POC in the Pharmacy: Practical, Legal, and Future Perspectives

Samantha Lewis:
Hello and welcome to a CHI podcast for the upcoming leveraging pharmacies for rapid diagnostics conference being held this August 19 through 20th in Washington DC. My name is Samantha Lewis and I'm the conference producer working on the meeting. Today I'm speaking with Allison Dering-Anderson who is a clinical assistant professor of pharmacy at the University of Nebraska college of pharmacy.

Ally coordinates and teaches the OTC and self care products course and the point of care testing course, does the didactic training for the immunization class and teaches pharmacy law and ethics in pharamcotherapy. Welcome, Ally, an thanks for taking the time to talk to us. My first question for you is, is theory having your local pharmacist be able to conduct a point of care test is pretty awesome, but many people are wondering if this is practical within the existing pharmacy workflow?

Allison Dering-Anderson:
In the existing pharmacy work flow no, because it's not a part of the existent pharmacy workflow. Can it be easily incorporated, absolutely. It will depend on a couple of things. First off, it depends on quality support staff, whether you call them technicians or whatever their job title is. Interestingly, those people actually manage the work process in the pharmacy much more than the pharmacist because as pharmacists we tend to focus on the highly technical professional pieces and let the people who are moving more than we are moving and who are managing some of the work processes do that.

Yes it is very possible that this can be incorporated into a new workflow that will not be a significant change, but it will be a change in some way because it doesn't exist in a number of stores. It is very similar to the way we changed things when we began to give vaccines. It was something we hadn't done before but it fits nicely into the process and we do it seamlessly now. I can see a time when some of the point of care tests will also seem very seamless.

Samantha Lewis:
Your background, and you have a lot of experience in law and ethics in this area. What do people need to be thinking about in terms of legality of these tests?

Allison Dering-Anderson:
First be sure that pharmacists can, of their own professional judgement, make the decision to run the test. In a few states that's not possible so you will need to find a collaborating prescribers to say, "yes, I trust her judgement." In these case I would run a test and it's fine if you do too. We have to remember that there's federal law that says that any time a patient asks for a test result it must be provided by the laboratory. The pharmacist is in fact a laboratory, happens to be doing waved tests, but it's still a laboratory.

Create a process so that you can give the patient a copy of their results and then decide what you're going to do with them. It's one thing to have a result, it is something completely different to take care of a patient. I could look at you right now maybe and say, "Wow boy, let's do this test" and we've done the test and they can say, "ops you have pink eye, bummer. Too bad for you" and I can walk away. That doesn't do you any good, that doesn't do me any good. We need to know exactly what I'm going to do with those results. In some cases we are screening, knowing full well that we are not going to be able to complete the full therapeutic process, but knowing that screening the patient and getting them appropriately referred should that screen be reactive, that's very important.

I really think that the ethics side of this is a bit more difficult then the legal side. Pharmacists have followed rules to the letter for years. Now that we're vaccinators we know if we have to register as medical waste generators or whatever. Making the decision it is better for the patient for me to test than not to test. Or the more difficult decision, at least early on, it is better for me not to test for the following reasons. That is a bit of a paradigm shift. I think we are well equipped to do it, now we just need a little practice.

Samantha Lewis:
Right. You mentioned collaborative care agreements. I want to go a little bit more into that because it seems like it will be a huge part of allowing pharmacists to not only run the diagnostic tests, which they can do anyway, but also to possibly make changes to medications or act on the results of that diagnostic test. Can you elaborate a bit on how those work for those who may not know?

Allison Dering-Anderson:
Surely. There is running a test under a CLIA certificate of waiver does not change the scope of a pharmacists professional practice. That is you don't suddenly have the authority to prescribe. You need to collaborate with someone who does have that authority. Clearly the pharmacist is still the drug expert, so your collaboration is under the following clinical circumstances with the following test results, I the prescriber am granting you, the pharmacist, the permission to dispense the best drug. The prescriber understand that the pharmacist is always going to pick the best drug because that's what we do. The pharmacist understands that there are certain clinical criteria that are not acute and not a crisis and that if those criteria are met let's take of the patient as quickly and reasonably as possible.

Included in that though is, what if a really sick patient comes in? They have a breath rate that is too fast, they have a fever, whatever is going wrong to the point where I as a pharmacist am not comfortable treating that patient. The patient needs more rapid, more intensive assistance, how am I going to evaluate those patients and get them sent to the right place? How can I guarantee that in sending them to the correct place there's going to be somebody there to care for them? That is the essence of collaborative practice.

There are some things that pharmacists do that prescribers could do with some guidance, and there are some things that prescribers do that pharmacists are clearly capable of doing with some guidance. This is a recognition that while we respect each others professional strength, we understand that there are places where our jobs rally do overlap. It's all about the patient. Nobody is going to collaborate to do something that nobody wants. You're only going to collaborate to provide a service that the patient or that the public health officials or what somebody is looking for. It's actually the ultimate in respect, I think, for all of our professionalism. It works very, very well.

Samantha Lewis:
In all of your travels and talking to various pharmacists and medical professionals, how open would you say people are to these types of agreements?

Allison Dering-Anderson:
I think that is a varied as opinions on whose going to the world series this year. It is mostly based on experience. Those prescribers who have trained with pharmacy students, those prescribers who have experience with collaboration are much more open to it. These prescribers who have participated in federal public health, or Indian health, or Native American health, or the military system of the VA system, those are all collaborative systems by design. Those folks are much more willing to collaborate. Folks with very limited experience in collaboration ... it's interesting, the most talented have the smallest ego, because they know they're the most talented, they don't need anyone to stroke that. Very very talented people, public health minded people, and people who have worked in collaborative systems are very willing to collaborate.

It's not just on the prescriber side, there are some pharmacists who are resident to collaborate. That's okay, this is not a service designed to be provided by everyone. You have to want to because it takes some effort and it takes some caring. For those who want to put forth the effort and who care very much about centering their practice on patients reluctance goes away very quickly, if it was there at all.

Samantha Lewis:
I want to get a little bit more into the actual practice of this. This ties back to the collaborative care agreements because you've got bigger boxes stores like CBS, who are skirting this by having PAs and MPs in some of their clinics. I know that you have spoken strongly about the fact that pharmacists are very capable of doing many of these tests. Going forward what model do you think makes the most sense to be used? Same thing using an MP or a PA, or do you think that this is something that pharmacists could and should be doing?

Allison Dering-Anderson:
Wow, can I pick both? I know that wasn't an option when you asked the question. I think that there is absolutely a place for walk in diagnostic care using a nurse practitioner, using a physician assistant, using a physician. There are some things for which there are no quick tests, there are some patients who are too sick or have some other clinical challenges that pharmacists shouldn't cope with and that's, frankly, what the nurse practitioners and PAs ought to be dealing with. For the patients where we have reasonably low acuity, reasonable confidence of what truly is best practice, it's fine with me if they come to the pharmacy counter.

Let's pick, I don't know how old you are and that's okay, you, your mom, and your grandma, and you all ache and you feel awful and you come to my counter. You, perfectly healthy, nothing going on, you have influenza; you I can test and treat. Your mom, maybe she's got a little problem with her blood pressure. When we check it it's normal, she's taking her meds, her I can probably test and treat. Grandma, very fragile, has had a problem with lung disease, I don't want to take care of grandma and you don't want me taking care of grandma. You want me to be able to say, "Two isles down and to your left we have a nurse practitioner, physician assistant, whomever, and your case is complicated enough that I want to use their talent. I can see it being a situation where we complement one another. If it is low acuity and you present to the nurse practitioner you may get referred straight to the pharmacy. If it is high acuity and you present to the pharmacy you may be get referred to the diagnostician.

Interestingly however, in most of the setting as where there is a walk up clinic with a nurse practitioner, physician assistant, whomever, they tend to have shorter hours than the pharmacy. If you get there too early in other morning or too late at night you don't have that opportunity, which is why I think pharmacists need to be trained and refreshed in their basic training to do all of these folks so that we can handle weird hours and those things. On those weird hours, who do we refer to if our primary referral source, the nurse practitioner in the store, is not available? I can see a huge role for both, especially if we begin to look at, I need a bit of data to complete my medication theory management review, I need cretin clearance to test kidney function, or I need hemoglobin A1C to look at diabetes, I need a potassium level.

There is absolutely no reason for you to wonder down the isle to see a nurse practitioner, to pay a copay, to have a lab test that I can run in the pharmacy. Because I m conducting the MTM I know what I need. By the same token, if you think possibly you have broken an arm, don't come see me. I'm a really good pharmacist but I don't do broken arms, you go on down and you check with my nurse practitioner and let her decided if you need a cast or referral or whatever. I think that we can compliment one and other within the same facility, especially when we look at what our true talents are. I think we can do that all without stepping on anybodies toes.

Samantha Lewis:
To wrap this up I want to get into training a little bit and future steps. I know that you personally are very involved in training pharmacists all over the country to take on theses new challenges. If you could elaborate a little bit on what that entails that would be great.

Allison Dering-Anderson:
Absolutely. Thank you very much for the compliment. I will tell you that I don't train them, I simply help them look at things they already know how to do in a different way. Pharmacists who gradate today already give vaccines, they already do physical assessments, they already have the skills and the talent to look at best practices and best drugs and decision making in the face of an allergy or whatever. What we do is we take pharmacists with all of this training and all of these talents and say, "let's bundle them together slightly differently, let's look at the patient. Are you capable of assessing patient reported symptoms to know if this is something that you can test by yourself?" Absolutely, we've been making OTC recommendations for years. Are you capable of doing the physical assessment? Absolutely, we have been doing that for years. Wonderful, are you capable of picking the best drug for the disease?

Then you begin to get that cross eyed look that says "okay, what are you doing?" It becomes evident to them, "Absolutely, I actually do have all of these talents, I've never thought of bundling them like this." Our certificate training program isn't so much about training as it is about refreshing and refocusing. We talked about everything to the disease states from a pathophysiologic level, to the pharmacology of the drugs, to the appropriate therapeutics of the drugs, to how to monitor the patients, how do we get referrals. We spend some time talking about business sense. My love, as you as indicated earlier, is the law and the policy, so I spend some time talking about laws that are going to come into play and how we will evaluate those. A little extra time on the clinical laboratory improvement amendments because those may be outside of the normal experience for the pharmacist. Beyond that, we help very talented people refocus those talents to providing this service.

Samantha Lewis:
Final question, obviously training is a huge part of moving testing into a pharmacy, but what other steps need to be taken to make point of care testing in pharmacy common place?

Allison Dering-Anderson:
If this is something that you want to do as a pharmacist, it is something you'd like to see your pharmacy do as a patient, I really think practically the first step is deciding, "Do I have the space, is there some place where I can draw a sample, whatever that may constitute and chat with a patient about the results?" If there is not currently a space, am I going to build one or am I going to make a different decision. I think that that's first. Secondly, many of these tests and the test manufacturers have not considered pharmacy as a viable business partner. I think that there are things that pharmacists would like to see, the CLIA waves that we can use them in pharmacies, that the manufacturers had not previously considered as something that would be useful. We need to chat with one another to say, "manufacturer, what kind of information do you need from us a pharmacists." For the manufacturers to say to us, "pharmacists, hey what can we do to improve this partnership and make our lives better."

I think that we're getting there. There are a number of groups who are working pretty diligently to help us get together. I think as word of the program begins to spread there will be more and fascinating conversations. It may be a bit embarrassing, but I suspect that it will be someone from my children's generation who are more technically savvy than me who are going to come up with things that I can't even dream up. For that I'm grateful to be a part of this at the very beginning, because I suspect that five years from now we're all going to turn around and look backwards and go, "Oh my goodness, look at all of the things that have changed so very quickly now that everybody understands how many benefits there are to this process."

Samantha Lewis:
Alright, Ally. That's all I have for you today. Thank you so much for taking the time to talk to us.

Allison Dering-Anderson:
Absolutely. You have a lovely day.

Samantha Lewis:
Thanks, you too.

This has been a CHI podcast with Ally Dering-Anderson of the University of Nebraska college of pharmacy. You can hear more from Ally, as well as other leading pharmacy and diagnostic experts, this August 19th through 20th in Washington DC.