Minimizing Misuse of Opioids in Chronic Pain

Transcription

1 Minimizing Misuse of Opioids in Chronic Pain Assessment and Monitoring Tools for Primary Care Settings October 23, 2010 Jeffrey Baxter, MD Assistant Professor, Family Medicine University of Massachusetts Medical School

2 Slide 1: Minimizing Misuse of Opioids in Chronic Pain MINIMIZING MISUSE OF OPIOIDS IN CHRONIC PAIN ASSESSMENT AND MONITORING TOOLS FOR PRIMARY CARE SETTINGS Jeffrey Baxter, MD Assistant Professor, Family Medicine University of Massachusetts Medical School October 23, 2010 [START Baxter_Tools.mp3] Baxter Tools DR. JEFFREY BAXTER: Good morning and welcome. This is quite a crowd here this morning. My name is Jeff Baxter, and I am a family physician and an addiction treatment physician. I'm on the faculty of the residency program here at the University of Massachusetts, and I'm also the Medical Director for Spectrum Health Systems Network of Methadone maintenance programs here in Central Massachusetts. To start then, I would want to just tell you why I'm here. In the last few years in the residency program I've been part of a team of people that has been trying to reengineer our pain practice within the residency practices in order to make sure that it meets treatment guidelines. I have also been part of an effort to create educational resources for primary care physicians. I'd be happy to talk to anybody about the case studies that we've created that are now part of NIDA's Center of Excellence website available to the public without charge; a number of tools that can be used to help teach residents or even teach other physicians about how to do this type of management more safely. My job today, however, is to talk to you about this practice reengineering piece, to talk about tools that can be used in ways that you can restructure your practice in order to help meet the guidelines.

3 Slide 2: Minimizing Misuse of Opioids in Chronic Pain Goal: Clinical Practice and Documentation = Practice Guidelines Universal Precautions in Pain Medicine: A Rational Approach to the Treatment of Chronic Pain Gourlay DL, Heit HA, Almahrezi A Pain Medicine 2005:6(2); Federation of State Medical Boards: Model Policy on the Use of Controlled Substances in the Treatment of Pain, Opioid Treatment Guidelines Chou R, et al. Journal of Pain, 10(2), 2009 The primary resources that we draw from when we talk about this type of clinical reengineering are these three references: The Universal Precautions paper from 2005; The Federation of State Medical Board's model policy on the use of controlled substances for the treatment of pain; and Opioid Treatment Guidelines published in These are all here for your reference.

4 Slide 3: Minimizing Misuse of Opioids in Chronic Pain Controlled Substance Policy Consistent application ( universal precautions )* Takes pressure off provider Reduces stigmatization Increases compliance with expert guidelines Standardizes practice Frequency of face to face visits Prescription refills Monitoring for benefits and harms Actions for aberrant medication taking behaviors Documentation *Gourlay DL, Heit HA. Pain Medicine 2005 What is recommended more and more is for practices to develop a controlled substances policy. The importance of this may vary depending on your practice; for example, I'm in a large community health center. We have more providers than I can count on both hands and both feet. You can see quite a variation in practice patterns. It has become very important for us to standardize this and make sure that a patient who comes in on Monday and sees provider A is going to have the same response to questions or concerns or needs in the area of controlled substances as they do if they come in on Friday and see Provider B. The benefit of that is it takes the pressure off the provider. You can say this is our policy here in the practice. It improves your ability to say that your practice is conforming to standard guidelines. I think it also gives you a chance to just educate each other and make sure that everybody is on the same page, build a better collegial working relationship.

5 Slide 4: Minimizing Misuse of Opioids in Chronic Pain Prior to the prescription of opioids for a new patient Determine diagnosis: are opioids indicated? Character of pain and functional assessment Informed consent and treatment agreement Risk assessment for misuse of opioids Screen for mood disorders/mental illness Screen for alcohol/substance misuse Screening tools, urine toxicology, RX monitoring program Treatment planning Goals and expectations Adjuvant meds and therapies Monitoring plan that matches risk profile I'd like to break this type of presentation down into two sections. This first section is what the guidelines say, what we recommend that providers should do before prescribing controlled substances. I say controlled substances because this really isn't, in many ways, only applicable to opioids, but these guidelines were written in the context of opioids for chronic pain. The steps that we're going to go over, as Dan has already mentioned are: (1) Determining the diagnosis, making sure that the diagnosis warrants opioid treatment, that patients have tried other things before you go into this higher risk treatment; (2) To do a functional assessment because how do you track the impact of your pain treatment. It's not just about decreasing pain levels. I always say to audiences that if a patient comes in and says I want you to make my pain go away, you can take enough opiate to make your pain go away, permanently. You can always make pain disappear. That's not safe, but the goal isn't just to make pain go away. It's to make a person's functioning improve. (3) To review informed consent and treatment agreement and make sure that they're signed in your record; (4) To do a risk assessment for the misuse of opioid medications; (5) To screen for mental illness; (6) Screen for alcohol misuse and substance use disorders, and I want to say specifically not just to use the screening tools, some of which I'm going to show you, but to get a urine drug screen before you prescribe. How many of you do that before you prescribe a controlled substance? Great, that's more hands than I usually see so that message is getting out. Also we'll have a great presentation about the up and coming changes in the prescription drug monitoring program, which is a tool that I've heard from my colleagues around the country where this is already functional, incredibly powerful tool to help you do a risk assessment and make sure that what you're doing is safe with patients. Finally, to do some treatment planning, review goals and expectations to make sure you've utilized adjuvant medications and adjuvant therapies to go along with your opiate therapy, and to set up a monitoring plan that matches the risk profile of your patient. We're going to talk about each of these things a little more in depth.

6 Slide 5: Minimizing Misuse of Opioids in Chronic Pain Agreements (Contracts) Rationale and risks of treatment Treatment goals Adjuvant therapies Monitoring plan Refill and other office policies Action for aberrant med taking behaviors Conditions for discontinuing opioids Fishman SM, Kreis PG. Clin J Pain 2002 Arnold RM et al. Am J of Medicine 2006 Starrels JL et al. Ann Intern Med 2010 A treatment agreement is the more PC term now for what we used to call in practice, these treatment contracts. How many of you have treatment contracts in play now in your practices? This is also very common. I think this is a message that's gotten out. People are trying to set up the foundation for their treatment in their practices. The idea is that you should talk about the rationale why you're undergoing this treatment, what the goals are. What are your expectations about adjuvant therapies? What's the monitoring plan? How do you manage this patient within the office? What should the patient expect when he or she calls in? What types of actions would you take if irregular behaviors were to arise around the prescriptions or the refills? We also recommend including a discussion of what would happen if you felt you needed to discontinue opioids. The good thing is this gets everybody on the same page. Everybody starts out with the same expectations. The bad thing is there isn't a lot of evidence to show that these make a lot of difference in terms of risk of abuse down the line, but it does give you a framework in order to interact with the patient, make sure you're all on the same page when you start out.

7 Slide 6: Minimizing Misuse of Opioids in Chronic Pain Informed Consent Side effects (short and long term) Physical dependence, tolerance Risk of drug interactions/over-sedation Risk of impairment: driving/machinery/employment Risk of abuse, addiction Legal responsibilities Disposing, sharing, selling Opioid Medication Trial If inadequate benefit, too much risk, will stop Paterick et al. Mayo Clinic Proc Most of us have gotten informed consent for procedures, for blood transfusions, for surgeries and things like that. How many of you actually get informed consent, formal informed consent, for medications that your prescribe? A few, so it's an interesting difference in the way we practice, because I think most of us who are in primary care would agree that prescribing medications is what we do most often. It's actually probably what we do that incurs the most risk to patients. What's recommended is a formal informed consent for these medications in a structure or pattern that's similar to what you would do if someone were going to have a surgery or a blood transfusion or another procedure. It's a process where you would review the side effects, the potential side effects of the medication, the risk of tolerance and physical dependence, and separate from that, the risk of addiction, the difference being; one is the expected result of taking a medication to which you have neural adaptation over a period of time; the other being the loss of control, the inability to control your use and continued use despite dangerous circumstances; to talk about drug interaction, the risk of impairment if you were to be driving or maybe taking care of others. Legal responsibilities; we include language about keeping this medication safe. It's not okay for teenagers to be able to go into medicine cabinets and take out grandma's bottle of Percocet and share it with their friends and that is what's happening. Finally, we do like to discuss that opiate medication is a trial just like any other medication that you would start. If you find that it's not working, if it's not helping you achieve the goals that you set out together to achieve, then you don't just keep going. The risks are too high to keep going with a treatment that isn't working.

8 Slide 7: Minimizing Misuse of Opioids in Chronic Pain Failure to warn What are the limits to prescriber liability? Coombes vs. Florio MA 2007 family of child killed may sue patient s doctor for failure to inform patient of risks Impact of medication not just on individual patient, but on third parties? Implications for informed consent side effects, discussion of possible impact on activities, risks to others? Documentation standards Mental capacity to give informed consent I think it's important to consider the standard now for liability. The standard was expanded somewhat; in particular, Massachusetts with this case in 2007 where a man who was on opiates, was actually a cancer patient, was on a number of sedating psychiatric medications and benzodiazepines, was behind the wheel of a car and hit and killed a child. The family sued. They did not sue the doctor; they sued for the right to sue the doctor. This is what's called third party liability. What they alleged is that the provider had not done enough to educate the patient about the risks of what could happen while he was under the influence of these medications. This is a significant expansion of what you would think about is your responsibility traditionally, which is what is the potential negative effect on the patient, him or herself, for whom you are prescribing these medications. There have been other cases afterward that have mitigated somewhat this extent, but you always have to think about, have you met the standard of potential third party liability. Have you done your job in terms of educating this patient about the potential risks so that if it were to come up, whether or not your patient was making the right decisions about what to do on the right medication, you can go back to your chart and say we have very carefully documented that we've reviewed the potential risks of being on this medication.

9 Slide 8: Minimizing Misuse of Opioids in Chronic Pain Opioid Misuse Risk Factors Young age Personal history of substance abuse Illicit, prescription, alcohol, smoking Family history of substance abuse Legal history (DUI, incarceration) Mental health problems Ives, 2006; Akbik, 2006; Webster, 2005; Michna, 2004; Reid, 2002; Compton, 1998; Chabal, 1997; Dunbar, 1996; Passik, 2006 In terms of screening for opioid misuse, the risk of opioid misuse, while taking opioids for chronic pain, there have actually been a number of studies that have shown association with certain factors and here they are in summary: (1) Younger patients; (2) Patients with a personal history of substance abuse and that goes as far as, the obvious one being someone who has a history of misuse of prescription opioids, extremely high risk of misusing them again, but also a history of other substance use problems, alcohol, even tobacco, use of tobacco which I know is not illegal has been associated with increased risk of misuse; (3) A family history of substance use problems; (4) Legal problems such as DUIs, just legal problems in general; (5) Mental health issues; in particular, some studies have shown correlations with past history of mood disorders.

10 Slide 9: Minimizing Misuse of Opioids in Chronic Pain Opioid Risk Assessment SOAPP - SF Screener & Opioid Assessment for Patients with Pain Short Form Evaluate for relative risk for developing problems (e.g. aberrant medication taking behaviors) 86% sensitive, 67% specific 0=Never, 1=Seldom, 2=Sometimes, 3=Often, 4=Very often 1. How often do you have mood swings? 2. How often do you smoke a cigarette within an hour after you wake up? 3. How often have you taken medication other than the way it was prescribed? 4. How often have you used illegal drugs (for example, marijuana, cocaine, etc) in the past 5 years? 5. How often, in your lifetime, have you had legal problems or been arrested? > 4 is POSITIVE < 4 is NEGATIVE 2008 Inflexxion, Inc. What s been developed for use in clinical practice? There are a number of tools that you can use to go through this screening process focused on these risk factors, and document in your chart that you ve done this risk assessment. This is one example. It s called a SOAP short form. You ll be happy to see this short form. The long form was near 40 questions and a bit cumbersome, so this has come out relatively recently. You can see it focuses on five things: Mood swings; cigarette smoking; taking medications other than they were prescribed; use of legal drugs and legal problems, so very consistent. It gives you a score. With this, any score greater or equal to four is considered positive. I do want you to take a look; for example in number two, how often do you smoke a cigarette within an hour after you wake up. If you answer four, very often, so for your daily smokers who have a high level of nicotine dependence, that s an automatic positive screen. It s not so hard to screen positive on one of these things. What you have to remember about that is a screen is just that, it is only a screen. If it puts someone into a higher risk category, it then requires a response, an additional assessment to see how severe or at what risk they may be.

11 Slide 10: Minimizing Misuse of Opioids in Chronic Pain This is an example, and I hope it shows up better here than it does in your handout. I was noticing a couple of my slides unfortunately didn t turn out very well. I ll just say I m happy to make any of this information available to anyone separately. I ll set up a system to make some of these things available that didn t print out well. We decided to use this because I particularly like it as a teaching and documentation tool because it has you go through with the patient each of these individual risk factors. You can see, again, the same pattern of risk factors: Family history of substance abuse; personal history of substance abuse; younger age; a history of preadolescent sexual abuse, psychiatric disease, and depression, psychiatric disease in general. Again, it gives a score putting people in risk categories so it not so much increases the likelihood, but it puts them into a different risk category requiring a risk response and evaluation, but it is helpful, again, as a documentation and teaching tool to make sure that we re covering this ground before we start people on medications.

12 Slide 11: Minimizing Misuse of Opioids in Chronic Pain Screening for Alcohol Misuse Screening for alcohol misuse, there are a number of tools available. What I have here is just an example of one of them. It s the AUDIT-C. The original audit has 10 questions, this has three. It s very manageable to include in your chart and easy to document. Again a score of greater or equal to four is sensitive for drinking above recommended levels, but this also identifies people who have more of an alcohol spectrum disorder. You start to identify people who may not meet criteria for alcohol addiction but do meet criteria for alcohol misuse.

13 Slide 12: Minimizing Misuse of Opioids in Chronic Pain Screening for Substance Abuse Disorders Using Single Questions Do you sometimes drink beer wine or other alcoholic beverages? How many times in the past year have you had 5 (4 for women) or more drinks in a day? (+ answer: > 0) How many times in the past year have you used an illegal drug or used a prescription medication for non-medical reasons? (+ answer: > 0) Smith PC J Gen Intern Med 2010; 24(7):783-8 Smith PC Arch Int Med 2010;170(13): In the spirit of primary care, trying to do more with less, less time and less resource, there has been a push to develop screening tools that have a minimal impact on your flow and get the job done really quickly. Peter Smith and the group at Boston University have been developing single question screening tools that they ve validated for use in primary care settings. You can see two examples here. The alcohol screening question, do you sometimes drink beer or wine other than alcohol? If you answer yes, how many times have you had five or more drinks in a day? Four for women, that s sensitive for identifying people who have alcohol problems. It s interesting to look at the drug question. These kinds of screening tools for drug misuse have been really challenging. There aren t a lot of effective screening tools which is why we recommend supplementing any screening question or tool that you use with a drug screen when people come in. Just by asking someone how many times in the last year they ve used an illegal drug or a prescription medication in a way that it wasn t intended is a sensitive screen for people at higher risk for drug misuse; and again, the references are here on the bottom of this slide.

14 Slide 13: Minimizing Misuse of Opioids in Chronic Pain Screening for Mental Illness PHQ 9 Other psychiatric history Mental status and competency Suicidality Careful medication history for interactions What about screening for mental illness? How many of you are using the PHQ 9 or have other standardized tools for depression screening in your primary care offices, a good number. So this has been something that through HRQ and other primary care based services, we ve been developing the capacity to screen for depression in primary care for years now. The PHQ 9 is what we re using. It s a great tool. It can be self completed or the patients can have an MA complete it with them. It s also helpful because you can actually track symptom improvement throughout treatment. Please make sure that you also consider other psychiatric histories, and not only that, but to screen for mental status and mental capacity. Make sure that if you re getting informed consent, that the patient is actually in a position to give you informed consent, that there aren t formal thought disorders or any type of impairment, maybe from drugs of abuse or other medications. I was just out in Los Angeles presenting to the Veterans Administration there. They were very clear that one of the issues they face is suicidality, so I do think it s important to document, at least a question about suicidality as you go through treatments and she ll be prescribing a medication with lethal potential. Finally, make sure you re screening medications because as Dan mentioned, any other medication that is sedating could put your patient at increased risk for overdose while taking opioids. Psychiatric medications can be quite sedated. They also have quite a few QT prolonging effects so if you re going to be using Methadone, which I do not recommend unless you know how to use it, then please consider that as well. The other thing that I m sorry I forgot to mention about Methadone, please do not use, I repeat, please do not use those conversion tables for Methadone. They have been shown over and over again to grossly overestimate the amount of Methadone once it s taken chronically that it s safe to give someone. Please do not use that. If you are going to use Methadone for pain, which I do very comfortably in my primary care practice, start with the minimum dose, no more than 10 to 20 mg per day and do not increase the dose more than once per week. Sorry, a little editorial addition out of the scope of my presentation.

15 Slide 14: Minimizing Misuse of Opioids in Chronic Pain PHQ9 Scoring: 1-4 minimal 5-9 mild moderate moderately severe severe This is just the PHQ 9 so that you do have it for reference. Most of you are probably already using it. Finally, what is the goal of all these steps? I know you re all thinking, how on earth am I supposed to accomplish all this in my primary care office? That s about four hours of work that I just put up there.

16 Slide 15: Minimizing Misuse of Opioids in Chronic Pain Adapting Care to Match Risks Setting of care primary vs. specialty care; team care Selection of Treatment Risk/benefit assessment for opioids Adjuvant meds and modalities Supply of Medications Weekly? Secured? Supervised? Supports for Recovery Sponsor, family, addiction treatment program Supervision and monitoring Pill counts, drug screens, collateral info. Savage SR 2008 How many 15 minute billable visits is that? To be honest what we ve done and it s been a learning curve for us as well, we ve developed a packet and much of that packet actually goes homes with the patient. They re expected to fill that out, so we may in fact be prescribing the informed consent and the treatment agreement are an absolute upfront as are reviewing the treatment goals, but a number of these things we accomplish on the way to starting patients are really getting them underway for good treatment. Ideally you can do it beforehand; if you can t, as soon as possible. The goal is to use this information to adapt your care to match this patient s risk profile. What do I mean by that? This is a model that said in Savage [phonetic], suggested in a paper in 2008, to discuss and think about the setting of care, whether or not your patient has an appropriate risk profile to be treated in primary care or they re high enough risk that they really shouldn t be treated in primary care, because I m saying this to you right here. There are quite a few people with chronic pain who it is not safe to treat in primary care due to their risk profiles. The selection of treatment; has the patient met the criteria? Is the potential benefit for opioids greater than the potential risk they would face by taking it? You may not choose opioids for patients. You may choose other things based on their risk profile. The supply of medications; you do not automatically have to write a 30-day supply of opioid or other controlled substances. If someone needs increased monitoring, please write them weekly prescriptions so that you see them on a frequent basis or someone sees them so they can check how they re doing with these medications. Do they need additional supports for recovery or supports for this treatment? Should they be involved in an addiction treatment program while you re doing this? Then finally, what level of supervision and monitoring are you going to have in place? We re going to talk more about that, but how often will you do drug screens? Will you have someone in place that can give you additional information? Will you ask permission to speak to a patient s spouse along the way so that you know and have outside validation of how well someone is doing with the treatment?

17 Slide 16: Minimizing Misuse of Opioids in Chronic Pain While the patient is in treatment Regularly assess the 4-A s Analgesia Activity Adverse effects Aberrant behaviors Affect? Specific strategies to detect/prevent diversion Call backs, urine drug screening (random), pill counts RX monitoring program Prescription intervals/quantities Refill policies and visit frequency Passik SD et al. Clin Ther We re going to shift gears and talk briefly about what to do when patients are in treatment. I think the easiest to remember model is the 4-A s: (1) What you want to follow during pain treatment is, is there an analgesic benefit from taking the medication; (2) The activity whether or not taking this medication has improved their functionality; (3) To monitor for adverse effects, side effects; and (4) To check for aberrant behaviors. We re going to talk about what that exactly means. Some people have suggested a fifth aid to monitor for affect. What I think they re really saying, obviously, is to make sure that you re doing some ongoing screening for changes in their mental health, to make sure things aren t worsening or their becoming unstable psychiatrically. Finally, of course, to think about your specific strategies for detecting misuse and for detecting diversion which we ll talk about.

18 Slide 17: Minimizing Misuse of Opioids in Chronic Pain Chart Tools: Monitoring Progress and Safety in Chronic Pain Cleeland Brief Pain Inventory (Keller S Clin J Pain 2004) PEG (Pain, Enjoyment, General Activity) (Krebs EE JGIM 2009) Pain Assessment and Documentation Tool (PADT) (Passik SD Clin Ther 2004) CurrentOpioid Misuse Measure (COMM) Addictive Behaviors Checklist (ABC) (Wu SM J Pain Symptom Manage. 2006) There are a number of tools available to help you do this. This is a resource slide. We ve chosen to use an adaptation of the Cleeland and the PADT. I m going to show you some of these.

19 Slide 18: Minimizing Misuse of Opioids in Chronic Pain PEG* Scale (Pain, Enjoyment, General activity) 1.What number best describes your pain on average in the past week? (No pain - Pain as bad as you can imagine) 2.What number best describes how, during the past week, pain has interfered with your enjoyment of life? (Does not interfere-completely interferes) 3.What number best describes how, during the past week, pain has interfered with your general activity? (Does not interfere Completely interferes) *Krebs EE, et al. J Gen Intern Med Examples, this is the PEG. It was published in 2009, and you can see that what it does is allow you to document quickly important aspects of the effectiveness of your pain treatment. If you think about blood pressure, if you think about diabetes, you have specific expected information that s going to be in your chart that you re going to use to track a patient s progress. You don t have that with pain treatment, so you need to create it with other tools. The PEG is one of the tools that you can use. You can see here with the underlined language, it focuses on pain level, whether or not patients are able to enjoy their lives and whether or not their activity has improved. This is one option; three questions. Patients can self complete or you can have an MA, for example, complete this on the way through the door and have it be part of your chart.

20 Slide 19: Minimizing Misuse of Opioids in Chronic Pain PADT This is one of the things that unfortunately didn t print out so well in your handout. It is, however, available on the internet. If you search this, you will find it. We liked this and adapted it slightly for our use because it covers the 4-A s very effectively; and again, we were thinking about teaching tools in addition to clinical tools. You can see it collects information about analgesia, how well someone s pain has been controlled over the previous week, their activities of daily living, whether or not important aspects of their life has been improving,

21 Slide 20: Minimizing Misuse of Opioids in Chronic Pain PADT using the medications, and then common side effects are listed; nausea, constipation, but also into the more important things, the things that could be riskier; sedation, cloudiness, confusion, make sure that we re tracking those. Finally, this list of what are called aberrant drug taking behaviors. This gave us the opportunity to document that we had screened and documented whether or not these things were going on.

22 Slide 21: Minimizing Misuse of Opioids in Chronic Pain Aberrant Medication-Taking Behavior More Likely to be Suggestive of Addiction Red Flags Deterioration in functioning at work or socially Illegal activities selling, forging, buying from nonmedical sources Injection or snorting medication Multiple episodes of lost or stolen scripts Resistance to change therapy despite adverse effects Refusal to comply with random drug screens Concurrent abuse of alcohol or illicit drugs Use of multiple physicians and pharmacies What s meant by aberrant drug taking or aberrant medication taking behaviors? It s medications that make you concerned that something s going wrong, that the patient is not safe taking the medications that suggest perhaps the patient s developing a drug use disorder, a medication use disorder. All of us know the obvious ones. Whenever we talk to groups about this, everybody comes up with the ones that are obvious and concerning. Dan likes to call these the Red Flag aberrant behaviors. Someone starts to deteriorate at home or at work. You re getting calls from spouses. You ve getting calls from work. They lose their job. Let s say you get a call from a pharmacy. They re forging a prescription. Someone tells you they re injecting or snorting their pills. They start to lose their prescription. The dog eats it. It gets flushed down the toilet. It gets flushed down the sink. We ve all heard these things. Someone comes in and you re supposed to give a drug test and they say no, I m not giving a drug test. Well, that s a positive drug test, right there; the use of other drugs and the use of multiple physicians or multiple pharmacies to get other medications.

23 Slide 22: Minimizing Misuse of Opioids in Chronic Pain Aberrant Medication-Taking Behavior Less Likely to be Suggestive of Addiction Yellow Flags Complaints about need for more medication Drug hoarding Requesting specific pain medications Openly acquiring similar medications from other providers Occasional unsanctioned dose escalation Non-adherence to other recommendations for pain therapy I think where it becomes more challenging is when we have behaviors that could indicate a problem but could also be a part of the natural history of someone s chronic pain and its treatment. Dan calls these Yellow Flags: Complaints about needing more medication or saving up medication; requesting specific medications; again, this is one of the only fields where if someone comes in and says Percocet really works for me, that s a guarantee they ll never get a prescription for Percocet from you; openly getting other meds from other providers and occasionally taking more than they re supposed to.

24 Slide 23: Minimizing Misuse of Opioids in Chronic Pain Aberrant Medication-Taking Behaviors Differential Diagnosis Inadequate analgesia Pseudoaddiction 1 Disease progression Opioid resistant pain (or pseudo-resistance) 2 Addiction Opioid analgesic tolerance 3 Self-medication of psychiatric and physical symptoms other than pain Diversion 1 Weissman DE, Haddox JD. 1989; 2 Evers GC. 1997; 3 Chang C et al 2007 The reason is that there really is a differential diagnosis for what s going on here. We d like you to keep that in mind. It could be that a patient is having more pain, that either their pain generator is less well controlled or that they have a new pain generator and need an additional evaluation. It could be that they re developing opioid resistance or increased tolerance. I ve had a few patients just openly say that they started taking the medications to medicate mood problems or stress or psychiatric problems; that is not uncommon. Fortunately for those that we identify, we ve been able to pull that back and get them back to using it just for its primary indication. You can see that whereas forging a prescription or being involved in criminal behavior might be grounds for immediately stopping someone s medication for safety, these kinds of things require a graded response and benefit from some treatment enhancement that I think Jane s going to talk about more in her presentation.

25 Slide 24: Minimizing Misuse of Opioids in Chronic Pain Monitoring: Urine Drug Tests Implementation Considerations Know limitations of test and your lab Be careful of false negatives and positives Talk with the patient If I check your urine right now will I find anything in it?? Random versus scheduled? Supervised, temperature strips, check Cr? Chain-of-custody procedures Gourlay DL, Heit HA, Caplan YH. Urine drug testing in primary care. Dispelling myths and designing strategies monograph ( Let s talk a bit about monitoring using urine drug tests. These are incredibly important tests. I hope that everybody has the capacity to do this if you re prescribing any controlled substance, that goes for benzodiazepines, even though they re scheduled three mostly, they re very highly co-abused with other medications. You need to know the limitations of your test and the limitations of your lab. Know about false positives and false negatives. Think about the logistics of this. If you re just going to do a drug test when a patient comes in for his or her scheduled appointment, we call that an intelligence test, because if they can t control what they re doing enough to know that they shouldn t use three days before they come in to your visit, then you really have a problem. We ve set up a system, fortunately now, where we have a central database of all of our patients that are getting opioids and we have a nurse who can actually call people in and expectation is that people can come in for random pill counts and random drug screens. That s been very effective, but you have to think if your office can be set up for that. How can you operationalize that? Are you going to observe the urine because you can alter urines? What quality controls will you have built in there?

26 Slide 25: Minimizing Misuse of Opioids in Chronic Pain Urine Drug Test Interpretation Positive for something other than prescribed meds False positive Substance detected is a metabolite Patient obtaining substances from elsewhere Negative for prescribed meds Incorrect test ordered Patient not taking the medication as prescribed Urine is adulterated or substituted Laboratory error UDT Interpretation Tables This is a nice slide to just consider, in general, what might happen if you get a urine drug screen. Your urine drug screen could come out positive for something other than the prescribed medicine, but please keep in mind that that doesn t necessarily mean that something s gone wrong. You could have what s called a false positive. It could be as bad as people getting something from somewhere else, but remember that this could be what s called a false positive. I ll show you some specific examples of that. It could come back negative for prescribed medicine but that could reflect a limitation of your test. That does not necessarily mean the patient is not taking the medication as prescribed. We actually had an example in our own program last week. The laboratory made an error. That could have a significant impact on somebody s treatment, so just keep in mind that a number of things could be happening.

27 Slide 26: Minimizing Misuse of Opioids in Chronic Pain 1. Manchikanti L 2008 Pain Physician 11:s155-s Gourlay DL, Heit HA, Caplan YH rth edition These are the things that showed up terribly in your handouts. I apologize because there s a lot of information. I m going to put this together on a single page handout and send it to Elana so that I can send it out for people to use as a reference if they need it. There are two types of drug tests in general that you should be aware of. The most commonly used ones are called immunoassays. They work the same as your rapid Strep test or your pregnancy test that you might use in the office. They have antibodies to metabolites on an elusion paper. They have a color indicator. You drip the urine on them and they come out either positive or negative. The advantage being that they re cheap. They re easy to use. They re CLIA waived off and you can use them in your office and you can bill for them. The disadvantage is they have cutoffs, so you have to reach a threshold level before you ll get a positive, and there s a chance of false negatives. If you don t have enough in your system, you could get a falsely negative test. There is also a chance of false positives. There s a lot of cross reactivity. The more specific test is called a GCMS or now LCMS. Liquid Chromatography is being used quite often. These are very specific. These are what people use to do comprehensive toxicology screens in the ER. They tell you everything that s there and they tell you what quantity is there. They re incredibly expensive. There s a time delay to getting them back. You can t get immediate results. You have to have a specialty lab and have someone that you can talk to, to know how to use them. Most people are using immunoassays as initial screens and GCMS or LCMS as backup when you need clarification or more information.

28 Slide 27: Minimizing Misuse of Opioids in Chronic Pain This table, which again didn t show up very well, has just some information to help support you in your practice. Cutoff levels, and then the fourth column which maybe you can see better here, is typical sources of false positives. Let s just focus here on the opiate screen. You can see that I have four medications listed there that could give you a false positive; poppy seeds being the one that maybe we ve all heard. Your patient comes in and screens positive for opiates and tells you they re eating poppy seed bagels every morning. Well, to be honest with you, it is true. You can eat enough poppy seeds to trip this test, so it s time for them to change their diet. Sesame seeds do not have any opiate in them. You can advise them to switch to sesame seed bagels. You have to keep this in mind as you re going through this test, this type of testing.

29 Slide 28: Minimizing Misuse of Opioids in Chronic Pain Finally, a really important point focused on opioids, on testing for opioids, follows up on Dan s comments about synthetic opioids versus opioids derived directly from the opium poppy. The standard opiate screen tests for morphine and things that get metabolized to morphine, so that s morphine, codeine, and heroin. Your purely synthetic opioids do not show a positive on those tests. So if you have somebody on Methadone, you send them for an opiate screen, you want to see a negative. That is the result you want. We have to keep in mind that your synthetics will never show. If you need to screen for Fentanyl or for Methadone, you have to screen for that substance specifically. The semi-synthetics really throw us off, so your Oxycodone, your Hydrocodone, things that we use quite often, because at high doses and depending on the screen you use, the technology, sometimes you can actually get a positive, but it s not reliable. So it makes interpretation difficult. If you need to screen for those substances, you should screen for them specifically. There are now immunoassays available for those tests, but just be aware, don t jump to conclusions when you get your result. Carefully step back, make sure you ve looked at the potential false positives and false negatives.

30 Slide 29: Minimizing Misuse of Opioids in Chronic Pain Pill & Patch Counts Confirm medication adherence Minimize diversion Bring pills to each visit If patient forgets pills, schedule return visit w/in a week Consider random call backs for pill counts and drug screens 28 day (rather than 30 day) supply Prevents the weekend run out Prescriber typically in clinic the same day of the week A really important thing to consider though, I ve gotten feedback from primary care providers that this type of monitoring can make us feel uncomfortable, but it s critical and for patients who are in this for the right reasons and doing well, it s actually reassuring to them to know that you think it s important enough to keep track of their prescriptions, to keep track of their medication supply, and to be able to call them in and check their pills and make sure they have the number they re supposed to have. It helps support medication adherence but it definitely minimizes diversion. A few years ago we went to a random call back count for our Buprenorphine practice and were able to operationalize that. We had a lot of feedback from the community that that made a big difference in the amount of pills that were being shared out there. The ideal is random, to set up a number of random callbacks even if it s once a year for your totally stable, low risk patients, to show that you have that system in place and reinforce the message that you are monitoring that. For your higher risk patients, it makes sense to be doing that a lot more often and to couple the pill counts, the callbacks for pill counts, with random drug screens.

31 Slide 30: Minimizing Misuse of Opioids in Chronic Pain Thank you! That s where I m going to stop in terms of office based tools. I do want to make you aware of a few things. First, that s my and you should feel free to me with any questions about the use of these tools or the drug testing information that I shared with you. I also wanted to make you aware of two additional tools and then I ll stop. You ll see on the table outside an informational paper about the Physician Clinical Support System, or PCSS. This is a great tool. It actually provides you with a one on one mentor for doing pain treatment. It s mostly focused on safety around Methadone, but its mission is expanding to include pain management with opioids. You sign up. You request a mentor. I ve been a mentor with multiple arms of that program since it existed. There s an addiction treatment one as well focused on Buprenorphine. Dan is one of the regional leaders for that program. It s really been great. People me. Some people call me with clinical questions and we help them. We provide tools. We provide a number of clinical guidances that have been published, so things to support you in trying to do this. You are not alone. The second thing is just to be aware, those of you in educational positions of the NIDA Center of Excellence. It s called the NICO CoE, which has a number of tools to help you, ready made curriculum tools, to use in your residency programs to help train people on pain and addiction issues. I ll stop there. Thank you. [Applause]