1. Risk Management During Opioid Analgesic Prescribing for Chronic Pain
Erik Gunderson, MD
University of Virginia, Charlottesville
© AMSP 2012

2. Chronic Pain ↑Opioid Rx since Mid 90s 20-40% prevalence
Costly & Disabling
Healthcare
Employment
General Function
↑Opioid Rx since Mid 90s
Animated 2
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3. Rx Opioid Problems Rising prescribing paralleled by:
67% ↑Rx opi use Dx (‘91-’01)
100% ↑Emergency admits (‘04-’08)
400% ↑Treatment admits (‘98-’08) 3
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4. MD Dilemma
Rx Pain
Avoid risk 4
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5. This lecture covers Definitions Universal Precautions
Recognition Rx opi problems
Management 5
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6. 3 Cases A: 70 F ↓pain, ↑fxn, stable meds
B: 50 F ↓pain, ↑fxn, extra meds
C: 45 M↑↑dose for pain & stress 6
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7. Definitions Opiate (e.g., morphine) Semi-synthetic (oxycodone)
Opioids used in Rx:
Opiate (e.g., morphine)
Semi-synthetic (oxycodone)
Synthetic (fentanyl) 7
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8. Definitions Opioids Standard UDS Opiate + Semi-synthetic +/-8
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9. Definitions, cont. Misuse Abuse Dependence Physiological dependence
Pseudoaddiction
Hyperalgesia 9

10. Misuse Reason other than intended Unsanctioned route Diversion
Non-medical use
Reason other than intended
Unsanctioned route
Diversion
Purpose:
To present the current DSM-IV-TR diagnostic criteria for alcohol dependence
Key Points:
Alcohol dependence is a maladaptive pattern of alcohol use, leading to clinically significant impairment or distress, as manifested by 3 or more of the following criteria occurring at any time in the same 12-month period:
Tolerance—a need for either increased amounts of alcohol to achieve desired effect or diminished effect from the same amount of alcohol
Withdrawal—alcohol may be taken to relieve or avoid withdrawal symptoms
Loss of control (ie, drinking larger amounts or over a longer period than was intended)
Preoccupation with controlling drinking (ie, persistent desire or unsuccessful efforts to cut down or control alcohol use)
Preoccupation with drinking activities (ie, a great deal of time spent obtaining alcohol, using it, or recovering from its effect)
Important social, occupational, or recreational activities are given up or reduced because of alcohol use
Continued use despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by alcohol
A diagnosis of alcohol dependence rules out a diagnosis of alcohol abuse
Sources: American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Text Revision (DSM-IV-TR). American Psychiatric Association: Washington, DC; 2000.
Schuckit MA. Alcohol and alcoholism. In: Harrison’s Principles of Internal Medicine. Braunwald E, Hauser SL, Fauci AS,et al, eds. New York: McGraw-Hill; 2001: 10
© AMSP 2012 10

11. Abuse 1+ criteria in 12-months: Failure to fulfill roles
Risky situations
Run-ins with law
Interpersonal problems
Purpose:
To present the current DSM-IV-TR diagnostic criteria for alcohol dependence
Key Points:
Alcohol dependence is a maladaptive pattern of alcohol use, leading to clinically significant impairment or distress, as manifested by 3 or more of the following criteria occurring at any time in the same 12-month period:
Tolerance—a need for either increased amounts of alcohol to achieve desired effect or diminished effect from the same amount of alcohol
Withdrawal—alcohol may be taken to relieve or avoid withdrawal symptoms
Loss of control (ie, drinking larger amounts or over a longer period than was intended)
Preoccupation with controlling drinking (ie, persistent desire or unsuccessful efforts to cut down or control alcohol use)
Preoccupation with drinking activities (ie, a great deal of time spent obtaining alcohol, using it, or recovering from its effect)
Important social, occupational, or recreational activities are given up or reduced because of alcohol use
Continued use despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by alcohol
A diagnosis of alcohol dependence rules out a diagnosis of alcohol abuse
Sources: American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Text Revision (DSM-IV-TR). American Psychiatric Association: Washington, DC; 2000.
Schuckit MA. Alcohol and alcoholism. In: Harrison’s Principles of Internal Medicine. Braunwald E, Hauser SL, Fauci AS,et al, eds. New York: McGraw-Hill; 2001:
Never dependent on this drug 11
© AMSP 2012 11

12. Dependence 3+ criteria in 12-months: Tolerance Withdrawal
Larger amounts
Desire/attempts to cut down
↑Time spent
Give up activities
Ongoing use despite problems
Purpose:
To present the current DSM-IV-TR diagnostic criteria for alcohol dependence
Key Points:
Alcohol dependence is a maladaptive pattern of alcohol use, leading to clinically significant impairment or distress, as manifested by 3 or more of the following criteria occurring at any time in the same 12-month period:
Tolerance—a need for either increased amounts of alcohol to achieve desired effect or diminished effect from the same amount of alcohol
Withdrawal—alcohol may be taken to relieve or avoid withdrawal symptoms
Loss of control (ie, drinking larger amounts or over a longer period than was intended)
Preoccupation with controlling drinking (ie, persistent desire or unsuccessful efforts to cut down or control alcohol use)
Preoccupation with drinking activities (ie, a great deal of time spent obtaining alcohol, using it, or recovering from its effect)
Important social, occupational, or recreational activities are given up or reduced because of alcohol use
Continued use despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by alcohol
A diagnosis of alcohol dependence rules out a diagnosis of alcohol abuse
Sources: American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Text Revision (DSM-IV-TR). American Psychiatric Association: Washington, DC; 2000.
Schuckit MA. Alcohol and alcoholism. In: Harrison’s Principles of Internal Medicine. Braunwald E, Hauser SL, Fauci AS,et al, eds. New York: McGraw-Hill; 2001: 12 12

13. Dependence 3+ criteria in 12-months: Tolerance Withdrawal
Larger amounts
Desire/attempts to cut down
↑Time spent
Give up activities
Ongoing use despite problems
Physiological Dependence
Purpose:
To present the current DSM-IV-TR diagnostic criteria for alcohol dependence
Key Points:
Alcohol dependence is a maladaptive pattern of alcohol use, leading to clinically significant impairment or distress, as manifested by 3 or more of the following criteria occurring at any time in the same 12-month period:
Tolerance—a need for either increased amounts of alcohol to achieve desired effect or diminished effect from the same amount of alcohol
Withdrawal—alcohol may be taken to relieve or avoid withdrawal symptoms
Loss of control (ie, drinking larger amounts or over a longer period than was intended)
Preoccupation with controlling drinking (ie, persistent desire or unsuccessful efforts to cut down or control alcohol use)
Preoccupation with drinking activities (ie, a great deal of time spent obtaining alcohol, using it, or recovering from its effect)
Important social, occupational, or recreational activities are given up or reduced because of alcohol use
Continued use despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by alcohol
A diagnosis of alcohol dependence rules out a diagnosis of alcohol abuse
Sources: American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Text Revision (DSM-IV-TR). American Psychiatric Association: Washington, DC; 2000.
Schuckit MA. Alcohol and alcoholism. In: Harrison’s Principles of Internal Medicine. Braunwald E, Hauser SL, Fauci AS,et al, eds. New York: McGraw-Hill; 2001: 13 13

14. Withdrawal 3+ criteria if ↓chronic opioids (DSM) Dysphoric mood
Nausea or vomiting
Muscle aches
Tears and/or runny nose
↑Pupils, “goosebumps,” sweating
Diarrhea
Yawning
Fever
Insomnia
Purpose:
To present the current DSM-IV-TR diagnostic criteria for alcohol dependence . Just to note: IV and IVTR are identical for all Dx criteria.
Key Points:
Alcohol dependence is a maladaptive pattern of alcohol use, leading to clinically significant impairment or distress, as manifested by 3 or more of the following criteria occurring at any time in the same 12-month period:
Tolerance—a need for either increased amounts of alcohol to achieve desired effect or diminished effect from the same amount of alcohol
Withdrawal—alcohol may be taken to relieve or avoid withdrawal symptoms
Loss of control (ie, drinking larger amounts or over a longer period than was intended)
Preoccupation with controlling drinking (ie, persistent desire or unsuccessful efforts to cut down or control alcohol use)
Preoccupation with drinking activities (ie, a great deal of time spent obtaining alcohol, using it, or recovering from its effect)
Important social, occupational, or recreational activities are given up or reduced because of alcohol use
Continued use despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by alcohol
A diagnosis of alcohol dependence rules out a diagnosis of alcohol abuse
Sources: American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Text Revision (DSM-IV-TR). American Psychiatric Association: Washington, DC; 2000.
Schuckit MA. Alcohol and alcoholism. In: Harrison’s Principles of Internal Medicine. Braunwald E, Hauser SL, Fauci AS,et al, eds. New York: McGraw-Hill; 2001: 14 14

15. Definitions, cont. Pseudoaddiction Not official dx Not meet DSM dx
Under treated pain
→ Drug seeking behaviors
NOTE: Hyperalgesia is the term that is here to be defined so I re-added it but with animation
Hyperalgesia: ↑ Pain sensitivity 15
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16. This lecture covers Definitions Universal Precautions
Recognition Rx opioid concerns
Management 16
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17. Universal Precautions
Goal: ↓pain, ↑fxn, ↓risk
A:↓Structure, periodic monitoring
B: Medium structure+monitoring
C: ↑Structure, referral
Considerations in cases 17
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18. Core Components Dx pain etiology Conservative Rx start Assess risk
Opioid treatment agreement
Adherence monitoring
Documentation
You might need some text in outline to cover this. 18 18

19. Dx Pain Etiology Hx/PE Review tests Seek consultation as needed
Review prior treatment/response
Document synthesis 19 19

20. Conservative Rx Initiation
Non-pharmacologic
Non-opioid meds
Minimally effective opioid Rx
Time-limited trial
Monitor + document response 20 20

21. Assess Risk Inquire about hx of: Family/personal substance Dx
Illicit substance use
Psychiatric Sx & Dx
Opioid misuse
Preadolescent sexual abuse
Legal problems 21 21

22. Opioid Rx Agreement Sets expectations Clarifies treatment structure
Limited data
Favored by some MDs
Some concerns 22
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23. Adherence Monitoring Urine Drug Screening (UDS) Rx monitoring programs
Pill counts
Corroboration
Must be documented 23
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24. Urine Drug Screening Must consider: How often
Sample collection monitoring
Laboratory vs. office testing
Opiate vs. opioid specific tests
Quantification drug/metabolites 24 24

25. Urine Drug Screening New case example: 30 F on hydrocodone (Vicodin)
Opioid specific test:
Animated
Hydrocodone + hydromorphone
What happened? 25 25

26. Prescription Monitoring Programs (PMP)
Online state registry with Rx info:
Drug name
Date
Quantity
Where filled
Prescriber
Animated
Limitation: lag time, often 1 state 26 26

27. Adherence Monitoring, cont.
Pill counts
Corroboration
Must be documented
Family
Healthcare providers
Pharmacy 27
© AMSP 2012 27

28. This lecture covers Definitions Universal Precautions
Recognition Rx opioid concerns
Management 28
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29. Recognizing Opioid Misuse
Hx: - Non-medical use
- DSM criteria
Stress relief
Energy
Sleep
Euphoria
Unapproved route 29
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30. Recognizing Opioid Misuse
PE: - Intoxication (DSM)
Euphoria
Pupils constricted
Drowsiness
Slurred speech
Attention or memory impaired
“Nodding out”
Animated
- Withdrawal if Rx out early
- Nose, skin, etc. signs 30 30

31. Recognizing Opioid Misuse
UDS/PMP/Pill Corroboration:
Rare false+
Discussion opportunity
Review Rx plan
Modify structure/monitoring 31
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32. Behavioral Factors Less Risk Stable use pattern Improved function
Concerned about side effects
Follows Rx plan
Has leftover meds 32

33. Behavioral Factors Higher Risk Loss of control ↓Function
Unconcerned adverse effects
Not follows Rx plan
Preoccupied with opioids 33 33

34. Assessment Repeatedly Document: All signs/symptoms (no 1 is key)
Review indicators of pain/function:
Stability
Concern
Emphasize misuse/ SUD 34
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35. The 3 Cases A: ↓Pain, ↑fxn, no concerns > Continue present Rx
B: ↓Pain, ↑fxn, some concerns
> Treat, but change plan?
C: Many concerns
> Management change 35 35

36. This lecture covers Definitions Universal Precautions
Recognition Rx opioid concerns
Management 36
© AMSP 2012

37. Opioid Misuse or SUD Options
Continue Rx with ↑structure
Stop opioids
Referral
Opioid refill clinic
SUD program
Pain program 37 37

38. Summary ↑Rx opioids →consequences Common MD dilemma
Implement universal precautions
Tailor Rx structure & plan
Document findings 38 38