The NOPAIN Act: Improving Access to Non-Opioid Pain Medications

[Dr. Steve McCarus]
One of the biggest problems I always saw was managing post-op pain. Every patient is different, right? You all know that some women can have a hysterectomy and never take a pain pill. It's amazing. It always shocks me.

Then when you see some patients post-operatively really require a lot of analgesics, whether it's a minimally invasive hysterectomy or an open hysterectomy, or a C-section. I guess we haven't figured out how to do a minimally invasive cesarean section yet. I have a surgical practice. About seven years ago in the state of Florida, there was a big program through the state on reducing opioid exposure.

I do about 25 hysterectomies every month. I was a high opioid prescriber. I realized I needed to do something to address the issue. I got exposed to bupivacaine liposomal. Bupivacaine is what Exparel is. I really didn't understand much about it and didn't know how to use it. I reached out and tried to figure it out and saw that there was actually some good data around Exparel and other specialties, like in orthopedics, in hemorrhoidectomy, in bunionectomy. The original trials with Exparel, these Phase III trials, were pretty remarkable.

I've never had a bunionectomy or a hemorrhoidectomy, and I hope I never do. The reduction of opioid exposure and the recovery was pretty impressive. That was really early on before we had good data on cesarean. I'm sure Paula knows, and Amy, you probably know, there's really been some. Most of them came out of Texas, Paula, and Dallas. That C-section data was pretty impressive. Prior to that, there wasn't a whole lot of data around gynecology. I was prescribing a lot of opioids and realized I needed to do something to change.

I learned about Exparel, a unique formulation that gives a delayed delivery of bupivacaine into soft tissue. It's indicated for soft tissue of any type. It's also indicated for some of these-- Which I don't know much about, but some of these brachial plexus, shoulder surgeries, and other types of blocks in orthopedics. It's used a lot in orthopedics. We mobilized the team and tried to figure out if Exparel would be worthwhile. It was pretty expensive to use back then. It's gotten much better, and now there's a lot of contracting to allow us to use it more freely. It was indicated on any open search. Exploratory laparotomy, TAHs, open myomectomies.

Back then, I couldn't find an anesthesiologist that would do a TAP block, a transabdominous plane block. Paula, you probably had the same experience early on. There's been a really wonderful educational opportunity with anesthesia. Now anesthesia will do a TAP block. A TAP block is a regional block, as you all know. That really has been a huge huge help in cesarean section post-op pain management, as well as open hysterectomy and open myomectomy. It now has moved into these multimodal pain management protocols.

The American College of OBGYN, the ERAS Society, the American College of Oncology all endorse some type of mechanism to manage post-surgical pain other than opioids. It really has moved into a viable option. You can either do it through a TAP block that anesthesia does, either prior or after your procedure. Of course, with cesarean section, you can't do it until after the baby's delivered. They'll take liposomal bupivacaine and do a regional block, and it works wonderful.

Or you as the surgeon, and this is where I'd like to hear what you all do, but you can do soft tissue infiltration, where you do volume expansion. Expiril comes in a 20 mL valve. You have 20 mLs, and you can volume expand that with normal saline. Bupivacaine, or hydrochloride bupivacaine, or what we know as Marcaine, and maybe-- Paula, do you use Marcaine with yours?
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[Dr. Amy Park]
Can you tell me how you arrived at your journey of being Exparel users? What about the patient experience? I think Steve shared his with the Bartholin's, the no pain after that. I think we all have these-- I remember for the laser, for instance, for Mona Lisa, I was like, oh God, this is so cheesy. Then I had this patient who had lichen sclerosus and we gave her topical clobetasol and it didn't work. Then it reactivated her herpes. I gave her tacrolimus and made her herpes worse.

We gave her a bunch of Valtrex, the Mona Lisa, then we just started doing it and it helped her. She got plasma cell vulvitis and then it just reversed all the changes. Then I became a believer. It sounds like the Bartholin's was the tipping point for Steve. How about for you, Paula? What did you think about it?

[Dr. Paula Bilica]
Initially at our hospital, the only surgeons that could get it were the GYN oncologists. They were using it, they started using it and I had talked to a couple of them and they really made it difficult for us to get it. We're the lowly OBGYNs. To do it for our C-section patients or hysterectomy patients. Finally, I was able to talk to admin and the GYN oncologists really believed in it because it was working so well for their patients. They jumped on board and helped us to allow us to get it on labor and delivery.

The first time I used it was on a C-section and I talked to the patient and I said, this is what it is. I explained to her what it is. I said, "I've heard great things about it. I've had some colleagues who've had great outcomes. What do you think?" She's like, "Let's do it." I had an anesthesiologist who was wonderful and who was all about the TAP blocks. He did the TAP block and I said, "Okay, I want you to let me know how you do and how you're feeling."

I went and rounded on her in the morning and she's a repeat C-section. She knows the difference between with and without Exparel. I went and rounded on her in the morning and she was up, she'd showered and I said, "How are you doing?" She says, "Oh my gosh, I feel amazing." She says, "This is so a 180 from my last surgery." She said, "Last C-section, they had to force me out of bed. I was in so much pain." She said she went home with narcotics and she really doesn't like the way she feels on it. Most people don't, and she was so happy. She said, "I don't need anything. I just need some Motrin. I'll take some Motrin home and I'm good." That really sold me on it.

Then I was able to get a team together at the hospital to get Exparel on board and started using it on all of my C-sections. Then I started using it on my GYN cases and I've had nothing but positive experiences with it.

[Dr. Amy Park]
In terms of your playbook, because I feel like that might be the roadblock is the administration portion. I think most physicians, we want our patients to not have a lot of pain. What were the compelling arguments to cover the cost? Because as of right now, 2024, it's not covered, but was it just the patient, the reduction in opioids?

[Dr. Paula Bilica]
That's one. You present them the data and you present them the studies. Then the other thing that, as we all know, hospitals are very interested in and very serious about are their patient satisfaction scores, right? When our GYN oncologist, presented, hey, look, these patients, they're very happy. They want to come back to this hospital for their next surgery and come back to us for the next C-section. Of course that got their attention, because that's very important to them. The Press Ganey scores, right? That's what they're called.

[Dr. Amy Park]
I really thank you guys for coming on the show and sharing your tips and tricks and also just how to get it on board, because a lot of people don't know how to get it. Getting a champion, getting your colleagues who can attest to its efficacy, talking to the pharmacy committee about it. Typically at hospitals, if you want to liaison with the pharmacy committee, what is the best method? It's going through your chair or your practice director. How did you guys know who to contact?

[Dr. Steve McCarus]
Mine was a little different because I was in the operating room and I wanted to use Exparel on a total abdominal hysterectomy patient. My GYN coordinator circulator said the pharmacy said you can't use. Which really ticked me off because I'm like, hey, who's he to say I can't use this medication? Then I then picked up the phone after the case and actually called him and asked for a meeting with him and went and talked to him. It was all about his budget. I just went right to pharmacy.

I think that was a little bold and maybe doesn't need to be the way to do it. I think what you can do at your OBGYN departmental meeting, I think a couple of things. What I'm planning to do at our next OBGYN departmental meeting is bring up the topic of the NOPAIN Act, so people just know about that because it's right around the corner where that will be applicable for our patients.

I would go to that OBGYN departmental meetings, say, hey, we need to talk about Exparel, there's good data on that now, and do it that way. Then the OBGYN department chair would then be able to talk to the pharmacy and the leadership team to get something together, maybe bring the pharmacy director to your next OBGYN departmental meeting and have a discussion around Exparel. That's probably the way to do it.

[Dr. Amy Park]
Okay, because I was going to say also every resident in this country and fellow have to engage in QI projects, so quality improvement. This is an opportunity to do that work, publish your outcomes on it, follow the outcomes. There's lots of mechanisms. It just takes one or two very motivated folks to discuss the data because it sounds very compelling.

[Dr. Paula Bilica]
That's how we did ours. We got a committee together and went through our OBGYN meeting, division meeting, and went through this chair. Like I said, we had the GYN oncologist on our side, so that was very helpful.