edward capparelli, m.d., f.a.a.f.p. october 3, 2019 · 2020. 5. 15. · clinical practice...

52
2019 Annual Conference Clinical and Care Innovations Track MANAGING CHRONIC PAIN AND THE OPIOID EPIDEMIC Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 CREDENTIALS AND DISCLOSURES I have worked with community health centers in east Tennessee since 1993: Rural Medical Services in Cocke County 1993‐2007; Morgan County Medical Center in Morgan County 2007‐2009; and Mountain Peoples Health Councils in Scott County 2009 to present. I have also worked as physician for Morgan, Anderson, and Scott County jails for over 10 years. I have been a member of the TennCare Pharmacy Advisory Committee since it started and am currently chairman. I have no financial connections with any products or services discussed in this presentation.

Upload: others

Post on 24-Feb-2021

2 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

MANAGING CHRONIC PAIN AND THE OPIOID EPIDEMIC

Edward Capparelli, M.D., F.A.A.F.P.

October  3, 2019

CREDENTIALS    AND

DISCLOSURES

• I have worked with community health centers in east Tennessee since 1993: Rural Medical Services in CockeCounty 1993‐2007; Morgan County Medical Center in Morgan County 2007‐2009; and Mountain Peoples Health Councils in Scott County 2009 to present. I have also worked as physician for Morgan, Anderson, and Scott County jails for over 10 years. I have been a member of the TennCare Pharmacy Advisory Committee since it started and am currently chairman.

• I have no financial connections with any products or services discussed in this presentation.

Page 2: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

OBJECTIVES

1. Describe the history of opioid use leading to our current opioid epidemic

2. Discuss Tennessee and federal guidelines to limit opioid misuse

3. Discuss non‐opioid options for management of chronic pain

4. Discuss safe and effective use of opioids for chronic pain

5. Discuss medication‐assisted treatment options

6. Discuss opioid misuse and drug overdose deaths 

AT THE END OF THIS TALK, I HOPE THAT  YOU WILL BE

Comfortable prescribing opioids if indicated and appropriate.

Unafraid to say no to opioids if not indicated or not appropriate.

Be knowledgeable about alternative treatments for chronic pain.

Page 3: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

FALLACYThe risk of addiction is low when opioids are prescribed for chronic 

pain.

Page 4: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

ADDICTION RARE IN PATIENTS  

TREATED WITH NARCOTICS

Jane Porter and Hershel Jick, MD, 

NEJM 302:1281980 

To the Editor: “Recently, we examined our current files to determine the incidence of narcotic addiction in 39,946 hospitalized medical patients who were monitored consecutively. Although there were 11,882 patients who received at least one narcotic preparation, there were only four cases of reasonably well documented addiction in patients who had no history of addiction. The addiction was considered major in only one instance. The drugs implicated were meperidine in two patients, 

Percodan in one, and hydromorphone in one. We conclude that despite widespread use of narcotic drugs in hospitals, the development of addiction is rare in medical patients with no history of addiction.”

OPIOID PRESCRIBING 1970s‐20081970s Morphine predominantly used for cancer or hospice

1980. Porter & Jick Letter to Editor

1990s Pharmaceutical Industry use of  misleading strategies to market long‐acting opioids

2001. Pain as Fifth Vital Sign. Joint Commission

2002. Patient Satisfaction Surveys

2002. Pain Assessment Tool (1‐10)

2000s Increasing use of opioids for chronic non‐cancer pain

2006‐2012: 76 billion hydrocodone & oxycodone pills dispensed in U.S.

2008. Drug overdose became leading cause of accidental death in U.S.

Page 5: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

OPIOID PRESCRIBING 2010 to date2010.  International Narcotics Control Board‐U.S. with 5% of world’s population used 99% of world’s Hydrocodone

2010.  Increasing numbers of opioid overdose fatalities

2010s Decade of increasing restrictions on opioid use

2012.  First Tennessee Chronic Pain Guidelines

2016.  CNBC reports U.S. consumes 80% of world’s opioid production

2016.  C.D.C. Chronic Pain Guidelines

2017.  Fewer opioids dispensed, but overdose deaths continued to rise

2018.  Tennessee Together Law for Acute Pain Management

2019.  Multiple lawsuits filed against opioid manufacturers &  distributors

OPIOID USE 2012

Page 6: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

TENNESSEE CHRONIC PAIN GUIDELINES 2012

Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain.

For primary care providers, patients with daily MME (Morphine Mg. Equivalents) above 120 should be referred to a pain specialist for consultation or management.

These guidelines are not meant to dictate medical decision making. They are guidelines of generally accepted medical practice rather than absolutes. Providers still have flexibility to deal with exceptional cases.•

NATIONAL INSTITUTE OF HEALTH 2014   

There is a subset of patients for whom opioids are an effective treatment method for their chronic pain. Limiting or denying access to opioids for these patients can be harmful.

Avoid disruptive and potentially harmful changes in patients CURRENTLY BENEFITING from this treatment.

The approach should be individualized, based on a comprehensive clinical assessment that is conducted with dignity and respect and without value judgements or stigmatization of the patient.

Triage those screening at highest risk for harm to more structured and higher intensity monitoring approaches.

Page 7: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

DRUG OVERDOSE IS THE LEADING CAUSE OF ACCIDENTAL DEATH IN THE UNITED STATES

Page 8: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

OPIOIDS PRESCRIBED PER PERSON 2015

C.D.C. CHRONIC PAIN      GUIDELINES      2016

Intended for primary care physicians who are treating patients with chronic pain (>3 months) in outpatient settings.

Intended for patients 18 years of age or older with chronic pain who are not in active cancer treatment, palliative care, or end of life.

These are RECOMMENDATIONS not prescriptive standards.

CLINICIANS SHOULD CONSIDER THE CIRCUMSTANCES AND UNIQUE NEEDS OF EACH PATIENT WHEN PROVIDING CARE.

Page 9: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

C.D.C. SPECIFIC RECOMMENDATIONS 1‐61. Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred.

2. Before starting opioid treatment establish realistic goals for pain and function. Continue opioid therapy only if benefits outweigh risks.

3. Before starting and periodically during treatment discuss with patients known risks and realistic benefits.

4. Prescribe immediate‐release (IR) opioids instead of extended‐release or long‐acting (ER/LA) opioids.

5. Prescribe the lowest effective dose, preferably 50 MME or below. Carefully justify doses above 90 MME.

6. For acute pain, prescribe the lowest effective dose of IR opioids in no greater quantities than needed for the expected duration of pain

C.D.C. SPECIFIC RECOMMENDATIONS 7‐127. Evaluate benefits and harms within 1‐4 weeks of starting chronic opioid therapy and then every 3 months or less. If benefits do not outweigh harms, taper opioids to lower doses or discontinue opioids.

8. Evaluate risk factors, and incorporate strategies to mitigate risks, including consideration of offering naloxone.

9. Review the state prescription monitoring database before starting opioid therapy and at least every 3 months during therapy.

10. Use urine drug testing before starting opioid therapy and at least annually.

11. Avoid prescribing opioid pain medications and benzodiazepines concurrently.

12. Offer or arrange evidence‐based treatment for patients with opioid use disorder.

Page 10: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

C.D.C. OPIOID SPECIFIC GUIDELINES

If your patient does not have a 30% improvement in pain and function, consider reducing dose or tapering and discontinuing opioids.

Continue opioids only as a careful decision by you and your patient when improvements in both pain and function outweigh the harms.

If harms outweigh any experienced benefits, work with your patient to reduce dose, or taper and discontinue opioids and optimize nonopiod approaches to pain management.

Improving the way opioids are prescribed can ensure patients have access to safer, more effective chronic pain treatment while reducing the number of people who misuse, abuse, or overdose from these drugs.

OPIOID BENEFITS AND HARMS COMPARED

• BENEFITS:

• Reduction in Pain

• Improvement in Function

JAMA Neuro 74:773, 2017

• HARMS:

• Worsening Function

• Substance Use Disorder

• Overdose and Possible Death

Page 11: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

AGE‐ADJUSTED DRUG 

OVERDOSE DEATH RATES 

2017

TENNESSEE TOGETHER LAW 2018Public Chapter 1039 effective 07/01/2018, enforced 01/01/2019. Public Chapter 124, 04/09/2019

Electronic prescriptions for controlled  medicines required 01/01/2021

Acute Pain:  3 day maximum  180 MME   (60   MME/day)‐ no restriction. 

10 day maximum   500 MME  (50   MME/day)‐ partial fill, ICD‐10

30 day maximum 1200 MME  (40    MME/day)‐ partial fill, ICD‐10, medical necessity

Major Surgery: up to 20 day supply of opioids allowed

Chronic Pain: 90 or more days opioids in last 365 days‐ exempt, ICD‐10

ICD‐10 Pain Codes‐ e.g., M54.9

Opioids include: Codeine, Hydrocodone, Oxycodone, Morphine. Tramadol (?)

Page 12: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

MORPHINE MILLIGRAM EQUIVALENTS (M.M.E.)

0.1   Tramadol                (50 mg. =     5.0 MME)

0.15  Codeine                 (30 mg. =     4.5 MME)

1.0   MORPHINE            (10 mg.=    10   MME)

1.0   Hydrocodone         (10 mg.=     10  MME)

1.5   Oxycodone             (10 mg. =    15  MME)

3.0  Oxymorphone         (10 mg.=    30   MME)

4.0  Hydromorphone     (10 mg.=     40  MME)

4.0  Methadone              (10 mg. =    40  MME)

100.0  Fentanyl                  (10 mg. = 1000  MME)             

10,000.0  Carfentanyl    (100x more potent than Fentanyl)     

EXAMPLES OF DAILY USE: 

40 MME‐ Hydrocodone 10 QID; Oxycodone 10 BID

45 MME‐ Hydrocodone 10 QID; Oxycodone 10 TID  

50 MME‐ Hydrocodone 10 x 5;   Oxycodone 10 TID 

60 MME‐ Hydrocodone 10 q4h; Oxycodone 10 QID

TENNESSEE TOGETHER EXEMPTIONS

Active or Palliative Cancer Treatment

Palliative or End‐of‐Life Care (Hospice)

Sickle Cell Disease

Direct Administration at Licensed Facilities (hospitals, nursing 

homes)

Prescriptions from Pain Management Specialists or Pain 

Clinics

Treatment for Opioid Misuse Disorder (Methadone, 

Buprenorphine)

Severe Burns or Major Physical 

Trauma

Non‐humans (veterinarians are 

exempt)

Page 13: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

Page 14: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

TENNESSEE CHRONIC PAIN GUIDELINES 2019

Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. 3rd Edition. January, 2019.

Accepted by medical and nursing boards and available online for free.For primary care providers, patients with daily MME (Morphine Mg. Equivalents) above 120 should be referred to a pain specialist for consultation or management or have clear documentation why not.Chronic pain shall not be treated by the use of controlled substances through telemedicine.Multiple detailed appendices including risk assessment tools, sample informed consent and patient agreement forms, use of opioids in workers’ compensation, opioid use in special populations including pregnant women, children, acute pain, ER use, perioperative pain management, unused drug disposal, tapering protocols, Medication Assisted Treatment, and multiple links and references.

PAIN MANAGEMENT BEST PRACTICES 2019

• Inter‐Agency Task Force, U.S. Dept Health and Human Services. May, 2019

• “Patients with acute and chronic pain in the United States face a crisis because of significant challenges in obtaining adequate care, resulting in profound physical, emotional, and societal costs.” 

• 50 million adults in U.S. have chronic daily pain. For 19.6 million adults, chronic pain “interferes with daily life or work”  

• “It is imperative to ensure that patients with painful conditions can work with their health care providers to develop integrative pain treatment plans that balance a focus on optimizing function, quality of life (QOL), and productivity while minimizing risks for opioid misuse and harm.”   

• “ Multidisciplinary and multimodal approaches to acute and chronic pain are often not supported with time and resources, leaving clinicians with few options to treat often challenging and complex underlying conditions that contribute to pain severity and impairment.”                     

Page 15: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

CONSEQUENCES OF UNDERTREATING PAIN

Loss of Function Depression Alcohol Abuse

Use of Illicit Street Drugs (Heroin, 

Fentanyl)SUICIDE

Page 16: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

CHRONIC PAIN MANAGEMENT OPTIONS

1. Nonpharmacologic Therapies

2. Non‐opioid pharmacologic Therapies

3. Surgical interventions (sympathetic nerve block)

4. Alternative Therapies

5. Opioids

ONE SIZE DOES NOT FIT ALL!

Page 17: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

TYPES OF CHRONIC PAIN

Nociceptive

Neuropathic

Central

NOCICEPTIVE VS. NEUROPATHIC PAIN

NOCICEPTIVE

throbbing pain

aching pain

pressure‐like pain

no sensory deficits

proximal radiation

exacerbation with activity

NEUROPATHIC  

shooting  pain

stabbing pain

electric‐like pain

numbness or tingling

distal radiation

exacerbations unpredictable

Page 18: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

NON‐PHARMACOLOGIC OPTIONS

Lifestyle Changes‐ diet, weight loss, exercise

Mindfulness Training, Cognitive Behavioral Therapy

Physical Therapy, Therapeutic Exercises

Body Manipulations (osteopathic, chiropractic)

Therapeutic Massage

Yoga, Tai Chi

Transcutaneous Electrical Nerve Stimulator (TENS)

Bracing‐ poor evidence for chronic use

Note: several of these options are not covered by insurance. 

Page 19: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

NONOPIOID MEDICATION OPTIONS & RISKS‐NOCICEPTIVE PAIN

ACETAMINOPHEN – mild to moderate pain.(dose dependent liver toxicity. Found in many OTC products)

CORTICOSTEROIDS‐ potent anti‐inflammatory. Should only be used short‐term for acute flares

NSAIDS – significant pain relief for inflammation. (GI bleed ‐>100,000 hospitalizations and 17,000 deaths annually, renal toxicity, increased risk of HTN, MI and CVA). Beers criteria in elderly. COX‐II somewhat safer than other NSAIDS, unless taken with aspirin.

MUSCLE RELAXANTS  (cyclobenzaprine, baclofen, tizanidine). Not indicated for long term use. Tizanidine most effective. Avoid carisoprodol (sedating, addictive)

TOPICAL AGENTS  (lidocaine patches, diclofenac gel, capsaicin, menthol, camphor, 50% Dimethyl sulfoxide cream (DMSO, clonidine) (local reactions)

NONOPIOID MEDICATION OPTIONS & RISKS‐NEUROPATHIC PAIN

ANTICONVULSANTS‐ (PHN, diabetic peripheral neuropathy, migraines). (sedation).Topiramate (renal stones, paresthesias, weight loss) Carbamazepine (trigeminal neuralgia, need lab monitoring). Lamotrigine (Stephens‐Johnson Syndrome)

GABAPENTINOIDS ‐ (gabapentin, pregabalin) (controlled, can cause sedation, edema, tremor. gabapentin often misused) Gabapentin has little benefit for nociceptive pain. Pregabalin 6x stronger than gabapentin.

ANTIDEPRESSANTS –SNRIs (duloxetine), TCAs  (desipramine, nortriptyline, amitriptyline). These agents also help with comorbid depression. Can cause weight gain, hypotension, hypertension. constipation, dry mouth, dizziness. SSRIs don’t help as analgesics.

MUSCLE RELAXANTS  (tizanidine. cyclobenzaprine, baclofen). Indicated for short term use only.  Tizanidine most effective. Metaxalone & Methocarbamol least effective. Side effects‐Sedation, somnolence. Lioresal may precipitate seizures. Avoid carisoprodol (addictive‐ metabolizes to meprobamate)

ANTI‐HYPERTENSIVES‐ (clonidine, guanfacine).  Guanfacine 10x more potent than clonidine for pain.

Page 20: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

SURGICAL INTERVENTIONS

Injections (cortisone, hyaluronic acid, clonidine) (local, joint, epidural, intrathecal)

Sympathetic Nerve Block (post‐amputation, ischemia, frostbite, PHN)

Radio Frequency Ablation  

Cryo‐neural Ablation

Spinal Cord Stimulator

Peripheral Nerve Field Stimulator

Intrathecal Pain Pumps

ALTERNATIVE THERAPIES

Ketamine (nasal, IV infusions) (may cause hyperalgesia)

Cannabinoids (CBD Oil) (legality?)

Acupuncture, Acupressure

Hypnosis, Aroma Therapy

Nutritional Supplements (omega‐3 fatty acids, curcumin, melatonin, coenzyme q10, alpha‐lipoic acid, glucosamine, turmeric)

Leech Therapy‐ anti‐inflammatory effect from leech saliva. used with knee OA

Genetic Testing

Note: most of these therapies are not covered by insurance.

Page 21: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

DANGEROUS DRUG COMBINATIONS

•OPIOIDS•Benzodiazepines•Alcohol•Marijuana• Sleep Hypnotics•Gabapentinoids•Muscle Relaxants• Seizure Medicines•Anti‐depressantsAVOID HIGH DOSES WHEN COMBINING DRUGS!

Page 22: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

OVERSTATEMENTA combination of 

acetaminophen with ibuprofen is as effective as oxycodone for 

relief of pain.

OPIOIDS VERSUS NONOPIOIDS

Effect of a Single Dose of Oral Opioid and Nonopioid Analgesics on Acute Extremity Pain in the Emergency Department

JAMA 11/07/2017 318(17):1661‐1667416 patients with moderate to severe acute extremity pain measured two hours after single dose treatment.Options:  A. 400 mg. ibuprofen       with 1000  mg. acetaminophen

B.      5 mg. oxycodone     with    325  mg. acetaminophenC.      5 mg. hydrocodone with    300  mg. acetaminophenD.    30 mg. codeine          with    300  mg. acetaminophen

11 Point Numerical Rating Scale (NRS) Improvement in Pain Intensity:A. 4.3,  B. 4.4,  C. 3.5,  D. 3.9

Page 23: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

S.P.A.C.E. RANDOMIZED CLINICAL TRIALEffect  of Opioid vs. Nonopioid Medications on Pain‐Related Function in Patients With Chronic Back Pain or Hip or Knee Osteoarthritis Pain

JAMA 03/06/2018 319(9):872‐882

In a twelve month randomized trial among 240 VA patients, there was no significant difference in pain‐related function.

Pain intensity was significantly better in the nonopioid group.

Adverse medication‐related symptoms were significantly more common in the opioid group.

Conclusions: Treatment with opioids was not superior to treatment with nonopioids for improving pain‐related function over 12 months. Results do not support initiation of opioid therapy for moderate to severe chronic back pain or hip or knee osteoarthritic pain.

S.P.A.C.E. RANDOMIZED CLINICAL TRIALS.P.A.C.E. is Strategies for Prescribing Analgesics Comparative EffectivenessNote: patients on long‐term opioid therapy were excluded. Mean age 58.3Prescribing Strategies includedOpioid Group: maximum 100 MME over all 3 stepsStep 1: hydrocodone/acetaminophen, oxycodone IR, morphine IRStep 2: oxycodone SA, morphine SAStep 3: transdermal fentanylNonopioid Group:Step 1: acetaminophen, NSAIDs (ibuprofen)Step 2: TCA (nortriptyline, amitriptyline), gabapentin, 

topical analgesics (capsaicin, lidocaine)Step 3: pregabalin, duloxetine, tramadol

Page 24: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

Association of  Long‐Term Opioid Therapy with Functional Status, Adverse Outcomes, and Mortality Among Patients with Polyneuropathy. JAMA Neurology 74:773 2017

Retrospective population‐based cohort study with 2892 patients and 14,435 controls in ambulatory practice over 5 years.

Results showed that no functional status markers were improved by long‐term use of opioids. Adverse outcomes were more common including depression, opioid dependence, and opioid overdose.

WHEN CONSIDERINGOPIOID USE       FOR CHRONIC PAIN

Detailed History of Pain:  pain history (where, how, when), pain description (quality, duration, severity), management options tried, impact on life functions. Brief Pain Inventory

Physical Examination: with special attention paid to areas of pain. Nociceptive pain may show joint swelling or stiffness. Neuropathic pain may show swelling or discoloration in the painful area. 

Review Medical Records: to include past pain treatment, previous imaging studies and Controlled Substance Monitoring Database

ESTABLISH A DIAGNOSIS JUSTIFYING A NEED FOR OPIOIDS

Page 25: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

WHERE DOES IT HURT?

FURTHER HISTORY & SCREENING

Comorbid Conditions: Morbid Obesity, C.O.P.D., Sleep Apnea, C.H.F., Elderly

Mental Health History: Depression, Anxiety, Substance Use Disorder, Alcoholism

Current Medications

Social History: Employment History, Marital History, Legal History

Screen for Risk: P.H.Q., A.C.E., Opioid Risk Tool, DAST‐10, S.O.A.P.P., D.I.R.E.

Page 26: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

Page 27: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

ADVERSE CHILDHOOD EXPERIENCES(ACES)

EXPERIENCES OF CHILDHOOD             (PRIOR TO AGE OF 18)

Individual (5):

Emotional Neglect or Abuse

Physical Neglect or Abuse

Sexual Abuse

Household (5):

Separation or Divorce of Parents

Domestic Violence in the Home

Alcohol or Substance Abuse in Home

Mental Illness in the Home

Household Member in Prison

A.C.E SCORE 

PREDICTABILITY

Four or higher:

Seven times more likely to be alcoholic

Six times more likely to have sex  by age 15

Four times more likely to have emphysema

Two times more likely to get cancer

Six or higher:

Thirty times more likely to attempt suicide

Twenty year shortening of life span

Page 28: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

RISK TOOL OPTIONS

Page 29: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

D.A.S.T.‐10: Last 12 months

1.  Have you used drugs other than those required for medical reasons?

2.  Do you abuse more than one drug at a time?

3.  Are you unable to stop using drugs when you want to?

4.  Have you ever had blackouts or flashbacks as a result of drug use?

5.  Do you ever feel bad or guilty about your drug use?

6.  Does your spouse or parents ever complain about your involvement with      drugs?

7.  Have you neglected your family because of your use of drugs?

8.  Have you engaged in illegal activities in order to obtain drugs?

9.  Have you ever experienced withdrawal symptoms when you stopped  taking drugs?

10. Have you had medical problems as a result of your drug use?

S.O.A.P.P.  Version 1.00=Never;1=Seldom;2=Sometimes;3=Often;4=Very Often

1.  How often do you have mood swings?

2.  How often do you smoke a cigarette within an hour after you wake up?

3.  How often have any of your family members, including parents and grandparents, had a problem with alcohol or drugs?

4.  How often have any of your close friends had a problem with alcohol or drugs?

5.  How often have others suggested that you have a drug or alcohol problem?

6.  How often have you attended an AA or NA meeting?

7.  How often have you taken a medication other than the way that it was prescribed?

8.  How often have you been treated for an alcohol or drug problem?

9.  How often have your medications been lost or stolen?

10. How often have others expressed concern over your use of medication?

11. How often have you felt a craving for medication?

12. How often have you been asked to give a urine screen for substance abuse?

13. How often have you used illegal drugs (e.g., marijuana, cocaine, etc.) in the past five years?

14. How often, in your lifetime, have you had legal problems or been arrested?

Page 30: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

D.I.R.E.: Patient Selection for Chronic Opioid Analgesia

DiagnosisIntractabilityRisk  (psychological, chemical health, reliability, social support)Efficacy

Page 31: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

USE OF CHRONIC OPIOIDS IN TENNESSEE

Opioid Naive Patients

Opioid Dependent Patients New to Our Practice

Opioid Dependent Patients Currently Being Treated For Pain in our Practice  (LEGACY PATIENTS)

WHEN STARTING OPIOIDS

• Consult Controlled Substance Monitoring Database (C.S.M.D.) with five year lookback on first screen. Enter results in EMR.

• Do in‐house 14 panel urine drug test  (Gabapentin and ethanol metabolites are not on any commercial cup tests. Dextromethorphan shows as meth.). Enter results in EMR. SEND OUT.

• For women of child‐bearing possibility, do urine pregnancy test. Assure use of contraceptives, preferably long‐acting.

• Obtain signed informed consent and pain management agreement.

• Formulate TREATMENT PLAN setting REASONABLE GOALS TO IMPROVE FUNCTION AND REDUCE PAIN. Treatment plan should include nonpharmacological and pharmacological modalities in addition to opioids.

• Start with the lowest dose possible, preferably with short‐acting opioids.

• Discuss Naloxone. Prescription recommended, especially when children are in the house.

Page 32: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

ONGOING USE OF CHRONIC OPIOIDS

• Regular use of in‐house urine drug screen (14 panel). Document in EMR.

• Check CSMD at every visit. Document in EMR. 

• Assess 5 A’s (Analgesia, Activity, Adverse effects, Aberrant behavior, Affect) REGULARLY

• Assess for clinically significant improvement in function and/or reduction in pain. Set realistic goals.

• P.E.G. Scores: Pain Average; Enjoyment of Life; General Activity Level

• Monitor for possible misuse, abuse, and diversion (pill counts)

• If prescribing outside of guidelines: DOCUMENT…DOCUMENT…DOCUMENT

Page 33: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

DEFINITIONS

Dependence: physiological effects of chronic medication use. Individual feels ill if the substance is stopped abruptly. (venlafaxine)

Tolerance: a person’s diminished response to a drug that is the result of repeated use

Page 34: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

Page 35: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

PROBLEMATIC BEHAVIORS DETECTED ON C.S.M.D.

Obtaining Opioids from Several Providers (including dentists)

Filling Prescriptions at Several Pharmacies

Frequent Early Refills (even 3 days early each month gives one extra prescription/year)

Taking Other Controlled Substances From Other Providers

PROBLEMATIC BEHAVIORS FROM HISTORY

Dismissed from Other Providers (reason?)

Taking Extra Doses and Running Out Early

Reporting of Lost or Stolen Medications

Frequent Visits to Emergency Rooms  

Page 36: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

PROBLEMATIC BEHAVIORS ON DAY OF VISIT

Inconsistent Urine Drug Screens

Subjective Behaviors: Patient is Overly Talkative, Nervous, Evasive, Emotionally Volatile, Agitated

Tearful Pleas for Opioids (female patient to male provider)

Aggressive Demands for Opioids (male patient to female provider)

Acute Opioid Withdrawal Symptoms: Pupillary Dilatation, Watery Eyes, Runny Nose, Muscle Spasms, Sweating, Chills, Stomach Cramps, Diarrhea, Vomiting, Restlessness, Anxiety, Irritability

SENDING OUT URINE FOR CONFIRMATION

In‐house 14 panel cup screen done regularly (at every visit).

Send‐out for gas chromatography confirmation:

A. Prior to first opioid prescription

B. Prescribed medicines not detected

C. Non‐prescribed medicines detected

D. Illicit drugs detected (cocaine, methamphetamine, MDMA, THC)

E. Concern about diversion

Send‐outs should include ethyl glucuronide/sulfate, gabapentin, cotinin

If unable to urinate, can do saliva testing or hair follicle testing

Page 37: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

OPIOID MISUSETERMS

Misuse: taking opioids in greater amount or frequency than prescribed

Abuse: opioid drug use with resulting harm to health or social functioning

Non‐Medical Use: opioid use without a prescription or for the feeling it causes

Diversion: selling, trading or giving away opioids to others

STOPPING CHRONIC OPIOIDS

Do not prescribe additional opioids if drug diversion is suspected!

Low dose opioids may not require weaning at all.

Weaning unnecessary if urine drug screen is negative

Page 38: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

OPIOID WEANING PROTOCOLS

If the decision is made to discontinue opioids, steps should be taken to minimize the impact of opioid withdrawal syndrome.

Rapid forced tapering can destabilize patients, lead to a worsening of pain, precipitate severe opioid withdrawal symptoms, cause a profound loss of function, or even cause them to seek out street drugs.

Weaning Protocols: very slow‐10‐25% per month; slow‐10‐25% per week; medium‐25% every 4 days; fast‐ 25‐50% every day (in‐patient). Abrupt withdrawal can be treated with new nonopioid lofexidine.

Medications to help withdrawal symptoms: clonidine for BP; dicyclomine‐for nausea, vomiting, and abdominal pain; hydroxyzine for anxiety, jitters.

DEFINITION of 

ADDICTION

Physical dependence on and subjective need and craving for a psychoactive substance either to experience its positive effects or to avoid negative effects associated with withdrawal. 

USE IS COMPULSIVE AND CONTINUES EVEN THOUGH THE DRUG CAUSES HARM.

Page 39: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

MEDICATION‐ASSISTED TREATMENT

“the use of medication, IN COMBINATION WITH COUNSELING AND BEHAVIORAL THERAPIES, to provide a “whole‐patient” approach to the treatment of substance use disorders.”  SAMHSA 

MEDICATION ASSISTED TREATMENT

1. Methadone‐

full opioid agonist

2. Buprenorphine‐

partial opioid agonist

3. Naltrexone‐

opioid antagonist

Page 40: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

METHADONE

Schedule 2‐ Prescription must be hand‐written or clinic dispensed.

Pure Opioid Agonist. Morphine Multiplier 3

Pregnancy Category‐ C

When used to treat addiction, methadone must be dispensed from a state‐licensed and federally regulated methadone clinic. There are only 12 such clinics in Tennessee, most in metropolitan areas.

Risks‐ QTC prolongation, torsade de pointes

Note: Elimination half‐life 1‐4 days, but analgesic effect only lasts 4‐6 hours.

Page 41: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

BUPRENORPHINE

Schedule 3‐ prescription does not have to be hand‐written

Partial Opioid Agonist and Antagonist. Morphine Multiplier 10

Pregnancy Category C. Naltrexone‐containing products not recommended in pregnancy.

Preparations‐ tablets, sublingual film, patches (for pain only), long‐acting injections

Prescriber must be a physician and must take a course and pass a test to get a special DEA X Waiver to prescribe. The physician is limited to a specific number of patients that can be treated.   Non‐naltrexone films should only be dispensed to pregnant women and others with a documented contraindication or allergy to naltrexone.                    

NALTREXONE

Non‐Scheduled Product

Pure Opioid Antagonist. Morphine Multiplier 0

Pregnancy Category C, although it is not recommended in pregnancy.

Preparations‐ tablet, long‐acting injectable

Useful for highly motivated patients after detoxification and/or rehabilitation. Extremely safe.  

No special clinic or provider requirements. 

Injectable form is very expensive, but is covered by many insurances including TennCare

Page 42: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

IMPROVING M.A.T. EFFICACY

Efficacy for each of the above agents is vastly improved if accompanied by one on one counseling, group meetings, and other wrap around services.

None of the agents are considered short‐term treatments. Naltrexone should be at least six months and buprenorphine often requires two years or even longer. Some patients require life‐long treatment.

Medication• Control cravings (block

negative reinforcement)• Prevent relapse (block

positive reinforcement)

Counseling• Learn about addiction

and recovery• Relapse prevention

skills• Treatment of

psychiatric co-morbidities

Community supports• Case Management• Peer support meetings• Sober social network• Family supports

Page 43: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

Page 44: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

Page 45: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

Page 46: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

AGE‐ADJUSTED DRUG 

OVERDOSE DEATH RATESBY GENDER

Page 47: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

AGE‐ADJUSTED DRUG 

OVERDOSE DEATH RATESBY AGE GROUP

Page 48: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

TOP DRUGS FOUND IN DRUG‐RELATED                     DEATHS, KNOX & ANDERSON COUNTIES

2010

1. OXYCODONE

2. ALPRAZOLAM

3. MORPHINE

4. METHADONE

2017

1. FENTANYL

2. COCAINE

3. METHAMPHETAMINE

4. HEROIN

Page 49: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

LETHAL DOSES OF ILLEGAL OPIOIDS

A VERY SCARY 

WEBSITE

Page 50: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

Page 51: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

2019 Annual ConferenceClinical and Care Innovations Track

ANY QUESTIONS?

Edward Capparelli, M.D.

[email protected]

Mountain Peoples Health Councils

EC1

Page 52: Edward Capparelli, M.D., F.A.A.F.P. October 3, 2019 · 2020. 5. 15. · Clinical Practice Guidelines for Outpatient Management of Chronic Non-Malignant Pain. For primary care providers,

Slide 101

EC1 Edward Capparelli, 8/17/2019