Instituting NOAC Therapy into Practice in NVAF

SEPTEMBER 25, 2018


Gary M. Besinque, PharmD, FCSHP; Jaime E. Murillo, MD; Juvairiya Pulicharam, MD; Ralph J. Riello III, PharmD, BCPS; and Peter Salgo, MD, consider why it is important for hospitals to establish a protocol for managing patients on novel oral anticoagulant therapy. 

Transcript:  

Peter Salgo, MD: Let’s talk a bit about instituting these novels agents into the health care system, in terms of a lattice, a whole workflow, if you will, or a protocol. How do you build a protocol into the hospital workflow to accommodate these new drugs? How do you affect prescriber choice, if that’s part of your protocol?

Ralph J. Riello III, PharmD, BCPS: That’s a good question. We recently had a P&T [pharmacy and therapeutics] anticoagulation cardiology subcommittee meeting and we actually deleted edoxaban from our formulary. We looked across the health system and it was the least prescribed. Less than 1% of all prescriptions were for that drug. The outpatient coverage just really wasn’t good for our market, so we made the decision to delete it. We removed it from our order sets. Honestly, I can’t give enough credit to our IT team. They created those order sets. It’s basically dummy-proofing prescribing, which makes it very, very hard to prescribe an inappropriate dose to patients. 

Peter Salgo, MD: But you don’t hear the other side of this. The practitioner sits down in front of his or her computer. The practitioner says, “Where’s the order? I used to be able to order this. Those gosh darn IT people are running my practice. I’ll bet pharmacy is behind this.”

Ralph J. Riello III, PharmD, BCPS: Oh, you bet we are. 

Peter Salgo, MD: You sound very proud of that. What’s the point? Why can’t a practitioner prescribe what that practitioner thinks is best for that practitioner’s patient?

Ralph J. Riello III, PharmD, BCPS: From the real-world evidence, we know that when we’re not prescribing medications at the appropriate dose—apixaban, for instance—we may lower their bleed risk if we give somebody who qualifies for the 5 bid [twice a day] dose the 2.5 bid dose. But, on the other end of that, we do increase the risk of ischemic stroke. It may start in the hospital. That problem begins because somebody prescribed the lower dose and it wasn’t appropriate. Nobody caught it.

Peter Salgo, MD: But you’re not talking about controlling doses. You’re not talking about putting up a latticework with click boxes, where you can only give the right dose. You completely took it off. I can hear the phone call now: “You took my drug away.”

Ralph J. Riello III, PharmD, BCPS: You can always pay for it on formulary, if you’d like to use something that is not on formulary.

Peter Salgo, MD: Well, I imagine that there’s a really easy bureaucracy. Does that disturb you at all?

Jaime E. Murillo, MD: It does if it’s done in a unilateral way. This is where the team approach is so key. For any protocol, or anything else that you’re doing at your hospital, you have to have collaboration. If it’s in a hospital, you have to sit down—the pharmacist, the cardiologist—with a hospitalist, or the administrator. You have to come up with reasons why is this agent could ultimately benefit the patient. The situation should never be driven by cost, period. It should be driven by the real needs of the patients. And then, once everybody agrees to it, you have the benefit of having an EHR [electronic health record]. When you have an electronic health system that allows you to set up a protocol to standardize the way that people do things, then there’s no need to worry about outliers. We’re no longer back 30 years ago, when the doctor said, “Either you do this or I’ll take my patients away.” No. We’re here for the patient and we all should be doing what is best for the patient.

Gary M. Besinque, PharmD, FCSHP: Yes. They all get blessed by the P&T committee—all of the order sets.

Jaime E. Murillo, MD: There’s still a process. You have to vet it through the cardiology committee, internal medicine, other P&Ts, clinical leadership, and so on. But, yes, there should be a process that ultimately ends up with a product that is well accepted by the doctors.

Gary M. Besinque, PharmD, FCSHP: And every revision, too. 

Peter Salgo, MD: Every revision. What I’m hearing in your voice is, “I’ve sat on this committee.” 

Gary M. Besinque, PharmD, FCSHP: Yes, sure. They ask for everyone to participate and come up with the ultimate product—something that helps you do the right thing.

Peter Salgo, MD: I’ve sat on these committees. After a while, I was like, “Oh my…” But, there is an endpoint. There’s something that you want to get, which is patient safety and efficacy. What this reminds me of is, a whole generation ago, in the airline business, the captains were the captains. They were going to do whatever they wanted. The airlines said, “No, stop. How about we standardize how we fly airplanes?” And look what’s happened—it’s safer. Is the analogy apt here?

Ralph J. Riello III, PharmD, BCPS: Absolutely. The whole point of politicalizing anything is to have a standardized approach that’s consistent with FDA approved labeling any time you’re going to prescribe a medication. With high-risk medications like anticoagulants, that safety cannot be understated.

Peter Salgo, MD: What do you do with the odd man or odd woman who says, “No, I won’t do it this way. My patients get thisdrug. I’ve always done it this way, and this is my judgment. I’m a physician. It’s my license. It’s my practice.” What do you say to that person?

Ralph J. Riello III, PharmD, BCPS: “Patient on formulary please.”

Jaime E. Murillo, MD: I’ve been a part of the literature for many years. The transformation of health care management is actually an easy conversation. People think, “Now we’re going to have to deal with that guy.” They call the pharmacy. The pharmacist says, “I’m sorry.” But the reality is that’s where you create a protocol. This starts with everybody at the table. The institutions are integrated with a huge number of practitioners. The management is collaborative. You have an administrator, technical staff, and the prescribing physician on the clinical side. You can go to the doctor and say, “This is what all agreed to do. This is what we are doing and these are the reasons why we’re doing it.” I can guarantee that once you have that peer-to-peer conversation, 95% of the time the problem goes away.

Juvairiya Pulicharam, MD: I agree with that, though the practice of medicine has changed. It’s becoming more collaborative. Physicians are realizing that they can’t just remain the captain and take on all of the responsibility, right?

Peter Salgo, MD: And that’s a good thing.

Juvairiya Pulicharam, MD: It’s easier when you have the data and the outcomes to show that. Then, nobody argues with that. Physicians love it if you can show justification and evidence.

Peter Salgo, MD: I love that you said that. I think that answers a lot of questions. It’s not, “We’re doing this arbitrarily. Here’s the data, doctor. Argue with this data if you dare.” Some will.

Juvairiya Pulicharam, MD: And sometimes it’s their own data. Organizations like ours are very mature in this area. We capsule a lot of information. It’s a lot easier when you put their own data in front of them. They will never argue with you.
 


Gary M. Besinque, PharmD, FCSHP; Jaime E. Murillo, MD; Juvairiya Pulicharam, MD; Ralph J. Riello III, PharmD, BCPS; and Peter Salgo, MD, consider why it is important for hospitals to establish a protocol for managing patients on novel oral anticoagulant therapy. 

Transcript:  

Peter Salgo, MD: Let’s talk a bit about instituting these novels agents into the health care system, in terms of a lattice, a whole workflow, if you will, or a protocol. How do you build a protocol into the hospital workflow to accommodate these new drugs? How do you affect prescriber choice, if that’s part of your protocol?

Ralph J. Riello III, PharmD, BCPS: That’s a good question. We recently had a P&T [pharmacy and therapeutics] anticoagulation cardiology subcommittee meeting and we actually deleted edoxaban from our formulary. We looked across the health system and it was the least prescribed. Less than 1% of all prescriptions were for that drug. The outpatient coverage just really wasn’t good for our market, so we made the decision to delete it. We removed it from our order sets. Honestly, I can’t give enough credit to our IT team. They created those order sets. It’s basically dummy-proofing prescribing, which makes it very, very hard to prescribe an inappropriate dose to patients. 

Peter Salgo, MD: But you don’t hear the other side of this. The practitioner sits down in front of his or her computer. The practitioner says, “Where’s the order? I used to be able to order this. Those gosh darn IT people are running my practice. I’ll bet pharmacy is behind this.”

Ralph J. Riello III, PharmD, BCPS: Oh, you bet we are. 

Peter Salgo, MD: You sound very proud of that. What’s the point? Why can’t a practitioner prescribe what that practitioner thinks is best for that practitioner’s patient?

Ralph J. Riello III, PharmD, BCPS: From the real-world evidence, we know that when we’re not prescribing medications at the appropriate dose—apixaban, for instance—we may lower their bleed risk if we give somebody who qualifies for the 5 bid [twice a day] dose the 2.5 bid dose. But, on the other end of that, we do increase the risk of ischemic stroke. It may start in the hospital. That problem begins because somebody prescribed the lower dose and it wasn’t appropriate. Nobody caught it.

Peter Salgo, MD: But you’re not talking about controlling doses. You’re not talking about putting up a latticework with click boxes, where you can only give the right dose. You completely took it off. I can hear the phone call now: “You took my drug away.”

Ralph J. Riello III, PharmD, BCPS: You can always pay for it on formulary, if you’d like to use something that is not on formulary.

Peter Salgo, MD: Well, I imagine that there’s a really easy bureaucracy. Does that disturb you at all?

Jaime E. Murillo, MD: It does if it’s done in a unilateral way. This is where the team approach is so key. For any protocol, or anything else that you’re doing at your hospital, you have to have collaboration. If it’s in a hospital, you have to sit down—the pharmacist, the cardiologist—with a hospitalist, or the administrator. You have to come up with reasons why is this agent could ultimately benefit the patient. The situation should never be driven by cost, period. It should be driven by the real needs of the patients. And then, once everybody agrees to it, you have the benefit of having an EHR [electronic health record]. When you have an electronic health system that allows you to set up a protocol to standardize the way that people do things, then there’s no need to worry about outliers. We’re no longer back 30 years ago, when the doctor said, “Either you do this or I’ll take my patients away.” No. We’re here for the patient and we all should be doing what is best for the patient.

Gary M. Besinque, PharmD, FCSHP: Yes. They all get blessed by the P&T committee—all of the order sets.

Jaime E. Murillo, MD: There’s still a process. You have to vet it through the cardiology committee, internal medicine, other P&Ts, clinical leadership, and so on. But, yes, there should be a process that ultimately ends up with a product that is well accepted by the doctors.

Gary M. Besinque, PharmD, FCSHP: And every revision, too. 

Peter Salgo, MD: Every revision. What I’m hearing in your voice is, “I’ve sat on this committee.” 

Gary M. Besinque, PharmD, FCSHP: Yes, sure. They ask for everyone to participate and come up with the ultimate product—something that helps you do the right thing.

Peter Salgo, MD: I’ve sat on these committees. After a while, I was like, “Oh my…” But, there is an endpoint. There’s something that you want to get, which is patient safety and efficacy. What this reminds me of is, a whole generation ago, in the airline business, the captains were the captains. They were going to do whatever they wanted. The airlines said, “No, stop. How about we standardize how we fly airplanes?” And look what’s happened—it’s safer. Is the analogy apt here?

Ralph J. Riello III, PharmD, BCPS: Absolutely. The whole point of politicalizing anything is to have a standardized approach that’s consistent with FDA approved labeling any time you’re going to prescribe a medication. With high-risk medications like anticoagulants, that safety cannot be understated.

Peter Salgo, MD: What do you do with the odd man or odd woman who says, “No, I won’t do it this way. My patients get thisdrug. I’ve always done it this way, and this is my judgment. I’m a physician. It’s my license. It’s my practice.” What do you say to that person?

Ralph J. Riello III, PharmD, BCPS: “Patient on formulary please.”

Jaime E. Murillo, MD: I’ve been a part of the literature for many years. The transformation of health care management is actually an easy conversation. People think, “Now we’re going to have to deal with that guy.” They call the pharmacy. The pharmacist says, “I’m sorry.” But the reality is that’s where you create a protocol. This starts with everybody at the table. The institutions are integrated with a huge number of practitioners. The management is collaborative. You have an administrator, technical staff, and the prescribing physician on the clinical side. You can go to the doctor and say, “This is what all agreed to do. This is what we are doing and these are the reasons why we’re doing it.” I can guarantee that once you have that peer-to-peer conversation, 95% of the time the problem goes away.

Juvairiya Pulicharam, MD: I agree with that, though the practice of medicine has changed. It’s becoming more collaborative. Physicians are realizing that they can’t just remain the captain and take on all of the responsibility, right?

Peter Salgo, MD: And that’s a good thing.

Juvairiya Pulicharam, MD: It’s easier when you have the data and the outcomes to show that. Then, nobody argues with that. Physicians love it if you can show justification and evidence.

Peter Salgo, MD: I love that you said that. I think that answers a lot of questions. It’s not, “We’re doing this arbitrarily. Here’s the data, doctor. Argue with this data if you dare.” Some will.

Juvairiya Pulicharam, MD: And sometimes it’s their own data. Organizations like ours are very mature in this area. We capsule a lot of information. It’s a lot easier when you put their own data in front of them. They will never argue with you.
 
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