Opioids: A Changing Standard of Care?

Erika Pierce, MMSc., PA-CElisabeth Mock, MPH, MD

Disclosures

Financial Off Label Medication Uses:

– TCAs, SSRIs, SNRIs, Cannabis, and AEDs (Antiepileptic Drugs)

Objectives

At the conclusion of the MICIS learning session, the learner will have the ability to:

1. Implement non-opioid and complimentary treatments for chronic pain

2. Utilize validated tools for chronic pain management3. Calculate morphine equivalents and compassionately

taper and discontinue opioid therapy

Materials Un-Ad Patient Brochure Tear Off Sheets Evaluation Form CME Certificate Case Study Form Additional Available: Evidence Document

Where are we going today?

Opioids:– In America/In Maine– Risks– Acute Pain– Chronic Non Cancer Pain: CNCP– Monitoring use in CNCP

Opioids in America

Opioids in MaineOpioid Pills Dispensed to MaineCare Recipients

MaineCare State of Maine State of Maine Total, 2013 Excluding MaineCare

(5,720,635)

(4,918,630)

802,006

Opioid Risks

Neuro: Sleepy, Dizzy Endocrine: Low T GI: Nausea, Vomiting, Constipation Sexual: ED Cutaneous: Itching

Opioid RisksDaily Opioid Dose Acute (0-90 days) OR (CI) Chronic (>90 days) OR (CI)

Low (1 - 36mg) 3.03 (2.32 - 3.95) 14.92 (10.38 - 21.46)

Medium (36 - 120mg) 2.80 (2.12 - 3.71) 28.69 (20.02 - 41.13)

High (>120mg) 3.10 (1.67 - 5.77) 122.45 (72.79 - 205.99)

Opioid Risks:Fracture Risk over Time

Opioid Risks: Percent of Annual Overdose Rates Increase with Dose

Opioid Risks:Protecting Against Opioid-Induced Adverse Events

Constipation Reduce doseMethylnaltrexone or naloxegolProphylactic mild peristaltic stimulant (e.g. bisacodyl or senna)If no bowel movement for 48 hours, increase dose of bowel stimulantIf no bowel movement for 72 hours, perform rectal examIf not impacted, provide additional therapy (suppository, enema, magnesium citrate, etc.)

Nausea or vomiting

If analgesia is satisfactory, decrease dose by 25%Consider prophylactic antiemetic therapyAdd or increase non-opioid pain control agents (e.g. acetaminophen)Treat based on cause

Sedation Determine whether sedation is due to the opioidEliminate nonessential CNS depressants (such as benzodiazepines)If analgesia is satisfactory, reduce dose by 10-15%Add or increase non-opioid or non-sedating adjuvant for additional pain relief (such as NSAID or acetaminophen) so the opioid can be reducedAdd stimulant in the morning (such as caffeine)Change opioid

Pruritus If analgesia is satisfactory, decrease dose by 25%Consider treatment with antihistaminesChange opioid

Hallucination or dysphoria

Evaluate underlying causeReduce doseEliminate nonessential CNS acting medications

Sexual dysfunction

Reduce doseTestosterone replacement therapy may be helpful (for men)Erection-enhancing medications (e.g., sildenafil)

Opioid Risks

Improving Safety: Prescribing Narcan (Naloxone)

Maine Law

Opioids in Acute Pain: Multimodal Approach to Severe Acute Pain

Multimodal analgesia

Non-pharmacologic

approaches

Topical agents

NSAIDsOpioids

Acetaminophen

• Short acting opioids• Limited #• Rx 30: Used 10

(Rogers et al.)

• RICE• heat/cold• electroanalgesia• relaxation training

Opioids in Chronic Non-Cancer Pain: CNCP

Non Opioid Options

Acetaminophen NSAIDs Topical Agents

– Capsaicin– Salicylates– Lidocaine– Topical NSAIDs (Effective for 2 weeks)

Non Opioid Options: Antidepressants

Agent Blocks reuptake FDA approval Trials supporting efficacy in non-FDA approved conditions

TCAs serotonin noradrenaline

Not approved for chronic pain DM neuropathyNeuropathic pain

SSRIs serotonin Not approved for chronic pain Neuropathic pain

SNRIs serotonin noradrenaline

duloxetine: DM neuropathy, OA, FMG,CLBP

None

venlafaxine: not approved forchronic pain

DM neuropathyPolyneuropathy

milnacipran: FMG None

FMG=fibromyalgia; OA=osteoarthritis; CLBP=chronic low back pain; DM=diabetic; TCA=Tricyclic anti-depressants; SSRI=selective serotonin reuptake inhibitors; SNRI=serotonin norepinephrine reuptake inhibitor

Non Opioid Options: Anticonvulsants

Agent (brand name) FDA approval Trials supportingefficacy in non-FDAapproved conditions

Druginteractions

Reduce dosein renalInsufficiency

pregabalin (Lyrica) DM neuropathyPH neuralgiaFMG

Central neuropathic pain

Few Yes

gabapentin (generics,Neurontin)

PH neuralgia DM neuropathyFMG

Few Yes

carbamazepine(generics, Tegretol,Equetro, Carbatrol)

Trigeminal neuralgia

Peripheral neuropathy

Many Yes

PH=post-herpetic; DM=diabetic; FMG=fibromyalgia

Non Opioid Options: Cannabis Limited Studies: Small & Short Term MOA: Increases Dopamine in Nucleus Accumbens May Stabilize Methadone Tx Decreases Opioid Withdrawal Symptoms Decreases the Rate of Opioid Overdose Causes: Pulm Symptoms, but no decrease in lung

function Causes: Amotivational Syndrome

Non Opioid Options cont.Potential therapeutic interventions for selected pain conditions

Condition Intervention

Neuropathies (e.g., diabetic,post-herpetic)

Antidepressants (TCAs, SNRIs)AnticonvulsantsPercutaneous electrical nerve stimulation

Osteoarthritis Exercise/strength training 117,118

Weight loss (combined with exercise)119

Tai Chi120

Electromagnetic stimulation121

Braces and insoles122

Fibromyalgia Cognitive behavioral therapy123

Exercise/strength training124

Tai Chi125

Low back pain Yoga115

Exercise/strength training126

Spinal manipulation127

Massage127

Cognitive behavioral therapy128

Trigeminal neuralgia Anticonvulsants129

Rheumatoid arthritis Disease-modifying antirheumatic medication130

Polymyalgia rheumatica Corticosteroid medications131

Migraine Abortive and prophylactic therapies (e.g., triptans)3

Opioids: Long acting and Immediate release opioids

Long acting opioids Immediate release opioidsBuprenorphine patch (Butrans) Codeine (generics)

Fentanyl patch (Duragesic) Fentanyl – transmucosal (Abstral, Actiq, Fentora, Lazanda, Onsolis, Subsys)

Hydrocodone (Zohydro ER) Hydrocodone+acetaminophen (generics, Norco, Vicodin, Xodol)

Hydromorphone ER (generics, Exalgo) Hydromorphone (generics, Dilaudid)

Methadone (generics, Dolophine, Methadose) Levorphanol (generics)

Morphine ER (generics, Avinza, Kadian, MS Contin) Meperidine (generics, Demerol, Meperitab)

Oxycodone (Oxycontin) Morphine (generics)

Oxymorphone ER (generics, Opana ER) Oxycodone (generics, Roxicodone)

Tapentadol (Nucynta ER) Oxymorphone (generics, Opana)Tramadol ER (generics, ConZip, Ultram ER) Tapentadol (Nucynta)

Tramadol (generics, Ultram)

OpioidsAbuse Deterrent Formulations

Targiniq ER: Oxycodone & Naloxone Embeda ER: Morphine & Naltrexone

OpioidsPatient Selection and Risk Stratification

Complete and Document H&P Acquire Appropriate tests Consider in Limited Circumstances

– Pain is Severe and Refractory to Treatment– Pain Adversely Impacts Function or Quality of Life– Potential Benefits outweigh Potential Risks

OpioidsMultidimensional Pain Assessment Tools

Initial Pain Assessment Tool Brief Pain Inventory McGill Pain Questionnaire Avoid: Scale of Faces or Numerical Scores 1 to 10

OpioidsPsychosocial Evaluation

Includes PHQ9 & GAD7 Baseline level of Function Impact Pain has on relationships, Sexual Activity and

Recreation

OpioidsAssess Risk of Opioid Dependence or Abuse

“Universal Precautions” Approach: Same Screenings for All Patients

Or Tools for Patient Assessment:Tool Who Administers? LengthDiagnosis, Intractability, Risk, Efficacy (DIRE)

Clinician 7 items

Opioid Risk Tool (ORT) Clinician or patient self-report

5 yes/no questions

Screener and Opioid Assessment for Patients with Pain, Version 1 and Revised (SOAPP, and SOAPP-R)

Patient self-report 24 items

OpioidsFunction Based Opioid Management Plans Written at 6th Grade level or lower Use Functional Goals Rather than Pain Scales Rationale (what you are treating and why)

Risks of the drug (side effects as well as risk of dependence, tolerance, addiction, misuse, and overdose; and risk of driving, working, etc., under the influence of the drug)Treatment goals (pain level, function level)

Monitoring plan (how often to return for follow up)

Refill policy

Action plan for suspected aberrant behavior (may include urine drug screens to ensure the patient is not diverting the medication)Conditions for discontinuing opioids (lack of efficacy, pain resolution, aberrant behavior)

OpioidsInformed Consent

Patient Understands Options for Treatment Informed of Potential Benefits and Risks Patient is free from Coercion Has Capacity to Communicate Preferences Query the Prescription Monitoring Program and

Health InfoNet

The Evidence for Prescribing Opioids in Chronic Non-Cancer

Pain: CNCP

Opioids Decrease Pain and Increase Function

However: Trial Duration is Short: < 6 Months Relevance to Chronic Opioid Treatment is

questionable Opioids Discontinuation Rate: > 30%

Little Evidence Supports Long Term Opioids

1. Provide clinically Significant Pain Relief2. Improvement of Quality of Life or Function3. Dosing or type is more effective than others

Agency for Healthcare Research and Quality (AHRQ)

No Studies to Address: Efficacy of Long Term Opioids vs Non Opioids

on Outcomes Efficacy of Opioids + Non Opioids vs Opioids or

Non Opioids alone Does not Support Use of Opioids in Chronic Pain

Initiating Opioids

Initiating Opioids

Other Treatments explored Physical and Psychosocial Condition Assessed Level of Opioid Tolerance Estimated Informed Consent Acquired Written Management Plan is Signed PMP is Queried

Initiating Opioids (continued)

No one opioid is better in any given patient Long Acting Opioids Reserved for Patients

Who:1. Cannot Manage PRN Medications2. Are Opioid Dependent

Continuing Opioids

Progress toward Functional Goals Presence and Nature of Adverse Events Change in Pain Condition Change in Medical or Psych Co morbidities Degree of Opioid Tolerance ID Aberrant Behaviors, Misuse or Diversion

Continuing Opioids (continued)Resources for patients with substance abuse:

Substance abuse treatment in your office:Screening, Brief Intervention, and Referral to Treatment (SBIRT)Materials and training available at: beta.samhsa.gov/sbirt

SAMHSA’s Behavioral Health Treatment Locatorfindtreatment.samhsa.govHelpline at 1-800-662-HELP (1-800-662-4357)

Framework for Managing Chronic Pain

Dose Escalation Not Proven to: Decrease Pain or

Increase Function Can Increase Risk

– 120 mg Morphine Equivalents Daily

!

Addressing Concerns about Rx Activity

Discuss Concern with Patient Clarify Expectations Increase Intensity of Monitoring

Persistent Problems Taper Opioid

Refer to Pain or Addiction Specialist

Questions?