Despite Early Excitement, Test-to-Treat Plan Does Not Drastically Alter Pharmacists' Roles

Experts David Pope, PharmD, and Christina Madison, PharmD, FCCP, AAHIVP, discussed the Biden Administration's new test-to-treat plan.

Aislinn Antrim: Hi, I'm Aislinn Antrim with Pharmacy Times. Today I'm speaking with David Pope, chief innovation officer at OmniSYS, and Christina Madison, The Public Health Pharmacist, to discuss Biden's new test-to-treat plan and what it means for pharmacies. And so, Dr. Pope, to get us started, can you explain your understanding of what this program is?

David Pope, PharmD: That's a great question. The test to treat program that was mentioned in the State of the Union address by President Biden certainly came across with some great acclaim within pharmacy within moments, because what we heard was that pharmacy would be involved in testing, ultimately leading to a treatment if a patient was positive. Again, they could prescribe an antiviral. Again, pursuant to that test, many pharmacies have been testing already. And we know that the nation has been leaning upon the pharmacy to be able to do that today. So, this is a welcome addition, that we initially heard to understand that pharmacists would potentially be able to prescribe.

In fact, if we look at the PREP Act, it actually paved the way for that already, with pharmacists being able to do so. However, we also know that whenever the FDA approved the new antivirals, they in fact did something that they usually don't normally do. And that is defined who could actually prescribe the medication, and they specifically carved out the pharmacist to be able to do so. And so ultimately, when we heard that testing, test to treat program, we were collectively excited. You saw many of the pharmacy groups out there today just express their appreciation and really love the approach towards that because we know that pharmacists do make a difference. They live in the places where our patients live, again. So. it made all the sense out there.

What we have found out later on through again, as data and details have come out, is that it is a bit different. And so, the test to treat program ultimately is a program where pharmacies who also have a physician's practice or a Minute Clinic, if you will, or again, we have others that are out there as well, that have a practitioner, non-pharmacist practitioner inside that pharmacy, they can prescribe, like they normally do. And they can ultimately get that prescription filled upon a positive test and the government will make sure that those pharmacies are adequately stocked with that. So not a big program out there. That's not an earth-shattering program. It's not a whole lot of new rules that need to be written or anything like that. Ultimately, it's just leaning upon an existing program that's already out there today. That does not mean, however, that we're not very far from test and treat with the pharmacists driving that.

Aislinn Antrim: Very interesting. And Dr. Madison, kind of from your public health perspective, can you discuss the need both for increased testing and increased access to these oral antivirals and treatments?

Christina Madison, PharmD, FCCP, AAHIVP: Absolutely. So, as we know, during this pandemic, it's been a multi-layered approach with mitigation measures, with vaccines really being kind of the epitome of what we know we can use. But ultimately, not everyone, for whatever reason, chooses to become vaccinated against COVID-19. So that's why it's extremely important for those who do test positive to have access to one of these very potent antiviral medications. And so, we look at the strategy. Obviously, testing is a great portion of our mitigation strategy, because ultimately, we don't want people leaving the home with a communicable illness, and therefore being able to spread it to others, especially when we think about our school-aged children, and those who may be in vulnerable populations and those who may, unfortunately, have complications associated with COVID-19 infection.

And so, when this announcement came out, I think we were all very excited within the public health space. But then ultimately, the devil is in the details, right? And so, I think, as much as this sounds like it's going to be revolutionary, I think it really is going to start off quite small when we think about maybe a few hundred pharmacies and federally qualified health centers and long term care facilities across the country that may be able to actually do this test to treat program, as it's currently laid out right now by the federal government. Just know that the access to these oral antivirals has been around since they were authorized by the FDA. And so, if you go to your primary care provider, you can go ahead and get prescribed that medication, even without having to go to one of the facilities that currently participates in test to treat. So that's still always an option. The key here was that we wanted to really make it easy for the consumer. So, if you do go to one of these facilities and test positive, we want you to immediately get access to the intervention that is likely going to keep you out of the hospital. Because really, that's what this is all about. From a public health standpoint, we know that vaccinations are extremely effective. But we know that it doesn't ultimately mean that you will not test positive. But what it does mean is that we can ultimately keep you from having complications associated with COVID-19, as well as keep you out of the hospital, and also from dying from COVID.

Aislinn Antrim: Absolutely. Now that we have kind of a feel for what this is, what is the logistical plan for how this is really going to work on the ground? You've both kind of touched on it. But what does the rollout for this look like?

David Pope, PharmD: Well, that begins this week. Pharmacies will begin receiving additional stock of the COVID antivirals, if in fact that they signed up for the program. But again, just as Christina mentioned a moment ago, it's kind of business as usual for most of these pharmacies already who have been keeping this in stock whenever it's available. The prescribers may get some additional information and educational materials, by all means. But again, these pharmacies already had a practitioner, a non-pharmacist practitioner, already there to really see very little outline for a logistical plan. Now, again, I go back to what Christina and I both echoed so far is that this is a great opportunity for us to show the power of the pharmacist in being able to do those. There's been a lot of pushback from providers saying that pharmacists may not be able to make the right decision, if in fact, they do have a drug interaction. And that drug interaction ultimately leads to a decision of should you take the medication for COVID? Or should you take the life-saving medication that is interacting, right, and not take that COVID medication. In fact, that could be something serious, such as a anti-seizure medication, and the like. What we as pharmacists are generally saying is we agree, we believe that pharmacy should go by protocol. And when things go to a moderate complexity, and not a straightforward complexity, that pharmacists should refer and still get that patient that medication for COVID in the right amount of time, because as we know, again, these anti-COVID measures, again, they have to be taken within a very specific amount of time, or they're just not effective. The pharmacists can do so and it's pretty straightforward.

Christina Madison, PharmD, FCCP, AAHIVP: Yeah, so from a logistics standpoint, HHS actually just released a pretty detailed fact sheet and an FAQ all around test to treat, which I think answers a lot of the questions that most of our pharmacies and pharmacists have been wondering, since this announcement was made last week. And ultimately, I would again, you know, dovetail on the remarks that have already been made. But it these are going to be done in existing areas where there already is a very finite relationship between the provider and the clinician, as well as the pharmacist that's working in that dispensing area. So, there's already that established rapport, where the provider would provide that individual who was seeking services with the prescription, and then that would in turn, be given him over to the pharmacist and then immediately be filled for the patient. So, I don't see there being a lot of challenges or changes with that.

What I do see, maybe a new factor here, is that we are enlisting long term care facilities. So that is new, not new necessarily to the PREP Act and allowing pharmacists as part of the federal pharmacy program, but new in the instance that if someone tests positive within a long term care facility, that that antiviral would be administered right away. And if you look at the algorithm, for when which treatment is indicated, those oral antivirals have now been pushed up in the algorithm that that is now the preferred agent over the monoclonal antibodies, which would be done via infusion. So, I think that's also part of this as well is that not only do we have this new tool in our toolbox, but we have something that isn't as cumbersome to the patient as well as to the health care system, because ultimately, we know that the monoclonal antibodies requires an infusion center, it requires a lot more specialized care. We also have outpatient remdesivir, which requires a three day treatment course. So again, anything we can do to make it as easy as possible for people to get a preventative medication. Once they've been tested positive for COVID-19, the better off we will be as a society as we continue to try to reduce the stress associated with new infections and possible emergence of new barriers moving forward.

Aislinn Antrim: Absolutely. And with all the other responsibilities in pharmacies now, how does this kind of fit into that busy workload?

Christina Madison, PharmD, FCCP, AAHIVP: Well, I think that if the test to treat as it was mentioned was going to be implemented, I think it would have added an additional stress to the workload of the pharmacist. But as it's currently laid out, I don't actually see this being an added burden to the pharmacist, especially if they're already in a location that was conducting testing, as well as the fact that part of that FAQ says that a patient doesn't actually have to be tested at one of those facilities in order to get the medication, they can have a home test at home, which by the way, starting this week, you can get 4 more at-home tests from COVIDtest.gov. So, you can get more tests for yourself for free. And you can take that home test into a pharmacy, federally qualified health center, or if they're in a long term care facility, they can get one of these oral antivirals. So I think when you look at it from that perspective, I think really the only extra step there would just be the patient walking over to the pharmacy and giving the prescription. But this would be part of our normal workload, not something that I think that would expand any needed additional time. However, if the decision is made later on, as we progress through the pandemic, and then potentially getting into the fall months, where we may need more activity in this arena, we may see the federal government change their mind on whether or not pharmacists will have this allowed expanded scope of practice. And if that happens, then yes, I would say that that would impact the workload. And we would need to add additional staff or maybe have specific hours for when these services could be available to patients.

Aislinn Antrim: Perfect. What is technicians’ role in this plan, as you've kind of said that doesn't have drastic effects on pharmacy, but where do technicians fit in with testing and then dispensing?

David Pope, PharmD: They play a vital role. Again, I used to work in a physician's practice. And the one thing that we always had is that you had the provider and the nurse work hand in hand, the nurse would go into the room would gather information data necessary to make the right decision for that, that provider to make the right decisions. They also were the ones to take a look at vaccine history, get everything together that way that again, that whenever the provider walks in the door, we knew that we could maximize their time. And this the same way with technicians. Technicians are absolutely vital. They're the many times the one person and the first line of defense for Whenever a patient walks up to the door or goes to the drive thru. And they say how can I help you today. And so they're seeking guidance in that regards. And so we need to make sure that our technicians fully understand the process, and the opportunity that pharmacists can provide, whether it be for testing and to guide them to the right testing pathway, which again, the majority of pharmacies today are in fact offering COVID testing. Again, whether it be a tabletop within a 15-minute window, you can get a response or even a more definitive PCR tests. Or it could also be the information about the COVID pill as well. And so again, our technicians are again an extension of the pharmacist and they're carrying that information, both to and from that patient. And so they're absolutely vital for us, it's just important for us to make sure that our technicians are consistently learning and staying up to date. As we all know, this is changing rapidly. And again, even if you were in the business working on this specifically on a daily basis, you can still find yourself getting behind on the information. And so we've got to make sure that we're giving that information to our technicians in the right time at the right place.

Aislinn Antrim: Absolutely. And there have been some concerns and critiques with the plan, including concerns about supply chains and things that could be affected that way. Can you discuss what some of these concerns are?

Christina Madison, PharmD, FCCP, AAHIVP: I mean, ultimately, we know that the last two years have been extremely challenging. One thing I will say in relation to the antivirals when we think about test to treat is that the federal government has actually been stockpiling these medications for quite a while. And so there is at this point, what seems to be adequate supply. However, we think about distribution. Now with rising gas prices, inflation, you know, all things being equal now having a conflict in Ukraine. There are many factors that are things that are outside of our control that may delay or defer whether or not those treatments may be able to get to the pharmacy in a timely manner. At this point, it doesn't look like we would have any difficulty but again, we don't know whether or not we're going to have to ramp up or ramp down these services based on whether or not we have a new variant, or we have a new surge of cases in the United States. And so I think we really have to think about this as a dance, we're going to be doing a dance with the virus. And so sometimes COVID-19 gets to take the lead. And sometimes we get to take the lead. And as of right now, I think we're in the lead. And I think that we are no longer letting the virus dictate how we live our lives, but that we are learning to live with the virus. And I think that is all part of the plan and the process that the federal government has, which is why they did such a good job of stockpiling these medications, as well as implementing new protocols for the Omicron-specific monoclonal antibodies that are now available, even though they're in shorter supply. And so again, this is all part of a larger strategy that we know is part of that COVID Response Team, in order to make sure that those who are positive are treated adequately and quickly, and those who are unvaccinated get the vaccine as quickly as possible.

Aislinn Antrim: Specifically, the American Medical Association released a statement that was more critical of the plan and said that prescribing decisions should be made by physicians. How would you respond to this critique and what's going on in this kind of debate?

David Pope, PharmD: Yes, well, we've seen the debate on both sides of this equation, both the American Pharmacists Association, who were saying that it doesn't go far enough and allow pharmacy and pharmacists to be able to prescribe, we have the American Medical Association, who's saying that actually it goes too far. And they're concerned, even whenever they have those nurse practitioners or physician assistants, who were inside the pharmacy today, who by the way, are generally overseen by physicians as well, that is in itself risky. What we're finding is, is that there is a fundamental difference here in the understanding of a straightforward decision-making process versus when it rises to something greater than a moderate decision making in so pharmacy believes that, again, under protocol, there is a straightforward decision making process. If in the event, there are contraindications that are found, whether it be with a disease state or a lab, or whatever it may be including a drug interaction, which by the way, pharmacists do a great job with drug interactions, that's really their job here. At that point in time, however, it needs to be referred to the provider, again, a family practice physician, as an example to that, where moderate complexity decision making needs to take place, there may be a trade off again, for the COVID vaccine to be the COVID, antiviral with perhaps a life-saving medication. That's not for the pharmacists to decide. It can be the pharmacist that helps be the extension, however, of the healthcare team, again, as that straightforward complexity and decision making is available.

Christina Madison, PharmD, FCCP, AAHIVP: So, my opinion on this is that I feel that the statement that was made by the American Medical Association is really out of sync with previous statements that they've made around health equity, and access to care. And ultimately, since they have made these statements, in particular saying that there is inherent mistrust and racial bias within the medical system that has led to health disparities amongst marginalized communities, and that they have had this very full-fledged, multi-pronged approach to addressing all of these health disparities and inequities and implicit biases within the medical educational model as well as in the medical profession. So I do feel that this is very out of sync with that statement. And with that declaration, especially because of the fact that they are now limiting access in areas where we see things like pharmacy deserts, food deserts, health care provider deserts, especially in areas that are rule in our country where the pharmacy may be the only provider for miles. And it may not be associated with or attached to a healthcare facility, because they may only have one provider for an entire town, and it's 1530 miles away. So I really do feel that this is short sighted on their part. And it does not align with those previous goals that they've stated in the past. And so I hope that they will revisit the statement and understand that it's not about competition is about collaboration. And ultimately, we need to do our best to provide increased access in an equitable fashion to all patients. And when you limit patient's ability to do that, by taking out an entire profession that can be helping with this. I think you really do your patients a disservice. And ultimately, that isn't what the profession is about. And if they think that they're helping by thinking that this is a turf war, I think that that's sorely misguided.

Aislinn Antrim: Absolutely. That's a very important point. And you've touched on the supply chain a little bit, can we just revisit that and talk about how that could be a potential issue? And how is that being dealt with? I know in the State of the Union and subsequent statements, President Biden has talked about Pfizer in particular, and ramping up production of their antiviral. What's being done in this area?

Christina Madison, PharmD, FCCP, AAHIVP: Yes, so as I mentioned before, there is something called the strategic national stockpile. So, if you haven't heard of that before, that is the federal government's ability, within a pandemic, to push things out from what we call the SNS. And so every state health department has access to that, during a declared emergency, which is what we're currently in, just know that those provisions go away once this emergency declaration is no longer in place. And so as a profession, we really need to think about some of these expanded scope of practices that we received, potentially going away from states that didn't already have those provisions in place. And so when we think about access to those resources, it's the federal government first, and then state allocation, and then what is currently within your marketplace based on level of activity of the virus, and vaccine coverage in your area. And so obviously, places in the south, which is where Dr. Pope is, we know that their area has a lower vaccination rates in some areas. And so they may get a larger allocation for medications in order to do test to treat because we are anticipating that they may have more individuals in the population test positive. And then those areas where we see less uptake of booster doses, we may anticipate they may need a greater need as well for some of those breakthrough cases in order to prevent them from being hospitalized as well.

Aislinn Antrim: Absolutely. Do you know what the timeline is for implementing this program?

Christina Madison, PharmD, FCCP, AAHIVP: So, based on the information that I've received from these weekly calls with the federal government, so I am one of those people who's on these calls for both therapeutics and for vaccinations, because I really want to make sure that I'm staying up to date on those calls. The plan at this point is to start out by the end of March, having several 100 pharmacies as well as federally qualified health centers and long-term care facilities. And that that will continue to ramp up as the year progresses, knowing that we're entering the warmer months. And so, we may not have as big of a need for those antivirals right now. But anticipation of the fall and the winter, where the services are likely going to be more utilized. So, we're kind of priming the pump, getting all the, you know, kind of the bugs out now, so that we can really ramp this up in the fall.

Aislinn Antrim: Absolutely. Well, do either of you have any closing thoughts, anything that you want to add to this discussion?

David Pope, PharmD: Sure. So I'll start here. So, pharmacists have proven over and over again, throughout this pandemic, that they are ready for the challenge, they are ready to step up and deliver life saving vaccinations as well as treatments, they are also very well established within a way that be able to be able to be interoperable with the providers. Again, they know their role. And that role is to be on the frontlines of health care, and they have the ability, and as well as just the enthusiasm to get out there and test America and provide the opportunity for a whether it be a vaccine or an oral antiviral. At the same time, some things need to happen. In order for this to take place. Number one, we need the FDA to be able to allow pharmacists to prescribe these things. Number two, there's a reimbursement issue here. We need to make sure that pharmacists have the collective ability to be able to bill for those services. They may or may not prescribe, but they absolutely every single time just like your provider today, if you were to walk into your physician's practice is going to ask the same questions right, that ultimately lead to a prescription or not. We have to shore up the pharmacists ability to be reimbursed for those services. It's an office visit at the end of the day. It's a very scoped office visit with a lot of rules bound around it, but it does provide the opportunity for pharmacists to do that. The conversation we've had earlier is all about saying when pharmacists get that opportunity, they will need some help here again, they they're doing everything that they can today to be able to immunize America and fill this prescriptions as well. And being that open, honest, healthcare professional that you can call anytime, we do need to provide a clear pathway for reimbursement. So we need CMS to be able to do that and open that up and give a clear pathway. This is not a difficult thing by any means. Again, it's very straightforward, but allowing pharmacists to be able to bill for an office visit, that leads to the coverage of that is necessary. The third piece of this is allowing HRSA, again, who covers HRSA is kind of a safety net that allows again, for patients who do not have active insurance, a place for providers to be able to bill for those services. And we need to HRSA to be able to open up to pharmacy pharmacists, as well, pharmacists are ready. Again, they can do this, they're excited about it, we just need to unleash the pharmacist, and I'm telling you, they will have going from a couple 100 of locations for test to three, we can go to 60,000, almost again, within a very short period of time, within weeks, we can have all of them activated, and allow us to be able to attack this virus and be on the offensive instead of the defensive.

Christina Madison, PharmD, FCCP, AAHIVP: Yeah, I agree with all of the points that Dr. Pope just made. And from my perspective, you know, working in public health for over 15 years, I think my biggest thing is that we need to invest, right. So the investment needs to be made and the training and education of all of our pharmacies and pharmacists and their staff. Because part of this is that, you know, things were rolled out quickly. And I think that that's why we saw responses from the AMA, and responses from some other health care advocates and allies within our medical space, because there was so little information and this was just kind of dropped on us at the State of the Union. And so it really comes back to having clear communication and clear messaging as it relates to where people can access these interventions, and where they can get access to testing and where they can get access to therapeutics. In addition to vaccinations, I think unfortunately, we had a really vaccine heavy platform, when we first have these life saving and life changing vaccinations available to the US public. And what we should have been investing in is a multi-pronged approach, which included testing, treatment, as well as things like high quality masks, and increasing good ventilation and indoor spaces. And so where can pharmacy really see themselves moving forward? I think we all know that we have become sort of the safety net of the public health space. And I am fine with that. But I also think we need more resources in order to really be able to practice at the top of our licensure and be that beacon of hope and light to our communities, which we've already been doing, because we are the most accessible healthcare professional. And so I just want to make sure that those pharmacists that are on the front line are not burning out leaving the profession that they so love, because they weren't given the resources in order to succeed. So I think that's how we need to think about this moving forward and then ultimately look at making the provisions in the prep act permanent in those states that didn't already allow those provisions for expanded practice, because this country is going to be in for a world of hurt if more than 50% of those pharmacies that are currently testing and are currently providing all of these services are no longer available anymore.

Aislinn Antrim: Absolutely. Well, thank you both so much for speaking with me about this. This was great.

Christina Madison, PharmD, FCCP, AAHIVP: Thank you so much for your time.

David Pope, PharmD: Thank you.