Dilution errors and product mix-ups were just a few early errors reported during the vaccine rollout. A PharmD shares his experience and provides guidance on how to avoid them in the future.
The coronavirus disease 2019 (COVID-19) vaccination campaign is thankfully in full force now in the US, with >128 million doses administered and almost 14% of the population having been fully vaccinated as of March 23, 2021. In Northeast Florida, where I work, we are aggressively vaccinating. The health system I work for, for example, has held clinics that have vaccinated close to 2500 people in 1 day (in addition to >5000 employees). Also, our health department, as well as other health systems, have been holding regular clinics as vaccine supply allows.
As the clinics have started to roll out, we are also seeing reports of errors in vaccine handling and administration. In this slideshow, we will look at early error reports compiled by the Institute for Safe Medication Practices (ISMP), and how you can avoid them in your vaccination or practice setting.
1. Dilution Errors. The Pfizer-BioNTech vaccine is reconstituted with 0.5mL of preservative-free sodium chloride for injection. Errors have occurred where too little diluent is used, resulting in a dose too concentrated, which could lead to more adverse events.
• Educate providers: All clinic participants should be familiar with the Fact Sheet for the vaccine being given. • Dilution verification: ISMP recommends using an independent check of the vial dilution, if possible. • Have pharmacy prepare syringes: During clinics I’ve participated in, we have had 4-5 pharmacy staff members preparing doses and putting them in baskets for vaccinators.
2. Vaccine Waste. COVID-19 vaccine doses have been wasted because some syringes are not efficient enough to get the 6th dose out of the Pfizer vial or the 11th dose out of the Moderna vial. Also, some clinics are trying to find people to vaccinate after scheduled appointments end or end up wasting leftover vaccine doses (limited beyond-use dating).
Tips on how to avoid vaccine waste:
• Syringe selection: ISMP recommends low dead-volume syringes, which are more capable of getting every last drop out of the vial. • Plan for leftover doses: At the public clinic I’ve participated in, we gave people who were waiting outside at the end of the clinic the leftover doses. We also gave them to family members who had come with those that had an appointment. • Designate a clinic worker to maintain an alternate recipient list.
3. Product Mix-ups. ISMP has reported cases of the Moderna vaccine being confused with casirivimab and imdivimab, monoclonal antibodies recently granted Emergency Use Authorization in the US to treat adults and children (aged ≥12 years weight at least 40 lbs) with mild-to-moderate COVID-19. ISMP notes that for each antibody, there are 2 different labels and neither one displays the name of the specific antibody or a bar code. Also, the Moderna vaccine and the monoclonal antibodies come in vials with a red cap, which might have contributed to the error.
Tips on how to avoid product mix-ups:
• Develop a system to immediately identify and label investigational products upon receipt. • The NDC is included in the Fact Sheet for casirivimab and imdevimab and can be used to generate hospital-specific barcodes for product verification. • One health system used color coding to visually separate the products and prevent errors.
4. Clinic Planning Errors:
• ISMP reported an error in a patient email address, resulting in the patient not getting the second appointment confirmation. • ISMP also reported 2 incidents of accidental vaccination of underage recipients. • Anecdotally, some potential recipients have experienced difficulty registering for clinics as well as long wait times. • Long telephone hold times and requirement to register online have made it more difficult (especially for vulnerable populations) to get an appointment.
Tips on how to avoid clinic planning errors. ISMP recommends the following for vaccine clinics:
• Establish a communication system to confirm vaccine appointments, including responding to undelivered emails with a phone call and setting up a hotline for scheduling questions. • Implement a system that does not allow underage individuals to register for vaccination.
In addition, many clinics are using an assembly-line structure with separate individuals handling registration, vaccine preparation, administration, and monitoring.
5. Misinformation. Online misinformation campaigns and unfounded claims of harm surround the COVID-19 vaccine, such as:
• It is being used to microchip recipients. • It hasn’t really been studied yet. • It will change the recipient’s genetic makeup. • Since it’s “only 95% effective,” there’s no point in getting the vaccine.
How to avoid misinformation. Take advantage of the numerous resources out there to help you discuss the vaccines with your patients and be able to refer them to reputable sources. Resources to help communicate COVID-19 vaccine safety and efficacy include: