Managing Chronic Pain in the Primary Care Setting: Advancing Practice in the Post-Opioid Era 1 David J. Tauben, MD, FACP Chief, UW Division of Pain.
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4th Annual Thoughtful Approach to Chronic Pain“New Horizons, What Clearly Works”
Managing Chronic Pain in the Primary Care Setting:
Advancing Practice in the Post-Opioid Era
1
David J. Tauben, MD, FACPChief, UW Division of Pain Medicine
Hughes M & Katherine G Blake Endowed ProfessorClinical Associate Professor
Depts of Medicine and Anesthesia & Pain MedicineUniversity of Washington, Seattle WA
DISCLOSURES
CME grant support from:
ER/LA Opioid Analgesics REMS Program Companies
NIH Pain Consortium Center of Excellence in Pain Education
Off-label use of many drugs is recommended in the management of pain and so will be
discussed
2
objectives
1. Evaluate the risks and benefits of drug and non-drug treatments used for pain.
2. Discuss new standards for use of opioids in chronic non-cancer pain.
3. Discuss the emerging models of primary care based pain assessment and treatment tracking
4. Make more informed pain drug treatment decisions in the outpatient setting
3
Understanding pain
“In order to treat something, we must first learn to recognize it.” -William Osler
1. Chronic pain, a complex condition, when understood, assessed, and then treated following a structured approach, improves outcomes
2. Thorough assessment of the common biopsychosocial domains of pain adds important diagnoses also requiring treatment
Pain is NOT nociception, even if it feels that way…
“Unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage” (IASP 1979)
Nociceptors selectively respond to noxious stimulation
What we observe during exam of our patients
Response to the experience of diminishment of one’s capacity
The “Loeser Onion”
Predictors of Abnormal Pain Response
History and examination: Demonstration of “non-
anatomic” territory of pain
Depression or other preexisting mood disorder
Distressed socioeconomic status
Overall poor life coping status and satisfaction
Preexisting pain processing disorders: Like fibromyalgia Prior persistent pain
problems
Active emotional distress Particularly anxiety and
fear (of the consequences or significance of an injury.)
Prior surgical complications or failure to resolve pain after previous surgery
Van Susante J, Acta Orthop Belg. 1998.Von Korff M, Pain. 2005 Carroll LJ, Pain 2004Carragee EJ, Spine J 2005
History shapes beliefs, behaviors, & outcomes: Adverse Childhood Events (ACE)
• Recurrent physical/emotional abuse
• Contact sexual abuse• An alcohol and/or drug
abuser in the household• An incarcerated household
member• Someone who is chronically
depressed, mentally ill, institutionalized, or suicidal
• Mother is treated violently• Emotional or physical neglect
Significant Events: Robust Correlation: Depressed affect, suicide
attempts Multiple sexual partners,
sexually transmitted diseases
Smoking & alcoholism Social, emotional,
cognitive impairment Disease, disability &
social problems Chronic Pain
Anda R., www.acestudy.org
Centralized Pain Syndromes
Irritable bowel
Tension headache
Temporo-mandibular disorder
Myofascial pain syndrome
Pelvic pain
Interstitial cystitis
Yunus 2007
Pain and the Primary Care Provider• 30% of adult PCP visits/week
involve chronic pain; but,1. Scant pain education and training2. “Haven’t got time for the pain”3. Limited or no access to
multidisciplinary pain care 4. Long-term opioids has become
the “de facto” pain treatment
9
Daubresse 2010; Dosa & Teno 2010; Giordano 2009; Mezei & Murinson 2011; Schatman 2006; Von Korff 2008
Pain care sites of delivery
20-52% of chronic pain presents and is managed in the primary care setting
• 30% of adult PCP visits/week involve chronic pain
40% receive care by chiropractors 7% by acupuncturists 20% care delivered in the ED
Only 2% by Pain Physicians10
Breuer 2010; Daubresse 2010; Giordano 2009; Krueger & Stone 2008; Marcus 2009; Von Korff 2008
“The Under treatment of Pain” American Medical Association
"In the past several years, there has been growing recognition on the part of health care providers, government regulators, and the public that the under treatment of pain is a major societal problem.”
“Physicians' fears of using opioid therapy, and the fears of other health professionals, contribute to the barriers to effective pain management.”
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AMA 2004
The Allure of Opioids
1. They make patients happy, …at least
initially.2. They are very available in even the
most remote sites.3. Insurance covers them better than any
other pain treatment.4. The signed prescription closes the visit.
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TOTAL OUTPATIENT PRESCRIPTIONS OF ER OPIOIDS1991-2008
SDI, Vector One: Nationale. Extracted 12/2009
Opioid Rx Choices
SHORT-ACTING Codeine Fentanyl
lozenge/buccal Hydrocodone Hydromorphone Morphine Oxycodone Oxymorphone
ER/LA Extended release
(“ER”) Morphine Oxycodone
▪ Oxymorphone Transdermal fentanyl Transdermal
buprenorphine*
Long Acting (“LA”) Methadone Levorphanol
www.cope-rems.org
“REMS”: Risk Evaluation and Mitigation Strategies
Long or Short Acting Opioid?CONVENTIONAL WISDOM:
Long-acting for Long-term use Stable and scheduled
dosing Fewer pills Trend toward worse
outcomes: More deaths and misuse
Short-acting taken regularly Activity/function
dependent dosing Lower levels while
asleep
CURRENT APPROACH:
Best patient function Least non-compliance Lowest “Morphine
Equivalent Dose” Risk/harm reduction
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Sipress D. New Yorker 4/6/2015HOW WE MEASURE PAIN
HOW PAIN should be MEASURED
1. Pain intensity*
2. Interference with Enjoyment/Quality of Life*
3. Interference with Function*
4. Impact on Mood*
Anxiety, Depression, PTSD5. Interference with Sleep6. Treatment Risks
Medical: ie. Sleep Apnea Behavioral & Addictions
*From Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials. J of Pain 2008:9:105-121
3-item “PEG” Tool
18Krebs et al. 2009
Identifying co-occurring MOOD diagnoses
Anxiety GAD-7 (or PHQ-4) Depression
PHQ-9 (or PHQ-4) PTSD
PC-PTSD ScreenIn your life, have you ever had any experience that was so
frightening, horrible, or upsetting, that in the past month you:
1. Have had nightmares or thought about it when you did not want to?2. Tried hard not to think about it or went out of your way to avoid
situations that reminded you of it?3. Were constantly on guard, watchful, or easily startled?4. Felt numb or detached from others, activities, or your
surroundings?
PHQ-4
“When your brain is on fire I can’t help your pain…”
Non-Drug Multimodal Analgesia
• Cognitive: • Identify distressing negative cognitions and beliefs
• Behavioral approaches: • Mindfulness, relaxation, biofeedback
• Physical: • Activity coaching, graded exercise land & aquatic
with PT, class, trainer, and/or solo• Spiritual:
• Identify and seek meaningfulness and purpose of one’s life
• Education (patient and family): • Promote patient efforts aimed at increased
functional capabilities
21Argoff CE, et al. Pain Medicine 2009;10(S2):53–S66.
Health professionals involved in Pain Management
1. Medical specialties2. Nursing3. Pharmacy4. Physical therapy5. Occupational therapy6. Behavioral health7. Social work8. Chaplain9. Addiction
22
PAIN MEASUREMENT BASED STEPPED CARE
Tauben, IASP Clinical Update, 12/2012
Measure and Track:• Function• Mood• Sleep• Risks• Treatment
adherence• Opioid MED
Get inter-professional help
when need identified!
Pain intensity alone is inadequate and in chronic pain a very
poor indicator of successful treatment
Chronic Pain Treatment “Comparing” Effectiveness
Opioids: ≤ 30% Tricyclics/SNRIs: 30% Anticonvulsants: 30% Acupuncture: ≥ 10+% Cannabis: 10-30% CBT/Mindfulness: ≥ 30-50% Graded Exercise Therapy: variable Sleep restoration: ≥ 40% Hypnosis, Manipulations, Yoga: “+ effect”
Extrapolated averages of reduction in Pain Intensity
Turk, D. et al. Lancet 2011; Davies KA, et al. Rheum. 2008; Kroenke K. et al. Gen Hosp Psych. 2009; Morley S Pain 2011; Moore R, et al. Cochrane 2012; Elkins G, et al. Int J Clin Exp Hypnosis 2007.
Yet In spite of Overwhelming evidence…
Efficacy of Behavioral Management/ CBT:
Astin, et al (2002); Keefe & Caldwell (1997); Bradley (2003); Brox et al. (2003); Burns, et al (2003); Chen et al (2004); Cutler et al. (1994); McCracken & Turk (2002); McGrath & Holahan (2003); Morley et al (1999); Okifuji et al (2007); Pincus et al (2002); Roberts et al (1980);Spinhoven et al. (2004); Turner et al (2006); Vlaeyen & Morley (2005); Weydert, et al. (2003)
Efficacy of Multidisciplinary Chronic Pain Programs
Aronoff 1983; Becker et al (2000); Deschner & Polatin (2000); Feuerstein & Zostowny (1996); Flor et al (1992); Gatchel &Turk (1999); Gatchel et al (2007); Guzman et al (2001); Lande & Kulich (); Lang et al (2003); Linton et al (2005); Loeser 1991; McAllister et al (2005); Okifuji (2003); Okifuji et al (1999); Robbins et al (2003); Sanders et al (2005); Skouen et al (2002); Turk (2002) Wright & Gatchel (2002).
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“This review clearly demonstrates that CPPs offer the most efficacious and cost effective, evidence-based treatment for persons with chronic pain.”
“Unfortunately, such programs arenot being taken advantage of because of short-sighted cost-containment policies of third-party payers.”
Gatchel & Okifuji (2006)
Opioid sales, Ods, and addictions
Opioid Overdose Risk
Non-user 1-19 mg. 20-49 mg. 50-99 mg. 100+ mg.0
1
2
3
4
5
6
7
8
9
101.79%
0.68%
0.26%0.16%
0.04%
9-fold increasein risk relative
to low-dosepatients
Dunn et al., Annal Intern Med 2010
**
**
** Significant increment in risk p<0.05
Rela
tive R
isk
by Average Daily Dose of Prescribed Opioids (Morphine Equivalent Dose)
BENZOdiazepines
Lack of evidence for sustained benefits Rebound insomnia Risk of over-sedation especially when
combined with opioids Complicating development of tolerance,
dependency, and addiction.
Use of benzodiazepines for sleep & anxiety are not recommended
in chronic pain 28
29
“Bending the curve”WA State First in NATION with decline in opioid related adverse events
30Source: Jennifer Sabel PhD Epidemiologist, WA State Department of Health, April 18, 2014
METHADONE ods >> other opioids
31
Source: SAMHSA Drug Abuse Warning Network Medical Examiner Component, 2009.
Methadone
For Pain Treatment Effective analgesic Chronic Opioid Therapy Long acting Inexpensive
For Addiction Treatment Requires special DEA
licensing and treatment support
Once daily liquid dosing eases administration
Reduces mortality among heroin users
Significant accumulation with
repeat dosing
• Initial T½ 13-47 hrs up to 48-72 hrs
• 100% hepatic cleared• CYPs: 1A2, 2D6,
3A4
Inhibits its own CYP metabolism
Drug overdosesWashington State 1999-2013
33
Source: C. Banta-Green WA State Department of Health
OpioidsThe Clinical conundrum
OpioidsThe Clinical Challenge
• Not all patients with pain are suitable candidates for chronic opioid therapy (COT).
• Short-term opioid therapy has different goals and purposes and should not progress to COT without reconsideration of goals and purposes.
• Opioid dependence develops in all patients receiving COT, may have a strong psychological component, and is not always easily reversible.
• COT should be goal oriented and discontinued if goals are not met.
• There are significant safety issues that need consideration during COT.
From Ballantyne J, Rehab Clin NA. in press 2015
Opioids are part of plan, not The plan
“Avoid … primary reliance on opioid prescribing, which, when applied alone or in a non-coordinated fashion, may be inadequate to effectively address persistent pain as a disease process and, when employed as the “sole” treatment, is associated with significant societal expense and treatment failure.”
▪ ABPM Pain Medicine Position Paper, Pain Medicine 2009:987-988.
Anti-Spasm drugs
• Antispasm drugs have limited evidence for effectiveness, are predominantly sedative, and add polypharmacy to chronic pain management with little benefit.
• Carisoprodol should never be used because of no benefit and high risk.
• When true spasticity is present, as in spinal cord injury and multiple sclerosis, baclofen and tizanidine may be useful.
• Avoid abrupt withdrawal off baclofen because of the potential for severe rhabdomyolysis and fever.
37van Tulder MW et al. Cochrane Library 2008
antidepressant analgesia
Principal neurotransmitters in “descending inhibitory systems”
Multimodal benefits: PAIN, SLEEP, &
MOOD
DESCENDING INHIBITORY NOXIOUS CONTROL SYSTEMS“Gate Theory”
Ascending pain pathways
Descending pain pathways
Proposed Mechanisms of Antidepressant analgesic effect
39Verdu B. Drugs 2008
CLINICAL KEY Points
Antidepressant Analgesia
• Antidepressants that elevate synaptic norepinephrine (TCAs > SNRIs) are effective analgesics
• Sedating antidepressants are useful agents to improve both sleep initiation and maintenance
• Anticholinergic side-effects are most common with TCAs
• Nausea is common with SNRIs• Dose related QTc prolongation occurs with TCAs
>SNRIs• Warn patient and family about risks of suicidality
when any antidepressant is prescribed• Mania may be precipitated by any category of
antidepressant
40
Tricyclic Antidepressant Effectiveness:
Post Herpetic NeuralgiaNNT* 2.1-2.7
Diabetic Peripheral NeuropathyNNT 1.2-1.5
Atypical Facial PainNNT 2.8-3.4
Fibromyalgia/Central PainNNT 1.7
Saarto T, Wiffen PJ. Cochrane Database of Systematic Reviews 2007
*NNT = Number needed to treat
“Gabapentinoids” for PainPrototypic Ca++ current inhibitors
Gabapentin Pregabalin
• Well studied• Fewer side effects than
other anticonvulsants• Limited drug-drug side
effects• 100% excreted in the urine• Gabapentin absorption via
active transport; not so pregabalin
42
Side-effects:Weight GainEdemaCognitive slowingDizziness/AtaxiaTwitchingSuicidality
Pharmacodynamics (“mechanism”):Selective inhibitory effect on voltage-gated calcium channels containing the α2δ-1 subunit.
Larsen MS, et al. Res. Pharm Res. 2014
Gabapentinoids efficacy: diabetic Pn and fibromyalgia
Pregabalin600 mg: NNT 4300 mg: NNT 6
Diabetic Peripheral Neuropathy
FibromyalgiaGabapentin
1200-2400mg
Pregabalin 300-600mg
NNT
>30% improvement: 5-9
>50% improvement: 8-12
NNH: 6-14
Freeman R. et al Diabetes Care 2008 Hauser 2009
Benefit/risks of Na+ channel Anticonvulsants
Risks of ACDs• SIADH• Increased LFTs• Sedation/Weight gain• Suicidality• Neutropenia1
• Hyperammonemia2
• Rash/Stevens Johnson Syndrome3
• Metabolic acidosis4
• Glaucoma4
• Kidney stones4
Carbemazepine1 & Oxcarbazepine
Valproic Acid2
Lamotrigine3
Topiramate4
Lacosamide
Variable effectiveness in different disease states
• Carbamazepine: Trigeminal neuropathy (TN)
• Oxcarbazepine: TN, Multiple Sclerosis
• Lamotrigine: TN, HIV PN, ± Diabetic PN
• Topiramate: MigraineCummins TR et al. Pharmacology of Pain. IASP Press; 2010
Other “off-label” use of anticonvulsants in pain*
1. Headache disorders:Migraine, Chronic Daily Headaches, Tension-type
2. Visceral “hyperalgesia” syndromes:(gabapentinoids)
Chronic Pelvic Pain Chronic Abdominal Pain
3. Peri-operative hyperalgesia prevention:(gabapentinoids)
Thoracotomy, abdominal and pelvic surgeries
45
*Variable levels of quality of evidence to support use
Key Points
Anticonvulsant Drugs for Pain
• Anticonvulsant drugs with both sodium and calcium channel modulating effects are effective in a variety of neuropathic pain disorders, fibromyalgia, and headache.
• Sodium channel ACDs have a wide range of potential serious adverse drug effects, including electrolyte disorders, pancytopenias, and skin rashes, and so require routine laboratory monitoring.
• Gabapentinoids side effects are usually clinically evident: cognitive slowing, weight gain, and edema.
46
Tauben D. Phys Med Rehab Clinic NA, in press 7/2015
From Finnerup et al., 2007 and adapted from Sindrup SH, Jensen TS.1999.
Drug Class MAJOR EFFECT ON PAIN NNT1 NNH2
Tricyclic antidepressants
Inhibition NE>5-HT reuptake, blockade sodium & calcium channels and NMDA receptors
1.5-3.7
10-25
5-HT/NA Reuptake inhibitors
Inhibition 5-HT/NE reuptake 3.4-14
Lidocaine Blockade voltage-dependent sodium channels
Carbemazepine/Oxcarbazepine
Blockade voltage-dependent sodium channels 1.6-2.5
13-79
Lamotrigine Blockade voltage-dependent sodium channels/inhibits glutamate release
3.5- 8.1
Gabapentin/Pregabalin
Blockade voltage gated calcium channel 4.0- 5.6 4-30
Tramadol/Tapentadol
Opioid agonist, inhibits 5-HT/NE reuptake 2.7- 6.7 2.7- 6.7
Opioids Mu-receptor agonists, partial agonists, and antagonists
2.0- 3.2 10-663
1NNT (# needed to treat)2NNH (# needed to harm)3Dose related
Key Points:Cannabis Use for Pain• Evidence supports use in neuropathic pain conditions
• >30 published RCTs, positively supporting moderate efficacy: BUT most low quality
• Most clinical trials use combinations of mixed varieties of cannabinoids
• 50% pain reduction in multiple sclerosis patients in a good quality open label long-term one-year follow-up study
• Demonstrated risks of reduced lifetime achievement, motor vehicle accidents and addiction
• May reduce opioid requirements and lower accidental opioid overdose deaths
• Complex regulatory and legal environment
48
Koppel BS, et al. Neurology 2014Aggarwal SK. Clin J Pain 2013Volkow ND, et al. N Engl J Med. 2014
OTHer Pain Rx
• Capsaicin• Transient receptor potential vanilloid
(TRPV1) agonist • Transdermal analgesic and is available in
several low-dose products (creams, gels, and lotions).
• Menthol (in combination with methyl salicylate)
• Mechanism of effect is not fully established• Magnesium
• NMDA antagonist, calcium channel blocker, and inhibits catechol release from peripheral nerve endings.
49
Anand P et al. Br J Anesth. 2011Topp R et al. Int J Sports Phys Ther. 2011Koinig H et al. Anesth Analg. 1998
Pain Practice 12(7) 2012
…And All Pain Providers!!!
INCREASE ACCESS TO PAIN EXPERTISE
“Telemedicine”: Patient/Provider interaction “Telementoring”: Provider/Provider support
Improving Access To Pain Specialists
UW TelepainContact Information: Cara Towle RN MSN ctowle@u.washington.eduhttp://depts.washington.edu/anesth/care/pain/telepain/index.shtml
or search: uw telepain
Sessions: (Pacific time)Wednesdays noon-1:30
Thursdays7:00-8:00 am
University of Washington
PAIN PROVIDER TOOLKIT
http://depts.washington.edu/anesth/care/pain/index.shtml
Summary
Chronic pain care is NOT:
… just a 5th vital sign… to be conflated with opioids … focused on misuse and addiction
Chronic pain care is: … a chronic multisystem disease… disabling to patients, practices, and communities… complex, so requires a structured assessment
… is challenging to treat, but when managed well is enormously satisfying to patient, provider, community and health care system
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