State Regulations for Long-Acting Injectable Medications

Troy Trygstad, PharmD, MBA, PhD; Adrienne Cervone, PharmD; and Tripp Logan, PharmD, examine the differences in state regulations for pharmacists administering long-acting injectable medications for serious mental illness. Adrienne Cervone, PharmD, discusses the importance of follow-up with these patients and strategies used to increase adherence.

Troy Trygstad, PharmD, MBA, PhD: So, this sounds really neat. You can do this in 50 states as a pharmacist, right?

Adrienne Cervone, PharmD: You can immunize in 50 states, but you can only inject long-acting medications in 28 states. In 8 additional states, you can have a collaborative practice, but there are 14 states out there that cannot do this. And as far as all 50 states, the pharmacists are allowed to inject vaccines, there are regulations on that, there’s stipulations. Some states can give maximum flu shots. There are age restrictions. But when you look at the long-acting injectables, there are 14 states that can’t even get into it, not yet.

Troy Trygstad, PharmD, MBA, PhD: So, Tripp, you’re in Missouri; could you go about this the same way that Adrienne can?

Tripp Logan, PharmD: I’ll say, no, I don’t think so. To the point of the regulations and the oversight from each individual state, it’s so different. We were researching this because it seems like a logical progression from where we are. It’s something that we should offer, especially in the area. We’ve been researching this since the beginning of the year just to see if this is something that’s available. And so, I think the answer is yes, and I’m not going to quote it for under oath here, but it appears that with some sort of collaborative practice, figuring that some signoff, that we could.

Troy Trygstad, PharmD, MBA, PhD: But that level of ambiguity is a problem, right?

Tripp Logan, PharmD: Well, it’s scary, too. Let’s say I’ve got 3 pharmacists and they’re like “Hey, we’re loving giving immunizations, what else can we do?” We bring this up and this wasn’t in my training. So, there’s all these challenges with it. I think this is a ripe area for organization and for collaboration, and for like a strategic plan from the community pharmacy space. Because we own this area, we should be doing this, everybody should be doing it. And I think part of the reason—and you probably know this better than I do—that many of these states don’t is because it hadn’t been brought to the table. Has it been?

Adrienne Cervone, PharmD: No. I can say that the first thing I did whenever I looked at the law was I made sure it didn’t say, “immunization;” it said, “injectable medication.” And ran it past the lawyer and we were good to go. So, absolutely, it’s all in that wording.

Tripp Logan, PharmD: Yes, and that’s kind of where our wording is in Missouri, but we’re not very interested, we’re not at this point. It’s scary.

Troy Trygstad, PharmD, MBA, PhD: Well, we need to take this from basement to convention, right? So, in this process then, because one of our goals here is to help the average pharmacy out there, consider this and look at it and not be afraid of the unknown. So, what about some of these detailed elements, like when you say you do fax back, there’s a prescribed frequency for that or it’s every single administration? There are different schedules of administration? Give us a feel for what the average management for the average patient looks like.

Adrienne Cervone, PharmD: We address it right then. So, we give the shot, and we fax it to the physician right then, it’s real time.

Troy Trygstad, PharmD, MBA, PhD: Every?

Adrienne Cervone, PharmD: Every month.

Troy Trygstad, PharmD, MBA, PhD: Once a month.

Adrienne Cervone, PharmD: Yes, we’re on the once-a-month schedule. I don’t have any on the 3 months.

Troy Trygstad, PharmD, MBA, PhD: And it’s very rare to have anybody deviate from that.

Adrienne Cervone, PharmD: Well, I’ve been in contact with our drug representative, and we’re 100% with our patients. I just assumed that everybody was 100% with their patients. But if the person is started on these shots, we follow up, and the follow-up is crucial. We get them in our door if they’re due for their shot.

Troy Trygstad, PharmD, MBA, PhD: So, some folks might end up on intervals greater than 30 days.

Adrienne Cervone, PharmD: They could.

Troy Trygstad, PharmD, MBA, PhD: But your goal is to make sure that it’s as prescribed and that the providers in your community now, the prescribers, their expectation is that if they don’t see that fax come through, they might say, “Well, wait a second, something’s going on here.”

Adrienne Cervone, PharmD: Right. And if we do, if somebody does miss a day, it’s usually because they got distracted and did something else. We really haven’t had anybody blow us off at this point. But if we do get to the point where somebody does not show up for a shot, we call them and we even offer to get them to the pharmacy for their shot.

Troy Trygstad, PharmD, MBA, PhD: This sounds a lot like the Pharmacist Care Plan, the Pharmacists’ Care Process, right?

Adrienne Cervone, PharmD: Absolutely.

Troy Trygstad, PharmD, MBA, PhD: So, you’re collecting, right? You’re assessing, screening, you put together a plan, you fax back, you implement, and then, of course, the part we all miss in healthcare, which is follow-up, right? And so, what I’m hearing is something that I would want for any of my family members, right? I’ve got somebody that is going to do something if they get out to day 31, or day 32, and if that person’s not showing up for their appointment, it sounds like you’re scheduling an appointment, and then you schedule the next appointment when they come in for their existing shot?

Adrienne Cervone, PharmD: We sure do.

Troy Trygstad, PharmD, MBA, PhD: That’s great. What best practices could you identify? Again, for the pharmacy out there that might be looking at this thing. Yes, maybe you can do that, but I don’t know if I know enough about this?

Adrienne Cervone, PharmD: I would say to talk to somebody who’s doing it, even a phone call. We have a lot of students who come through and I instantly bring them back with me. You know when the patient comes in, “Hey, this is my student. Do you mind if he comes back to watch, because he’s going to be a pharmacist someday and I don’t want him going in cold like I did.” So, it’s just simply asking the questions that make it scary. And when you hear those answers from somebody who’s doing it and who has kind of seen everything—all of the good, the bad, and the ugly—it’s really reassuring knowing that it can be done. And I’ve had a lot of people say, “Well, we’re too small to do anything like that.” And I just tell them, “I’ve got 1000 square feet in my pharmacy and I made it happen. So, that’s not a good excuse. Give me more.”

Troy Trygstad, PharmD, MBA, PhD: So, if you’re at 100%, you must be really good. What’s the most interesting follow-up story for a patient who didn’t show up for their appointment? What did you go about doing?

Adrienne Cervone, PharmD: We sent a cab. We did.

Troy Trygstad, PharmD, MBA, PhD: You sent a cab, for your protection.

Adrienne Cervone, PharmD: We were really worried. We were really worried because he was a couple days out and we were getting to the end, and it was going to be out of his system soon. And so, we were calling and calling and calling, and he finally answered the phone. He said, “I’m having a bad week.” And he said, “My caretaker called off,” or whatever the situation was, she wasn’t able to drive him. And I said, “OK, keep your eye out, we’re going to send a cab.” So, he came, and he has never missed since then. And he knew that we were not going to stop, because we didn’t stop. And it truly is my staff. We implement our follow-up procedures and then we follow it, and we make sure that we do, and that’s such a crucial purpose of this whole thing is that follow-up.