February 24, 2021


Hello, I'm Gabrielle Ientile with Drug Topics®. So today I'm speaking with Lee Rosebush of Baker Hostetler law firm about their interactive state-by-state COVID-19 vaccination rollout guide and the issues of regulation and compliance within pharmacies amid the pandemic. Lee, thank you so much for joining me today.

Rosebush: Thank you for having me, really appreciate it.

Drug Topics®: What do you see as some of the best practices for distribution amid the pandemic?

Rosebush: It's interesting, we get that question a lot, because a lot of people would point to the Cardinal, AmerisourceBergen and say, “Look, they distribute so many drugs across this country to so many pharmacies, that they should be the ones who are distributing this out.” And why isn’t there more involvement with this? Why is it more of a push towards the federal government angle?

And, to me, that is one thing that I think there could be some improvement here on the Biden administration is how do we distribute it? But there's been a huge push here in DC to include the Defense Procurement Act, or the DPA.

And what a lot of people don't understand is, you may push and require a vaccine to be manufactured more, but they can only go as fast as Current Good Manufacturing Practice (CGMP), or the manufacturing practices, the policies that the manufacturer of the vaccine will allow them to go.

Forcing them to go further or beyond what CGMP requirements are actually doesn't do us any good. While it may look good in the press, it doesn't help us with the distribution angle.

What I would actually push for in this angle is more of looking towards the reporting and getting the vaccine to those who are doing the most shots. So, if we're getting a larger use of certain medical centers, or larger use through independent pharmacies, allow Cardinal and McKesson to take some of those vaccines that we have through Pfizer, Moderna, and distribute them up the change of those facilities at a much larger percentage and a quicker rate.

Drug Topics®: A lot of people are dealing with issues related to cost. So I wanted to ask you, if you had some recommendations for pharmacists, or other health care professionals who are dealing with this issue.

Rosebush: This is to me is one of the biggest concerns that I have listening to the press here in DC, and this goes to both the Trump administration and the Biden administration.

They continue to push the fact that there's no cost associated with the vaccine, what they forget to mention is there may be costs associated with, for example, those supplies that are required to actually administer, or the individuals time for pharmacists, for example, or nurse who's required to actually administer the vaccine, their cost potentially associated with that.

And so, they ignore a lot of the peripheral issues, which, one, can go to a pharmacy’s bottom line and, two, actually encourage more individuals to be able to be involved with it because we, as pharmacists, if we're going to walk away from the bench and dispensing prescriptions, to be able to do this, we need to ensure the survival of our pharmacies while we're administering these continues moving forward.

And so that is my one big pet peeve with a lot of the discussions around the PR of free “vaccines,” is they ignore some of the other costs besides just the shot itself. And they seem like when an individual walks in that it would be completely free, when there may be additional costs that may be charged to an employer or an employee or a benefit plan when it comes to the administration of the vaccine itself.

Drug Topics®: And you also mentioned keeping records as well, has been an important part of COVID-19 vaccination. In regard to doses records, and also cold chain records, what can you recommend?

Rosebush: To me, that again is a big concern, because there's a difference between the Pfizer vaccine in the Moderna vaccine: 21 days and 28 days.

And that is also, in addition to that 72-hour time period we were talking about, the second concern related to record keeping is to ensure that when you do receive a vaccine, you have a clear and concise record as to which one you received.

That follow-up time period is important, whether it's 21, or 28 days. Because one of the bigger concerns that we have, and this comes from those on the CDC side, is what happens if we get out to 35 days, or what happens if we're at 14 days, right, and we don't know what that impact may have on the actual immunity that you would receive from the vaccine?

It’s important to not only on the 24 and 72, to report to the state and federal government correctly, but also to ensure that the individuals, when they're receiving the vaccine, they've got a clear and concise record as to which vaccine they've actually received. So that way, for treatment purposes, we're clear as we move forward.

The big one for me on the main takeaways is ensuring that individuals are following the proper procedures, the 24 versus 72 hours, they're properly documenting. And the big one is that you make sure that you review your state plan to ensure the individuals who are receiving the vaccine are eligible to receive the vaccine or that you're following the proper plan.

The other one is on the payment. If you're not documenting things correctly, especially on the supplies as it becomes to Pfizer versus Moderna, for example, it's going to be tough from a reimbursement perspective as we move forward.

The last is on the adverse event (AE) reporting. Now, there's been some questions related to thrombocytopenia, for example, with a vaccine and some of the immune reactions. It's important that we have a clear record as we move forward as to those adverse events just to ensure that they're properly documented.

Drug Topics®: Lee, thank you so much for taking the time to speak with me today. And thank you for your work during the pandemic, as well.

Rosebush: I greatly appreciate it. Thank you for your time.