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.

READ MORE