Drug Topics®: In this interview, I’ll be speaking to Kaitlyn Rivard, PharmD, infectious diseases clinical pharmacist at the Cleveland Clinic in Ohio. Kaitlyn has been instrumental in getting their COVID-19 vaccination clinics off the ground, and in our interview, she’ll be discussing some key insights, advice and experience in developing an effective COVID-19 vaccination program.
So to start, Kaitlyn, can you give us a little bit of your background as a pharmacist and your work at the Cleveland Clinic prior to the pandemic?
Rivard: Sure. My name is Katie Rivard, and I am an infectious diseases trained pharmacist here at the Cleveland Clinic. I did my pharmacy school training at Ferris State University in Big Rapids, Michigan, my first year of residency in Grand Rapids, Michigan, and then my second year of residency specializing in infectious diseases here at the clinic.
And then I stayed on, primarily in the role of the pediatric infectious diseases pharmacist. Part of that role was helping to manage vaccinations for the health system in terms of which vaccines clinically are most appropriate to use, when do we use them. Helping to advocate for vaccine coverage on insurance companies and those types of things.
So when we began to experience the COVID-19 pandemic, I was somewhat protected from it because children are less affected by COVID than adults. My colleagues in adult infectious disease really took on the majority of the work with COVID therapeutics.
But then in the Fall, when vaccines became available, it kind of fit naturally into the work that I had been doing. And since I wasn't doing COVID therapeutics planning, I had the room on my plate to take on the vaccines. And that's kind of how I ended up in this role.
Drug Topics®: Great. So I wanted to go back quickly to the onset of vaccination back in November. I wanted to ask you, so obviously, these clinics are something that's very new, so how did you and your team approach the planning part of administering COVID-19 vaccines?
Rivard: Sure. I think the first thing is we wanted to leverage what we were already doing.
We have a very successful history of our influenza vaccine campaign, having all of the product centrally stored at one location, and then we handle our own distribution. And we wanted to mimic that process for the COVID vaccine using the infrastructure we already had in place and knew to be successful.
We also had to work with the manufacturers and the CDC, Operation Warp Speed (OWS) to get as much information as we could ahead of time on the particulars for the vaccines. What temperature did they need to be stored at? Did we need specific special freezers? How long would they be stable at refrigerated temperatures and ones prepared? So that we could outline that standard work to ensure that we wouldn't have any challenges.
And so, we modeled as much as we could off of our influenza vaccine campaigns. But that typically allows for walk-ins, we knew that that would not be available because of the multidose vials of the COVID-19 vaccines that are preservative free, so you only have a 6-hour window once the vial is opened. We knew we would need to do appointment-based, but we basically took what we were already doing and then modified it to the needs of the COVID vaccine.
Drug Topics®: And also just another baseline question here. Can you give us a little bit of an overview of who is on your vaccination team?
Rivard: Sure. Our COVID-19 vaccine committee is truly multidisciplinary.
We have leadership, hospital leadership, from medical operations, who is kind of leading the charge, we have our Epic Systems and Electronic Health Record (EHR) folks who are doing the build. We have communications, both internal and external, to help with any messaging. We have representation from facilities, because they're the ones who were physically building our vaccine clinics. From patient registration, nursing, nursing education.
We have also engaged our pharmacy supply chain. So while I handle some of the clinical aspects, we also have our non-clinical pharmacists who do the supply chain and logistics and continuous improvement to ensure we have great standard work.
And I'm sure I'm missing other groups, but certainly it has been a team of teams to make this successful.
Drug Topics®: And I was told that once a clinic decides which vaccine, like the actual brand, like Pfizer, Moderna, they kind of keep that vaccine. So I'm interested in which vaccine or vaccines that you're offering at the clinics.
Rivard: That is determined by the state and every week, the state tells vaccine clinics how much and what products they're going to receive.
And so we offer, we have offered both Pfizer and Moderna in the past, and just week to week, it depends on what the government tells us. We're able to flex to use either product, we have training protocols in place for both.
Drug Topics®: So that's interesting. With Pfizer, has the cold chain and maintaining ultracold kind of been a challenge with that, or were you ready for tackling that?
Rivard: We were fortunate to have ultracold temperature freezers available to us.
So we have, I think what the news has been calling our freezer farm, so a segmented area with the special freezers to be able to store the Pfizer product more securely than in the thermal shippers with dry ice, which allows us to kind of keep them on site in the freezer more securely.
And certainly we don't want to hold on to them for too long, because it's they're not helpful if they're in the freezer, they're helpful once we've given them to patients. But it certainly helps us mitigate waste, and that we only pull in thought what is needed for each day. So that way, we don't have to worry about product that's going to expire soon.
Otherwise, we do have processes, if there are vials leftover at the end of the day, on how to get those doses into patient arms, then we have a zero waste tolerance policy. We've been very fortunate to have this technology so that way we really can minimize how much the number of doses that have been wasted, which is incredibly minimal for such a large health system.
Drug Topics®: Yeah, that's incredible. And since you began in November, have you altered or improved any of your processes, when you're going forward? And how do you stay prepared in a situation like this when there's always new or different information every day and more vaccines entering the pipeline as well?
Rivard: Yeah, we have definitely had to be nimble and try practices, assess if they're working, and then kind of pivot if they're not.
So things that we learned really quickly about the thought process is that the Pfizer vaccine itself thaws really quickly in the vial, but the rubber stopper actually needs 30 minutes out of that ultracold freezer before it can be pierced. So we kind of changed the way that we're pulling that from the freezer. So that way, we ensure that the rubber stopper is at an appropriate temperature to be utilized.
We had originally planned on only using Moderna at our regional hospitals and keeping Pfizer at a central location just because of that more specific cold chain and a shorter expiration. However, because the Ohio Department of Health tells us what we're going to receive, we don't have control, we had to pivot and work on a process for getting Pfizer to our regional sites.
And then we have twice weekly pharmacy site coordinator meetings, where the pharmacy leads at each site and I meet to discuss what's working well, and what isn't. Even things as simple as how we're labeling the syringes with the lot number and expiration date. We started off one way it was handwritten and quickly realized that that wasn't the best use of anyone's time. And so now we're kind of printing those so it's a more streamlined process.
So definitely, it's a continuous improvement cycle. We assess what's working and then we make changes to see if it improves both safety as well as efficiency, with safety, of course, being our number one priority.
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