Risk Management During Opioid Analgesic Prescribing for Chronic Pain

 

Erik Gunderson, M.D. 

University of Virginia School of Medicine

©AMSP 2012

                                                                    (Title Slide)

I.  Introduction

A.  Prescription opioid misuse is an epidemic (Slide 2)

            1. Major impact of chronic pain on function and cost

                        a. 20-40% U.S. adults have chronic pain1,2

                        b. Pain impacts on employment

1’ ~50% take sick day, left early or late3

2’ 1.4 mil lost workdays/yr for acute/chronic pain4

                        c. Pain impacts on health

1’ 20% of physician visits are for chronic pain4

2’ Associated with poor health and disability3

2. ↑ emphasis on pain Rx paralleled by ↑ opioid prescribing5

                        a. Mid 90's:   pain level became 5th vital sign6

                        b. Pharma marketing claimed long-acting opioids “safe”

                        c. Opioids became #1 Rx’d med category in U.S.5

                        d. Ave doses/million people/day: 7

                                    1’ USA: 40k

                                    2’ Canada: 21k

                                    3’ Europe: 5k

                                    4’ Asia: 0.2k

            3. Opioid prescribing → ↑ personal consequences  (Slide 3)

                        a. 67% ↑ Rx- related opioid use disorders 1991 to 20018

                        b. 111% ↑ ER visits for misused opioids 2004 - 20089

                        c. 400% ↑ admissions for Rx opioid use disorders 1998 - 2008 10    

            4. Physician dilemma: to manage pain must consider risk/benefit ratio  (Slide 4)

                        a. Docs concerned about: 11-12

                                    1’ Risk of opioid use disorders

                                    2’ DEA oversight

                        b. Medical house staff feel unprepared to:

                                    1’ Manage opioid Rx 13

                                    2’ Diagnose Rx related opioid use disorders in chronic pain pts 14   

            5. Most misused Rx opioids directly or indirectly from MD Rx 10   

                        a. Friend/relative (70%), 81% of whom got Rx from MD    

                        b. MD prescription (19%)      

B. This lecture covers  (Slide 5)

1. Definitions and terminology

2. Universal precautions and other risk management strategies

3. Recognition of Rx opioid misuse, abuse, dependence

4. Management of Rx opioid misuse

C. Use 3 brief cases to frame the lecture  (Slide 6)

            1.  A: Physiological dependence (tolerance& withdrawal)

a. 70 yr old woman osteoarthritis

b. Stable long-acting oxycodone (Oxycontin) use

c. ↑ function, ↓ pain

d. Self-D/C’d opi after learned of celebrity “addiction”

e. Withdrawal after opi cessation

            2.  B: Ambiguous untreated chronic pain vs. Rx misuse

                        a. 50 yr old woman kyphosis/scoliosis, low back pain

                        b. Long-acting oxycodone and oxycodone/acetaminophen (Percocet)

                        c. ↑ function, ↓ pain (5 out of 10 points = “tolerable”)

                        d. ED visits for meds

                        e. Clinic visits scheduled erratically, no continuity

            3.  C: Misuse: nonmedical use, dose escalation, early refills, ED visits

                        a. 40 yr old man, low back pain

                        b. h/o cocaine/etoh dependence (sustained full remission)
                        c. oxycodone/acetaminophen dose  ↑ over 6 mo

                        d. Early refills, ED visits

                        e. Use for “stress”                                                                                                      

II. Definitions and terminology   (Slide 7)

A. Opioids include:  opiates, semi-synthetics, synthetics, and endogenous opioids 

          1. Opiate: Natural alkaloid derivatives from the opium poppy

            a. Examples include:

1’ Morphine in all forms (e.g., MS Contin)

2’ Codeine

3’ Heroin (diacetyl morphine):

b. Detected on opiate urine drug screening (UDS)

2. Semi-synthetics

a.  Common examples:

Hydrocodone (Vicodin)

Oxycodone (Oxycontin or Percocet)

b.  UDS detection erratic

3.   Synthetics

a.  Common examples

1’ Methadone (Dolophine)

Fentanyl (Duragesic; Actiq)

b. Undetected on UDS

         4. As result of these differences: (Slide 8)

                        a.  Opiates vs. Opioids: important for understanding UDS 

                        b. Docs need order "opioid specific testing with or without quantification”

5. > > Definitions, continued: (Slide 9)

               a. Misuse

               b. Abuse

               c. Dependence

               d. Physiological Dependence

               e. Pseudoaddiction

               f. Hyperalgesia

B.  Opioid misuse:  non-medical use: (Slide 10)

1. Other than intended (e.g., sleep, anxiety, to get high)

2.  By unsanctioned route (e.g., nasal, intravenous [IV])

3. Diversion (sale, sharing)

C.  Opioid abuse vs. dependence (DSM-IV): repeated probs in same 12 months with:

            1. Opioid Abuse ≥ 1 in same 12 mo. of: (Slide 11)

           a.   Inability to fulfill role obligations

           b.   Use in physically hazardous situations 

           c.   Legal problems

           d.   Social or interpersonal problems

           Note: not meeting criteria for dependence

      2. Opioid dependence ≥ 3 in same 12 mo. of: (Slide 12)

      a. Tolerance: ↑ use for same effect; ↓ effect with same amount used

      b. Withdrawal (symptoms opposite of intoxication as discussed below)

      c.  Use larger amts/longer time than intended

      d.  Desire or unsuccessful efforts to cut down

      e.  time spent to get, use & recover

      f.  Give up important activities

      g. Ongoing use despite problems

       3.  Physiological dependence: (Slide 13)

              a. Used as a "specifier" for the Opioid Dependence dx             

             b. The specifier further characterizes the diagnosis in 2 ways:

                   1' Opioid Dependence with Physiological Dependence

                   2. Opioid Dependence without Physiological Dependence

             c. Requires physiologic adaptation with chronic opioid use

                   1’ Tolerance (criterion 1) and/or

                   2’ Withdrawal (criterion 2)

             c. Is not the same as DSM Opioid Dependence dx (i.e., 3 of 7 possible items)

             d. Neither necessary nor sufficient for DSM dependence dx

1’ Case A: ♀ with stable use opioid for her pain

          a’ Appropriate use

           b’ Physiological dependence (tolerance and withdrawal)

           c’ But not DSM dependence

2’ Case C: ♂ with early refills who used for “stress”

            a’ Uncontrolled compulsive use

            b’ May be DSM dependence even if lacks physiological dependence          

E. Opioid withdrawal  

1. Constellation of signs/symptoms with stop/↓ chronic opioids

a. DSM Criteria (3+) (Slide 14)

Dysphoric mood (sadness)

2’ Nausea or vomiting

3’ Muscle aches

4’ Tears and/or runny nose

Pupilary dilation, “goosebumps” or sweating

6’ Diarrhea

7’ Yawning

8’ Fever

9’ Insomnia

b. Non-DSM common signs/symptoms

1’ ↑ BP/pulse

2’ Flushed

3’ Muscle jerks

4’ Anxiety

5’ Tremor

6’ Fatigue

7’ Chills/hot flashes

2. Generally not life threatening, but may feel "like they want to die"

F. Pseudoaddiction: (Slide 15)

                  1. Not an official diagnosis

                  2. Not meet DSM dependence criteria

3.  Tries to get opioids for inadequately treated pain

3. Real problem is need for better Rx

4. Can mislabel as DSM dependence

5. Cause, Rx, and course not = dependence

6. Rx: give proper Rx of pain and monitor progress

       G. Hyperalgesia: ↑ pain sensitivity with chronic opioid use 15

                        1. Needs be considered in Rx chronic pain

                        2. Contributes to ↑ pain and dose escalation       

Transition Slide 16: Lecture now goes onto Universal Precautions

III. Avoiding problems using universal precautions and other risk management 16  (Slide 17)

 A. Structuring care: general goals for Rx chronic pain

1. Decrease pain

2. Improve function

3. Minimize

         a. Adverse effects of meds (e.g., over-sedation, stop breathing)

         b. Risk for misuse or opioid use disorder

4. Patient-centered but standardized care

            a. Case A: ♀ pt functioning well, low risk for drug problems, no adverse effects

                        1’ Needs low level of structure/monitoring

                        2’ Periodic re-assessment

            b. Case B: ♀ with scoliosis but unclear if adequate pain control vs. misuse

                        1’ Medium level of structure/monitoring

                        Requires longitudinal assessment

                        3’ Risk for misuse may change  so must continue to monitor

c. Case C: ♂ opioid misuse or dependence is more concerning

  Need ↑ structure/monitoring by:

        a’ ↑ visits

        b’ Urine drug testing

                        1’’ Confirm presence of Rx'd opioids

                        2’’ Rule out non-Rx'd opioid or illicit drug use

2’ Consider referral to pain specialist

      5. Core Components of Universal Precautions are detailed below (Slide 18)

                  a. Dx the pain cause

                  b. Start with conservative treatment approaches

                  c. Assess the patient's risk for misuse

                  d. Consider an opioid treatment agreement

                  e. Monitor patient adherence with the treatment plan

                  f. Document your findings                

C. Diagnosis with appropriate differential: (Slide 19)

1. Hx/PE to evaluate cause of pain

2. Review of appropriate dx tests of source of pain (e.g., MRI)

3. Seek appropriate consultations

           a. For pain source (e.g., neurology)

           b. For pain management

4. Review all prior treatments and response: (pharmacologic, non-pharmacologic)

5. Integrate and document in Assessment & Plan to justify opioid Rx

C. Begin conservative approaches to treat pain  (Slide 20)

1. Non-pharmacologic approaches

a. Physical therapy

b. Yoga 

2. Adjunctive non-opioid medications:

            a. Non steroidal anti inflammatory meds (NSAIDS) like naproxen (Aleve)

            b. Low dose antidepressants (e.g., 25 mg/day amitriptyline (Elavil))       

3. Minimally effective opioid dose to ↓ pain & ↑ function

a. Fewest number of opioid pills

b. Lowest effective strength (e.g.,oxycodone 5 prn not Oxycontin 20mg standing)

c. Teach pt that ↑ doses are associated with ↑ side effects and mortality 17

4. Time limited trial (e.g., 1 month) while assess Rx response based on: 

a. Pain level

b. Function

c. Problematic behaviors (e.g., early refill, use for stress)

d. Adverse effects (e.g., sedation) 

D. Assess ↑ risk factors for substance use problems based on:  18, 19  (Slide 21)

1. Family/personal history of substance dependence

            a. Includes alcohol, tobacco, other drugs

            b. Personal smoke a cigarette < 60min after awaken ↑ risk 18

2. Illicit substance use in the past 5 yrs

3.  Psychiatric co-morbidity (e.g., severe depression, post traumatic stress, etc.)

4. History of opioid misuse (e.g., for a high)

5. Preadolescent sexual abuse

6. Legal problems, arrests (lifetime)

E. Utilize opioid (controlled substances) treatment agreement (Slide 22)

1. Previously called pain contract

2. Goals

            a.  Sets expectations re pain control and how drugs are used

            b.  Clarifies structure of the treatment plan for pt, such as

                        1' Prohibition of non-Rx'd opioid or illicit drug use

                        2' Requirement of urine drug screening each week or month, etc.

            c.  Pt signs that has been told dangers if he/she drug doses

3. Limited data on clinical effectiveness

4. Favored by some physicians (e.g., some medical housestaff 20)

5. Potential legal liability if the MD deviates from contract 21

6. Potential negative impact on MD-Pt rapport

            a. Paternalistic  (doc =“parent”) 22

                b. Pt may feel stigma about need for opioid for chronic pain

G. Adherence monitoring strategies are detailed below (Slide 23)

      1. Urine drug screening (UDS)

      2. Online Rx monitoring programs

      3. Pill counts

      4. Corroboration

      5. Documentation

H. Urine drug screening (UDS): (Slide 24)

1. Doc must consider how wants to get and use UDS for a patient

a. Frequency: how often will they be done?

Every visit (costly and inconvenient)

2’ Periodic (e.g., 1/month)

3’ Random (may be best: no set schedule—but regularly)

Annually (if use at all—this is a minimum)

                                            5' Adjust frequency based on signs of use, stress, or any sign of problems

b. Need to monitor to be sure sample is really from patient

1’ Observed or witnessed collection of the urine sample

            a” A burden on clinic staff time

            b” Uncomfortable for patients

2’ Temperature confirmed: i.e., temp strip on cup (range 90-100 deg F)

c. Be sure choose good laboratory to test sample

Must be accurate

Must give quick feedback

d. In-office dip tests: can be performed at the point-of-care

1’ But are less accurate

Do give rapid result

2. Doc needs know what test that lab uses

            a. Opioid specific tests: confirm presence/absence of specific metabolites

              1' Morphine metabolite detected with opiate use (review Opiate definition)

              2' Oxycodone metabolite for Percocet, Oxycontin, etc

              3' Methadone (Dolophine)

              4' 6-MAM (6-monoacetyl morphine, a heroin metabolite)

              5'  Hydromorphone (Dilaudid): secondary metabolite of hydrocodone

            b. Qualitative vs. quantitative testing

              1' Qualitative→ presence/absence of metabolite only

              2' Quantitative testing →numerical concentration (e.g.,ng/ml)

 c. Case example  (Slide 25)            

                                     1’ Mid-30s woman on hydrocodone (Vicodin)

                                     2’ Opioid specific test confirms: hydrocodone + hydromorphone

                                      3’Low quantititative hydromorphone level: not Dilaudid use

                                      4’ Conclude: Findings c/w appropriate Vicodin use

H. Medication adherence can be monitored several ways

1. MD subscribe to online program called a Prescription Monitoring Program (Slide 26)

            a. Computer database supplies info for specific patient, including

                     What pills were Rx’d

  Date given

3’ Quantity: number of tablets

Where filled: pharmacy location and telephone number is listed

5’ Prescriber: MD name and practice location is listed

But is potential lag time: Rx filled last week may not be listed

Most give info for 1 state, a few with neighboring states

            b. Log-in and check in office while with patient

2. Pill counts: patient brings bottle and medications to clinic for pill counts (Slide 27)

3. Direct corroboration about use from

a. Family

b. Health care providers

c. Specific pharmacist

1’ Review last Rx fill/amt

2’ Non-opioid controlled prescriptions

I. Doc must regularly document all use and problems

      1. For lawyers, other docs, etc: If not documented, it didn't happen

2. Notes must be comprehensive

3. Documentation is required in Federal regulations

Transition Slide 28: Lecture now goes onto recognition of Rx opioid concerns

IV. Doc can recognize Rx opioid misuse, abuse, and dependence through  (Slide 29)

A. A good history

1. Ask all patients given opioids if extra doses or use for

a. Stress relief

b. To enhance energy

c. Sleep

d. Euphoria

e. Unapproved route (including chewed, crushed, nasal)

f. If 1+ true, need careful detailed search for Rx drug problems

2. Review DSM criteria for abuse and dependence

B. Physical exam re appropriate Rx  (Slide 30)

1. Evaluation for intoxication/withdrawal at each visit

a. Opioid intoxication (from DSM)

1’ Euphoria

Pupilary constriction (miosis)

3’ Drowsiness

4’ Slurred speech

5’ Impairment in attention or memory

6’ "Nodding out" head nodds up & down, pt appears half asleep/wakes up

b. Withdrawal: e.g., if run out early due to misuse, diversion

gut pain, diarrhea, runny nose, goosebumps (etc as described above)

2’ May be subtle

3. Nasal mucosa redness from intranasal use, "sniffing" or "snorting" drug

4. Skin evaluation for injection "tracks"

5. Signs of hepatic disease (e.g., hepatitis from injection drug use)

6. Cardiac murmur (injection ↑ risk endocarditis)

C. Diagnostic testing & monitoring: may ↑ recognition & prevention of misuse23  (Slide 31)

            1. Urinary drug screen

a. Rare false +

b. If positive →opportunity for discussion of:

1’ Drug use pattern

2’ Drug problems

2. Pill counts

             a. Running out early or lost meds could indicate a problem

             b. Limit early fills (e.g., annually) to establish treatment structure with patient

3. If find unsanctioned med use

a. Opportunity for open discussion of recent opioid rx

b. Chance to take steps to optimize care including

            1’ 1 MD opioid prescriber

            2’ 1 pharmacy

            3’ No unauthorized benzodiazepines

D. Behaviors suggesting an opioid use disorder 24-26

1. Less risk if Pt (Slide 32)

a. Stable med use pattern

1’ Makes regular appts

2’ Fixed dosing as recommended

b. Meds ↑ function

1’ Employment

2’ Activities of daily living (ADLs)

c. Concerned about side effects

d. Follows treatment plan (non-opioid approaches)

e. Leftover meds (e.g., of prn’s)

2. Higher risk if Pt (Slide 33)

a. Loss of control with meds

1’ Escalates dose

Takes more than Rx’d

b. ↓ function on opioids

1’ Employment

2’ ADLs

3’ Social

c. Wants meds despite adverse effects

d. Not following treatment plan (e.g, exercise, stretch, etc.)

e. No leftover meds

f. Early refills

1’ Lost scripts

2’ Emergency dept visits

f. Preoccupied with obtaining opioids

g. Request for brand name meds (higher street value if selling Rx)

E. Assessment: tying this together and documenting the thought process (Slide 34)

                  1. Often no single factor is definitive to indicate abuse or dependence

            2. Review and document factors suggesting misuse or substance use disorder

            3. The 3 Cases (Slide 35)

       a) Pt A: ↓ pain, ↑ fxn, no concerns > continue treatment

       b) Pt B: ↓ pain, ↑ fxn, some concerns > continue treatment/monitoring?

       c) Pt C: many concerns > likely management change

Transition Slide 36: Lecture now goes onto management of Rx opioid concerns

V. Management options for suspected Rx opioid misuse or use disorders (Slide 37)

1. Continue prescribing but ↑ structure

2. Stop opioids 27

a. Eval need for taper

b. Manage withdrawal if physiological dependence

3. Referral

a. Opioid pain medication dispensation clinic

Occasionally located in primary care

2’ Structured beyond a "refill" clinic (e.g., pill counts, urine testing)

b. Addiction Medicine/Addiction Psychiatry eval

c. Opioid Treatment Program

VI. Summary (Slide 38)

       1. ↑ Opioids ~ consequences

       2. Common MD dilemma

       3. Implement universal precautions

       4. Tailor Rx structure & plan

       5. Document findings

 

 

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