Preparing for COVID-19 Testing in Community Pharmacies

Aislinn Antrim: Hi, this is Aislinn Antrim from Pharmacy Times. Before we get started today, one of our top stories on Pharmacy Times is about the potential for pre-exposure prophylaxis drugs to treat COVID-19 because remdesivir and Truvada, a PrEP drug, work by the same mechanism of action to treat the virus in its replication cycle. So, there's more of that on Pharmacy Times. But today I'm speaking with Nancy Lyons, chief pharmacist for McKesson Health Mart, about steps pharmacies can take to begin implementing COVID-19 testing, which

is obviously a big issue for pharmacists right now. So, Nancy, I guess first, is this something that's currently being rolled out or are there regulatory and availability issues that have to be

sorted out first?

Nancy Lyons, BSPharm, MBA, CDE: Great, thanks for that question. Health Mart pharmacies have been ready to assist their communities since the beginning of the COVID-19 response in really any way possible. They’re, as you know, on the front lines in their communities and rapidly have responded to keep those essential medications available and to educate and protect their patients from the transmission of the virus. A few of our stores have already partnered with local Public Health Departments to assist with testing. With the HHS announcement last week on

April 8th that authorized pharmacists to order and administer COVID-19 tests, they are really ready to take on a greater role. Yes, as usual with the practice of pharmacy there are multiple issues that need to be sorted out to fully utilize our pharmacists—access to accurate and reliable test kits and supplies are top of mind for all of them. However, regulatory barriers

for pharmacists are also problems that need to be solved. Even with the HHS announcement that called on pharmacists to play a bigger role in the COVID-19 response, the billing and payment processes are undefined still and multiple state practice acts place a limit on pharmacists’ abilities.

Aislinn Antrim: Okay, so how widespread? You said a couple of pharmacies are ready to implement testing—do you have any more specific numbers or how widespread is that right now?

Nancy Lyons, BSPharm, MBA, CDE: We have a handful. We are in discussions with Health and Human Services to help fill in some of the gaps, especially in those areas where there is a care desert, where our pharmacy is matched up. So, again, now it's small numbers mostly based on the number of test kits available and the delays with PPE. You know, those hospitals and more

primary care centers receive the test kits first, now. I think as production is going up we're going to see that that rapid ramp up dramatically. We surveyed all of our Health Mart locations at the beginning of the crisis and we have 3,300 that expressed an interest in helping [and are] just waiting for more details.

Aislinn Antrim: Excellent. So, are most testing sites prepared to be drive-through or how else could they be organized?

Nancy Lyons, BSPharm, MBA, CDE: Great, yeah, I think most of us have probably seen the

television reports with the drive-through testing and that's really how many of the early community-based testing programs achieve the scale and that was necessary working hand in hand with those public health departments. And we are looking at honestly a number of

models as testing moves into next phases, including curbside appointments. You know, our pharmacies have—if they don't have drive-throughs, they've been taking the medications out to patients and doing those deliveries, and the curbside model seems to work well at being able

to separate those who might be infected from the patients that they're trying to keep healthy on the inside of their store. And then it's a great way to limit the amount of PPE that's necessary, as well.

Aislinn Antrim: Certainly. What regulatory bodies or higher powers do pharmacies need to go through in order to begin this process of implementing testing?

Nancy Lyons, BSPharm, MBA, CDE: Sure. All of that really depends on the test type and how the test is processed. We are expecting more of the tests to fall under the Clinical Laboratory

Improvement Amendment, or CLIA, definition of waived tests. Any pharmacy who will perform a waived test needs to obtain a CLIA waiver by completing the CMS form and sending that to their state for processing. We are finding that each state may have different rules and requirements first about CLIA, and in particular who can be the laboratory director. Additionally, each state’s

pharmacy practice act or other laws that may be in place also could limit or could become barriers for pharmacists. And finally, there are a number of requirements that are needed for pharmacists to be paid for the ordering and administering of tests. Our current billing system isn't really set up for a pharmacist to work on the medical side. Medicare, private payers, and

state Medicaid all may have different specific requirements that we're trying to help them sort out.

Aislinn Antrim: Okay, definitely. What should pharmacists know—just at the base level? What should they know going in?

Nancy Lyons, BSPharm, MBA, CDE: This is a funny question. Everything is that the first thing that comes to mind, or at least everything they can. Especially in these days of rapid change with COVID-19, just when we think we have a process or a method figured out there's a new development or a law that changes everything. But in addition to all of the CLIA and billing requirements that will get straightened out eventually, I think the pharmacist is also now responsible for that ordering and administering the COVID-19 tests, and that means they need to follow the same clinical guidelines as physicians and others who have been ordering this test before. So really it starts with just taking a step back and looking at the operational processes that are necessary to ensure patients and their employees are safe, and then looking at those clinical guidelines and seeing how all of that can come together. They also have to know how to select the appropriate tests for the what that individual needs to do with their result, and then of course know all of the procedures to administer that test appropriately so that they don't introduce error into the process.

Aislinn Antrim: Absolutely. Are there risks involved with this and how should pharmacies handle them?

Nancy Lyons, BSPharm, MBA, CDE: In health care there are always risks, and I think a number of our pharmacies that have already been doing CLIA-waived tests know those risks related to the airborne pathogens and the things that they need to be concerned with. I'm just taking, again, a step back. The HHS declaration protects the pharmacist with immunity as a provider so that's a little bit different than something that they may have had to concern themselves with before, but it does allow pharmacists to qualify as covered persons under the act when they administer or use an FDA-approved COVID-19 test. The results are related back to the actual collection of the test specimen that has to be managed as with any point-of-care test administered before. The collector needs to be well informed and trained and have the OSHA airborne pathogen training, as well as immunizations up to date. But especially with this virus we need to make sure that they're using proper protective—or PPE—to protect themselves from all of the transmissions that can happen. Again, especially with the known transmission risks of COVID-19 virus.

Aislinn Antrim: Certainly. So after reaching out to these regulatory bodies and educating yourself as much as you can, what are the next steps to really get this started?

Nancy Lyons, BSPharm, MBA, CDE: You know, once all of those processes are behind the pharmacist, that's really where that local community provider can shine with a little bit of planning and preparation. Again, the operational steps need to be sound and their whole team needs to know how they fit into the workflow and into the billing, and then getting those

test kits in, making sure everybody understands how to run the tests and put the PPE on. Then it's really just executing it, like any other pharmacy process that they're already familiar with, with just a little bit more specificity of some of the protections that are necessary.

Aislinn Antrim: Okay, excellent. Many pharmacists you've mentioned said that they want to help in any ways that they can, but they are also already overwhelmed with day-to-day work. How do you recommend adding this to the to-do list that's already so long?

Nancy Lyons, BSPharm, MBA, CDE: That's a great question. No matter what comes in front of pharmacy, they always have to try to fit in just another activity in the day. They really have a lot on their plate even before COVID-19, and now with all the extra precautions of those frontline

workers they really need to have a hand to get all of those things done. But many of the pharmacists that I've talked with already that are asking every day when they can get access to

the test, realize that this is an opportunity for a profession that we all have to make together. My best advice moving forward is to thoughtfully plan and make sure that they look at their

resources—all of their resources, including, you know, front door staff and technicians who may be able to fill in for some of the processes to take away some of the things that they have to do. Health Mart and multiple other organizations and associations have been developing tools and processes so they don't have to try to build it all themselves, but really when they pull

together with their team—again, including those well-trained technicians—and just ask everyone to step up, we've already seen overwhelming responses when people are given

the opportunity to do something for their communities. We just need to help them make sure that they can.

Aislinn Antrim: Absolutely. You mentioned that this is an opportunity to grow for pharmacists, and we've spoken with people and so many pharmacists who said that they can do even more with broader practice laws. So can you speak about the roles pharmacies are playing and the value that they could provide if given the chance?

Nancy Lyons, BSPharm, MBA, CDE: Absolutely, and this is a topic honestly that I could go on and on about and something that I'm very passionate about. For my entire career, pharmacy has been working on gaining provider status for pharmacists. Among other things it will allow pharmacists to be on the official Medicare provider list with doctors, nurses, midwives, and other health care professionals. For my entire career this omission of pharmacist as official health care providers has created barriers for providing sustainable patient care services, for decades. It’s the healthcare professionals who, as the HHS with the Secretary for Health Alex Azar stated, are the first point of contact for many Americans with the health care profession. Community pharmacists, for decades, have impacted public health and wellness with access to immunizations, collaborated with prescribers to optimize medication regimens, and provided medication therapy management services. We've delivered prevention education and chronic condition management, prescribed medication under protocols for acute conditions where speed of treatment is critical, and numerous other conditions where patient barriers exist. But the pharmacist is there and ready, ready and willing and able to help these patients. Care services have demonstrated cost saving multiple times and positively impacted patients. Pharmacists are care providers, capable of so much more than many practice acts allow. And, you know, with the things after COVID that we're going to take a look at, we're going to see that community pharmacies delivered and that those local community pharmacists really have a chance to do the things that many of us have been working our entire careers to get the chance to do.

Aislinn Antrim: Absolutely. Well thank you so much for taking the time to join us. Now we're going to hear from some of our other MJH Life Sciences brands on their latest headlines.