• LecturehallPrescribing Controlled Substances: Know Your Rights (And Your Wrongs) Under The New Law
  • Lecture Transcript
  • TAPE STARTS – [00:00]

    Unidentified Male Speaker: For our final presentation, but certainly not our last. We have the Executive Director of the Nevada Podiatric Medical Association. The state board, excuse me for the state board. That's even more important, Executive Director for the State Board of Podiatry. This is Carolyn Cramer, an attorney who loves working in government. In fact, she left government, retired, and quickly went right back in the government. So, I think that says something a little bit about you for liking the government that much. So, let's welcome Caroline Cramer. She's going to be talking about prescribing controlled substances. Something we're all interested in. Thank you.

    Carolyn Cramer: Thank you very much. [Indecipherable] [00:00:51]. Yeah.

    Unidentified Male Speaker: Okay. Thank you.

    Carolyn Cramer: I'm kind of short. I got to kind of stand to this side, so I can actually see the slides. Good evening. I know that you've had a really long day. This is the second day of this conference. You've got a long day ahead of you tomorrow. So, hopefully, I'll get through this pretty quick. This morning, when I ran to the slide deck, it took me about 37 minutes. So, hopefully, I'll shave some more time off of that. I know that you want to be able to get out and enjoy Las Vegas for all of the things that it has to offer.

    The one comment I will make about Las Vegas and podiatry is that you people really know how to party because where I do my regulatory tune up as an attorney was Portland, Oregon. So, I think you guys are really doing a good job. So, this is the topic. We're going to talk about controlled substances in Nevada. We've had some major changes here, but some of the things that I'm going to talk about aren't just Nevada. They're really geared towards all practitioners and in all states.


    But as a codicil, I will say that if you're not a Nevada podiatrist, you are from California or Washington, please be aware that the laws in your state may be different. You need to check those out because some of the states have had significant changes over the last few years. Neither I nor the Nevada State of Podiatry have a financial relationship to disclose. There're objectives, you can read those. When I sat down to really put this presentation together, I thought back about how do we get here? How are we in this situation that were in, not only as a state but as a nation? And I thought back over my career, and a few decades ago when I was a young DAG at the Nevada Attorney General's Office, one of my clients was a Nevada of Board of Osteopathic Medicine.

    And for osteopas, they were a very conservative group. They were much more aligned towards maybe chiropractors as we know the profession today. They did prescribe some medications, they were very big on weight-loss because they didn't like the effect on the musculoskeletal system, but they didn't use a lot of pain medications with their patients. And from time-to-time, we would actually get complaints from patients because they were experiencing pain and they thought that their pain need should be addressed and they weren't. And what the philosophy of that time was is that pain was an important component of understanding what was wrong with the body, and you didn't want to mask it, you want to be able to learn it, and look at that, and deal with it. If he gave somebody pain pills, you weren't dealing with the underlying problem. But as time went on, Jacob got involve and all at once, pain was being undertreated, and pain was the fifth modality, and all at once, things started to change, and then you had this all these new drugs that were out there.


    And the drug started out as cancer drugs, and these were wonderful things, but then it kind of changed, and pretty soon, you saw oxycodone being prescribed for grandma and grandpa's arthritis. And then you saw kids with skateboard injuries, just simple strains or having hydrocodone, and then you just saw it kind of morph. And some of us who were kind of here and looking at this way, we kind of all jokingly said, "What's going on here?" And you would hear regulators try to talk to the FDA, and the DEA about what we were seeing in our communities, and they would say, "Yeah, it's a problem for us," and they would listen and then they would move on.

    Well, things kept spiraling out of control and I became general counsel of the Nevada Board of Pharmacy in 2008, and here I am taking the calls, and I'm monitoring the prescription drug monitoring program, we call it the PMP in our state. California has cures, just about 50 states now has the PMP. And I would look at some of these prescribing practices, and I would see Xanax for flu clinics because people didn't want to get shots, and kids getting hydrocodone, and just pills upon pills, upon pills, upon pills. And the same prescribing practice over, and over, and over again. It was like it's got to end, and we would just see more, and more of this build up.


    And then by the time I left in 2013, and I went into retirement, there all these people who were coming from all over the United States to get pills in Nevada. I would see people drive from the State of Washington to have their prescriptions filled in Winnemucca, or people from Ohio drive to Las Vegas. Every month, 27 hours, car loads of people were coming here to our state to get this medication. It was like, "How can this be? What do we do?" Well, things went on, and I left the Board of Pharmacy, and Northern Nevada – we've had some very significant controlled substances cases in Southern Nevada, but in Northern Nevada, we first had Dr, Rand here, and Dr. Rand, he was implicated in a pill mill, and he started out. He was a family practitioner.

    He had a controlled substance registration, and a dispensing registration. And like a lot of the guys that I would see, everybody would think it's got to be your pain management guys were your heavy prescribers. It wasn't. It was the family docs. Most of these folks got in over their head, they took a 12-hour course on weekend, thought they understand pain management, advertised it to their practice, would start prescribing, and pretty soon, they had a tiger by the tail and they were in deep. Dr. Rand was one of those guys and now, he's gone to prison. So, things got worse, and boards, and commissions, and regulators, they didn't know what to do. And as usual, we kind of all shake our heads. Well, Brian Sandoval, the Governor of Nevada, thank god for him, because he finally got sick of it, and he did something about it and AB 474 was passed.


    The underlying philosophy of AB 474, and this was passed by the Nevada Legislature in the last session is that treat patients with real pain appropriately. It's what you do every day. In the four years that I was general counsel for the Nevada Board of Pharmacy, I never saw a podiatrist implicated in a pill mill. You were doing the hard work. You were treating patients appropriately, but now, it's a law and everybody should be doing that. They're just catching up with what you've always done. So, we want you to treat patients. The people that need pain medication, they should get it. You should treat your patients, but you got to make sure that they have real pain. That means you've got to do your end as a doctor. You need as a podiatrist to go in there, do the diagnostics. Take the histories, get the records, go through it, make the assessment.

    And then you need to do it appropriately, you already do that. You start at the lowest level, what do you do? You start out, you evaluate. Can you do it with an OTC drug? Do you need maybe a something a little bit harder? Maybe tramadol? Do you go up from there? Is there something else that can be done? You don't want to necessarily grab the biggest bazooka you've got in your medicine chest. You want to get the lowest drug that you need to appropriately treat that patient with the fewest number of pills. Don't go for that extended time release. Go for the lesser. All we're asking that you do is think before you prescribe a controlled substance. Show your thinking in your records. Think, show. Its what you were taught probably in the second grade. [Ms. Yang] [00:09:54] told you, think about what you're doing here, show your work.


    Even If you get the answer wrong, I'll give you partial credit. That's how we're asking that you do from your records. We want you to show your thinking in your records, and that's before you make the decision to prescribe a controlled substance. Mandatory CME, we now have mandatory controlled substance CME here in Nevada and many states too. That's why you're here tonight. That's how the new laws impacted your practice. Mandatory registration with the PMP. Before, this was something that you could choose to do, now it's a law. The good news is I know that podiatrist here in Nevada are in 100% compliance with that requirement because the people who weren't, I personally called, explained the law, and now they're in compliance. Prescription changes, we're going to go over those.

    Physician-patient relationship, rules related to an initial prescription, rules related to additional prescriptions, and new usage of the PMP. Mandatory CME, this is why you're here. Right now, we've got some regulations that are pending before the legislative commission. Hopefully, they will approve those next week. They may be rejected, but we'll see. But the reason why you're here tonight is that are doing one unit of CME on the topic. So, you've met your mandatory requirement. Mandatory registration with the PMP, we've talked about that. We have 100% compliance. Many states are adapting similar strategies. Prescription changes, you are the doctor, it's your prescription, it is your medical order. Remember that at all times, even when you give it to your patient, it is your order. When that is in the pharmacy, it is your order. You are irresponsible for that document. These are the changes that the Nevada legislature required, and a lot of them are common sense.


    Have your DEA number on your prescription, you'd be surprised how many time pharmacists have to guess and they would guess wrong. The practitioner address, again, goes back to the heart of what we're talking about, making sure that everything is appropriate that you've done your work. Data birth of the patient, this is kind of where I get real picky on this stuff. The reason why you have to have all of these identifiers, you have to have the information of the patient, you want the date of birth is because you'd be shocked of how many people the have the same name, the same spelling and the same date of birth, it's happened. I've seen records where people's entire pharmacy history have been scrambled because they look like one person, but it's three.

    You want to make sure that you have identifiers on there because that would be your number associated with that patient, and that might save that patient's life. The number of days for which your drug is to be used beginning on the day that your prescription is filled, that was kind of a change before, it was always the next stage. Directions for use must also include the dose prescribed, the right administration, the number of authorized refills if any. And ICD-10 code, I don't know. It's not like you don't have enough on your plate already, but now, you have to be a bill or two. To me, that seem like a strange thing, but again, I think if you're trying to reduce errors, and you're trying to make sure that you have the right drug for the right patient, to treat the right ailment, I can understand where that is a benefit.


    Beginning in 2018, a practitioner may raise a dosage of a controlled substance once, but before second rising of the dose, practitioner must meet with the patient in person or by Telehealth to evaluate the treatment plan, makes sense. If your patient is still having problems, maybe they're not getting better, you need to see them. Some people heal a little bit slower, but it makes sense that you only raise it once, and on second go around that you actually see that person because you're doing your job. You want to make sure that you get credit for the good work that you're doing with your patients. Patient-physician relationship, this was a new change. Mandatory reporting of overdoses, that has recently come about. The State Board of Health has a new regulation on that. So, if you suspect that there is an overdose, you have to report it. I'm going to go over just some general considerations of the physician-patient relationship.

    These are just a few things. A lot of them, you're going to say, "Well, of course, I already do that." Yes, you do. You'd be surprised how many people didn't. That's how we ended up in this circumstance. You're doing the hard work. You're making the right call. We just want to make sure that you document your record so you get credit for the work that you're doing. First thing, whether there's a reason to believe that the patient is not using a controlled substance as prescriber is diverting their controlled substance for use by another person. If you prescribe the pills, but somehow the patient isn't getting better, but they're coming back to you, are they doing it early? Do you have a situation here where maybe there's somebody else in the households that's diverting the pills? It happens all the time. Whether the controlled substance had the expected effect on the systems, why would you prescribe something if it wasn't working, and then why would you do it again, and again, and again thinking that you're going to get a different result?


    With a controlled substance, that can have deadly consequence for the patient, and the patient is not getting pain relief. You all go, "Yes, that's what we're doing, we've always been doing it." Yes, you have, but you'd be surprised how many practitioners in this state weren't. Whether there's a reason to believe that the patient is using other drugs including without limitation alcohol, controlled substance is listed and scheduled one or prescription drugs that may interact negatively, have not been prescribed by the practitioner, the number of attempts that the patient has, tried to obtain an early refill of the prescription, and any time there has been a claim that a drug is lost or stolen. Again, this happens all the time. All we're saying is you need to evaluate that.

    You need to be not overly skeptical, but you need to be somewhat critical of that because that indicates to you as a practitioner is putting all this hard work into this patient that maybe you're not on the same team. Again, some more things to consider, information from the database of the program. Look at the PMP, pull that, use that as a tool. Again, I hate to harp on it, but it's a database. You can use that in your evaluation of your patients. The way you do that is you get your patient profile, you sit down with the patient, you say, "Marry, I see here that we have some entries on your patient profile, have you ever had a controlled substance?" Marry may say, "No, I've had back pills." She may not know that she's had a controlled substance. That may be legitimate, but he gives you a point in which to explore with Marry that she's had it.


    If Marry says oh no, I've never had one, this is the first time I've ever had a controlled substance or even thought about a controlled substance, but you can see that there's a bunch of entries, you've got to point at which you need to be talking with your patient about what's really going on with their health and what really is he expectation at the patient. Part of what is going on now is that you have some doctors who are actually using blood or urine test to look for inappropriate controlled substance use, and it's unfortunate that people have to go to that extreme. But some doctors when they look at urine, they're finding that their drugs that they've prescribed aren't there, and maybe some elicit drugs are, or some other drug. So, it's another tool to be consider. Whether the patient has demonstrated aberrant behavior or intoxication. Again, you'd be surprised how many people will come in, requesting controlled substances thinking they're perfectly fine, not realizing how messed up they are and how obvious it is.

    I'm going to start picking up some speed here because I promise, I'm going to get you guys out of here. All right, general considerations, again, for all controlled substances. Get a good history, if a patient is somewhat reluctant to cooperate with a physical examination, back up, try to figure out why. Look at major changes in health without limitation, pregnancy, mental health issues, that might be some red flags that a controlled substance is not for that person. Any other evidence that the patient is chronically using opioids, misusing, abusing, illegally using drugs or addicted to any other substance, any other factors that the practitioner determines that is necessary. This is where it goes down to your judgement. Your judgement as a practitioner is critical use it, and document.


    Initial prescription, initial prescription that changed a little bit in this last session. It also means the first time you see that patient, and even if it's an established patient, if you were looking at a new course of treatment for controlled substance, you're going to have to pull the PMP. It does not include somebody that has an on-going prescription for a controlled substance. So, you're going to be looking for a new patient. You're going to pull, first thing you're going to do before you prescribe, you pull the PMP or a new course of treatment. Rules to in relation to the initial prescription, before writing that initial prescription and at least every 90 days thereafter, you must review the patient utilization report to asses whether the prescription for the controlled substance is medically necessary, and determine whether the patient has been issued another prescription for the same controlled substance that provides for ongoing treatment using the controlled substance.

    This is kind of where you're becoming the cop now. You're looking for a doctor shopper at this point, and the law is requiring you to do that. It's just one of the things that you're going to have to do because so many people refuse to really see what was going on with their patients. Limits on initial prescription. An initial prescription for a controlled substance is two, three, four, for acute pain is limited to 14 days supply, and if the prescription is for an opioid, and the patient has not before had an opioid, or was not prescribed one within 19 days before the prescription had issue, the dose may not excide 90 morphine milligram equivalence, MMEs per day. That was a big change in the law.


    So, before you write that initial prescription for a controlled substance, you want to make sure you have a bonified doctor-patient relationship. You want to perform your evaluation, you want to do a risk assessment for your patient, you want to establish preliminary doses, diagnoses, treatment plan tailored for that patient, and the cause of pain. You want to document in your records, the reasons why you selected a controlled substance instead of alternative treatment, and obtain a written informed consent from the patient or appropriate patient for the patient for that treatment. You want an evaluation of the risk assessment. It must include obtaining and reviewing the patient's medical history, conducting a physical examination of the patient, making a good faith effort to obtain the records of others or proceeding practitioners, and documenting those efforts, and assessing the mental health, and risk of abuse dependency, and addiction of the patient, using methods supported by peer-reviewed scientific research, and evaluated by a nationally recognized organization.

    One of the things that we have found already in Nevada is that getting medical records is very difficult. Getting medical records that is useful to you and what you're going to be looking at. When we say medical records, do you really need to get some of these dental records? Do you need their optometry records? Do you want some woman's abortion history? Do you really need that? So, right now, the board of pharmacy, they're trying to look at ways that they constructively look at that to make sure that you get the records that are most useful to you. Informed consent, this is where I think my ilk, attorneys will be doing backhand springs, and clapping because informed consent is probably the only thing we can understand out of any of this. We don't have the medical training, we're not going to go after you for all of that.


    We're going to get bogged down in the paperwork. It's going to be, "Let's see, did your informed consent have number four? A clear simple explanation of the important provisions of the treatment plan. Oh, you didn't, tsk-tsk, I win." Okay. Methods to safely store and legally dispose of the controlled substance, not there. So, really, what you want to do is you want to go down this laundry list, you want to make sure that your release meets the mandates of the law. I would think at some point, having your attorney take a look at it, or I could even see where a lot of the malpractice providers may actually want to provide a legally sufficient informed consent because this is I think, going to be the big heyday for lawyers.

    Prescribe 365. I don't understand it, I've tried. I've read it and read it. I think this is going to get changed. I can't say that for sure. I would encourage you to talk with your peers about that. Maybe they can figure it out. Next three slides are related to that, I don't get it. Treatment in excess of 90 days before issuing the prescription that continues beyond 90 days, this is where we get into the whole thing about medical based peer review articles. You can look at that. I'm not certain how many times you'll be looking at this, but if you do, you're going to end up having to really start digging into this, and you're going to have bring in a pain management doc.


    New usage for the PMP. This comes back to what my ilk as regulators will have to do. Boards are going to have to access and search for inappropriate prescriber behaviors. I have not been contacted by the Board of Pharmacy to actually sign up and start doing this. They've not told me that I need to start prowling the records here in Nevada, but I can see at a point that they will do that. Mandatory reporting by the PMP to the board. This, I think is going to start happening. It hasn't happened yet. Nobody has been prosecuted. Nothing has been reported, but I think what you're going to see is more and more times where the PMP, when they suspect that there is a problem is going to be much more opt to report, and make the boards investigate, and take appropriate action when it applies.

    New usage of the PMP, we have not any of that yet. I spoke with the Board of Pharmacy the other day. They haven't done anything, but it's there in the law. You as a practitioner will need to look at your PMP at least every six months, and if I were you, I would do it more often than that. Why? Because of a few horror stories that I lived through. One was a nephrologist in Reno, he had the same name as a pain management specialist. When he went to get his malpractice insurance updated, the malpractice carrier ran his PMP, it showed all of these controlled substances. He saw all of these people, he didn't know who they were, he didn't prescribe any of those medications. When we clawed our way back through it, what happened is, doctors have the same name. Somebody all the way up to DEA, when they did their list for the PMPs and for all of the insurance carriers and everybody, they transposed the numbers, and it was only caught by the malpractice provider.


    Neither one of the doctors knew what was happening, nobody else caught it. So, you want to make sure that you're on top of your own history. Even if you're not actively prescribing any controlled substances, you need to look because what I found a lot is hospitalists, they were required to have a CS and a DEA number, but they weren't writing any controls because they were inside institutions, and they were dispensing inside of a hospital environment. So, why did they have to look? Well, they had to look because guess what? There's a lot of crooks and thieves out there, they knew who they were, they got their numbers, and they were using it. So, you need to be on top of it. Just make a note to yourself, I would look at it every 30 days just because I'm paranoid, and I've seen so many mistakes made.

    The future, regulations without a doubt, we've had to adapt to regulations as the Board of Podiatry. There are other agencies that are adapting regulations to implement, some are to counterbalance some of the effects. Do I think they're all be statutory changes in the next session? Yes, they do. Disciplinary actions, so far, there haven't been any, but I can see a day and age where there will be some. Criminal prosecutions, you should know, DEA has active criminal investigation units for prescription medication, north and south now. So, they're out there, they're established and they're ready to work. Civil litigation, I've told you what I think, I think the trial attorneys will try to use the new law. Good news, no podiatric physician has ever been prosecuted. In the time I was with the board, I saw a few folks maybe use their own pills, but they were never implicated in anything that was causing problems anywhere else.


    No podiatric physician has ever been implicated in a pill mill to my knowledge. Script counts are down by a third, pill counts are down. Practitioners report they are prescribing less. The reason why this whole thing started, and I'm sure you heard Brian Sandoval talk about these numerous times. This was a real piece of his. Unfortunately, every day, a Nevadan dies because of a prescription drug overdose. That is why we did all of this. We're hoping to reduce the death rate, the lethality rate in Nevada. So far, it's too early to tell. It's going to take a couple of years before those numbers start to bubble up, and we really know what's going on. But right now, it's just too early to tell. But I should tell you, there is the dark web and you can get a lot of these drugs off the dark web. And even though there may be a popular belief out there that behind every drug addict is a prescription pad, it isn't that way.

    If you have access to the dark web, you can go to websites and they were literally free text websites that would challenge you to describe your high and they would send it to you. All you needed was visa, master card, Bitcoin and they would send it to you, US postal service, FedEx, or UPS. So, if you've got questions, I have absolutely no authority to answer anything, but there is a website, these are the folks that supposedly you're in charge of answering your questions. If you want to just call me or e-mail me, I can certainly talk to you about what's going on, try to help you get any informations, but otherwise, thank you very much to my board members for allowing me to be here tonight. Thank you very much to Superbones. I'm assuming you don't have any questions, and this is it, go play.

    TAPE ENDS [0:32:19]