Before we get into the weeds of the technical changes, we need to make sure that we are all speaking the same language. The first thing we're going to define is opiate. And yes, it does need to be defined because opiate classically is a drug that is derived from opium. It's morphine, heroin, codeine. Naturally occurring opium derive opiates. Semi-synthetic opioids, however, are drugs that possess the same narcotic properties as the opiates, but they are derived either from natural opiates or morphine esters. They are semi-synthetic compounds, specifically hydrocodone, hydromorphone, oxycodone, and oxymorphone. These are all clinically useful narcotics that bind to opiate receptors in the brain and other parts of the body. But you have to expect people outside of our profession will use the terms opiates, opioids interchangeably, and we have to be ready for that. Now looking at the testing for the semi-synthetic opioids as an MRO, I always like to simplify things. That way I can remember them. So here's what I think about. Hydrocodone is metabolized to hydromorphone. Similarly, oxycodone is metabolized to oxymorphone. So the codones get metabolized to the morphone. From the previous slides where you've seen parent compounds breaking down into their metabolites, there is a truism that is true almost all the time that we do these types of reviews. The parent compound will be eliminated more quickly than the active metabolite. So it is very possible that somebody taking oxycodone may test positive only for oxymorphone. It is also very possible somebody taking hydrocodone will test positive only for hydromorphone. The body excretes the parents much more quickly and holds on to the more psychoactive metabolites. So here we see the actual cutoff levels for the four new opioid drugs. You'll notice that hydrocodone and hydromorphone have an initial testing level of 300 and a confirmation level of 100, whereas oxycodone and oxymorphone have the same initial and confirmation readings. The test levels for MDMA and MDA have not changed. Now that we're dealing with so many prescription drugs, MROs are going to need to become very familiar with the brand names of the different prescription products. So here you see some of the many prescription drugs that contain hydrocodone, and I have highlighted Vicodin because that's one of the most commonly prescribed. Similarly, there are different forms of hydromorphone. The one that we most often think about is Dilaudid. In dealing with oxycodone, we have again a great many prescription products. Two of the most common are bolded here, and those are oxycontin and Percocet. There is less use of the oxymorphone products. The expansion of the drug testing panel is going to dramatically draw MROs into the middle of this discussion because there's going to be many more prescription medications that test positive. So it draws us into what HHS has called the opioid dependency crisis, but it's more than just an opioid crisis, right? I would like to put forth the idea that what we really have is not so much an opioid crisis. What we have is an addiction crisis. The current drugs of convenience happen to be the opioids. The crisis of addiction had been around as long as the human race. We have seen ups and downs for various different drugs of convenience, including heroin in the 1900s, crack cocaine, all the ones that you very well remember. What happened when the drugs diminished, the addictive crisis continued. And the importance for the MRO is that we must be concerned about workplace safety concerns with the widespread use of powerful psychoactive drugs that are prescription medications. So let's drill down into the specifics of the opioid crisis and look at a little data. In 2012, there were 259 million prescriptions for opioid drugs. In 2015, that represented an average of 17.4 days of annual use per U.S. resident. That's a lot of opiates for a lot of days. The U.S. Centers for Disease Control and Prevention has called this an epidemic, not only in terms of the use of opioids, but in terms of overdose, admissions to hospitals, and deaths. Do you know that drug overdose is the leading cause of death for people under the age of 50? It used to be motor vehicle accidents. Now it is drug overdoses. And the numbers have been shooting up dramatically. In 2016, there were a total of 64,000 lethal drug overdoses, which included heroin and often heroin, which included fentanyl and the fentanyl analogs. This next chart shows you the dramatic rise from 1999 up through 2016, where you see that we reached the level of 64,000 overdose deaths. So a further breakdown of the slide that Kent just showed you shows the deaths related to specific compounds themselves, not just the totals. What I want you to do is take a close look at the blue line. The blue line is synthetic opioids other than methadone. It is not heroin. It is not the semi-synthetic opioids. It is fentanyl, the various versions of fentanyl that are available on the market, and the fentanyl analogs that we are being inundated with from overseas. Now, I want to say that most of the cases are not just related to pure fentanyl. These are mixtures of heroin and fentanyl, multiple different types of fentanyl. These are statistics from autopsies where the main drug in the deceased person's system is fentanyl or one of the analogs. Heroin may have already been there as well, but it's not reported. Heroin-specific dosage is in the line below the synthetic opioids. See how significant the influx of the fentanyls actually has been. How have expert medical groups responded to this growing epidemic of opioid use in the United States? Well, here you see that the Washington State Agency Medical Directors Group reviewed the literature and came up with opioid guidelines in two different years. In 2007, they basically said there's a high risk of overdose in chronic users of opioids, and they specifically declared a yellow flag for anyone who was taking a dose that reached the MED equivalent of 120 milligrams per day. For those people, they said, these people should be referred to a pain management specialist. When they reviewed the literature in 2015, their recommendations changed dramatically. They said there is no completely safe dose of any opioid, and the risk is double at an MED of 20 to 49. The risk is nine times higher at an MED of 100 and more. So clearly, the warning level for a yellow flag has dropped dramatically. And in fact, they did not recommend the use of opioids for chronic conditions such as low back pain or for fibromyalgia. Do you all remember this book that you're looking at on the slide right now? This book came out in the 1990s. We were all trained back in the 90s that someone feeling real pain, real honest-to-goodness pain, would not become addicted to properly prescribed opioids. This book was paid for by manufacturers of opioids. It was distributed by the Federation of State Medical Boards. It was around for many, many years as dogma about the inability to addict a patient to opioids. During those years, we saw the number of opioid deaths increase in parallel to this publicity. In 2012, this was investigated by the U.S. Senate. In 2016, the Senate for Disease Control has published two things, a guideline for prescribing opioids for chronic pain, which basically says be very, very careful and don't do it, and a checklist for that same prescribing. We have given you the link. You can download those for yourself and for your own knowledge that will help you in the reviews that you do. But keeping in mind, as an MRO, you cannot question the prescribing physicians' right to prescribe a drug. The American College of Occupational Environmental Medicine has conducted extensive research on developing evidence-based practice guidelines. In 2014, they addressed the subject of opioids, and here's what they concluded. Notice that acute or chronic opioid use is not recommended for people who perform safety-sensitive jobs. Now, how do they define safety sensitivity? Look closely. These jobs include operating motor vehicles, other modes of transportation, forklift driving, overhead train operation, heavy equipment operation, sharps work, and tasks involving high levels of cognitive function and judgment. So the ACOM Task Force says safety-sensitive jobs include those that require a high level of cognitive function and judgment. The level of evidence for this was C, which was moderate confidence. The risk of auto crashes, for example, was more than twice that for people who were using opioids, and there was a clear dose-response relationship. It was maximum for opioid-naive people, and their level of waving the yellow flag was a level of 50 milligrams MED. So before we go a little deeper, we want to emphasize that the medical review officer has two very distinctive roles, and it's important that we look at the implications of these regulation changes in both of these roles. So I put on a white coat because I'm going to represent the classic MRO role that we've been teaching for 20 years, that we've been doing since 1991. The MRO reviews laboratory results, the MRO interviews donors, the MRO verifies prescriptions, and then verifies authorized use of that prescription. But the MRO also has a safety role and a concern about a worker's fitness for duty. So we need to be aware of the job duties and the potential hazards in the workplace. We need to review at our interview the medications that they're taking and think about the implications for safety. We need to assess what the safety risks may be. And if we have concerns about safety, we have either the option to report that to the employer, or some agencies would say we have a duty to report our safety concern. We are now going to look at things that should have already had a seed germinating in your minds. With all the stuff that we were talking about in the last segment, you have to imagine that there are going to be some concerns that you might have as an MRO when you are reviewing some of these opioid prescriptions. Let's look at the various organizations and see what you're allowed to do and what you're not allowed to do. For HHS, if you identify a safety concern, you have the option to report them to the agency who is going to employ the donor. It is not mandated. It is an MRO option based upon reasonable medical judgment. However, DOT has strengthened that to a very considerable amount. DOT has given you, the MRO, a duty to report specific concerns and given you a protocol that you must follow when you're making your decisions on how to do that. Once you verify a prescription or are ready to report a verified negative, you must do so. You must report the verified negative immediately. However, if you have a concern for safety, you have a pause, a hiatus, if you want to call it, of five days, up to five days, before you can tell your client employer that you do have that safety concern. We will let you know in the following slides what happens during that five-day pause. But at the end of it, if nothing has changed your mind, then you report the safety concern to the employer. In the HHS MRO Guidance Manual, it gives the paragraph that you're looking at now, basically saying reasonable medical judgment on the part of the MRO regarding reporting of a safety concern to the agency. It's up to you. So in contrast, DOT has not only authorized, but in fact required, MROs to report safety concerns. Let's look at the specifics. DOT has required MROs to disclose medical disqualifications or safety risks to the designated employer representative. This involves the release of medical information that can be sensitive, like prescriptions, medical diagnoses, et cetera. And these are prohibited except if an MRO believes that a donor is medically unqualified for a DOT safety-sensitive position. An example of that might be a commercial truck driver who has epilepsy and is taking medication for that, or someone who is on methadone. The second reason for disclosing medical information is if the MRO believes that there's a safety risk associated with the donor's performing of safety-sensitive duties. So there's this obligation that has been there and has been authorized by DOT for some time. Now, note that the American College of Occupational and Environmental Medicine has a code of ethical conduct that has prohibited the release of specific information on diagnoses or findings or test results. So how do we as an MRO deal with this dilemma? This slide shows the example of what I put to my clients in writing. And I make it very general. I say, based upon the information that I have learned about the donor's medical history, the results of tests, diagnosis, or treatment, I have a reasonable concern about the donor's ability to safely perform essential job functions. And note that I'm using the language of the Americans with Disabilities Act, to safely perform essential job functions. I strongly urge that the donor undergo a fitness for duty evaluation by a qualified clinician. That is someone who has a face-to-face examination, who is going to be in a clinical relationship, which is very different than that of an MRO. And as an MRO, I will release pertinent information to the examining health professional. So that's the way that I have dealt with this dilemma about being required to notify an employer about safety concerns, but at the same time protecting confidentiality. Okay, as I said on previous slides, DOT has given a protocol that we as MROs have to follow when we are doing the obligatory safety notification to the employer. The next four slides are going to go over that protocol specifically. You must notify the donor that you have safety concerns during your interview with the donor. When you notify the donor that you have safety concerns, you must give the donor the option to have the physician who prescribed the medication that you're concerned about get in touch with you. That contact has to happen within five business days after the interview. And the discussion that you will have with that physician is whether or not the physician is willing to change the medication to a different one that would take away your concerns for the donor's safety. Remember, this is a donor option. You must, regardless of what option the donor selects, you must give the employer the verified negative result as soon as you have made that verification. You do not hold it for five days. You do not tell the employer anything about your concerns for safety. The new requirement is that if your safety concern is about a prescription and not about a medical condition, then you advise the donor during the interview of the donor's option to have the prescribing physician call you within five business days. You must not release the safety concern to the employer for those five days. But if your concern is relative to a medical condition, however, you must report the concern immediately. Otherwise, the five-day pause begins at the interview. The donor may elect to accept the option or not to have his doctor talk to you. If the donor elects not to accept the option, fine. You report the safety warning right then. Case closed. But if the donor does accept the option, then you should do everything that you possibly can to help facilitate the contact with the prescribing physician. And the reason for that should be really, really clear. You've got a negative out there. You've got an employer who thinks there's a non-problematic negative. And who knows what's happening to the donor during that five-day period. If the prescribing physician does not contact you within that five-day period, then you notify the employer of the safety concern. If the prescribing physician does contact you, then you have the conversation. And if the prescribing physician agrees to change the drug, you can elect to leave off the safety concern if you're happy, if you're satisfied with whatever drug the patient wound up on. You don't have to report the safety concern then. But if the prescribing physician contacts you later than the five-day period, after the five-day period is over, when you've already given the safety concern to the employer, and if at that time, even though it's after the five-day period, if the prescriber changes the medication to remove your concern, you must, not you may, you must give that notice to the employer and remove the safety concern that you've already put on the donor. You have to use your reasonable medical judgment about the safety concern. The prescribing physician may not want to change the drug. He may become very defensive about the drug. And the prescribing physician may insist to you that you don't know what you're doing, Mr. MRO, that the drug is safe, that you don't have a doctor-patient relationship with this donor. The prescribing physician does. He knows more than you. He's not changing the drug. And you're in left field. Still your decision. Still your decision. You may not agree with that. And if you don't, then you leave the safety concern on, regardless of what the prescribing physician said. This creates a potentially awkward scenario, a time lapse here. I would strongly encourage you to talk about this new federal regulation early on with your clients, hopefully before the situation actually arises in actual MRO practice. Explain to your clients the regulation. Talk to them. Tell them you are obligated to follow Part 40. It is your risk and a risk to the employer if you deviate from Part 40. Make sure that you've done all reasonable communication with your client. Bottom line is, regardless of what happens with that five-day period, regardless of what happens with the conversation with the prescribing physician, regardless of whether you accept what the prescribing physician says about the medication being safe, you as an MRO cannot, you are not allowed to, you must not, in the words of Part 40, question the physician's right to prescribe that particular medication for his patient. So Jim, you've just taken us through the detailed steps of the new DOT five-day pause. But I have to tell you, there are some real concerns that MROs have. Here are four of them. First of all, I think that MROs may be less inclined to report safety concerns, to flag them and report them, given the new regulations. Secondly, there's the potential that they may forget, in a busy practice, to report them after five days have gone by. Thirdly, there's a challenge to the employer. First, they're hiring an applicant or returning an employee to work. They get a negative report on a drug test from the MRO. And then later, five days or more later, they receive a safety warning. That's going to really be awkward for the employer. And finally, there's going to be liability. What about accidents that occur when the MRO knew that there was a safety concern but had not yet reported it? So these are some of the concerns that we, as MROs, are going to have to deal with. And our good communication with our clients is going to become essential. First thing, a list of do's and don'ts. Don't think of an MRO review as a fit-for-duty decision. Fit-for-duty is the responsibility of a clinician who has the ability to do a hands-on examination. But remember, you, as the MRO, are going to know things that that physician does not know. As that physician knows things about the patient that you, as the MRO, don't know. This is a perfect chance for collaboration. This should happen. Both HHS and DOT want this collaboration to happen. So even though you're not putting on that hard hat that Dr. Peterson was wearing earlier today, remember that you have a very important role in helping the right answer to fit-for-duty decisions come out. Remember what we said about prescription verification. I won't go over it all again. Remember about the ease of the forgery that's out there. Consider double verification as a routine form of prescription verification. Remember there is no dose-result relationship in the results that we review. And most importantly, document, document, document. If it's not documented, it didn't happen. Guidances under HHS that has been much more specific about giving prescription verification guidance than DOT has. From the HHS manual, they want you to use your reasonable medical judgment to make a decision that the provided prescription was given in response to a current medical condition. Does a root canal a year prior to the drug test count? If during the interview, the donor tells you he's taken the prescription for back pain, does it count? That's a very tough decision. What's written on the bottle? Does it say take this prescription for root canal or does it say take it for pain? You have to consider this. When determining whether a legitimate medical explanation for a positive test exists, was it used during a reasonable period of time after the prescription was written? Remember, DOT is not going to the place where they will dictate how old a prescription is acceptable or not. HHS wants you to make a reasonable medical judgment about the time period of the prescription use falls within a reasonable period of time after it was written. Again, don't question why it was written, but did it fall within a reasonable period of time?

opiates

opioids

definitions

testing

addiction crisis

DOT regulation