A session from EduCon 2021Virtual, which was held on February 4, highlighted best practices for pharmacists currently administering, or planning to administer, coronavirus disease 2019 (COVID-19) vaccines.
The session, called “COVID-19 Vaccine: Best Practices for Pharmacies,” featured a crash course presented by Tracy Dabbs, PharmD, emergency preparedness pharmacist, from the Georgia Department of Public Health. Dabbs is on the forefront of the COVID-19 vaccination response in her state.
In the session, Dabbs provided recommendations for the most critical issues involving vaccinating patients for COVID-19, including clinical requirements, billing and reporting of the various vaccines available, and key information on currently available vaccines.
While there are currently 2 COVID-19 vaccines that have received emergency use authorization (EUA) status by the FDA, and another currently being reviewed by the agency’s advisory committee, there still are many candidates in the pipeline – including 63 in clinical development and 174 in pre-clinical development. “Having a different variety of vaccine candidates is extremely, extremely important right now, just to make sure that we have more vaccine that’s available,” Dabbs said during the presentation.
However, with pharmacies either receiving the Pfizer-BioNTech or the Moderna vaccine at this point in the rollout, Dabbs clarified key information including temperature requirements, inoculation procedure, and expiration dates for each of the authorized vaccines.
Pfizer-BioNTech COVID-19 Vaccine
The BNT162b2 vaccine, requires ultra-cold temperatures in order to remain stable at -80°C to -60°C, or -112°F to -76°F. These requirements make the vaccine less pharmacy-friendly, according to Dabbs, as pharmacies often do not have the resources already in place to keep ultra-cold temperatures.
Pfizer ships the product directly from its manufacturing site on dry ice in an ultra-cold cooler, and pharmacists need to wear gloves to handle the vaccines. The product will remain stable at refrigerated temperature, or 36°F, for up to 120 hours.
Each vial of the vaccine requires 30 minutes to thaw at room temperature, or 2 hours at refrigerator temperature, and must be diluted with sterile 0.9% sodium chloride (1.8 mL) and the final concentration produces a 0.3 mL injection, Dabbs explained. Once the vial is punctured, the vaccine must be used within 6 hours.
The 2-dose Pfizer vaccine has an average of 55% efficacy following the first dose at day 10; the second dose should be given 21 days later, or between 19 and 23 days later. Patients will be protected against COVID-19 at up to 95% efficacy following 10 to 14 days after the second dose. For this reason, Dabbs highly recommends this COVID-19 vaccine.
As for delivery time frames, Dabbs mentioned that Pfizer’s vaccine usually takes about 72 hours due to ultra-cold storage conditions.
Moderna COVID-19 Vaccine
Dabbs’ crash course additionally covered the Moderna’s mRNA-1273 vaccine. Unlike the Pfizer-BioNTech vaccine, Moderna’s product requires standard freezer temperatures to stay stable at -20°C, or -4°F, with a range between -25°C to -15°C. Dabbs therefore called Moderna’s candidate the “pharmacy friendly product.” It is also stable at room temperature for 12 hours; once the vial is punctured, the vaccine expires in 6 hours.
Importantly, Moderna is labeling its vials with a manufacturer date rather than an expiration date, Dabbs said. According to Dabbs, this may complicate inputting the vaccines into a pharmacy’s software system. Dabbs circumvents the issue by either inputting 6 months following the manufacturer date or looking up the lot number on Moderna’s website.
The deliveries are shipped directly from McKesson, and, in Dabbs’ experience in her state, the shipments are being delivered very quickly. “When the order is placed into the CDC by public health, we usually see it within the next day or 2, so pretty fast turnaround time,” she said.
Compared with Pfizer’s 120-hour usage requirements in refrigerated conditions, the Moderna vaccine can last for 30 days. The 2-dose series has a 45% to 82% effectiveness about 10 days following the first dose, and up to 95% effectiveness 10 to 14 days after the second dose. Because of the conceivable 82% efficacy of the first dose, there have been suggestions to use Moderna as a single-dose vaccine, but the FDA has not yet weighed on the issue. As of this article’s posting, Moderna should be given in a 2-dose regimen.
Moderna’s vials currently contain 10 doses each, but the company is working with the FDA to increase the number of doses per vial. Moreover, this vaccine does not require dilution, unlike the Pfizer vaccine.
However, according to Dabbs, since both the Pfizer and Moderna vaccines use mRNA technology, they are more sensitive and should be protected from light.
The Pharmacists’ Role in COVID-19 Vaccination
Pharmacists have been declared health care providers under the Public Readiness and Emergency Preparedness (PREP) Act, which has been a big win for pharmacists, according to Dabbs. “It’s been a while and we’ve been waiting for it. Because of this you can administer COVID-19 vaccine in your pharmacy with you being the health care provider,” she said. As a result, pharmacists can register for a National Provider Identification (NPI) number and bill for COVID-19 vaccines.
Pharmacists are also critical in the success of the vaccine rollout because of their proficiency in usingaseptic technique. Both currently authorized vaccines are preservative-free products and must not be contaminated, Dabbs explained.
The Phased Approach and Other Key Recommendations
The US is operating under a phased approach, Dabbs explained. At this point in time, the US is in the first of 3 stages, where limited doses are available. Because there are only 2 companies manufacturing their products with cold chain restrictions and centralized distribution, there is a demand for vaccine that is higher than the supply. Dabbs pointed to Johnson & Johnson’s candidate now under review by the FDA. As more candidates are ushered through to EUA status, the US will move into phase 2 and supply will meet demand and other vaccine products allow wider range of administration locations.
Pharmacists should also be aware of considerations related to costs of administering the vaccine. Both Pfizer-BioNTech and Moderna, as well as Johnson & Johnson and AstraZeneca, are government-sponsored vaccines. Therefore, providers will receive them at no cost. As a provider, pharmacists can also choose to charge an administration fee, but only if a patient’s insurance covers the cost.
“It’s a very interesting time because we’re not used to having a product where we didn’t pay something for it, so you have to go into your software and change the cost to 0. Or if your software rejects it because things don’t cost 0, then you have to put it for a penny when you bill,” Dabbs said. She also recommended that pharmacists reach out to their billing software and ask how they should be billing for COVID-19 vaccines.
Because the government also covers ancillary supplies, pharmacies will receive:
However, Dabbs recommended that pharmacists have extra swabs handy to sterilize patients, as the ancillary kits do not provide enough for this purpose. Pharmacies receiving ancillary kits from Pfizer should also be aware of its size. Each kit is designed to accommodate 1000 individuals and weighs about 40 pounds so immunization sites should ensure that they have the space.
With the accelerated pace of the pandemic, some kits may be missing supplies. Dabbs suggested counting supplies once they are received so that the manufacturer can be notified about replacing products in time for a vaccination clinic.
Dabbs also remarked on the rapidly changing COVID-19 vaccination guidelines amid the evolving pandemic response. As of press time, the CDC recommends that any patient with an allergy to oral medications or food, pets, insect, venom, environment, latex, family history of allergy, should be observed for 30 minutes to make sure they don’t have an anaphylactic reaction. Additionally, a patient with a history of allergic reaction to vaccines or any injectable therapies should undergo a risk assessment. Pharmacists should stay updated on changing recommendations.
As for last advice, Dabbs highly recommended the CDC COVID-19 Vaccination resource page. She also advised pharmacists to be flexible, accept that there may have to be changes to a vaccination strategy before it works, be open to discussing strategies with your team, and schedule regular update meetings.