Expert: FDA Announcement of Pharmacists’ Prescribing Authority for COVID-19 Antiviral Paxlovid ‘Is Pharmacy’s Moment’ to Seize the Path to Provider Status

David Pope, PharmD, CDE, the EVP of Innovation and Industry Relations at OmniSYS, discusses the FDA’s announcement updating pharmacists’ prescriptive authority for the COVID-19 antiviral Paxlovid.

Pharmacy Times interviewed David Pope, PharmD, CDE, the EVP of Innovation and Industry Relations at OmniSYS, on the implications of the FDA updating pharmacists’ prescriptive authority for the COVID-19 antiviral nirmatrelvir/ritonavir (Paxlovid; Pfizer Inc).

Alana Hippensteele: Hi, I’m Alana Hippensteele with Pharmacy Times. Joining me is David Pope, the EVP of Innovation and Industry Relations at OmniSYS, who is here to discuss the announcement by the FDA that approves pharmacists’ prescriptive authority for the COVID-19 antiviral Paxlovid.

So, David, what did the announcement from the FDA on Paxlovid entail exactly, and what are the implications of this announcement?

David Pope: Yes. So super exciting news that pharmacists, as of this week, can now prescribe Paxlovid under specific protocol, again, this was a not something that was written into the law, but it was actually written out of the FDA rule that excluded pharmacists, and that again, under specific protocol, would allow pharmacists, as long as they have the right information and document that, that they might be able to prescribe Paxlovid, again, within a specific window for patients who are COVID-19 positive.

Now, pharmacists today are doing some testing themselves, but this also means that a patient could walk right up and say, ‘I'm positive. Here's my test, and would you mind could you prescribe Paxlovid.’ That initiates essentially an evaluation by the pharmacist to determine whether or not that is effective. Such a big win for pharmacists, but more so for patients.

Alana Hippensteele: Absolutely. Yeah. Was this announcement from the FDA broadly expected by the industry and the pharmacy field?

David Pope: So no, it was not to be honest with you. We expected this whenever Paxlovid EUA was approved months ago, and it was a shock to everyone that the FDA excluded pharmacists at the time. But there was nothing that any of our industry teams were hearing on the sidelines, we quietly were hopeful just knowing that pharmacists were making such a big impact in today's health care that this is a no brainer—it absolutely was. There was quite a big groundswell of support on social media platforms and the like and the decision that came down was very quick, and not a whole lot of people were expecting it this week, that's for sure.

Alana Hippensteele: That's interesting. That's really interesting. 3.As COVID-19 winds down, are more changes to pharmacists role in fighting this disease expected to come, or is there a potential for a shift to their role in fighting other diseases as well.

David Pope: So we're seeing both. We're seeing, first of all, a need for pharmacists to be able to do this permanently. Right now, this allows pharmacists to be able to prescribe for COVID during the public health emergency, but we need federal and state legislators to make that permanent. But what we're already seeing is both small market, mid-market, and large market—pharmacies are now engaging in planning on providing the same level of care for strep, the flu, and even RSV at times as well, as long as those state and federal regulations are met.

So we're seeing a mass adoption right now of pharmacy to say, ‘We can help here. Pharmacists make a difference. Not only in many states can I test, but now we can treat.’ And that, as a patient, is key because as we're talking about trying to improve health equity in the rural, suburban, and even honestly, in the urban spaces, we need pharmacists, because again, 9 out of 10 Americans today live within 5 miles of a pharmacy. So I not only want to be able to get tested at a pharmacy and then say, ‘Now what? Now I've got to go to some other health care provider.’ But now we can, in many cases, prescribe, again, giving that quickness to treatment, which again, results in positive outcomes.

Alana Hippensteele: What do you think is next on the horizon in the push for provider status for pharmacists?

David Pope: Well, this is a crossing the Rubicon moment today, right. So again, we're seeing this in multiple ways. First of all, this forces the conversation with payers to allow pharmacists to be able to be recognized as providers in a network.

Again, if a pharmacist is going to stop what they're doing, evaluate the patient, gather lab data, including kidney function, liver function, speak with other providers, at times, connect with the patient and do a full interview, gather the prescription fill history, they have to have a way to be reimbursed for that, otherwise, we will not see the adoption that we're all hoping, and it flies in the face of the pharmacist in solving the challenge of health equity. So, we have to be able to have that conversation with payers. So this crossing the Rubicon moment is all about payers number 1, again, accepting pharmacists, as licensed providers.

The second thing that this forces is a conversation about lab and pharmacy coming together. So, for the very first time, we have, again, the largest material needs ever for lab and pharmacy to connect that we've seen in our industry to date. That is the ability, again, for that data in the lab space to be able to be shared with the pharmacy. Again, it doesn't have to be the lab that shares that data, it could also be the prescriber, and that's what we're all about here from the XIFIN perspective. At OmniSYS, XIFIN and OmniSYS are now together, and that thesis, again, of lab and pharmacy being together to propel provider status for the pharmacist, again, is coming true because we need our pharmacists to be able to be armed with the right tools, the right information to make those decisions. So that's a big deal. Again, with pharmacy that we've seen this week again, I don't see us going back as an industry or as a nation back to pre-COVID rules, where some states you can't actually vaccinate as an example of that for all vaccination opportunities.

Alana Hippensteele: Absolutely. What do you think are some challenges still left to address to make provider status for pharmacists work not only for patients, but for the healthcare system more broadly and for key stakeholders?

David Pope: So it comes down to really 2 things. First of all, I go back to the payer acceptance piece. If we are going to address health equity through the pharmacist, the pharmacist has to have a pathway to reimbursement; otherwise, the pharmacist may not elect to do so. Or even worse, the pharmacist says, ‘I'm here, but yet the patients who really are trying to meet in the rural suburban, sometimes urban space, again, are left with a big bill if they go to the pharmacy.’ We don't want that to happen. No one wants that to happen. it's a no brainer for us to be able to ensure that pharmacists can get involved and partner with in an in-network status with payers so that patients aren't left with an out of network claim or something like that.

Also, I would say that technology plays a key role here, we need to be able to take disparate data, and be able to tee it up for the pharmacists within their workflow. I think about the patient who walks into the pharmacy today, seeking a Paxlovid prescription. That pharmacist has just seen a patient to fill a prescription, the patient after that was the patient who needed a vaccination, and now I'm here to be able to serve that patient for Paxlovid, but now I need disparate data that's not in my system, I need to go get lab data. So again, it's absolutely vital that my documentation, my communication with providers, my communication with lab updates, again, that's required by state and federal authorities, in this lab itself, like the test data again, I need that altogether. So technology is going to play a key role here if we're going to operationalize this on a scale that's necessary to meet the demands of America.

Alana Hippensteele: Absolutely. Any closing thoughts, David?

David Pope: I would just say this is pharmacy’s moment. Pharmacy and pharmacy organizations have fought for this. So, the conversation is not over by any means because now that pharmacists have that ability for right now for a short period of time, we need to make it permanent, and pharmacies moment also includes the expansion and the adoption of that.

So if our pharmacists are not engaging in this solution and this opportunity, then again, our nation will probably look at that and say, ‘Maybe pharmacist didn't want to.’ I fundamentally believe that this is taking our pharmacists back to their first love that is that is helping patients and engaging patients in a way that improves the health outcomes as well. So this is an awesome opportunity for our pharmacists to be able to continue the story, as they've done so well through the vaccination process in COVID to be able to share, again, the impact that they're making. It's very clear that America sees the pharmacist and the pharmacy today as that destination of health care.

The last thing I would say is that, again, this is something that we're doing in partnership with physicians. We, as pharmacists, love our physician teams, and again, by no means is this pulling from them as we've seen in the reaction from the AMA. We respond to that and say, ‘We love our physicians.’ Again, we're here to be able to address together those health equity problems, and we'll seek to solve those together.