Dr. Steven Passik: I am going to spend the next few minutes with you talking to you a little bit about how to set up a treatment paradigm so that you can deal with people like Larry without cynicism. Not every single patient that we see for opioid therapy obviously, and I do not have to preach this to this room, is an addict waiting to happen, right? But without the right tools and without the right treatment paradigm set up and then tailored for each individual patient, and each individual patient gets their own risk assessment no more of the sort of nonsense that characterized the early days of the opioid movement when it was a lot more like a religion than it was a scientific movement, where we just basically said opioid phobia must go right? Let's reduce the fear. All the pain in the world will be treated, we will all march off into the sunset, and we were successful. We did decrease a lot of the fear and a lot of patients benefited and prescribing of drugs like oxycodone went up 400% in the last couple of decades, fentanyl 500%. Tremendous increases and a lot of people were helped but, of course, in our naveté, rather than saying we were going to teach the principles of addiction medicine to every practitioner, every nurse, every doctor, every psychologist involved in opioid therapy, we decided that that addiction was not going to happen, that pain patient did not get addicted, that people with addictions do not, they are not the patients in our clinics anyway and all that sort of rhetoric. Of course, it has come back to bite us, bite us on the backside. Now we are in retreat.

I think it is really important, if we are going to salvage pain management, keep these medicines available to our patients that everyone in this room, and rooms like it around the country, people learning pain management and learning opioids learn enough addiction medicine to bring it to bear when necessary in the treatment paradigms so that when you have the tools in your hands and you know how to use them you do not have to be a cynic and be fearful of managing all the Larry's in the world because the population of people who now use these drugs is a very, very heterogenous population of people. Most of my work in my career has been on the pain patient side of this, although I have done an occasional study on the non-medical users. But if you want to read that literature, read the work of Carol Boyd who is over at the University of Michigan and you will understand better what is going on with all of these young people, particularly college-aged women and teenagers and kids in high schools now using these drugs in tremendous numbers to great detriment for a lot of them. And they have all kinds of different use patterns from addicted users to recreational users to people who sit around college dorms self-medicating. They sit there and they share granny's medicines that they brought to school with them for a headache or a this or a that; and because they are prescription drugs they think they are safer and they cannot get hurt by them.

Now we in the pain community, not only are we responsible for trying to figure out who our pain patient is. Are we dealing with a pain patient who has a history of addiction or substance abuse? Are we dealing with those patients in the middle who are so-called chemical copers, the kinds of patients who dabble in overuse and do not make progress towards goals and that kind of thing? Because they need a different approach than the addicted patient. Or are they likely to be an adherent patient? It is very important in all of this rhetoric to always remind the world that every study that exists so far indicates that over half of patients on opioid therapy take their medicines as prescribed. They are law-abiding citizens doing well. So we do not need an approach that makes every little 75-year-old granny pee in a cup every time she comes in, but we do need to assess everybody so that we have a strategy so that we bring these tools to bear as we need them and we decide which kind of a pain patient we are taking care of. Also be mindful of maybe granny's not the problem but does granny live with her college-aged granddaughter who might take a few Vicodin^® away to college with her or does granny have the plumber or workman coming in and out of the house that might steal them so granny may have to learn something about how to store her medicines. This has become the new paradigm, risk stratification and then addressing the level of risk in every patient and in every treatment scenario in which we meet them, because as I said the use of these agents, and you have seen this data before, exponential increases in new initiates to drug use to non-medical drug use and the focus has been prescription painkillers.

We now have to approach pain management with a different paradigm, not act as if there is no risk, not act as if the risk is in the drugs because the risk is not in the drugs. The risk is in a complex interaction between the people we treat and the medications. We need to understand the risk in each patient by using some kind of screening, formalized or not, interview or assessment tool, can be either/or. Use of a prescription monitoring program data if it exists in your state and figuring out a way to get that data and integrate it into the way you think about care. To use some form of compliance monitoring once people are started. You might want to use a questionnaire. You might want to use a family member. You might want to use a urine screen or a pill or a patch count. You might want to also educate every single person about not sharing their medicines and storing them correctly. Then we have to have highly structured approaches for the highest risk patients, perhaps people like Larry. And then perhaps early next year we are also going to have abuse deterrent formulations of sustained-release opioids that we can also add in as another layer into this risk management package. We can pick and choose and know how to use these tools as appropriate with each patient that we see.

It was not all that long ago that I was writing papers bemoaning the lack of screening tools that were normed and validated in the pain clinic. We now have, as this slide illustrates, veritable alphabet soup of these tools. There are so many of them that it is actually confusing to nurses out there which one was normed and validated on a population close to mine or in a treatment setting like mine? And if, and which one is appropriate for where I work and who I see? For those of you who do not get the journal Pain Medicine this past addition of Pain Medicine had a supplement that I wrote with Ken Kirsh and Ken and I reviewed all of the tools, and provided the data that exists on them, and a commentary about where they might fit best. It might act as a guide that you might want to take a peek at. It was a supplement, as I say, to the latest Pain Medicine journal. So you can pick and choose from one of these measures, institute it as I said before, institute it in a non-judgmental way, normalize it when you show it to your patient and try to pull for truthfulness. There are longer ones like the SOAPP, which in 1 study that I recently did that is still unpublished, actually outperformed the other measures in predicting high-level aberrant behavior like misuse and drug abuse that got people kicked out of a clinic in Tennessee. It actually outperforms that but the SOAPP may not be the right measure for your clinic. It may take too long, it may take too much scoring expertise and so on. So you have a lot of choices or you could learn how to do a more detailed psychiatric interview that might help you come to the same conclusions that you need.

One other approach that I advocate sometimes is hand the measure to the patient and carefully observe their behavior. Many of you have seen the ORT. The ORT takes 5 minutes. The patient responds historically, this was done by Lynn Webster. You add up the weights for the items that they check off, anything above 8 Lynn's initial validation study showed a 90% chance of aberrant behavior in the first 6 months of therapy for these high-risk patients. It is a very valuable tool. It takes only 30 seconds.

Are people likely to lie? Is this a transparent instrument? Yes it is. If they lie first you can try to set it up to get hope for truthfulness as I said, but if they lie one of the things that we have to also recognize is that we have a duty to do our due diligence and to document this risk stratification effort. If you put it on the chart and they lie and it is in their own handwriting it is actually a felony to mislead a doctor or a nurse to get a controlled substance. So if things go array or therapy needs to be discontinued down the road, you have it in black and white that the patient tried to mislead you.

Use your prescription monitoring program. In New York, we have a program that is in its infancy. It is not very useful. Six months after you have been prescribing, when the horse is already out of the barn, New York State in its infinite wisdom notifies you that your patient is getting drugs from 6 other providers. Ohio has the best system in the country. You enter the patient's social security number, in 15 seconds you get the data back on every controlled substance the patient has filled in the state of Ohio, Kentucky, West Virginia, and Indiana and who wrote it for them. But it is still a struggle. If you are in a busy pain clinic, not unlike some of the ones my friends run, and you have 50 to 75 people scheduled during the course of a day and they all have to get seen and you have to input all that data and make that data clinically available to the prescribers, you are talking about an hour of FTE time. So it is still a struggle even in the best case scenario.

Use urine screens. Urine screening will help you pick up 1 in 5 additional patients whose behavior will not tip you off as problematic. If you look at this study from Katz and Fanciullo, you can see that in a study where they did a surprise urine screen in their clinic the patients came in the next time they got handed the urine specimen cup and they asked them are we going to find anything in your urine today that we should not find? What do you think they said?

To a person, they said no. Every last person said no because what do people lie about in this world? Sex, money, drugs.

What I want to point out to you from this study is that they looked at the patients' behaviors and these are experts and the physicians looked at their behaviors and what they found was that some people had problematic clinical behavior and some did not. I would bring your attention to the box where it says no aberrant behaviors but had a positive urine, 1 in 5 people that had no clinically obvious misbehavior had a positive urine. It is important to do urine screening. It is important to do it randomly.

We have urine technology now that gives you a urine and gives you the results at the point of care. This is one company's product that is not important but what is important is that if you are going to use urine screens that you get the data back quickly so you can make a decision and you do not have to bounce every person with a positive urine out of your clinic. If somebody comes back with a positive urine for marijuana you might want to sit them down and talk about their behavior and what else you might do to get them to stop but you might also make the decision you can have a week's worth and I will see you next week as opposed to here is a month's worth, I will see you next month, because we have a duty to avoid diversion in our community.

You might want to employ a strategy that Nancy Wiedemer did in Philadelphia at the VA System, which I think is ingenious, I will not be able to do it justice now, but very quickly in this opioid renewal clinic that they opened up very germane to those of us who work in pain clinics because we rarely start opioids but we often see people who get in trouble on opioids. And so they come to us already problematic in primary care. What Nancy and colleagues did, Matt Gallagher did was they had a pharmacist or a nurse see the patient and the patient signed a second chance agreement, and in the second chance agreement they said we are going to see you more often, we are going to prescribe only a small amount to you at a time, we are going to monitor your behavior, and we are going to counsel you.

And just to show you what happened, 45% of people treated in this fashion got their behavior under control. So there are some simple strategies that may help turn patients around and allow them to stay and avoid becoming persona non grata in pain management.

Finally, in a very important study from Debbie Haller, 40 active substance abusers with pain -- how much pain? Lots of pain -- were put on a methadone-based program and given motivational counseling, compliance monitoring, 12-step work to do.

And these patients came into the clinic actively abusing.

At the end of 6 months everybody got titrated up on methadone. Their urine started to show methadone in 100% of the patients. There were significant drop-offs in non-prescribed opioids and trend level improvements in the abuse of illicit drugs. So it is not enough to treat pain aggressively in your dual diagnosis patients, but if you treat pain and you address their addiction you might be able to expect some decent outcomes even in some very difficult patients.

Thank you very much for your attention. And now we are going to watch a much better assessment.