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THE DILEMMA OF CHRONIC PAIN MANAGEMENT:

WHAT TO DO IF YOUR PATIENT IS NOT APPROPRIATE FOR OPIOID

THERAPY

Laura A. Hogan, MS, NP ACHPN

Senior NP Palliative Care Service

Associate Professor of Clinical Nursing

University of Rochester

OUTLINE

• Overview of the crisis of opioids

• Opioids and chronic pain: how did we get there?

• Opioid risk evaluation tools

• What about Patients with serious painful illness and need for opioids?

• Alternatives to opioid therapy

• Communication tips/strategies for goal setting with the patient around chronic pain management.

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OPIOIDS AND CHRONIC PAIN: HOW DID WE GET THERE?

• 1986 Portenoy & Foley study thought to be seminal paper to promote chronic opioid therapy*

• Retrospective observational study of 38 cancer surviors with unrelated chronic cancer pain, treated for up to 6 years with opioids

• Only 2 patients developed issues with opioid misuse

• Authors reported substance abuse rates of 1-5%

• More recent estimates 12-25%

*Portnoy, RK & Foley, KM. Chronic use of opioid analgesics in non-malignant pain: reports of 38 cases. Pain. (1986); 25:171-186

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OPIOID AND CHRONIC PAIN: HOW DID WE GET THERE?

• Pharmaceutical companies began to market to prescribers long acting opioids with assurances that addiction and abuse issue were low risks.

• More longitudital studies have demonstrated that long term opioid analgesics are not necessarily effective in improving overall function / quality of life.

• CDC did 2 intensive systematic reviews to look at chronic opioid efficacy and concluded “evidence could not be found to support long-term efficacy, “ though there was strong evidence of harm, especially at high doses.*

• *Contextual evidence review for the CDC guideline for Prescribing opioids for chronic pain-US. https://stacks.cdc.gov/view/cdc/38027. 2016

While opioids can reduce pain during short-term use, there is no good evidence that opioids improve pain or function with long-term use and “complete relief of pain is unlikely.”

Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain—United States, 2016.JAMA. 2016;315(15):1624-1645.

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HIGH DOSES = INCREASED RISK

• Intention of opioid therapy is to improve function

• However: often high dose opioids can lead to falls, fractures, accidents, social dysfunction, loss of libido, infertility, and loss of productivity.

• Additionally, risk of diversion adds to societal risk of abuse

ASSESSING RISK

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CAGE RISK ASSESSMENT

RED FLAGS FOR OPIOID THERAPY

• Risk tool assessment

• Past history of substance abuse

• Current substance abuse; concerns for diversion

• “doctor shopping”, multiple prescribers

• Multiple mishaps with medications

• Lack of participation in non opioid recommendations

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APPROACHES TO CHRONIC PAIN:

EDUCATION AND COMMUNICATION:

• Chronic pain is not an emergency : often multidimensional

• Pain score of “0” is not realistic

• Pain score often is influenced by anxiety, anger, frustration, depression

• Pain score is not only outcome measure: look at function, activity, sleep, mood , impact on self and others

• Importance of patient active participation in treatment

• Explanation to pt why therapy is not in their best interest

• Need to taper/reduce current therapy~ “what we are doing is not working”

COMMUNICATIONS TIPS FROM SMH ED

• Useful Phrases for ED Providers/Nurses

• “The emergency department will not prescribe opioids in situations where there is not a clear acute medical indication or emergency.”

• “It is a departmental policy not to prescribe opioids for chronic pain or chronic conditions without an acute change.”

• “It is unsafe for the emergency department to manage chronic conditions including chronic pain, do you need a list of doctors accepting new patients?”

• “For your safety, chronic pain or long term pain should be managed by one medical provider and medications filled at one pharmacy.”

• “If you are needing to take more than your prescribed doses of pain medications at home, you need to change your long term pain management plan with your primary medical provider. At this point, the risks outweigh the benefits of additional opioid use.”

• “I am happy you came to be evaluated so we can rule out emergencies today. If your work up does not reveal an acute issue, I will help you navigate how to complete your evaluation as an outpatient.”

•

COMMUNICATIONS TIPS FROM SMH ED

• Treatment

• “I apologize for your discomfort, would you like to know some options for pain relief other than opioids?”

• “I understand you are in pain, I can offer you several forms of analgesia that do not include opioids such as…” (Can offer, APAP/ibuprofen/ice/heat/nerve block when appropriate/positioning)

• “I know you are in pain and I understand you are not comfortable, please understand I do not want to put your health at risk by prescribing potentially addictive and life threatening medications without a clear indication.”

• “I understand that you are in a lot of pain and that you want opioids to help you feel less pain. At the same time, those types of medications aren’t safe/aren’t the right kind for the pain you have. I share your concerns about your pain and want to help you feel better. Let’s talk about some other things we can try.”

• “I hear you when you tell me that you are in pain. We want to help make your pain more manageable. Opioids are not the safest option for your pain at this time. We are going to try _______. We will reassess your pain in 30 minutes.”

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PATIENT OUTCOMES IN DOSE REDUCTION OR DISCONTINUATION OF LONG-TERM

OPIOID THERAPY : A SYSTEMATIC REVIEW

Joseph W. Frank, MD, et al. Ann Intern Med. 2017;167(3):181-191.

Conclusion: Very low quality evidence suggests that several types of interventions may be effective to reduce or discontinue LTOT and that pain, function, and quality of life may improve with opioid dose reduction

THE EFFECTIVENESS AND RISKS OF LONG-TERM OPIOID TREATMENT OF CHRONIC PAIN

EXECUTIVE SUMMARY

• US Department of Health and Human Services : Agency for Health C are Research and Quality.

https://effectivehealthcare.ahrq.gov/sites/default/files/related_files/chronic-pain-opioid-treatment_executive.pdf

MULTIDISCIPLINARY TREATMENT

• Communication with PCP, and other specialists

• PT /OT, behavioral therapy, psychiatry, addiction specialist, pharmacist

• Identify primary provider for coordination of care and oversight of prescribing

• Clear expectations of what can be provided, what to expect from the patient.

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MEDICATION OPTIONS

Peripheral nociceptive input

Central Processing

PG and Bradykinin inhibitors

PG inhibitors

Vibration

Massage

Heat

Cold

TENS

Acupuncture

Acupressure

Endorphins

Enkephalins

Opioids

Spinal cord stimulation

Analeptics

Antidepressants

Opioids

Endorphins

Anxiolytics

Biofeedback

Hypnosis

Spinal Cord Integration

MULTIMODAL APPROACH TO PAIN MANAGEMENT

Transmission Transmission

PAIN

ANALGESICS

Acetaminophen

NSAIDS

Topical formulations

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NSAIDS

•Nonspecific Cox inhibitors:• Salicylates~ aspirins • Propionic acids~ibuprofen, naproxen• Oxicams~meloxicam

•Cox-2 inhibitors:• Celecoxib• Rofecoxib ~ removed from the market 2004 d/t increased MI &

Stroke

NSAIDS: MECHANISM OF ACTION

• Decreased production of prostaglandins:inhibition of cyclooxygenasemembrane stabilizing effect

• Central and Peripheral effects

• COX-2 enzyme responsible for inflammation and pain

• COX-2 is the therapeutic target.

TOPICAL NSAIDS

• Voltaren gel- 1% diclofenac; approved for use with osteoarthritis of joints• Flector patch – 3% diclofenac; approved for tx of

sprains • Solaraze – 3% diclofenac; approved for tx of

actinic keratoses• GI SE slightly less in studies but highly variable

dependent on application• 60g tube 1% approx $25.00

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ANTIDEPRESSANTS

• Inhibit the uptake of serotonin and norepinephrine at neural junctions

• Tricylic antidepressants (TCA) most studied (amitriptyline, nortriptyline, doxepin); SSRI ; SNRI

• Most useful in the treatment of neuropathic pain, & restore sleep cycle

ANTIDEPRESSANTS

• SSRI’s less efficacious for analgesic relief of neuropathic pain (Paxil, Prozac, Zoloft)

• SNRI’s may be more effective (Effexor, Cymbalta)

• New SNRIs, Pristiq (10/08); Savella, FDA approved 9/09 - not used for depression

ANTIDEPRESSANT SE

Sedation (TCA’s); Activation (SSRI, SNRI)

Constipation

Wt gain (TCA’s); wt loss (SNRI’s)

Sexual dysfunction

Increased blood pressure (SNRI’s)

Serotonin syndrome (w/ SSRI / SNRI); do not use w/ triptans, MAO inhibitors

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DULOXETINE (CYMBALTA)

• SNRI approved for the tx of depression and diabetic neuropathy, fibromyalgia; approved for LBP 2011

• 20, 30, 60 mg tabs; depression dose 40-60/day;DPN dose 60mg QD

• Metabolized in liver

• Renal excretion 70% ; 20% feces• ½ life 12 hr

MILNACIPRAM (SAVELLA)

SNRI approved for fibromyalgia 2/09

Do NOT use w/ pts on mellaril or any MAOI (Nardil, Marplan, Parnate, Azilect)

Most common SE – palpitations, GI distress, constipation; can be more activating

12.5, 25, 50, 100mg – rec dose 50mg BID; adjust for renal impairment

ANTICONVULSANTS-INDICATIONS

Neuropathic Pain

Headaches

CRPS

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ANTICONVULSANTS

• Used in the tx of neuropathic pain syndromes Stabilizes nerve cell activity in damaged or irritated nerves.

• Older anticonvulsants widely studied, (Tegretol, Dilantin), high SE profile

• Gabapentin (Neurontin) widely used, better tolerated

• Newer meds: trileptal, zonagran, topamax, pregabalin

GABAPENTIN (NEURONTIN)

• Approved for tx of partial seizures, PHN & neuropathic pain; (100,300,400, 600, 800mg & 50mg/ml)

• Exact mechanism unknown• Excreted unchanged in urine; ½ life 5-7hr• Major SE; CNS sx- dizzy, somnolence, ataxia, fatique,

tremors, diplopia• Dose range from 300 – 3600mg/day

NEUROPATHIC MEDS

• Gabapentin ~ Approved uses:Post-herpetic neuralgia:

Seizures, partial onset (immediate release only):

• Off label uses: Alcohol dependence; Alcohol withdrawal; Brachioradial pruritus; Cough, chronic (refractory); Diabetic neuropathy; Fibromyalgia syndrome; Hiccups;Hotflashes; Neuropathic pain; Post-operative pain (adjunct); Restless legs syndrome; Social anxiety disorder; Uremic pruritus

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NEUROPATHIC MEDS

• Gabapentin -> consider renal function range: 1,800 to 3,600 mg/day in divided doses,

• Lyrica: Approved uses:

Fibromyalgia

diabetic peripheral neuropathy

Neuropathic pain associated with spinal cord injury

Postherpetic neuralgia:

Dose range 150 – 450 mg/day

PREGABALIN (LYRICA)

• Peak plasma concentration in 1.5 hr

• Oral bioavailability >90%; some decreased absorption w/ food (Tmax may be 3hr) but efficacy unchanged

• Primarily renal excretion as unchanged drug

• Mean elimination ½ life of 6.3 hrs

PREGABALIN (LYRICA) PRESCRIBING GUIDELINES

• Multiple doses available: 25, 50, 75, 100, 150, 200, 225mg

• Schedule 5 (requires DEA #)• Decreased renal dosing guidelines• Normal generally healthy adult; 75mg QHS, increase to

BID after 4 days; incremental increases to dose effect/SE• If discontinuing tx, taper over 1-2 wks

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LIDODERM PATCH 5%

• Topical patch approved for the tx of PHN

• Applied over affected area, 12hr on/ 12off

• Absorption of lidocaine gel at the peripheral site provides analgesia, inhibiting nocioceptive response

QUTENZA (8% CAPSAICIN) PATCH

• Capsaicin is an agonist for the transient receptor potential vanilloid 1 receptor, an ion channel-receptor complex on nocioceptive nerve fiber in the skin

• FDA approval 2009 for tx of severe PHN• 3 hr procedure in monitored setting• Approximate 3-6 month reduction in allodynic PHN symptom

control• High cost

MUSCLE RELAXANTS--INDICATIONS

• Myofascial pain with spasms, insomnia and anxiety

• Painful Spasms in Central Nervous system disorders

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CYCLOBENZAPRINE (FLEXERIL)

• 5 &10mg tabs; variable PRN dosing

• Renal excretion; ½ life 18hr

• Metabolized in liver; mild impairment, adjust dose; severe impairment, do no use

• Do not use in pts with: abnormal cardiac conduction or glaucoma

• Prolonged use can increase depressive sx

METAXALONE (SKELAXIN)

• Less sedating muscle relaxant- 800mg

• Typically dosed at TID PRN

• Metabolized by liver

• Should be taken on an empty stomach

• Cautious use if mild renal or hepatic impairment; avoid if mod-severe impairment

TIZANIDINE (ZANAFLEX)

• Approved for chronic spasticity

• 2 & 4mg tabs; max 36mg/day

• Monitor LFT’s at baseline, 1, 3, 6 months

• Mechanism of action: binds to central alpha2 adrenergic receptors, increasing presynpatic motor neuron inhibition

• Excretion: 60% urine, 20% feces; ½ life 2.5hr

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NON PHARMACOLOGIC MODALITIES

• Physical therapy /Occupational

• Cognitive behavior therapy

• Psychiatric evaluation/ treatment

• Accupuncture

• Yoga, massage, reiki,

USING INTEGRATIVE MEDICINE IN PAIN MANAGEMENT:

AN EVALUATION OF CURRENT EVIDENCEYUAN-CHI L IN, MD, MPH,*† L IMENG WAN, BS ,‡ AND

ROBERT N. JAMISON, PHD‡

• Overall, weak positive evidence was found for yoga, relaxation, tai chi, massage, and manipulation.

• Strong evidence for acupuncture as a complementary treatment for chronic pain that has been shown to decrease the usage of opioids was found.

• Few studies were found in which integrative medicine approaches were used to address opioid misuse and abuse among chronic pain patients.

• Additional controlled trials to address the use of integrative medicine approaches in pain management are needed. (Anesth Analg 2017;125:2081–93)

CASE#1

• 35 yr old male, construction worker, with low back pain with left radicular leg pain x 3 years currently on disability

• PMH: obesity , hernia repair age 26 yrs

• Substance use hx : DWI at age 25, no current ETOH use, smokes 1ppd

• Multiple specialists, ortho, chiropractic, physical therapy

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CASE #1

• Pain # 8-10 low back, left leg radicular pain “aching, burning, sharp” aggravating factors: movement, sitting, alleviating factors: rest, hydrocodone,

• Associated symptoms: Insomnia, Anxiety/depression/anger , 15# weight gain

• Financial concerns

• Family unrest

• Social hx: married, 3 children, wife works since pt on disability

CASE #1

• Medications:

hydrocodone with acetaminophen 10/325 up to 10 tabs / day. ( no longer prescribed due to compliance issues)

ibuprofen 400 TID

• acetaminophen 500mg BID

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CASE #1

• High risk for opioid therapy

• Maximize NSAID

• Referral for physical therapy

• TENS unit

• Neurontin 300mg TID

• Cymbalta 30mg Q daily.

PAIN CLINIC REFERRAL

• Interdisciplinary program with PT, behavioral medicine, pain specialist

• Full physical and psychosocial evaluation

• Interventions: PT, behavioral techniques: relaxation, biofeedback, trigger point injections or other interventions

• Medication adjustments

CASE #2

• 63 year old female with met. Breast cancer, with diffuse multiple bone metastasis , liver mets.

• PMH : HTN, DM2 , hx of polysubstance abuse , borderline personality

• Social Hx: divorced, lives with adult son, on disability from retail job.

• Pain: “ 7-12+ “, intense aching pain, acute on chronic, bone pain, RUQ pain r/t liver mets.

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CASE # 2

Pain Medications: MSContin 60 mg TID, Morphine IR 30 mg Q 4 hours prn,

Pain management has been problematic due to self escalation, running out too soon.

Insurance won’t refill early , and primary care provider feels that she can no longer prescribe pain medication

Referred for Pain management to palliative care clinic

CASE # 2

• High risk for opioid therapy BUT has painful, terminal illness

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CASE # 2

• Involve patient, family and other providers in developing care plan

• One prescriber, one pharmacy

• Pain management agreement / “opioid contract”

• Clear expectations what can be provided

• Urine drug screens

• Consider medication options to minimize amount of medication dispensed

• Dispense in small amounts / see pt frequently

CASE # 2

• Engage family in medication monitoring

• Use adjuvants medications

• Alternative therapies

SUMMARY

• Chronic pain is a difficult problems for many people, impacting individuals as well as society

• Impacts all aspects of quality of life

• Treatment focused on pain reduction, but also learning to control pain, via multiple modalities, not necessarily eliminating the pain

•Increase reimbursement and better access to pain management modalities

• Need for more research on chronic pain management,

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QUESTIONS