Establishing Real-World Protocols for OPAT

Segment description: Peter L. Salgo, MD; Bruce M. Jones, PharmD, BCPS; and Yoav Golan, MD, discuss the importance of establishing real-world protocols for patient identification, qualification, and eligibility for outpatient parenteral antibiotic therapy.

Peter L. Salgo, MD: Now we need to talk about protocols because if you’re going to do it, you have to have some idea of how to do it, institute it, tell the folks who have to do it, and what we expect of them, if you’re in the C-suite. Who are the members of this team who are responsible for making these decisions regarding the appropriateness of all of this?

Bruce M. Jones, PharmD, BCPS: If you’re looking from the emergency department side of it, a big component is going to be the emergency department physician and identifying these patients. What I encourage a lot of times is a pharmacist who can function as a gatekeeper because the big thing with these agents is they are high-dollar agents. Being able to make sure the patient is a good candidate and not somebody who is going to be admitted—that’s a very key thing. A good way to derail a great program like this is to start having these patients get admitted and falling into the inpatient setting.

Peter L. Salgo, MD: Wait, what you’re saying is, you don’t want to give these long agents to patients who are coming in anyway?

Bruce M. Jones, PharmD, BCPS: Yes. I always encourage that if it’s somebody who’s going to be admitted, whether it’s for comorbidities or other reasons beyond infection, they are not a candidate in my mind.

Peter L. Salgo, MD: But if the drugs work, why not admit them?

Yoav Golan, MD: Remember 1 thing: Those drugs don’t do anything different from vancomycin, besides the fact that they are far more convenient because you give the entire dose. If you infuse them in the emergency department, but you didn’t avoid the admission and they are admitted, 2 things happen. First of all, the question of how did you exactly benefit them is unclear because they are finding themselves in the hospital; and second, the hospital is not going to get reimbursed. I absolutely agree

that when you put together a program, first of all, you want to avoid bad experiences. The first bad experience is that someone is concerned, and they just want to make sure that there is an ability to follow those patients. The second one is that you infuse those antibiotics thinking that if you use them as outpatient, you’re going to get reimbursed for them because the cost is substantial for both of those antibiotics; and you find out that that’s not the case. One time, 2 times, the third time, the pharmacy director is going to kill the option, and you don’t want that to happen. We have a person, a PharmD, who will look into the patient qualifications. In fact, I think both companies have an assistance program in which they can actually help you find the eligibility of the patient for reimbursement and so forth.

Peter L. Salgo, MD: You have a PharmD involved in this decision. Is there an MD involved in the decision, as well, or is it all through the pharmacy?

Bruce M. Jones, PharmD, BCPS: The big thing with the MD is identifying the patient and saying, “Hey, I have who I think is a great candidate.” I think you just need somebody, as you said, checking the criteria to make sure that it is a good candidate. I think those are the main things, from the ED side specifically.

Peter L. Salgo, MD: There has to be buy-in from the clinicians, too, and buy-in from the executives as well. Somebody has to say to the CFO (chief financial officer) that it’s an expensive drug, but here’s the cost savings. It may not be in your silo because after all, this drug is coming out of the pharmacy budget, but everything else is not.

Yoav Golan, MD: The drug actually doesn’t have to be expensive from the hospital’s perspective. The hospital should get reimbursed for the drug.

Peter L. Salgo, MD: If it’s an outpatient, is that it?

Yoav Golan, MD: If it’s given in the ED, that’s why it’s important to not admit the patient. For example, in our ED, all our physicians know about this drug and actually use it in the ED. We made a decision that the same physician, who decides on the disposition of the patient, is going to prevent infusing and then admit the patient. The hospital should get reimbursed for that, if it’s being used in the ED.

Bruce M. Jones, PharmD, BCPS: A big question to ask yourself, too, is, are you a 340B institution? If you are, now we’re really talking about a much larger margin, which makes a difference.

Peter L. Salgo, MD: All right, you’ve lost me—340B, what’s that?

Bruce M. Jones, PharmD, BCPS: Drug companies have this setup, where they are essentially required to provide this drug at a discounted rate, compared with if you’re not a 340B. It’s based on being an either disproportionate-sharing hospital or seeing a high indigent population. I mentioned earlier, we have a high percentage of those.

Peter L. Salgo, MD: You want to avoid—I just thought of a phrase I’m going to use for you—the infusion confusion.

Yoav Golan, MD: That’s right.

Peter L. Salgo, MD: I don’t want to be confused; I’m going to infuse and then admit. That would be confusing. You need a protocol, and what does this protocol look like? Are there places where this protocol is in place? What do these clinical pathways actually look like in real-world practice?

Bruce M. Jones, PharmD, BCPS: I’m a picture guy; I think it’s an algorithm. If you take lab values, you take patient presentation, you look and see it comes down to: Are they a good candidate for orals? Do they have some of the other factors we talked about? Are they willing to do it?