S.B. 87 Naloxone Amendments: transcript

uh, move forward and I'll talk about that as I prevent present. Okay. So as member of the committee, you can make that motion. So the most force is to, uh, pass out or to adopt substitute number one.

You. And, uh, the sub actually, uh, was a, a little bit further on cleanup just to know what it was adding. We were, after dealing and speaking with some pharmacy types and medical types, we wanted to be clear, uh, by changing the term opiate to opioid. And there had been a couple of spaces where that had been missed in the initial bill. So the sub itself just added a couple more spaces where we were changing opiate to opioid. And really the difference clinically, opiate and opioid looked the same, act the same. You treat them the same in the way you deal with them in overdose. You use them for pain relief. Opiate means pure plant-based substance and opioid means either synthetically created or altered. So it's almost everything other than opium. So when we were referring to an opiate antagonist, while it's still appropriate, according to the pharmacy and many of the toxicology and medical types, opioid is actually more, uh, appropriate to the things that we're referring to in, in our current day medicine. So that's where that came from, and that's the substitute. This bill, uh, actually came out of an NCSL conference that they took a whole bunch of us from Utah too, to include myself, Senator Vickers, um, the DHHS, uh, office of Substance Use and Mental Health. Brett Kelsey at the time, now it's at Eric Tahara. But, uh, Veronica Little, uh, Megan Brockmeyer, who's in the office of the Medical Examiner. There was, uh, were folks from EMS through DPS. And then we took, uh, one of the lf, or excuse me, LRGC folks, Lisa Sorenson with us, with the goal of saying, what are states doing in their opioid response spaces and what can we learn from each other as other states? I'll tell you, I've, I've never gone to a conference like that where the convening organization brought like a group of 10 people from a state. I was like, all right, they mean business. They want us to actually work together, put us in rooms, uh, where we talked out some of the issues and some of the things that we were seeing in our spaces, learn from some of the other states. And, and one of the concepts that came up around Naloxone, which is a substance and a space that I have a, a decent amount of, of bandwidth and experience in, is that a lot of states are having difficulty paying for Naloxone. So Naloxone is the opiate antagonist, it's the virtual reversal drug. If you can get it to somebody on time, you can get them breathing again from an opioid overdose and you can save their lives. When we started getting access to this in Utah 2014, um, there were just a couple forms that were available. I personally am still a believer in the medical gold standard injectable. It's the one we've used since 1971. It's the least expensive, but there's other products. There's a nasal product that's since come online. There used to be an autoinjector that one's no longer on the market, got too expensive for folks. But in some spaces, especially public safety spaces, the nasal form is what's preferred. And although I don't love that the cost is different, I understand why our public safety folks don't necessarily wanna be stuck with needles or have that needle stick risk while they're at it. They don't maybe have enough. They already got 52 things on their belt to be pulling up, uh, something out of a vial. And so agencies now, I've worked with over 80 of them across the state, training them and getting them equipped with Naloxone. They've really bought in and they've saved over 1200 lives that I'm aware of. There's likely more in the line of duty in addition to their other job duties, and they'd like to continue doing this. But the expense part has been a, a limit for them. And these little nasal devices dug on it. I probably have one in my purse, but I'm not gonna make you watch me dig through my purse. Purse of doom is real. Um, that it, they cost, at the time when agencies first started, they were $75 for each kit. And each kit is two doses. So 37 50 a piece. Now it's somewhere closer to $40. Sometimes I'll hear a little less. Sometimes I'll hear a little more. So $20 a dose or so. And when the pharmaceutical companies label these such that they're expiring in 14 months or so, this is something that the agencies have to over and over and over re-up on. It also happens in some of our public health spaces with our local health authorities and, and our DHHS offices. They buy a whole bunch. They're trying to get 'em in the right spots, whether that's, you know, medical settings or settings where there's syringe exchange or settings where there's other involvement with people who use drugs. But when they're expiring, it's this enormous loss of resources. Um, I one time had as an organization that I co-founded with my brother called Utah, and we had someone call us and say, we got 2000 expired kits. What can you do with them? And I was like, ah, that was like $90,000 at the time, which is the budget for some, uh, not for profits. One of the solutions we found at this NCSL conference was brought to us by a doc, an ER doc in Colorado by the name of Dawn Stater. And they had run legislation in Colorado to say, you know what? We know that Naloxone is active and still itself far past its expiration dates. In fact, there's studies and I, we tried to print it out. Unfortunately that wasn't working for us, but I can get 'em forwarded to everyone that show even Naloxone, 30 years old, back into the 1990s that say has been held by EMS agencies or law enforcement entities, or for whatever reason, it's still around. They check it on something called a mass spectrometer, which looks at what substances still there. Looks at the potency of it. Some of them are 95% still intact. So Colorado had passed this law. Now Montana has passed it too, to allow expired naloxone to be carried as well as to be distributed out in communities. And it takes away the liability protections for that. I personally feel absolutely comfortable carrying expired Naloxone, but I know agencies don't always, and, and I know that they all, you know, they have certain concerns. This bill, we took a pretty conservative route and working with Senator Vickers, who's a pharmacist, myself, who's a physician and some other folks who work in the spaces. We said, all right, what do we feel like would be a really conservative way to start with this? And the way Senator Vickers explained it was, well, in the pharmacy setting, what we tell people is, please take your prescriptions before they expire. But sometimes that doesn't happen. Sometimes for whatever limitations you have some that have been expired for a little way, please don't take 'em after two years expired. That's kind of a standard go-to in the pharmacy world. And so we went with that in this, the Colorado and Montana bills just say expired Naloxone. So it could be 1993 even. We wanted to start this out kind of responsibly and, and make sure it goes okay before we go further than that. And so this bill essentially would allow pretty simply the distribution of, or the use of expired Naloxone that's expired for up to two years. It does require that if you are supplying, so say Utah, Naloxone has some expired naloxone, and we're supplying to someone, we explain there is always the risk that after expiration something could be a little bit less potent. For me, that means, I'm gonna say, I wanna make sure you have a couple extra kits just in case. But it does require that education piece so that people know. But it's going to save this state, hundreds of thousands of dollars in purchasing something that does not need to be repurchased simply because the pharmaceutical companies put an expiration date on it. FDA went ahead and gave a whole additional year on the nasal naloxone's saying one additional year we feel completely comfortable with. So I really feel like we're in the bounds of a safe zone. And I feel like it'll be really good for our, our first responder spaces as well as our public health spaces. Um, certainly open to any questions or thoughts or anyone who's here to share. I'd love to hear 'em.

Still got student loan to prove it. Oh, there It is.

Um, I make motion to pass this bill.

I'd like just to comment on it. Yeah, this is only my second committee meeting ever. So you

Um, as someone whose life has been saved with expired EpiPens, I support this a lot, so,

What does that mean? Wave means you don't have any further comment. Oh, Just part. Okay. Yeah. Waive.

So moved. So moved. Do you any discussion that motion?

Correct. Okay. Go ahead. Alright, so the handouts that you all received, just as, uh, by way of description, there is a group of students who are engaged with civic engagement and wanted to put together some informational pieces on a bill that policy and public health were overlapping. So there a group with, with, uh, Salt Lake City, I'm totally spacing on their name. It'll come to us. Um, they work with Representative Romero as well and with the Salt Lake City, uh, kind of municipality space. So thanks to them for the handout that came around. Um, and I wanna tell you a little bit of where this bill came from. So there was a group, uh, brought together by NCSL of Utah folks engaged in the opioid overdose prevention space and death prevention space. And they took about 10 of us to Denver. And it was Senator Vickers and Representative Gwynn and myself. Lisa actually was along for the ride, taking a lot of notes diligently. Um, we had people from DHHS there, the Office of the Medical Examiner, the Bureau of E-M-S-D-P-S boy, I'm probably leaving off a couple of names. Uh, bill Newell from the Fentanyl Task Force. And, and Bill, in fact, affectionately refers to us as the STP the same 10 people. 'cause it's the same 10 people that you get in the room to talk about these things. And we had some really enlightening, um, conversations about ways that we could, you know, incremental change. And, and I, I hate to say move the needle when I talk about the space, but it still applies. So I use it anyway, um, in preventing opioid overdose deaths. And there were five other states there with us. And they presented different policies from things that they were trying or had tried and didn't work or things that had, they had tried and they wanted to, um, sell to share. And we definitely shared some of the pieces that had come together in Utah. And in fact, when you looked at the numbers from the states, our our numbers of overdose deaths had fallen lower than than any of the other states. And so there was a lot of picking of our brains on, on trying to figure out how they could get policy ideas from us. And one of the policy ideas that was, that was brought to us during that and brought to our attention was, uh, policy that is in Colorado, Montana. There's one other state I think it might, I don't wanna misspeak. There's another state as well where they had said, you know, we are spending a ton of money on Naloxone rescue kits and on naloxone, naloxone kits, especially in the non-medical settings. Um, and the pharmaceutical companies are often only putting a 12 to 14 month expiration date on them. And so every year, whether it's a public health entity or a law enforcement agency or a a recovery community group, every year they're having to re-up these. And, um, I have a study here. I don't know how many of you actually want to read research studies with the whole thing. My intern has a couple of them, if any of you want to. But this quality assessment was done on expired Naloxone products from first responders supplies. And it, it's, it's the most fascinating study. The doc that did it, a Dr. Daley in New York. Basically there were all of these expired Naloxone products. They actually had a bunch of different products. But this paper particularly focuses on Naloxone products back to over 30 years. And they would run these through the mass spectrometer and they would say, all right, how much of it is still intact? Because some medications really don't break down much. Tetracycline is one of them. Um, Naloxone is one of them. Others do Aspirin breaks down a ton. You don't wanna really take an aspirin past its expiration date 'cause it's probably not the same thing it was when you first got it. But given that these medications, even 30-year-old medications were 90 plus percent intact closer to a decade, were 95 plus percent intact. There was a discussion about, well boy, this feels like we're wasting a whole lot of resources calling something expired that is actually still safe as well as effective. Well add to that, now that the FDA has increased the expiration date on the nasal Naloxone products by an additional year, they just kind of took an additional year and put it on there. Some companies, I understand there's one locally that's even advocating for a four year addition on there. And so we, we thought about policy options and the other states that have done this just said, ah, it's fine to use expired Naloxone. And working with Senator Vickers and, and knowing kind of both of our, actually all three of our, with Representative Gwynn's desire to, to be having safety in mind as well as the confidence of the folks that have the Naloxone, whether that's a law enforcement officer or someone who works in a community setting. We wanted to be pretty conservative with it. And so we chose the number of two years. And, and what that means is that this, the way the bill is written is that you may as a community group, or even as a recovery group, as a clinic where they're giving, um, methadone or another medication for opioid use disorder, still supply someone the naloxone that you have up to that two years past the expiration date. Now, it does require that you educate that there's always a possibility when something is expired, that there's less, uh, efficacy there. And, and I learned a lot from Senator Vickers on this because as a pharmacy, he, he said that the thing we typically tell people when they are, you know, inquiring about expired medications is that you, we really want you to take it on time. We really want you to take it by the time that it expires. But definitely within six months and absolutely within two years. So that also kind of gave us the two year kind of comfort zone with this. But with the thousands and thousands of dollars that I have watched be expended over the last 10 years of working on Naloxone efforts, this feels like a way to help save lives as well as to save resources. Uh, when I got a call from one of our health public health spaces saying, Hey, I have 2000 Naloxone rescue kits. Anything you can do with them, they're expired. And at the time they were $75 a piece, so that was $150,000. That's a budget of a lot of not-for-profits. So there's kind of a longer story maybe than it needs to be, but hopefully it frames it out for you for why we were considering this and also why we think it is solid, safe, and fiscally responsible policy.

Yeah. Um, does this apply to both community based organizations and health based organizations medically based organizations?

It does. And and the reason that that's important because there's a line in here where it talks about, uh, may prescribe or dispense. So prescribe is typically, um, writing it dispense is what the pharmacist does. Furnish is what any one of us would do that's a non, uh, pharmacist. When we would hand a medication to somebody, it's important to have all of those pieces in there because a lot of the spaces where people are receiving naloxone do have medical oversight or involvement. So I have a clinic downtown where we see people for wound care and to try to help them find their way onto recovery. I'm there, uh, all the kits that I have have my name as a prescriber on it. And you certainly wouldn't wanna make it that I had done something unprofessional by providing that to someone. Same thing with, say, an Odyssey House clinic or an emergency department center, or a family practice center. So it, it's to cover those places where there may be a prescriber there furnishing it. Um, so it does kind of cover both of them. Also to add that there are many settings which, and there's like a, a middleman in between, right? So I sometimes supply dozens of Naloxone kits to, um, a law enforcement agency, uh, for their needs. 'cause they don't have the funds for it. We wanna make sure they have them. So it was important to cover the liability piece for all of those people, um, who would be potentially supplying the kits.

And then a second question. Yeah. What are, what would the policy impacts on this be in the sense of if an organization has a policy outside of this bill?

So, so their policy is that they cannot use expired medications, then the law if, if, if passed says this is okay up to this, this amount of the 24 months. Um, what's the impacts of that? Uh, the way I would see it is that they have two choices. They can either say we feel good about our policy. We have, you know, been on board with, for X amount of time that we've been doing it, we're gonna stick with our policy. And they could certainly repurchase every, you know, 12 to 14 months that their kits were coming up expired. Or they could work through whatever their quality assurance, quality improvement process is to see if their medical direction or their, uh, kind of executive direction is okay with what the laws now states. So I think it would leave it to the discretion of each individual organization.

Okay. And then just, uh, when I first read this, I had a, a concern. My, my district is very rural. Yeah. And, and I worried that if there was a, um, a way for liability to be extended that rural agencies would get these products with a expiration date that is closer to the current date. Because that's kind of how it works. We just, it trickles down and we get, we get the last of things. Oh, yeah. Um, so, so, so that was a concern.

But this doesn't change, um, the, the availability or the, the ways that the companies send medications to anyone. It's, it's just the policy that liability would be different.

Am am I understanding that correctly?

Yeah, absolutely. And I think also that it, my hope is, and I've watched this happen in a couple of settings, you know, law enforcement agencies maybe got a grant and they bought Naloxone and they had it, their officers trained and they were carrying it and they maybe used it a couple times. And then the grant funds ran out and the kits expired and they didn't have any more money. And so they just were no longer able to stock the Naloxone. And, and that's kind of a shame. Um, and so knowing, especially like I have seen these thousands of kits that have expired, it, it feels like we might actually be able to get further out into spaces where people had very limited resources. And what I'm sort of thinking in my mind, I maybe a little off the cuff, maybe a little more information than you need, but I'm thinking the way I would feel safer, and this is what I always tell people when they have Naloxone kits that are expired. Now go ahead and hang on to that. 'cause you know, we never know what happens if we lose the ability to buy things. Hang on to that. But I'm gonna send you an updated kit too, so that you have both, it doesn't go bad. It doesn't turn into something scary or harmful. Might as well hang onto it. 'cause you, you just never know if you may need it and you can never give someone too much Naloxone. So I don't worry that by equipping someone with, you know, even five kits or or whatever else, that I would have to worry that they were going to hurt someone around them. Okay.

Oh, thank you, Mr. Chairman. Uh, yeah, at the free clinic in Davis County, we go up to seven years, ah, on medications. Interesting. Yeah. And I was just going to, to ask you a question. Have you ever had a case where someone has refused to give it to someone who's, uh, you know, sick or, or otherwise and did not use a medication because it was outdated?

I sure haven't. I I haven't either. I sure Haven't. Surprised that doesn't happen more often.

Yeah. I've had people say I was worried because I didn't realize that my kit was expired. And I looked down and it said 2025. Actually, it was 2024 when the person said it to me, it said 2024 on it. But I knew I needed to give them this medicine and they, they had called me to tell me, Hey, just so you know, this stuff works when it was expired. And I, I, of course thank them for both using it and for letting me know. But I have had people tell me that they got a little nervy, but that they gave it and, and that it did still work. So, but I have not in my career had someone say no, I, I won't, I wouldn't give that to somebody.

If I might just make a comment? Yeah. Mr. Re, vice chair, I think it's useful to understand how the FDA makes expiration date determinations. So in general, a company comes in and says, I got a medicine here. FDA says, if you showed it works, and they say, yep, here's my study. I show what it works. And the FD says, okay, well fine. Um, before we're gonna let you sell that, we need to have an expiration date. And the company says, all right, what would you like me to do? They say, well, we'd like you to take that and put it on a shelf and leave it there for one year. And then after one year, we'd like you to test it and see if it's still that thing. And so the company will do that. They'll put it on a shelf, they'll wait one year, they'll come back in. Yep. Still the same thing. And the FD says, okay, you can sell that with an expiration date of one year on it. Nothing about the process actually measures when it breaks down. There's some things, if you have a potassium tablet, it can be a billion years later and it cannot be anything else, but still a potassium tablet, but it will be stamped for one year. So products like this are really, they're really fine, um, to use later. And it just does not make sense to be throwing 'em away when they're so expensive.

Bill? I'm not seeing anyone in person. No one online. Okay.

Thank you, Mr. Vice Chair. I'd make a motion that we favorably like to recommend Senate Bill 87. That motion is in order. The, the motion is that we favorably recommend Senate Bill 87, um, to the bill sponsor on the motion.

No, I, I appreciate all the, the insight and, and thank you. I'm gonna remember that piece, uh, from Representative Ward to add. I, I just, like I said, when I finished, I really believe this will continue to save lives as well as, as save monies. So, And to the important Thank you.

I I think this is a, a, a fine candidate of a bill for consent giving no opposition and solid science behind it. So my motion is to place is be 87 on the consent calendar. So the motion is in order, um, to place Senate bill 87 on the consent calendar, um, to the bill sponsor.

Yes. It's been an interesting journey. There's this back and forth conversation between whether we use opioid or opiate in terminology, opiate actually means pure plant-based substance and opioid means either synthetically created or altered. And throughout the code there's a lot of back and forth. And so in discussing with the drafters, we've decided to go back to opiate and we'll deal with the opioid question later. So it really is kind of a semantics piece.

Exactly. Thank you Mr. President.

Uh, yes. So this bill actually came out of, uh, really kind of a cool thing that happened. NCSL brought about 10 different folks from Utah over and other states. I think there were five other states there to look at how we're addressing our opioid crisis and find strategies that might make us have, uh, movement forward. We had Senator Vickers there and myself. We had Lisa Sorenson from the lrg C'S office. We had Bill Newell from the Fentanyl Task Force. We had people from DHHS and DPS and it really was a great opportunity for all of us to be in the same room. Uh, we, we started calling ourselves STP the same 10 people because we were the same 10 folks who were really engaged in this. And at this, um, con at this conference or convening, one of the concepts that came to us was something that was already happening in Colorado and Montana and that's that they were allowing, um, naloxone rescue kits that had expired to still be furnished out into their communities. And this is based on solid science. There's actually data back into the nineties with Naloxone kits that have expired naloxone's, the antidote for an opiate overdose if, if I haven't said that enough for you, but it's the opiate antidote. So if someone's experiencing an overdose, you get to them in time, you can get them reversed. And this stuff is super stable. Kits from the nineties are still 95% plus intact. So I spoke with Senator Vickers on the, on the pharmacy side, and we tried to come up with what we thought was a responsible policy to say we'd like to save our agencies, both our Department of Health and uh, human services, public health agencies, as well as our DPS agencies who are spending perhaps thousands of dollars every 14 months when the kits are purported to expire. What's the responsible way to give a little bit more time on those? And we felt that two years would be very appropriate. That is a kind of a common term expressed out in the pharmacy and medical world. We do encourage people to take their medications on time and before they expire, but definitely before that two hour window. So this bill would help across the board, it would help our agencies, it will help our individuals, it will help our community groups, it will help the state fiscally significantly by not having to keep spending every 14 months. So with that, that is the first of my STP bills and I'm open to any questions.

Thank. Thank you Mr. President. Uh, don't have any questions, but I do rise in support. Uh, as, uh, good senator mentioned, we were able to collaborate together with a group of legislators, I and some experts from NCSL and others to talk about some specific issues. This one does make sense, especially specifically when she's talking about the expiration date on some of these medications. You know, it's interesting. Um, certain federal laws require us to put an expiration date on certain products, uh, for example, compounds. When we do any kind of a specialty compound, it can, no, it has to have at least a six month expiration. Can't be, can't be longer than that even though the medications within that compound are good for six extensively longer. Um, as a kind of a general rule, when you see an expiration date on a, uh, a manufactured medication, it's usually good for somewhere between six and 24 months after that. These, there are certain drugs, uh, codeine, um, tetracycline in this case naloxone. They're good for years later. And so it doesn't make any sense to just throw away a real good product. And so I think that the senator's work on this is really important and, and take into some consideration common sense. So I support the bill.

No, I would waive a summation and call the question please. Thank

Senator Vickers Baldy Aye. Lewin Aye. B Brammer Aye. Bus Aye. Willmore Aye. Escamilla Fillmore Grover. Aye. Harper Aye. Kins Aye. Ipson Aye. Johnson Aye. Juab Aye. McKay Mikel Aye. Milner Aye. Musselman Owens Aye. Pitcher Aye. Plum Aye. Rebe Aye. Sandal Aye. Stevenson? Aye. Stratton Vickers Aye. Weiler Aye. Wilson Aye. Winterton Aye. President Adams Aye.

Thank you Mr. President. Uh, this was a bill we talked about yesterday where we worked with a whole group of folks via NCSL and about 10 different Utah State folks and came up with a concept to save the state money by extending the usable time of Naloxone, which is the opiate antagonist or the way you reverse an opiate overdose. This will save money for agencies, for our public health structures and, and allow us to continue getting these kits out as broadly as possible. There's been wide, uh, evidence from within the scientific community and our pharmacy community that this is safe and it feels like good policy. Thank you for the presentation.

Thank you, Mr. President. I would waive and call the question.

Senator Vickers for Thank Mr. President. Personal privilege.

Thank you, Mr. Speaker. So SB 87, uh, pertains to, uh, Naloxone. And for those of you that don't know what Naloxone is, that is an opioid reversal medication. It can be administered either INTRANASALLY or through iv. And it's typically used by EMS and law enforcement when they're responding to an overdose call. Uh, Naloxone is only effective on opioid overdoses. This bill seeks to provide immunity when first responders EMS, uh, nonprofit groups, um, are utilizing Naloxone past its expiration date. Studies have shown time and time and time again that Naloxone remains, uh, effective years after its expiration date. And even the FDA has noted while there is an expiration date on it, it is effective post expiration. Uh, so this bill just says, look, we know Naloxone can be expensive. We know that there's a lot of, uh, good faith actors out in the community. And so those organizations that say have Naloxone vending machines in their lobbies, or if a first responder has expired Naloxone in their car, that, uh, you know, taxpayers are probably paid pretty good money for these doses. And so we're gonna allow first responders to and, uh, our nonprofit agencies who seek to combat opioid overdoses in their communities to utilize expired naloxone up to two years. Postex expiration, uh, without threat of suit. That's all this bill does. Mr. Speaker,

Waive. Thank you. Summation