites.
In
community pharmacies, the pharmacist is often busy both preparing and dispensing
medications as well as administering vaccinations. And today’s pharmacies are
experiencing not only professional staff shortages, but many are also seeing
shortages of non-professional staff. So, sometimes pharmacists are even
performing tasks usually done by non-professional staff. Given how busy those
pharmacies are, it is easy to see how distractions and interruptions might
contribute to errors. The lack of a second clinician to perform an independent
double check is also a problem in many community pharmacies.
The
ISMP NANA alert goes on to describe measures to prevent such mixups from occurring:
- Schedule flu and/or COVID-19 vaccines
during dedicated blocks of time each day and ensure adequate staffing is
available.
- Explore the use of qualified and trained
volunteers to assist in the vaccination process to alleviate some stress
caused by professional staffing shortages.
- Provide a separate area for vaccine
administration, away from distractions and interruptions.
- During the production and/or
verification phase of the dispensing process, scan the vaccine barcode to
verify the correct product has been retrieved. Ideally, prior to
administration, barcode scanning should again confirm the correct
vaccine.
- Clearly label all individual syringes
containing vaccines. To facilitate proper labeling, provide vaccine
preparers with any necessary labels (Moderna, Pfizer-BioNTech) to affix to
the syringes.
- Only bring the intended and labeled
vaccine syringe(s) for one patient into the vaccination area.
- Immediately before vaccination, ask the
patient to provide at least two patient identifiers (i.e., full name and
date of birth) and verify the patient’s vaccine(s) with the patient’s
signed consent form(s).
- Prior to vaccine administration, ask the
patient/parent to read the syringe label (and vial if present) and
expiration date aloud to confirm the correct vaccine.
- Document the vaccine lot number and
expiration date before vaccine administration. Document the vaccine
administration afterward in the patient’s profile, on vaccination records,
and via state or other immunization registries.
- If a vaccine mix-up occurs, apologize to
the patient and provide the intended vaccine
either before the patient leaves or ask the patient to return to the vaccination
site.
- Report all vaccine errors internally as
well as to the US Food and Drug Administration (FDA) Vaccine Adverse Event
Reporting System (VAERS), which is mandatory for COVID-19
vaccine errors under an Emergency Use Authorization (EUA). ISMP also asks
providers to report vaccine errors to the ISMP National Vaccine Errors
Reporting Program (ISMP VERP).
In
our November 19, 2019 Patient Safety Tip of the Week “An Astonishing Gap in Medication Safety” we
noted there are guidelines for doing mass vaccination programs. The CDC has
published “Guidelines for Large-Scale Influenza Vaccination Clinic
Planning” (CDC
2015). The CDC guideline also
has a link to a valuable skills checklist from
Immunize.org for
those administering the vaccines. CDC also has a “Vaccine
Storage and Handling Toolkit” and Immunize.org also has a nice “Checklist
for Safe Vaccine Storage and Handling”. Immunize.org has a wealth of valuable materials for those
providing immunizations. One of their resources is a handout “Don’t Be
Guilty of These Preventable Error s in Vaccine Administration!”, which describes common mistakes in vaccine
administration.
And we offered the following questions you
should be asking if your organization provides vaccinations:
- Do you store your vaccines in a location
separate from other medications that might be dangerous?
- Do you ever send your staff to a
location that stores its own vaccines and other medications?
- Is any diluent intended for use with
each vaccine stored with the vaccine so no one might use a vial of a
different solution as a diluent?
- Do you use independent double checks?
Prior to administration? Prior to preparation?
- If not true independent double checks,
are at least 2 people involved in the process?
- Is the person administering the vaccine
ever solo?
- How do you minimize
distractions/interruptions at the location?
- What are your routines for monitoring
patients after vaccination?
- How do you screen those who have
impaired ability to communicate for contraindications?
- How do you monitor those who have
impaired ability to communicate?
- Do you use a skill set checklist like
the one noted above?
- How do you document vaccinations?
There are obviously many other considerations
in vaccine programs. We are only considering some of the safety issues
associated with the processes of vaccine programs. We refer you to many other
good resources involving all those other vaccination program issues, such as
the CDC guidelines, Immunize.org resources, and ACIP (ACIP, Ezeanolue
2019) recommendations.
Fortunately, such mixups
related to vaccination are relatively rare, but we can anticipate that they
will increase during this period where a flurry of both coronavirus
vaccinations and influenza vaccinations are being given. And, of course, there
are numerous other vaccinations being given (shingles, hepatitis, HPV, etc.) that
could also become part of similar vaccine mixups. Now
is a good time for all organizations that provide vaccinations to review their
practices. You could do a FMEA (Failure Mode and Effects Analysis) to identify
potential vulnerabilities, but don’t wait to do your FMEA. Heed the
recommendations in the ISMP NAN alert and those in our November 19, 2019
Patient Safety Tip of the Week “An Astonishing Gap in Medication Safety”.
References:
Genovese
D. Walgreens says vaccine mix-ups are rare after Indiana family claims kids
received COVID, not flu shots. Fox Business News 2021; October 15, 2021
https://www.foxbusiness.com/lifestyle/walgreens-vaccine-mixups-rare-covid-flu
ISMP
(Institute for Safe Medication Practices). Mix-Ups Between the Influenza (Flu)
Vaccine and COVID-19 Vaccines. ISMP NAN Alerts 2021; October 15, 2021
https://www.ismp.org/alerts/mix-ups-between-influenza-flu-vaccine-and-covid-19-vaccines
CDC.
Guidelines for Large-Scale Influenza Vaccination Clinic Planning. CDC 2015;
December 16, 2015
https://www.cdc.gov/flu/professionals/vaccination/vax_clinic.htm
Immunize.org
Immunize.org.
Skills Checklist
https://www.immunize.org/catg.d/p7010.pdf
Immunize.org.
Don’t Be Guilty of These Preventable Error s in Vaccine Administration!
https://www.immunize.org/catg.d/p3033.pdf
CDC.
Vaccine Storage and Handling Toolkit. CDC
https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf
Immunize.org.
Checklist for Safe Vaccine Storage and Handling.
https://www.immunize.org/catg.d/p3035.pdf
ACIP
(Advisory Committee on Immunization Practices). ACIP Vaccine Recommendations
and Guidelines.
https://www.cdc.gov/vaccines/hcp/acip-recs/index.html
Ezeanolue E, Harriman K, Hunter P, Kroger A, Pellegrini C.
General Best Practice Guidelines for Immunization. Best Practices Guidance of
the Advisory Committee on Immunization Practices (ACIP). Accessed on November
16, 2019.
https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-recs.pdf
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