Expert: Pharmacists’ Paxlovid Authorization is a “Significant Step” Toward Provider Status

In addition to expanding patient access to Paxlovid, the antiviral approved for patients with COVID-19, the recent authorization of pharmacists to prescribe the drug marks a step toward provider status, according to Ron Lanton III, Esq. In an interview with Pharmacy Times, Lanton discussed how the FDA approval happened and what it could mean for the future of pharmacy.

Aislinn Antrim: Hi, I'm Aislinn Antrim with Pharmacy Times. I'm here with Ron Lanton III, Esq., partner at Lanton Law, to discuss the recent FDA authorization of pharmacists to prescribe Paxlovid and what that really means. So, this authorization happened fairly recently. Can you discuss the specifics of exactly what pharmacists can do under this authorization?

Ron Lanton III, Esq.: Of course. And you're right, it was fairly recent, it was July 6th that the FDA put this out. And what they put out was the emergency use authorization. So, for people who aren't familiar with that term, basically, whenever a drug wants to or needs to be approved by the FDA as a new drug, they go through a process. But if you have something like COVID-19 happen, where we can't afford to wait for that long process, there's another process to make sure that people can actually get help when they need it. So, it's the emergency use authorization, or the EUA. And it authorized state-licensed pharmacists to prescribe Paxlovid to eligible patients.

So basically, in this guidance, or in this EUA, what's in there is that if a patient wants to go to the pharmacy, they have to make sure that they take electronic or printed health records that are no less than 12 months old, including the most recent reports of lab bloodwork, to the state licensed pharmacist to review for any kidney or liver problems. The pharmacist could also receive this information through a consult with the patient's health care provider. And they also mentioned a lot about a state licensed pharmacy, so they want to make sure of that, obviously. I can't really imagine an unlicensed [pharmacist], but they just put that in there just to be sure. They also say that they want the pharmacist to see a list of all medications that the patients taking, including over the counter medicines, so that the patient can be screened for any potential drug interaction with Paxlovid, which I can't think of a better health care professional to screen for things and to see if there's a drug-to-drug interaction, because that's where the pharmacist arrives at.

Now, there are exceptions to this EUA. So, the pharmacist should refer patients for clinical evaluation with a physician or like an advanced nurse practitioner, if any of the following situations apply. If there's sufficient information that's not available to assess a renal function, if there's sufficient information that's not available to assess for potential drug interaction—which, like I said, pharmacists really should know if that's the case or not. If there's modification of any other medicines that are needed due to a potential drug interaction, that is just not an appropriate therapeutic option. So, they want you to go and see your doctor for that. But otherwise, you know, I think this is a great thing for pharmacists to be used in a way that I think everybody should use a pharmacist and I'm glad this has happened.

Aislinn Antrim: Yeah, absolutely. The announcement of this was a little unexpected, from my understanding. Can you discuss the process of the EUA and how we got here?

Ron Lanton III, Esq.: Yeah, I was a little surprised by this too, right? And I mean, I'm happy for it, so it's a happy surprise. And it's kind of weird saying that we're happy about this surprise, because pharmacists have always been here, right? I just don't think that people realize the importance of a pharmacist. It's always an afterthought, even though when you really look at what a pharmacist does, it's pretty essential to the system, right?

So, in the original EUA, the pharmacist was not included as a prescriber. But because of some industry pressure, which I'll talk about in just a second, the FDA did make a label change that removes that barrier so the pharmacy can actually prescribe. So basically, there were a lot of industry stakeholders that went to the FDA and said, “We need to do something else and include a pharmacist because the numbers of people that are getting COVID-19 are too high. And there is plenty of us that can help with the situation.” But there has always been this divide between the doctor and the pharmacist. And before I get a little bit further into it, I really hope that that resolves itself for the good of the patient, because I know there's been a lot of barriers. It just works when the pharmacists and the doctor can talk and try to figure things out, you know. I think we're eventually moving towards that situation.

But what the American Pharmacists Association did was put out was an analysis about how pharmacists can actually help. So, they basically said, hey, look, you know, 90% of the population lives within 5 miles of a pharmacy. There are 28,000 community pharmacists that are in federally recognized underserved communities, but there's only 838 test-to-treat sites. And if you engage with pharmacists, you can increase access to these treatments by 3200%. So, it's a win-win. And I think, you know, the FDA finally got that and allowed the pharmacists to prescribe, which is the right thing to do in this case. A lot of times, you know, you can't get to a physician's office, the pharmacist is the only health care provider in a certain community. It really makes sense. That's a no brainer.

Aislinn Antrim: Yeah, especially with Paxlovid, they do need to be prescribed within a certain period of time.

Ron Lanton III, Esq.: Five days within exposure. So, you really need to make sure you get it as quick as possible. Yeah, you don't want the effects of long COVID-19, either, because that's expensive. And it's detrimental to the patient, so let's just cut it off at the knees and make sure the pharmacist has the tools they need to make the patient better.

Aislinn Antrim: Definitely. Are there legal implications or things that pharmacists should be aware of when they're taking on this new responsibility?

Ron Lanton III, Esq.: Well, because the EUA talked a lot about a state licensed pharmacist, and they mentioned that several times throughout this EUA, just make sure your license is up to date. So, just take care of that, and I think pharmacists are able to take care of that, that's pretty easy to lay up. After that, I think just make sure that you follow the standards within the EUA about the patient tests and making sure the patient has the appropriate information if they're coming to you about those liver tests and things that I mentioned earlier. That's pretty much it. I think if you follow that, I mean, you follow what the federal government is telling you, you should be good to go.

Aislinn Antrim: Good. One of the major obstacles for pharmacists being able to take on more responsibilities like this is getting payers on board. So why is this step really important and do you think this is a step in that direction?

Ron Lanton III, Esq.: I do think it's a step in that direction. I think ultimately, where we're going is this whole provider status recognition, which we've been fighting for years about. And I'm sure this will come up in one of your questions about provider status. So, I'll do my best to try not to deviate too much into that. But the payers have a lot of influence over our system, right? That's how Medicare, you know, the federal government doesn't negotiate drugs yet. The reason I say yet, that's because we have this reconciliation bill right now in Congress, where they're actually talking about having Medicare negotiate for lower drug prices. But for right now, the way the system is, it gives a lot of deference to the PBMs and the payers. So, this is the system that we're in. Unfortunately, because of this system, this is where the pharmacists have found themselves not being reimbursed, not being recognized for their services the way that they should. So, we're kind of living with the devil that you know, but it's getting better. And it's getting better because unfortunately, we've had an unfortunate event such as COVID-19, but it's actually showing people why a pharmacist is needed to alleviate a lot of these problems, which is what we were just talking about. So, I think that getting payers on board, because they are the gatekeepers, and they're the ones that the government, both federal and state turn to to say, “Should we do this instead of just passing a lot?” If they're on board, that really just cuts a lot of red tape and gets it to where the pharmacist and the patient both need to go.

Aislinn Antrim: Absolutely. Well, to your point, what would gaining provider status mean for pharmacists and what they're able to do?

Ron Lanton III, Esq.: We've been fighting for this for so long, and I think it's been so piecemeal. When you look at provider status, you know, pending bills and different states means different things. There's smoking cessation, there's, you know, it just depends on what disease states they've decided to focus on at that particular time. But the whole reason about provider status is one, making sure the pharmacist gets reimbursed, but really getting reimbursed for their clinical knowledge. You don't go to a physician's office and tell them all the problems and then walk out the door. They're like, “You got to pay the bill.” Right? So why is pharmacy the only thing, the only profession where that's expected, or pharmacy really shouldn't be asking for anything else other than giving the knowledge? Which, again, if it were any other profession, they'd be paid for that. So, really, it's not it. Yes, it's the money. But it's really the recognition that the pharmacy has something valuable to offer the patient, and that's good for everybody. You know, being able to analyze a drug interaction, which is what we talked about in the EUA, that's something that pharmacists thrive at. So, making sure that they are not able to just test but also to treat.

So, I think we're going from this this whole circular journey of starting where we know that we ended up having to treat, it's just how do we get there and making sure people feel comfortable with that journey, and it's taken a pandemic to do it. But I really don't think that people understand completely what a pharmacist does. So, I mean, I'll just say a couple of things that I know this audience is very familiar with. But you know, for people that aren't, this is a good educational piece. So, pharmacists are trained and qualified to prevent or to provide preventative service, right? Immunizations, monitoring blood pressure, looking at cholesterol, doing foot checks for diabetic services, smoking cessation, point of care testing for blood glucose, strep, flu, COVID-19. They can also educate and counsel patients on how to stay healthy. There's, you know, kind of natural alternatives if you want to look at that. So, there's a lot of different things that a pharmacist can do, especially the drug-to-drug interactions, I don't know how important that is to really stress because the doctor doesn't necessarily do that. Not to say the doctors aren't qualified to do that, but a lot of times, because of the way our system is and they're just turning things around, they don't have time to look at everything that [the patient is] on. And, you know, sometimes the patient takes something off the shelf OTC as a supplement, and the pharmacist is able to see all that. So that's why we need the pharmacist. Well, not the pharmacists, we need the policymakers to understand why the pharmacy services need to become full circle like that.

Aislinn Antrim: Absolutely. And what efforts are there are being made to push for this provider status?

Ron Lanton III, Esq.: Well, I know there's both federal and state. State, one because I'm doing some of the state, especially in Massachusetts, that's what I'm working on at this very moment, trying to make sure that this is recognized. Our pharmacists have the recognition statute already in Massachusetts, just for example. But we need to understand exactly what that means. So, I think that's the next step. And some states that have recognized a pharmacist. Okay, so it's like, alright, we have that. Great. So, what's the next step to that? Can we do lab stuff, you know, what kinds of disease states can we test and get paid for? So, a lot of those statutes need to be fleshed out on the state level.

On the federal level, there is a bill that I wanted to tell your viewers about: HR 2759. It's called the Pharmacy and Medically Underserved Areas Enhancements Act. And basically, what that does is that it tries to get at what we're getting at now, making sure that a pharmacist is recognized so that we can treat the patients. And like I said, we're not just doing the test and treat, we need to come full circle with the provider status. So federal and state efforts are underway.

The last thing I think that we really need to look at as a community instead of just like congressional policy stuff, is go back to your Pharmacy Practice Act. I don't think enough people look at that. The Pharmacy Practice Act is in some states, it's not in all. But you know, like, for me as an attorney, right? I don't go to the legislature. If I have a grievance or need to add something to my profession, we're not going back and forth with the legislature and saying, “Well, you know, for trial, we need to like do this.” Then you have to tell [legislators] about stuff and they don't know what you're talking about. It's the same thing as a pharmacist. So, you have to explain everything that you do. Most of the time they don't know, because they're not pharmacists. But if you have a state Pharmacy Practice Act, that might be something you might be able to amend. So that's another example if you guys are getting nowhere in your state efforts or federal efforts, it might be something you can use.

Aislinn Antrim: Very interesting. Well, finally, do you think the Paxlovid authorization is a one-off? Or do you think this could really be a significant step towards this provider status?

Ron Lanton III, Esq.: think is a significant step towards provider status. Because, you know, it took a pandemic to show what a pharmacist is capable of doing. But I think that instead of it being pharmacy provider status, and you know, a lot of different stakeholders getting mixed up as far as what that actually means and turf wars and all of that, I think we're starting to have the right conversation around provider status with health equity, because you're starting to see a lot of things come out from the FDA, from Congress about health equity. And I think that including a pharmacist as part of the health care provider team, with that stamp of, we want to help care, we want the pharmacy provider status tag with pharmacists, is going to lower a lot of costs. If you're the only provider in a community, and you're the pharmacist and you're recognized, the patient can get some help. You know, sometimes a physician can't see you right there, s what does that mean? The patient is forced to go to urgent care, the ambulance driver because there's something that happens, you know, God forbid in the meantime, or the hospital, and most of that stuff's expensive. So, if we can offset a lot of those costs by seeing the pharmacist that's always there, then I think it's better for everybody involved.