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AOCOPM 2024 Midyear Educational Conference
346719 - Video 20
346719 - Video 20
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Our next speaker, Dr. Ferguson is a medical director for Vault Health Recovery Management Solutions. He's a diplomat of the American Board of Addiction Medicine and a distinguished fellow of the American Society of Addiction Medicine and a medical review officer certified by MROC. He has directed the ASAM Comprehensive MRO course from 2003 to 2013 and currently teaches MRO training through this college and ACOM. He is chairman of the Board of Directors of MROC and is a author of the MRO Team Manual and co-author of chapters on addiction medicine in several different texts. He's a former member of the SAMHSA Drug Testing Advisory Board and so consults to SAMHSA's Division of Workplace Health Programs. He was instrumental in the development of the National MRO Database Project and serves as a member of the Industry-Based Oral Fluid Advisory Board, which is a part I'm especially interested in hearing more about since that's coming up soon maybe. Welcome to the penultimate talk. I know you're probably waiting for Mike Decker to come along and I will happily make way for him in relatively recent time, but I wanted to start with some disclosure and it's fairly limited. You see it right there, but I wanna just emphasize the fact that along with what Dr. Wirtz kindly said on the introduction, you don't see the term MRO on that disclosure slide. So one of the things that I would actually like to get across, even though the title of this talk has to do with rules and regulations, which is like really boring for the penultimate discussion, but that isn't a place that MROs need to stop anymore. Can I see a show of hands about how many people are MROs now? Couple, I see, good. Then I would also like to get on my little soapbox and maybe try to talk everybody else into thinking about becoming an MRO. I know maybe a really in-depth discussion of rules and regulations isn't the best way to do that, but nevertheless, what I wanna emphasize is that what we're gonna spend our time on today is really MRO 101. It's the basis for a whole lot of evolution in MRO practice. And we are at a time right now where MRO practice is in great need of evolving, is evolving anyway, but the world in which we live is forcing that evolution, making what we do potentially much more relevant. Now, following up on great discussions about AI that we've had in the past and statistical evaluations and Dr. Best's talk about addiction. And by the way, my full disclosure is that I am an addiction doc, as you might've heard, not an occupational medicine doc. So I may be coming at this from a slightly different angle. It's arguable that MROs in 1990, when the federal program started, that process could have been pretty well handled by non-doctors. Could AI do this? Heck, DOT just got around to doing electronic custody and control forms a couple of years ago. So how quick do you think they're gonna embrace AI? Don't hold your breath. Well, I'll be retired. But how many of you know what the most common positive drug finding in the federal program is? I understand I can't really hear you. So is anybody saying anything? We have a marijuana? Yeah, exactly. Or amphetamine. Well, we'll get into that. Amphetamine is the most commonly downgraded positive, but no, even in 2024, the most commonly found substance is the marijuana metabolite. Now, what is the most common formerly Schedule I drug in the country that is currently being descheduled by a significant number of states and ultimately possibly the federal government? Also weed. What's gonna happen to MRO practice and indeed the whole federal drug testing program once they can't test for weed? Or employers in non-federal programs choose not to test for weed. Or states like California and Washington decide all you can test for is a psychoactive drug. You know, I said the positive is the marijuana metabolite, right? Well, that's not psychoactive. Parent compound is psychoactive, but the metabolite is not. What is going to be the future of MRO practice? And we're not gonna spend the hour talking about that even though arguably it'd be much more interesting. SAMHSA spent a summer, two summers ago, gathering a bunch of us together to just discuss that for basically the entire summer. And the only thing we could get to is that MROs are gonna have to get more involved with fit for duty discussions rather than what you see in the third bullet point there, purely forensic testing. That, folks, I think is really, really interesting and I would hope would be a stimulating factor for people to think about, number one, renewing their MRO certs. And if you're not, if you haven't suffered through our 101 level courses, please do so. And, you know, maybe at some point we can get to have an ongoing discussion from Dr. Best's talk and how I spend my days nowadays, which is not reviewing federal drug tests, sorry to tell you that, but I'm doing professional health monitoring and I spend half of my days reviewing alcohol biomarkers in dilute specimens. That's something you're not gonna learn in the 100 level courses, but I think if anybody's interested, it might be a good way to spend an hour or longer at a conference in the future. Okay, I'm leading up to this, that all drug tests are not created equal. Okay, what Dr. Best was talking about is one thing and what I'm talking about is completely different. Drug tests are answers to a question. What is the question you are asking? Do you wanna detect every single use of a drug, like maybe I should in professional health monitoring? Or do you wanna deter use of drugs in a population where maybe the vast majority of people taking your drug tests don't use drugs? Okay, if you wanna detect everything, it's a problem if you get false negatives. If you wanna take a population like a general workforce where SAMHSA studies have pretty much shown year after year in the annual study that they do with 65,000 respondents, the worst thing you can have in that kind of a population is a false positive. 88% of the people you're testing don't misuse substances. Okay, so you have the testing population of higher user populations versus lower user populations. That really is the depending thing about which type of testing program you are going to be doing. What is the population being tested? What is the question you want answered? When do you most need medical review? And when is it helpful versus required? I'm going to argue that in a case like a deterrent program, like the federal drug testing program, MRO review is required, not only because they say it is in the rules, but because the worst thing you could have in the federal program is a false positive. Where you're very concerned about false negatives and the questions that I get all day long is I know these people are cheating. How come the tests aren't showing it? Then medical review can be helpful. Okay, and again, we have Dr. Best versus what I do. I do forensic stuff, okay? Dr. Best does clinical stuff. I think most of you, except when you're wearing your MRO hats, do clinical testing. Well, clinical testing is for therapeutic purposes. Forensic purposes can be deterrent, can be detection, can involve disciplinary outcomes. Hope you can see the difference. And by the way, if you have questions, please ask. You might need to get them translated so I can hear, but I'm happy to be interrupted with questions, okay? We talk about point of collection testing, which is very useful, as Dr. Best said, in the office, but folks, got to tell you, point of collection testing is not accurate. So if you're gonna do it as a face-to-face part of the examination with your patient, have the discussion and understand what you're seeing may or may not be the case. Point of collection testing is screening. Screening is sensitive, not specific. Keep that in mind. Lab testing, sensitive and specific, but you don't want to wait for the lab turnaround. Did I see some hands there? No, those were waves goodbye. Bye. I'm, wait, I'm not going anywhere. Anyway, screening versus confirming. Point of collection testing mostly involves immunoassay screens, okay? They, again, sensitive, not specific. Opioid, lots of cross-reaction. Be careful between the various opioids. Tons of false positives for benzodiazepines. Be careful. Confirmation in the lab, lab turnaround time, lab costs, all of the above. The confirmation test is very specific as well as sensitive. Again, when is medical review helpful versus required? I leave that up for discussion. Leaving you with this thought, which I want you to carry out of here if you don't carry anything else out. What you do with the result is more important than the result itself. Okay, we teach this in the course. We continually get asked, what the heck's the difference? Okay, these are two different, completely different departments, and believe it or not, they have their own testing programs. HHS funds research, establishes standards, more scientific stuff. They issue funny-sounding title of, what's a mandatory guideline? Well, that's what they issue, only covering federal employees. Okay, DOT is a different cabinet level, okay? They are required by OTEDA on the bottom there, the Omnibus Transportation Employee Testing Act of 1991. They are required by OTEDA to conform with the HHS drug testing panels, and they must use HHS National Laboratory Certification Program certified labs, but it's their own separate program. Before they can, before DOT can do what SAMHSA has decided to do for the federal employees, DOT must issue a proposed rule, get public comment, and then come to conforming regulations. And their DOT program can differ from SAMHSA. Remember, these are two different executive level departments. There's the acronyms defined for you. Now, if we're gonna limit this talk, the changes in DOT, folks, the talk's already over. Haven't been any changes in DOT since the last MRO course that we did. All the changes are in SAMHSA. All the changes have come from the Drug Testing Advisory Board. At this point, DOT has not issued any conforming regulations. They have a way around it if they want to. All that requirement that I gave you in the previous slide, they could issue an interim final rule. They haven't done it. When you go to work tomorrow, will it be there? Maybe, I don't know. I don't think so. They could, to this date, they just haven't shown any inclination to issue an interim final rule. So right now, the changes we're gonna talk about are all mandatory guideline changes from SAMHSA for federal employees, not for DOT. All right, summary of recent changes. SAMHSA changed mandatory guidelines. In there, it included the Schedule II opioids. That was a big deal at the time. It still is a big deal. We're gonna talk about the most recent DTAP meeting and we're gonna learn to forget about MDMA and MDA. Yeah, adulterated pH in the lower end changed. Even though the mandatory guidelines were issued, remember, there's still guidelines. So the agencies in the federal government were authorized, but not mandated to begin the new program. Why? One of the reasons they can't begin the new program is there still aren't any certified labs to do oral fluid. Okay, but believe it or not right now, SAMHSA agencies are not mandated to test for Schedule II opioids. They all do if they test, but they're not mandated to do it. They're authorized to do it. DOT did issue a final rule for that, conforming with that. And now in the DOT program, they are all testing for the Schedule II opioids, but they also, DOT added the five-day pause, which the HHS program does not have. Okay, there's little things here, sometimes not really important, just there for you to summarize, not to spend a whole lot of time going, in spite of the fact that we have oral fluid out there. Right now, urine is the only specimen authorized for DOT testing because there are no certified labs for oral fluid. You can't take the specimen and test it for PMA. You have to subscribe to the listserv if you don't do it, yada, yada, yada. If you don't do it, yada, yada, yada, we will move on now. These are just a summary of the changes that have been in effect for about the past five years. Another set of mandatory guidelines in 2019, DOT issued a final rule in 2023. Okay, again, no certified labs for oral fluid. Federal testing process though, in spite of the potential change in the testing matrix, has not changed. You still have to have screening, still have to have confirmation. The main difference in oral fluid, this is a big one, especially for non-federal testing, especially in California and Washington. The big one in oral fluid is that you test for parent compound, not metabolite. There's lots of science reasons for that because metabolite doesn't get that easily into oral fluid. We talk about that in the course. Most of the parent THC in oral fluid is absorption as THC goes through the mouth. Secondary exposure and CBD will not cause positives. In oral fluid testing, unlike urine testing, confirmation is for both parent cocaine and benzoylecanine. Remember, in urine, it's only for BE. In oral fluid, they confirm for both. there is discussion about when one's positive and one isn't in oral fluid, that helps you determine to some degree, not to a very forensically accurate degree, but just give you some idea of the timing of the use. Always split specimens are used in all federal testing, and I would recommend it all forensic testing, whether it's federal or not. Certainly if there is going to be a disciplinary decision in a detection program like I work in, please do split specimens all the time. There are proposed hair mandatory guidelines out. Now these have been out for the past three and a half years. They are stuck right now in OMB in DC. So one of the things we will not go off on today is governmental dysfunction. We just won't discuss it at all. But these hair guidelines are still in the work. And the proposed guidelines included some really unpopular things like urine and oral fluid specimens have to be collected at the same time. And if the hair specimen confirmed positive, you can report a canceled result and direct the testing of the alternate specimen that was collected at the same time. Nobody liked that. The labs hated it. So what are you gonna do with these other specimens? You gonna stick them somewhere? It's logistically nightmarish. I'm not supposed to let some information out yet, but I would not put any money on when the real mandatory guidelines come out that that is still a thing in the guidelines to come. Okay, the certification for all of you MROs that was held off in COVID has to be done now. Recertification timelines have expired. So if you're getting notes from either MROC or from AMRO or from TED, gotta recertify. I just got mine, so I better do it. Okay, the last ETAB meeting a couple of weeks ago. Finally, no more talk about, remember how long it takes sometimes the government do things. They're figuring out about testing for fentanyl and a metabolite. Okay, that will be added to the panel because in the latest issue of the mandatory guidelines, SAMHSA has given themselves the ability to make adding analytes to the SAMHSA recommended federal panel a lot easier and they can do it now annually. Didn't used to be the case. So again, we're not gonna talk and they're gonna remove MDMA and MDA from the HHS panel. Those are proposed. Hasn't happened yet, but they are proposed. I do wanna just say one thing in defense without again, touching on any kind of dysfunction which we're not gonna discuss. The federal drug testing program is the gold standard. More research, more defensible case history has gone into the federal program. More taxpayer bucks through SAMHSA has gone into the federal program and into any of the analytes used in the multiple non-federal programs that are not mirrored in the federal testing panel. There has to be a gold standard for forensic testing because anything we do by definition in forensic testing can't go to court, has to be defensible in court. So you've gotta have a goodly amount of research to cite when you have to get on that witness stand and testify. So there is some reason for SAMHSA to be relatively slow in adding analytes to panels and adding testing matrices to their program because once they do, it becomes the federal standard and that's the standard, all the non-federal testing that in some cases aspires to it to some degree. The degree varies with the program. Workplace programs will try to mirror that as much as they possibly can. Monitoring programs, maybe not so much. So there's some reason for governmental delay and governmental conservatism in their programs. Okay, remember the major use of the MRO staff. They can start to do things that have previously been required for the MRO. It's about time, because I have found that my MRO assistance can sometimes- Jim, Jim, we're losing audio from you. You're losing audio from me? There, that's better, that's better. I will remove my hand from where it was probably blocking the microphone. Thanks for that, thanks for that because there's no way I would know. Okay, I did say that my MRO assistants sometimes do things way better than I do. So calling pharmacies, double checking on prescription data. Remember how, remember we got AI out there, lots of good things going on, lots of ability to Photoshop. So when you are verifying a prescription, take into consideration what you have to do, really verify the authenticity of that prescription. Always helps to use staff that are trained and knowledgeable and you have oversight of. All of those things are required, but then now even DOT has allowed the increased use of your staff. That's an overdue, very, very good thing. But remember, you have to have really good oversight. There are things that you have to retain that you can't give to your staff. You cannot delegate the interview of the donor or the discussion with the donor of a legitimate medical explanation or not. Only you can cancel a test, only you can verify a test, only you can verify what your MRO assistance may have obtained from the donor or the pharmacy. So remember they can collect, but it's up to you to verify it. And you can't get rid of that for all of you folks involved in federal testing. One of the most enjoyable things you get stuck with doing is review of 5% of the negatives. That's one I would love to get rid of. Maybe AI could do that one way better than I can. Jim, real quick before I get past it too far. Are you saying that MRO assistance now can directly call the pharmacy or is that still on the MRO? No, no, no, they can do that. Okay, thank you. They can, and I encourage them to do that because I don't know how many of you have done that regularly on yourself, but when you call up and you say your doctor so-and-so and you're doing a drug test, all of a sudden, the pharmacist, they're still covered by HIPAA, right? They don't know, they've got a voice on the phone. They don't know who you are unless you keep calling the same pharmacist over and over again. It's a lot less threatening and sometimes the discussion goes, well, if you do a good job training your MRO assistance, let them do it, let them explain what it's about, okay? And you get the same information and you can do the verification that way. I think that's a long overdue change. Okay, you have to think, is it the right specimen? Is the chain of custody electronic or paper intact? Are all the numbers intact? Most importantly, especially outside of the federal umbrella are there anything on the remarks line from the collectors? The remarks line is one of the most ignored lines I've ever seen on any form, but every once in a while, it gets filled up with really good information like was there a shy bladder protocol done? That's really important to know sometimes. Is the laboratory report accurate? Is all this stuff where it's supposed to be? There are very, very few changes to what you as an MRO will do in the federal oral fluid testing program if it becomes available in our public careers. I would expect, and we're gonna talk about it in a few slides, but I would still expect that we will not see federal oral fluid testing probably for a good year yet actually come into being. Okay, there is the safety notice that everybody hates and I'm throwing this in here just in case anybody wants to discuss it. There's lots of issues with it. Remember, this is only DOT, it is not HHS. If anybody actually is working with federal employees, there is nothing in the SAMHSA MRO manual, which I had a little bit of a hand in, there is nothing that even allows an MRO to mention a safety notice to a federal agency. Now, we got a little paragraph in there that said, yeah, if you think about it, you might be careful about it, you might say something, but unlike DOT, which typically spells out safety notices, SAMHSA doesn't do it at all, okay? But you must give the donor the notice that you're gonna do it. Then you have to give the donor five business days to discuss with the doc and see if there's gonna be an alternative treatment. Now, you can imagine how excited the doc who prescribed that meds gonna be to hear that, well, maybe you gotta change it. Sometimes, it might be, it maybe should be changed. There's still gonna be very difficult discussion to have. The problem with the five-day thing is if this is something that you are going to downgrade anyway, like amphetamine, that's the most common one, if you're gonna downgrade an amphetamine to a negative because of the existence of a valid prescription, but you're really concerned that the prescription that you've seen verified is for the instant-release amphetamine plus the extended-release amphetamine, like 120 of each, so that even though you can't renew an amphetamine prescription, you can't refill it, you can write for 120 of each at a time, and if I'm reviewing MRO and I see those numbers, I'm a little concerned about how the amphetamine's being used. Is it because you can't refill it and that's actually a 90-day supply even though it doesn't say so? How do we know that? How is it being used? So you might wanna think about a safety notice and maybe get the doc who gave the CDL exam to pursue this a little farther. Tough, you've gotta give a negative result before you can give that safety notice and wait five days and then go back to the employer and say, you know, I got a safety concern about this if the doc isn't gonna change that prescription. And yeah, they change it to Vyvanse, guess what? It's still gonna show as amphetamine. The five-business-day hold is a problem. Nobody likes it. It's not gonna change. So I want you to think about the different ways to do it. We get into more detail on this in the course, but that's the issue. You have to do it still. Okay, if you don't hear anything back, that's when you give the safety notice at the end of five days. What if they change to Phentermine? Okay, if they change to one of these stimulants that will not show in the federal panel, methylphenidate, okay? What if they change to Ritalin? Is that gonna alleviate your concern? Now you're not even gonna know what they're taking, at least as far as the federal testing. That's a tough question. And I don't have a good answer for it. I'm just raising it as something for you to consider on a case-by-case basis. Reasonable medical judgment. That's why there are docs involved. Remember I started off by saying MRO practice is evolving? I will guarantee you that, especially if THC descheduling happens, moving forward, MROs are gonna be looked on more and more and more to cross the boundary of purely forensic evaluation into fit for duty. Look, the Nuclear Regulatory Commission, that's hard to say, NRC, that's easier to say, is doing it right now. Lots of arguments about how effectively their program is being handled, but they're doing it. So yeah, MROs are gonna get more and more involved in the fit for duty process. I think that's a good thing. I think finally, we're getting into some areas where docs can use reasonable judgment, not just do something that AI could do better than us anyway. Remember though, even though you have a question like I just raised about methylphenidate versus a whole lot of amphetamine, you cannot question as an MRO whether the prescribing physician should have done what they did. If they did it, it's legal, it's there, then you're back in the safety warning discussion. So Robert Swiatinski, back when he was doing the MRO update, raised these questions. It's pretty much just what we talked about. There are always concerns relative to the five-day pause. A lot of us have argued about this since 2017. Guess what? Nothing happened. Now we're getting into the meat, opiate cutoffs. The last iteration of the HHS mandatory guidelines made some really major changes in the opiate cutoffs. I'm gonna remind you what they are now for DOT and what they were before the mandatory guidelines. 2,000 nanograms per mil for both codeine and morphine, 6M always, OxyCode on the schedule twos at those cutoffs there. Remember the codeine morphine cutoffs. Oral fluid are gonna test again for all of the above at the required cutoffs. You're not taking the test. If you're not taking the test, the cutoffs will be on a little chart I'm giving you in a few slides, you'll have them, you don't have to remember. But here goes the crossouts now. As of last February 1st, HHS, but not for DOT, all of the benefit of the doubt, we've been teaching for years and years and years for poppy seed ingestion, above 2,000 goes away. Why? Because HHS is changing the cutoffs. Everybody hates the 15,000 nanogram per mil benefit of the doubt. Sorry, the DOT, it's still in effect. For HHS, all of this stuff is gone, okay? No face-to-face exam, no unauthorized use, no admission of unauthorized use, it's gone. The guideline changes raise the morphine cutoff to 4,000 nanograms per mil. Keeps the codeine cutoff at 2,000. No more poppy seed issues. If the morphine concentration is below 4,000, where you normally might've considered poppy seeds, guess what? You won't even know it. You don't hear it from the lab if you're doing federal testing in the HHS, not in DOT testing. DOT has not issued the conforming regulations. Yeah, I said that about a zillion times. I'm probably gonna keep saying it because I don't wanna confuse you. The MROC Examination Development Committee has met and the questions around these new guidelines are written. For those of you taking the exam, hurry up because they're not in the exam yet and they won't be in the exam until, I'm not supposed to know this because I teach courses and I'm not on the exam development committee. Okay, take the exam, go ahead, do it quick. Enough said. Codeine confirmation, 2,000, poppy seed issue completely goes away. Clinical evidence of illegal use, gone. In oral fluid, MROs report codeine, morphine, oral fluid confirmed positives less than 150 as negative. Okay, And the important thing we said about Fentanyl and Norfentanyl before is that now HHS is annually publishing a notice that allows them to change their testing panel. They don't have to go through the entire long process that they used to do. DOT has to conform, we talked about it, they haven't done it yet. Okay, real quick, I'm gonna definitely try to get Dr. Decker up here on time today. Oral fluid, it's not happening even though it's authorized. It is not happening because labs are getting blamed because the labs aren't certified for oral fluid. The labs are holding up a defense, we'll get to it in a minute, but just as a review, remember, it's a swab, okay? It collects a very, very tiny amount of oral fluid. It is not saliva testing, okay? It's oral fluid testing, which is a mixture, a whole bunch of things, including saliva, mucous glands, some of fluid from your upper respiratory tract. There's a lot of things in oral fluid and the concentration of oral fluid can vary depending sometimes on the person, the diagnosis, if there's any existing medical conditions in the donor. So oral fluid is not always the same stuff, okay? It's federal, you gotta have a split specimen somehow. So is it gonna be split from a bilateral or a simultaneous collection? Sequential collection, is it gonna be a neat device where you spit in a cup, buffered two swabs in the mouth? All those things that are on the table right now, collection devices exist for all of them. They're not FDA cleared yet. So what about the lab? Okay, the panel components are essentially the same as for urine except parent THC in oral fluid and except for parent cocaine in oral fluid. So the cutoff levels have to be way lower because it's oral fluid, right? There's way less drug in them. So you have to use more involves confirmation techniques and more expensive and more difficult to do confirmation techniques, GC tandem, LC tandem spectrometry, way different windows of detection. There's people out there gonna be knocking on your doors if they haven't already been there saying, oral fluid testing will allow you to determine impairment. Forget about it. There is no good data, especially the kind that Dr. Teitelbaum just spent an hour talking to us about. There's no good data that defends the assumption of impairment based on an oral fluid. A lot of the lab reps or a lot of the product reps will try to argue with me there, doesn't exist. So do not accept an oral fluid positive for anything other than more recent use, likely than a urine positive by the window of detection. Okay, in oral fluid, there is no specimen validity testing. If as an MRO, you think you know of a substance that will be adequate to do good validity testing, you can request the lab to do it. They can do it or not, but you can request it, okay? If there are new biomarkers, they're calling them, coming out specifically that will potentially be added on the guidelines, that's gonna require National Laboratory Certification of Approval. Very few of them out there right now. The labs are saying they're not gonna get certified until the FDA gets its act together and clears the immunoassay system. The problem is that there just are not FDA cleared paired immunoassay test systems yet. So the labs aren't gonna spend the money to get their processes certified. Now, remember, we're talking about collection devices here. It's not like you have a urine cup or a hair swab, okay? Or a haircut. These are collection devices and labs get certified by device. Immunoassay reagents are certified by device. It's much more complicated than getting certified for your intestine, where it's all pretty much the same. It's in a cup. Devices now are very different. This is why I made the statement earlier, it's gonna be at least a year before we see federal oral fluid testing happening. And some labs do their own stuff. All labs are doing their own stuff right now. If you're doing non-federal oral fluid testing and you wanna do split specimens like we do, you have to find multiple labs that are certified or can test the same collection device. That's not so easy. And because split specimens are required in federal testing as opposed to just being desirable in the kind of testing that I'm doing, okay? Before HHS and DOT allow these things to happen, they're gonna have to have two certified labs. You always have to have a lab B. So it gets more complicated as we move on. Now, you don't have to look at these. You're not taking a test. I just wanted you to have no SVT for oral fluid, no amphetamine rule. You all who took the course will remember that. If you did take the course, forget about it, it's gone. Dr. Decker's gonna talk about marijuana. I just wanna say that in the testing that we do, CBD is used very commonly as an excuse for a THC metabolite positive. And yes, even for oral fluid as a parent THC positive. Well, in urine, it can happen. CBD has a very minimal amount of change with gastric acid. Really though, the THC is more likely to have been a contaminant in CBD products. Remember, with all the different manufacturers of hemp CBD products doing their own proprietary testing, there ain't no oversight of that testing. And do you think the confidence intervals that Dr. Teitelbaum talked about would stand looking at testing that is being done by the manufacturer or the product that wants to sell the product being tested? Bottom line, we can't trust them, bottom line. CBD may cause it. Another bottom line is you can't accept that as an excuse. It's a marijuana positive, period. In oral fluid, you're testing for the parent compound. The parent and the metabolites diffuse only with great difficulty into oral fluid. Yes, we do have labs out there in the non-federal world that can test for THCA, very, very tiny concentrations. Has to be a pretty good lab, some pretty good internal standards to do it, not on the federal level. All the things that can give you prescription, reasons for a THC metabolite positive in urine don't qualify as excuses for oral fluid, THC positives. Unless they're taking the meds as an oral solution and swishing it around in their mouth before they swallow it. It's possible because remember, in oral fluid, THC comes from absorption in the mouth, not from passage from the plasma, okay? Now, that was held off, that fact held off this federal approval of oral fluid testing for years because it's not an oral fluid test. It's a federal approval of oral fluid testing for years because the legislation that allowed federal testing in the first place, okay, they demanded proof of ingestion. Well, if it only comes from absorption of THC in the mouth, how do you prove it was actually ingested? A small point, but enough to hang up the lawyers for a good long time, you can see that. Ed Cohn, over years of studies with Ryan Vandrie, Johns Hopkins, they looked at this stuff. They have shown that as long as the oral fluid sample is collected beyond three hours of exposure to a heavy, smoky atmosphere, it is consistent with ingestion. So when you're doing your MRO interview, you don't necessarily have to ask that because if you do, you open the Pandora's box and I'll guarantee you every time that person tests positive in the future, they're gonna say, oh yeah, I was just in a smoky atmosphere and I collected the sample right away. But keep in mind, after three hours, it's not an issue. Even though it's parent compound, it represents ingestion. THCV, real quickly, is a contaminant. It's only found in smoked or eaten THC. It is not in the medications. THCV, though, when it's present, THCV is like 6-AMP. If it's present, it proves it. If it's not present, it does not disprove ingestion. There is no limit on the time period that has not changed. There is no limit on the time period for the validity of a prescription under DOT. DOT is not likely to ever issue a time limit on the acceptability of a prescription. So while you, as an MRO, may see a prescription that's five years old, under DOT, you're gonna have to downgrade it if you verify it properly, but that might be cause for a safety warning. HHS is toying with the idea of changing that, giving the doctor, the MRO, a little more judgment, but DOT, not so much. Another one of the differences between HHS and DOT. Real quick, shiobladder. Once alternative specimens are allowed, simplest thing to do in shiobladder, just collect a different specimen. Shiobladder, three hours, 40 ounces of fluid. Try to get the 40 ounces of fluid right away so you can get them to you right away and not have to wait for three hours. Does that? Try it. It works. Dry mouth, though, for oral fluid, 15 minutes. The device does not indicate collection of a substantial specimen after 15 minutes. Now, who's gonna keep that thing in the mouth for 15 minutes? Okay, give them eight ounces of water, wait an hour, then try to complete the collection process. So it's not a three-hour thing for oral fluid. It's only a one-hour dry mouth protocol. Always there is a 10-minute observed deprivation period before an oral fluid collection. If any of you have had the experience of working in a methadone clinic, working in a correctional facility, which we spent a lot of time talking about in this conference, you get to know how good certain people are at gumming. And you gotta do a really good examination of the oral cavity. Some folks are really, really good at it. So you need a deprivation period. I always recommend, and especially in the non-federal world now, a lot of the TPAs are selling virtual oral fluid collections. It's very hard to do a good oral fluid exam virtually, but you try to get collectors at least trained as best you can in doing that. You need at least a 10-minute deprivation period. Again, simplest thing to do is just switch specimens once the feds decide to allow, or once the labs get to the ability of collecting or testing other specimens. You also need in the federal system now, and ultimately when DOT gets around to it, employer permission is going to be required to do that. And remember, a collection issue is between collectors and the designated employer reps. The MRO is not involved in that, period, except maybe as a database. Okay, I'm done. Real quick. These are resources about making a living. Hopefully they are helpful. Again, I cannot get off my soapbox and not beg people to think about becoming MROs if you're not already, to recertify if you are. And if there's any questions, I think we've got a couple of minutes. Hey, Jim, Keith Proctor. I have a shy bladder question. It's not about me. Mine's about to rupture. Sorry, I try to go fast. No, it's my fault. So you talked about the 40 ounces of fluid that they can consume, try and get them to do sooner rather than later. If a person is refusing to drink, claiming shy bladder, and does not provide an adequate amount of urine for a specimen, do we just need to go ahead and default out to the urology evaluation or? A couple of things. Refusal to drink- Rather than PCP. I should have specified, rather than sending them to their PCP. Yeah. Refusal to drink, Keith, is not a refusal to test. If they refuse to drink, you're stuck with keeping them there for three hours. Now, in the course, I gave you graphs about how quickly creatinine drops when people ingest fluid. The ideal way in a shy bladder situation is get the collector to give them eight, 16 ounces of fluid right there and get them back and test them within 30 minutes. Fluid doesn't get to the bladder that fast, but anything more than 30 minutes, anything you drink will get to the bladder and potentially give you a dilute specimen or at least a low creatinine specimen. If they refuse to drink, you're stuck. Got to stay there for three hours when they can't produce a specimen, then it's a refusal to test unless you get the evaluation. And again, you know as well as I do how long it takes to get somebody into a urologist. If this is being done in an OCMED clinic, get them in to see the doc on site because remember the federal requirements are twofold. The examination physician has to give you a diagnosis of why this person can't produce a specimen. Got to be legitimate, not paruresis unless that's previously documented. But not only do they have to give you the diagnosis, they have to relate it to the collection event. So they have to show that that diagnosis specifically kept the person from providing the specimen that day. You can't do that if the examination takes place two weeks after the event. Does that answer the question? It does and I'm out in rural Kentucky so getting into specialists is three months at best. And you're also in an area where the non-federal folks are really pushing virtual oral fluid collections. They are but I'm at a federal facility. Yeah, no, that's not gonna happen. Although unspecified people did ask me about it one time and I kind of, sorry if I put you in a bad position but I kind of downplayed it a little. I just don't see how, you know, no matter how good your collector, I don't see how you can do a really good oral cavity exam virtually. It's just hard. Anything else? Any other questions here in the room? Any questions virtually? Okay. Well, thank you very much. That was a very informative talk. Thank you for bringing me up to date and making me think maybe I don't really wanna re-up my MRO. Oh, yes you do. Since I don't do it often enough to stay current, which is currently correct, true. The course is there online. You can always refresh. Absolutely. I appreciate it. Thank you.
Video Summary
Dr. Ferguson, a renowned medical director and expert in addiction medicine and medical review, delivered a talk focusing on the evolving role of Medical Review Officers (MROs) in drug testing, particularly in relation to federal and non-federal programs. He highlighted the need for MRO practice to adapt, emphasizing the potential integration of more fit-for-duty evaluations into their roles as the landscape of drug legality changes, such as the descheduling of marijuana. Dr. Ferguson explained that while urine remains the primary specimen for testing, oral fluid testing is on the horizon, albeit delayed by certification and FDA clearance issues.<br /><br />He detailed the changes in opiate testing guidelines, noting that the old benefit of the doubt for poppy seed ingestion is no longer applicable in HHS guidelines, though it remains for DOT pending further rule changes. He also discussed the increasing reliability on MRO assistants for verifying prescriptions, which allows for a more streamlined process amidst stringent federal regulations. While federal guidelines for oral fluid testing await lab certifications, labs are hesitant due to stringent FDA device certification processes.<br /><br />Dr. Ferguson encouraged those in attendance to pursue or renew their MRO certification, highlighting the significance of MROs amid evolving drug testing protocols and societal changes.
Keywords
Medical Review Officers
drug testing
addiction medicine
fit-for-duty evaluations
marijuana descheduling
urine testing
oral fluid testing
opiate testing guidelines
MRO certification
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