Regulation and Compliance Amid COVID-19 Vaccination

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®: So before we get into our topic today, can you give us a little bit of your professional background in pharmacy and your areas of expertise?

Rosebush: Sure. I went to school way too long. My background includes being a Doctor of Pharmacy, or PharmD, from Purdue University. I'm a registered pharmacist in multiple states still today. I have a degree from Case Western Reserve University in Cleveland, Ohio, and I also have an MBA and master’s in finance from Indiana University Kelley School of Business.

In the pharmacy world, I’ve done everything from working and stocking shelves at CVS and Walgreens, to working in hospital pharmacies, and all the way up in the regulatory department, including spending some time at the FDA.

Drug Topics®: So getting more into the regulatory issues related to COVID-19 vaccination, what do you see as some of the biggest challenges facing pharmacists, in administering vaccines regarding these regulations and compliance issues?

Rosebush: Sure. So we actually get 3 big questions.

As somebody who's sat behind the bench, and I've probably personally filled 10s of 1000s of prescriptions, the question is, are these substitutable? Are they interchangeable? For example, if I start with the Pfizer vaccine, in the second shot, is the Moderna vaccine okay?

And we point to CDC guidance, we point to some of Dr. Fauci’s statements, and actually Pfizer’s and Moderna’s own statements on the substitutability. And a lack thereof at this point - we just don't have the data to be able to determine that.

The second really is to the data reporting. There's a huge issue when it comes to state versus federal. And there's some confusion that is out there.

One of the things that we often hear, especially as the Biden administration came in, is that we were going to make this a much more federal rollout and a federal plan, and the federal government was going to have much more involvement in it.

The thing is, while that is true to an extent of, for example, distributing the vaccine to pharmacies and independent pharmacies, which I think is a great thing, we still have reliance on the states and the state plans. And that is a heavy reliance on those plans.

For example, who's eligible and all the things we just talked about who could administer, one of the big things that comes into that is the data reporting. The federal government wants to know who has actually received the vaccine so we can keep track of how many arms it's actually went into, but also so that we have an understanding of who are the individuals who have actually received the vaccine themselves.

And if you look at the CDC’s and HHS’s requirements for the plan, they have a 72-hour time period. In other words, if patient Lee Rosebush were to receive the vaccine, right, whoever actually gave me that vaccine is supposed to report it within 72 hours.

Now, not all the states have adopted that same 72 hour time period. There's some that are that require it within 24 hours, for example. And if you have an IT program, like many major pharmacies do, that is used across state lines, the issue becomes is, if you're using a reporting requirement that meets the federal guidelines, it may not necessarily meet each of the state reporting guidelines.

And that becomes a major issue, because you want to make sure you're meeting both deadlines, right, both the state and the federal. And there's actually been some issues with that, again, I point in New York and not to throw shade or knock Governor Cuomo or New York. But in this situation, they've actually said, if you don't meet the reporting guidelines, that they will reduce the amount of vaccine potentially that comes to your pharmacy.

In this situation, they would take what was supposed to be given to you and send it to another location, which obviously could be a major issue if you're trying to do a second round, for example, or you're trying to continue to and you've got more arms that you could put the vaccine into.

So again, it's a major concern that we're considering, and I think those that are administering the vaccine should also consider.

The last one really is related to how it's approved. In this situation, the FDA put out what they call an EUA or emergency use authorization, which is a good thing, because it was able to get to the market fairly quickly.

On the flip side, as this pandemic starts to slow down, and we start to take away the emergency authorizations, these aren't technically “FDA approved.” If we've lost the emergency authorization, that means in the situation, they're not FDA approved, they technically should come off the market.

And so one of the things that we're watching for is when are these going to actually apply for FDA approval? And once they are approved, does it make a difference from payers perspective, because now we're actually administering a vaccine that's been FDA approved versus an unapproved product, which most of your listeners are aware of in the compounding space.

Drug Topics®: I just wanted to follow up on that point. Do you have any updates on when they're thinking of trying to get approvals for these vaccines or is that a little bit of a ways out still?

Rosebush: So, the biggest push from the agency from here in DC, as somebody who sits in DC and watches what the FDA does, has been on the new vaccines that they're trying to move forward.

Just as an example, the Johnson & Johnson vaccine, which we hear about because it's one shot and it's refrigerated instead of in an ultracold freezer.

The emphasis has really been on the authorization for those additional, not necessarily the approval of what's out there. So that that's my major concern.

As we start to get closer to herd immunity, more people have received the vaccine and more people have been sick, and so therefore we have immunity across the larger patient population. Do we start to get a slowdown in the authorization emergency status, and therefore lose the status without getting an approval process? I just want to make sure the agency and those who are administering the vaccine keep their eye on that ball.

Drug Topics®: I also wanted to ask you, you mentioned some changes since Biden took office, have there been some other pretty significant shifts since he took office and changes that pharmacists had to deal with as well?

Rosebush: There has been into the credit to the American Pharmacists Association (APhA) and the credit to the American Society of Health-System Pharmacists (ASHP), they both have been pushing hard for the inclusion of additional pharmacists. IT’s great to be able to administer the vaccine, this vaccine, which I personally think is a great thing.

And I point to the state of West Virginia as a perfect example. They really have used more independent pharmacies, and because of their continued push for the independent pharmacies, you hear about the success that they've had with vaccinating those in long-term care facilities, for example.

And so APhA has sort of taken it on and pushed as well for more involvement of pharmacists, ASHP has as well, to their credit, and the administration has said recently that they're going to start sending the vaccine directly to pharmacies.

So there has been a change in the view of how pharmacies are viewed. It doesn't mean that the Trump administration or the last administration didn't use pharmacies, because they did. It just seems to be that there's been a larger focus now on using pharmacies.