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Barriers to Opioid Monitoring in
Primary Care

Erin E. Krebs, MD, MPH
Minneapolis VA Health Care System
University of Minnesota Medical School
Disclosures
   I have no financial relationships that may pose a
    conflict of interest to disclose
   I will not discuss off-label use of drugs, biologics
    or medical devices
   My work is supported by the VA. The views in
    this presentation are mine and do not necessarily
    reflect the position or policy of the VA or the US
    government
Outline
   Background—goals and current practice
   Specific barriers
   Implications for practice
Opioid monitoring
   Ongoing assessment of benefits/harms of
    treatment and adherence to therapy
       Primary goal is patient centered – to maximize benefit,
        minimize harm for individual patient
       Secondary goal is for public health – to minimize
        potential harm to others
   Tools: regularly scheduled visits, history-taking,
    care plans, outcome measures, drug testing, pill
    counts, prescription drug monitoring programs,
    tracking/documentation of aberrant behaviors
Balancing benefits and harms



       Pain          Abuse/
       relief        addiction
Balancing benefits and harms
                      Symptoms      Dependence
         Social      Mood    Tolerance      Abuse/
         role
Pain relief Uncertain         Uncertain addiction
    Work
            benefits          risks          Injuries
                                        Hypogonadis
  Physica                               m Sleep
  l                                         disorders
  activity
                                       Pain hyper-
                                       sensitivity
Limitations of monitoring
   ―Although evidence is limited, the expert panel
    concluded that chronic opioid therapy can be an
    effective therapy for carefully selected and
    monitored patients with chronic noncancer pain.‖




    Chou et al., Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain. J
                                                                                Pain 2009;10(2):113-130
Limitations of monitoring
   ―Although evidence is limited, the expert panel
    concluded that chronic opioid therapy can be an
    effective therapy for carefully selected and
    monitored patients with chronic noncancer pain.‖
        Most evidence for benefits of opioid monitoring
         strategies is low quality or indirect




        Chou et al., Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain. J
                                                                                    Pain 2009;10(2):113-130
Limitations of monitoring
   ―Although evidence is limited, the expert panel
    concluded that chronic opioid therapy can be an
    effective therapy for carefully selected and
    monitored patients with chronic noncancer pain.‖
        Most evidence for benefits of opioid monitoring
         strategies is low quality or indirect
        Monitoring doesn’t correct for lack of careful patient
         selection
   Doesn’t address underlying deficiencies in pain
    management training and services


        Chou et al., Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain. J
                                                                                    Pain 2009;10(2):113-130
Opioid monitoring in practice
   Studies show low use of opioid monitoring
   Evidence of risk stratification is mixed
       High risk patients receive more recommended
        practices
         Urine drug testing
         Mental health visits
         Documentation of adherence assessment
       But high risk patients also receive more high risk
        practices
         Early refills
         High opioid doses
         Concurrent benzodiazepines
          Krebs EK, Pain Med 2011;12: 740–746; Morasco BJ, J Gen Intern Med 2011;26:965–71; Seal
                  KH, JAMA. 2012;307(9):940-947; Starrels JL, J Gen Intern Med 2011; 26(9):958–64
Opioid monitoring in practice
   Primary care providers rarely follow
    recommendations for monitoring of opioid
    effectiveness, harms, and adherence


                     Why?
―The biggest problem in the whole thing is lack of
  time. Typically these are complex people with
  multiple problems, and you really could spend the
  whole appointment, more than one whole
  appointment just talking about this. We have all
  these reminders that we have to do, and all the
  scripts, and they’re wanting a podiatry
  consult, and an eye consult, and you just have to
  really sit down and go through a person’s
  record, and try to make a rational decision. It’s a
  horrible time problem. But I take it very
  seriously... What if you do create an opiate
  problem for somebody?‖
Structure of primary care practice
    Short appointment times (15-20 minutes)
    Infrequent visits
    Heavy burden of non-reimbursed tasks
    Competing demands
        Complexity of visits and number of clinical tasks per
         visit increasing faster than visit duration
        Estimated time to accomplish all recommended
         preventive services: 7.4 hours/day
          One study found patients on chronic opioids received
           fewer cancer screenings


      Abbo ED, J Gen Intern Med 23(12):2058–65; Buckley DI, Ann Fam Med 2010;8:237-244. Chen MA, J
    Gen Intern Med 2010;26:58–63; Dyrbye LN, Arch Intern Med epub 2012; Yarnall KS, Am J Public Health
―For those patients that have a legitimate reason
  for wanting to take it and if I can trust them—that
  they are not selling, they’re not abusing—and
  most of these are older patients of mine, I don’t
  have them sign a contract because they never
  request early refills, they don’t go to the ER in
  between visits to get them, and so there’s no
  need for me to do periodic drug screenings and
  so forth.‖
Confidence in risk perceptions
   Many physicians do not monitor adherence when
    patients are perceived as low risk
       Commonly cited factors: older age, verifiable source of pain,
        absence of red flags, ―gestalt‖
   Research does not support this selective monitoring
       Neither patient report nor physician impression accurately
        identifies illicit substance use
       Physicians do not accurately perceive opioid misuse
       Presence of aberrant behaviors does not discriminate
        between patients with and without rx drug use disorder
   Good news : Many patients support universal
    monitoring, often based on personal experiences
    and concerns
    Fishbain DA, Clin J Pain 1999; 15:184-91; Fleming MF, J Pain, 2007;8:573-82; Melzer EC, Pain Med
                                       epub 2012; Vijayaraghavan M, J Gen Intern Med 2011;26:412–8.
―I think it’s destructive to a basic patient-doctor
   relationship. You’re there to help them and they
   can tell you their deepest, darkest secrets, but
   yet you’re policing them.‖
Negative attitudes about monitoring
   Many physicians described opioid monitoring as
    being more like policing than doctoring
       Focus on trustworthiness of patient
       Conflict with patient-centered care
   Good news: Most patients did not view opioid
    monitoring this way
       Patients viewed opioids as dangerous drugs (causing
        addiction, interacting with other substances)
       Patients wanted physicians to focus on their safety
―I usually don't have to ask them if their pain is
   under good control. Most of them will come to
   me with their concerns.‖
A quick poll
   Please take a moment to think of the last patient
    for whom you wrote an opioid renewal
    prescription…

   How confident are you the patient is
    experiencing substantial benefit that is clearly
    outweighing adverse effects?
         Highly confident
         Somewhat confident
         Not at all confident
Assumption of effectiveness
   Several patients, but no physicians, mentioned
    lack of effectiveness as a reason to discontinue
    opioids
       Discontinuations/tapers were initiated by patients
   Some patients continued opioids without benefit
       Reasons: doctor’s advice, belief they would be worse
        off without it (supported by experience with brief
        withdrawals), belief that higher dose/stronger medicine
        was needed
   Assessing benefit is harder than it sounds, but is
    the most important task of opioid monitoring
       In the absence of benefit, no risk is acceptable
Cycle of ineffective opioid use

                  Persistent
                 pain/distress




     Unmet
                                  Help-seeking
  expectations
  +/- physical
  dependence
                                   Physician
                                   response



                    Opioid
Cycle of ineffective opioid use

                  Persistent
                 pain/distress




     Unmet
                                  Help-seeking
  expectations
  +/- physical
  dependence
                                   Physician
                                   response



                    Opioid
Cycle of ineffective opioid use

                  Persistent
                 pain/distress




     Unmet
                                  Help-seeking
  expectations
  +/- physical
  dependence
                                   Physician
                                   response



                    Opioid
Cycle of ineffective opioid use

                  Persistent
                 pain/distress




     Unmet
                                  Help-seeking
  expectations
  +/- physical
  dependence
                                   Physician
                                   response



                    Opioid
Cycle of ineffective opioid use

                  Persistent
                 pain/distress




     Unmet
                                  Help-seeking
  expectations
  +/- physical
  dependence
                                   Physician
                                   response



                    Opioid
Interrupting the cycle

                  Persistent
                 pain/distress




     Unmet
                                 Help-seeking
  expectations
  +/- physical
  dependence
                                  Physician
                                  response



                    Opioid
Implications for practice
   Assumption of effectiveness
       Patients starting opioids
         See principles
       Patients on established long-term opioid therapy
         Ask about pain, invest time in listening
         Assess opioid expectations, concerns, and
          experiences
         Provide education on evolving opioid evidence
         Address readiness for change at each visit
Implications for practice
   Negative attitudes about monitoring
       Maintain focus on benefits and harms of
        medication, rather than trustworthiness of patient
       Consider broad differential diagnosis for aberrant
        behaviors
       Read and recommend:




                                    Nicolaidis C. Pain Med 2011; 12: 890–897
Implications for practice
   Confidence in risk perceptions
       Train entire care team about harms
       Educate patients about harms
       Make it easier to do the right thing (see below)
   Structure of primary care
       Develop systems
       Institute clinic and facility-level protocols
Thank you!




             erin.krebs@va.gov

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Barriers to Opioid Monitoring in Primary Care

  • 1. Barriers to Opioid Monitoring in Primary Care Erin E. Krebs, MD, MPH Minneapolis VA Health Care System University of Minnesota Medical School
  • 2. Disclosures  I have no financial relationships that may pose a conflict of interest to disclose  I will not discuss off-label use of drugs, biologics or medical devices  My work is supported by the VA. The views in this presentation are mine and do not necessarily reflect the position or policy of the VA or the US government
  • 3. Outline  Background—goals and current practice  Specific barriers  Implications for practice
  • 4. Opioid monitoring  Ongoing assessment of benefits/harms of treatment and adherence to therapy  Primary goal is patient centered – to maximize benefit, minimize harm for individual patient  Secondary goal is for public health – to minimize potential harm to others  Tools: regularly scheduled visits, history-taking, care plans, outcome measures, drug testing, pill counts, prescription drug monitoring programs, tracking/documentation of aberrant behaviors
  • 5. Balancing benefits and harms Pain Abuse/ relief addiction
  • 6. Balancing benefits and harms Symptoms Dependence Social Mood Tolerance Abuse/ role Pain relief Uncertain Uncertain addiction Work benefits risks Injuries Hypogonadis Physica m Sleep l disorders activity Pain hyper- sensitivity
  • 7. Limitations of monitoring  ―Although evidence is limited, the expert panel concluded that chronic opioid therapy can be an effective therapy for carefully selected and monitored patients with chronic noncancer pain.‖ Chou et al., Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain. J Pain 2009;10(2):113-130
  • 8. Limitations of monitoring  ―Although evidence is limited, the expert panel concluded that chronic opioid therapy can be an effective therapy for carefully selected and monitored patients with chronic noncancer pain.‖  Most evidence for benefits of opioid monitoring strategies is low quality or indirect Chou et al., Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain. J Pain 2009;10(2):113-130
  • 9. Limitations of monitoring  ―Although evidence is limited, the expert panel concluded that chronic opioid therapy can be an effective therapy for carefully selected and monitored patients with chronic noncancer pain.‖  Most evidence for benefits of opioid monitoring strategies is low quality or indirect  Monitoring doesn’t correct for lack of careful patient selection  Doesn’t address underlying deficiencies in pain management training and services Chou et al., Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain. J Pain 2009;10(2):113-130
  • 10. Opioid monitoring in practice  Studies show low use of opioid monitoring  Evidence of risk stratification is mixed  High risk patients receive more recommended practices  Urine drug testing  Mental health visits  Documentation of adherence assessment  But high risk patients also receive more high risk practices  Early refills  High opioid doses  Concurrent benzodiazepines Krebs EK, Pain Med 2011;12: 740–746; Morasco BJ, J Gen Intern Med 2011;26:965–71; Seal KH, JAMA. 2012;307(9):940-947; Starrels JL, J Gen Intern Med 2011; 26(9):958–64
  • 11. Opioid monitoring in practice  Primary care providers rarely follow recommendations for monitoring of opioid effectiveness, harms, and adherence Why?
  • 12. ―The biggest problem in the whole thing is lack of time. Typically these are complex people with multiple problems, and you really could spend the whole appointment, more than one whole appointment just talking about this. We have all these reminders that we have to do, and all the scripts, and they’re wanting a podiatry consult, and an eye consult, and you just have to really sit down and go through a person’s record, and try to make a rational decision. It’s a horrible time problem. But I take it very seriously... What if you do create an opiate problem for somebody?‖
  • 13. Structure of primary care practice  Short appointment times (15-20 minutes)  Infrequent visits  Heavy burden of non-reimbursed tasks  Competing demands  Complexity of visits and number of clinical tasks per visit increasing faster than visit duration  Estimated time to accomplish all recommended preventive services: 7.4 hours/day  One study found patients on chronic opioids received fewer cancer screenings Abbo ED, J Gen Intern Med 23(12):2058–65; Buckley DI, Ann Fam Med 2010;8:237-244. Chen MA, J Gen Intern Med 2010;26:58–63; Dyrbye LN, Arch Intern Med epub 2012; Yarnall KS, Am J Public Health
  • 14. ―For those patients that have a legitimate reason for wanting to take it and if I can trust them—that they are not selling, they’re not abusing—and most of these are older patients of mine, I don’t have them sign a contract because they never request early refills, they don’t go to the ER in between visits to get them, and so there’s no need for me to do periodic drug screenings and so forth.‖
  • 15. Confidence in risk perceptions  Many physicians do not monitor adherence when patients are perceived as low risk  Commonly cited factors: older age, verifiable source of pain, absence of red flags, ―gestalt‖  Research does not support this selective monitoring  Neither patient report nor physician impression accurately identifies illicit substance use  Physicians do not accurately perceive opioid misuse  Presence of aberrant behaviors does not discriminate between patients with and without rx drug use disorder  Good news : Many patients support universal monitoring, often based on personal experiences and concerns Fishbain DA, Clin J Pain 1999; 15:184-91; Fleming MF, J Pain, 2007;8:573-82; Melzer EC, Pain Med epub 2012; Vijayaraghavan M, J Gen Intern Med 2011;26:412–8.
  • 16. ―I think it’s destructive to a basic patient-doctor relationship. You’re there to help them and they can tell you their deepest, darkest secrets, but yet you’re policing them.‖
  • 17. Negative attitudes about monitoring  Many physicians described opioid monitoring as being more like policing than doctoring  Focus on trustworthiness of patient  Conflict with patient-centered care  Good news: Most patients did not view opioid monitoring this way  Patients viewed opioids as dangerous drugs (causing addiction, interacting with other substances)  Patients wanted physicians to focus on their safety
  • 18. ―I usually don't have to ask them if their pain is under good control. Most of them will come to me with their concerns.‖
  • 19. A quick poll  Please take a moment to think of the last patient for whom you wrote an opioid renewal prescription…  How confident are you the patient is experiencing substantial benefit that is clearly outweighing adverse effects?  Highly confident  Somewhat confident  Not at all confident
  • 20. Assumption of effectiveness  Several patients, but no physicians, mentioned lack of effectiveness as a reason to discontinue opioids  Discontinuations/tapers were initiated by patients  Some patients continued opioids without benefit  Reasons: doctor’s advice, belief they would be worse off without it (supported by experience with brief withdrawals), belief that higher dose/stronger medicine was needed  Assessing benefit is harder than it sounds, but is the most important task of opioid monitoring  In the absence of benefit, no risk is acceptable
  • 21. Cycle of ineffective opioid use Persistent pain/distress Unmet Help-seeking expectations +/- physical dependence Physician response Opioid
  • 22. Cycle of ineffective opioid use Persistent pain/distress Unmet Help-seeking expectations +/- physical dependence Physician response Opioid
  • 23. Cycle of ineffective opioid use Persistent pain/distress Unmet Help-seeking expectations +/- physical dependence Physician response Opioid
  • 24. Cycle of ineffective opioid use Persistent pain/distress Unmet Help-seeking expectations +/- physical dependence Physician response Opioid
  • 25. Cycle of ineffective opioid use Persistent pain/distress Unmet Help-seeking expectations +/- physical dependence Physician response Opioid
  • 26. Interrupting the cycle Persistent pain/distress Unmet Help-seeking expectations +/- physical dependence Physician response Opioid
  • 27. Implications for practice  Assumption of effectiveness  Patients starting opioids  See principles  Patients on established long-term opioid therapy  Ask about pain, invest time in listening  Assess opioid expectations, concerns, and experiences  Provide education on evolving opioid evidence  Address readiness for change at each visit
  • 28. Implications for practice  Negative attitudes about monitoring  Maintain focus on benefits and harms of medication, rather than trustworthiness of patient  Consider broad differential diagnosis for aberrant behaviors  Read and recommend: Nicolaidis C. Pain Med 2011; 12: 890–897
  • 29. Implications for practice  Confidence in risk perceptions  Train entire care team about harms  Educate patients about harms  Make it easier to do the right thing (see below)  Structure of primary care  Develop systems  Institute clinic and facility-level protocols
  • 30. Thank you! erin.krebs@va.gov

Editor's Notes

  1. An oversimplified view of benefits and harms that is commonly presented
  2. A more reality-based depiction of benefits and harms.
  3. This is a summary statement from the APS/AAPM guidelines. I’d like to draw attention to a couple of points:-evidence is limited. -careful pt selection. Pts with conditions that are unlikely to respond, with high risk of harm, without established longitudinal relationshipOpioid monitoring doesn’t address underlying deficiencies… Not a substitute for comprehensive pain management plan. Many frustrations with opioid prescribing may result from relying too heavily on opioids
  4. This is a summary statement from the APS/AAPM guidelines. I’d like to draw attention to a couple of points:-evidence is limited. -careful pt selection. Pts with conditions that are unlikely to respond, with high risk of harm, without established longitudinal relationshipOpioid monitoring doesn’t address underlying deficiencies… Not a substitute for comprehensive pain management plan. Many frustrations with opioid prescribing may result from relying too heavily on opioids
  5. This is a summary statement from the APS/AAPM guidelines. I’d like to draw attention to a couple of points:-evidence is limited. -careful pt selection. Pts with conditions that are unlikely to respond, with high risk of harm, without established longitudinal relationshipOpioid monitoring doesn’t address underlying deficiencies… Not a substitute for comprehensive pain management plan. Many frustrations with opioid prescribing may result from relying too heavily on opioids
  6. We know it isn’t because they are unconcerned about opioid prescribing—many surveys have shown that PCPs are concerned about opioid prescribing and often uncomfortable with it. I don’t believe it is due to lack of awareness of guidelines either—opioid monitoring is a complex task, so simple reminders, incentives, or guideline dissemination are unlikely to be effective. I’m going to focus on four key barriers to improved opioid monitoring—this isn’t a comprehensive review of all barriers, but a discussion of several I think are particularly relevant based on literature, my research, and my own experience as a primary care physician. To illustrate the barriers, I’ll present you with some physician quotes from semistructured interviews on this topic.
  7. This physician was specifically reacting to the one page model opioid agreement from VA guidelines.
  8. Singing to the choir… but these factors are not evident to many well meaning experts and policy makers.
  9. This represents a common sentiment among physicians in our interviews. Only a few disagreed—saying it was impossible to tell who would have trouble.
  10. Neither patient report nor physician impression accurately identify illicit substance use—studies comparing patient and physician report to drug testingPhysicians do not accurately perceive opioid misuse—study comparing physician impression with patient report of misuseAberrant drug related behaviors do not discriminate between patients with and without rx drug use disorder—ADRB can be associated with many factors (dysfunctional coping, social chaos, etc); PDUD can occur without ADRB
  11. This physician is talking about drug testing.
  12. We asked “how do you define a good response to opioid therapy?” A striking finding was that few actively assessed effectiveness and several stated that they assumed a lack of complaints indicated that the opioids were working. This is important considering that only a minority of patients with chronic pain can be expected have a significant clinical response to opioids while most with long term use will develop physical dependence. Many patients also had a hard time describing specific benefits of therapy.
  13. We don’t have much existing literature on this issue, so I’m going to quickly survey those of you in the audience who prescribe opioids in primary care.I’m not asking this to judge your practice, but to illustrate that assessing effectiveness of opioid therapy is harder than it sounds, even for us, in this relatively expert group. Now another question, but I won’t ask for hands. If you are not confident that benefit is outweighing risk, are you discontinuing the medication?
  14. Steady state where opioids are continued without discussion or reevaluation. Pt resigned to poor pain control, but believing she would be worse off without them and physician resigned to continuing opioids but not feeling too bad about it as long as patient isn’t requesting early refills or dose escalations.
  15. Key points to intervene are when starting opioid therapy and when monitoring response and re-evaluating therapy