COVID-19 Vaccine Risk Mitigation

By: Randy McDonough, B.S., Pharm.D., M.S., CGP, BCPS, FAPhA 

In the past several weeks, there have been news reports about pharmacies, health care clinics, and remote vaccination clinics giving the wrong dose of a vaccine. Previous to these reports, there were also stories of health care providers not appropriately diluting the Pfizer vaccine resulting in a wrong dose delivered to adult patients.

Whenever we hear about these news reports, it causes most health care providers to become concerned, stressed, and anxious as to how to mitigate these types of errors.

As we layered on COVID 19 vaccines to our existing practice, it became apparent that our already stressed practice became even more stressed. That is likely not all that surprising to anyone in Pharmacy Practice right now. At my pharmacies, we quickly realized the need to develop additional strategies to prevent—or at least minimize COVID-19 vaccine errors. Below is a summary of changes that may help your practice. These risk mitigation procedures came out of our due diligence to create even better systems and processes to minimize errors. The following processes were developed and implemented for both our remote and in-house vaccination clinics. It is important to note that our processes are comprehensive and with multiple checks and balances.  What have you implemented in practice to support risk mitigation? Join the conversation with me at The Pharmacy Network so we can all share the best practices and ask questions.

Online Scheduling: A must

Our Pharmacy uses an Acuity Online Scheduling tool that is easily accessed on the Towncrest Pharmacy website. With online scheduling, the patient can get access to a vaccination quickly and schedule without engaging pharmacy staff.  Here’s what we learned that helps with risk mitigation:

• Determine and ensure eligibility through your online scheduler. You can incorporate a patient questionnaire and prevaccination checklist to determine eligibility as well as screen for potential contraindications/risks.
• Incorporating your HIPAA policy and acknowledgment form into the scheduling tool. We allow patients to access and acknowledge the form using an online link. This reduces our workload and saves us time so we free up the pharmacy team to focus on safety and service, not tasks at the point of care.
• Give access to the CDC Vaccine Fact Sheet via a link in your scheduling tool. Patients can acknowledge that they have read and understood it.
  The patient selects an open appointment day and time.
• Patient information can be reviewed ahead of time to determine if any patient needs to be contacted regarding their completed questionnaires, eligibility, and contraindications. This helps make onsite vaccination faster and safer. 

Best Practices for Appointments Logistics 

Here’s the process we’ve implemented at Towncrest, adapt to fit your workflow applying risk mitigation principles highlighted. 

1. Prior to the clinic starting, have the online patient paperwork reviewed and printed out, and organized by appointment time.
2. Using a Dymo printer, we create stickers with the required information prefilled so it may be easily placed on the COVID-19 vaccination record card.
3. We utilized File Maker Pro to develop a Towncrest Pharmacy COVID-19 Manager program. This means when the patient arrives, we can check them in on a tablet verifying their name and DOB. We then collect their insurance card and appropriate paperwork is pulled. Check out a video tour of this feature (coming soon!).

Safety Pearls for Onsite Vaccine Administration 

• • If Pfizer vaccine is used, due to the time to prepare the vaccine, we prep and draw syringes in advance complete with a timestamp of preparation. This means we can monitor the appropriate duration of time that the prefilled syringes can be used. 
    Tip:  The step-by-step instruction for dilution and amount to draw up are included in the Pfizer vaccine baskets at our pharmacy 
  • How many patients can you schedule at a time? Consider these factors when deciding the number of patients to schedule per time slot:
    • Remote or in-house clinic
    • The number of vaccinators
    • Space and layout.  Appropriately spaced patient vaccination areas are key to allow for social distancing.

      Example from Towncrest Pharmacy: We have 6 areas that we can socially distance patients in our vaccination areas.  Due to this, we schedule 4 to 6 patients every 15 to 30 minutes depending on demand. This allows adequate time to monitor patients post-vaccine before the next group arrives. At remote clinics, we can vaccinate more patients because of a larger venue so we’ll offer about shots to 12-15 patients every 15 minutes.

  • Monitoring patient vaccine outcomes can be done by sharing times to wait on completed vaccination forms. When the vaccine is given to the patient and the vaccination form is completed and signed by the vaccinator add the time patient can leave post-vaccine. 
    • During the time that the patient is waiting,  the order entry technician bills for the vaccine.
    • When the allotted time is reached, the patient is evaluated by the vaccinator, their COVID-19 cards are given to them along with their insurance card.

Other Risk Mitigation Procedures

Here are some additional best practices we have implemented. 

• Our pharmacy uses different colored forms for each vaccine paperwork. Pfizer Pediatric = Pink Moderna = White, Pfizer Adult = Green, and John & Johnson = Gray. All other vaccines (e.g. Flu, Pneumococcal, Shingrix, etc = Yellow).
• Prefilled syringes are kept in different colored baskets along with the name of the vaccine, lot and expiration date, and an empty vial of vaccine, pre-drawn.
• All prefilled vaccines (syringes) are checked by two people (using our students, technicians, or pharmacists) to determine the correct vaccine, and volumes are drawn.
• Pediatric COVID-19 vaccines are separated during the day from all other vaccines to reduce errors. For example, adult COVID-19 and other vaccines are given from 9 AM to 3 PM. Starting at 3 PM only pediatric COVID-19 vaccines are given
• If at remote clinics and both influenza and COVID-19 vaccines are given and if multiple COVID-19 vaccines (manufacturers) are being used, we separate the patient vaccination areas.  Influenza is in one area and each COVID-19 vaccine will have its own area. Even the preparation and drawing of vaccines into syringes is separated based on the vaccine. For example, the preparation and drawing of vaccine for Pfizer vaccine will be close to the Pfizer vaccine patient vaccination area, etc.

Evolving procedures as boosters and pediatric vaccines have come to market, is critical. As Pharmacists, we always need to think ahead and consider what can possibly go wrong; then, develop strategies, policies, procedures, and processes to mitigate possible errors.

It is important that these risk mitigation strategies are developed in advance of providing the services and understand that they are dynamic and evolve as information changes, potential gaps for errors are recognized, and workflow efficiencies are considered.