Graves Owen, MD

Dr. Graves Owen graduated from the UT Medical School Houston in 1990. After

completing a residency in anesthesiology, he completed a pain management

fellowship in pain management at the University of Pittsburgh Medical Center in

1995. After completing his fellowship, Dr. Owen practiced interdisciplinary pain

management in Round Rock, Texas.

Graves Owen, MD has nothing to disclose.

Disclosure

Opioid Prescribing During An Opioid Epidemic

Graves T. Owen, MD

Chairman of the Board, Texas Pain Foundation

Past President Texas Pain Society

Conflicts Of Interests:None

How does not initial use of opioids contribute to long term opioid use?

Exposure in days Risk of long term opioid use

• 1-3 6%

• 8 or more 13.5%

• 30 30%

Shah et al. Morbidity and Mortality Weekly Report 2017:66(10):256-9.

In 2016 >64,000 deaths -CDC

7

The Opioid Pendulum

2016 National Drug Threat Assessment Summary

9

Ethics

• Beneficence:

Defined as action(s) done for the benefit of others. Beneficence actions taken to prevent or remove harms or to simply improve the situation.

• Non-maleficence:

Defined as to “do no harm.” Physicians must refrain from providing ineffective treatments or acting with malice toward patients.

Standard of Care (SOC)

• The standard of care is what a reasonable and prudent physician does in the same or similar clinical situation.

• A reasonable and prudent physician will look to the evidence based literature for a foundation of knowledge.

• A reasonable and prudent physician exhausts conservative evidence based treatments prior to treatment with higher risk and lower evidence based treatments (First do no harm). Failure to exhaust conservative evidence based treatments prior to higher risk or non-evidence based treatments is both a breach in the SOC and unethical.

• A reasonable and prudent physician uses sound medical judgment.

What is Pain? What is Suffering?

• Pain is defined as an unpleasant sensory and emotional experience with actual or potential tissue damage or described in terms of such damage.

• Suffering is one’s inability to cope with adversity.

How to assess pain?

• Primary assessment is by functional changes as a result of pain.

• Function is more objective and reproducible.

• The 0-10 VAS scale is actually assessing suffering rather than pain (a complex interaction of physical and psychosocial conditions).

• Treating function rather than pain will result in better outcomes and minimize risk of over- or under-treatment.

Disability Perception

• Disability perception has never correlated well with physical pathology.

• Strongly correlates with unstable psychosocial issues.

• Therefore, severe pain intensity (suffering) and disability perception indicates unstable psychosocial issues until proven otherwise.

Incidence of Psychosocial Comorbidities

Chronic pain syndrome

•80% depressed

•70% anxiety/panic attacks

•30-60% personality disorders

•35% incidence of addiction

•Majority with maladaptive coping strategies• Manchikanti et al. Pain Physician 2013; Owen et al. Evidence based PM for the PCP in

press

Opioids

Risk factors for aberrant drug taking behaviors:

• Family or personal history of ETOH or drug addiction

• Nicotine dependency

• Depression and/or anxiety

• Impulse control problems (ADD, OCD, bipolar, schizophrenia, personality disorders)

• Hypervigilant state (PTSD, abuse history)

• Somatoform disorders

• Multisite pain (> 3 body parts)

• Age 16-45

Psychosocial Comorbidities

• Physicians commonly underestimate the degree of psychosocial comorbidities found in their pain patients unless psychometric testing is performed.

Daubs, et al. J Bone Joint Surg AM. 2010

• Psychosocial comorbidities magnify the perception of pain and disability. Thus, patients complaining of severe pain and disability are at greatest risk of aberrant drug taking behaviors.

• However, patients reporting the greatest pain and disability are most likely to be prescribed opioids. This is why mental illness is strongly associated with opioid use for pain. Suffering is not recognized. Pain is treated as a vital sign.

Treatment Options

Rehabilitation• Cognitive behavioral therapy (CBT)

• Physical Therapy, Occupational Therapy, Yoga, Tai Chi

• Compliance is often low without psychosocial support

Pharmaceutical• Neuromembrane Stabilizers (TCA, gabapentin, pregabalin, etc.)

• Note that TCA and gabapentin are off label.

• Topical (lidocaine gels)

Interventional• Spinal Cord Stimulators, Injections

American College of Physicians (ACP) Guides

Recommends Non-pharmaceutical Treatments as 1st line

• Physical Modalities:

• Exercise (any exercise is helpful)

• Tai Chi

• Yoga

ACP Guides (cont.)

Psychological Modalities:

• Cognitive Behavioral Therapy (CBT)

• Mindfulness-Based Stress Reduction

• Multidisciplinary/Interdisciplinary Rehabilitation

ACP Guides (cont.)

Complementary Treatments

• Acupuncture

• Massage

• Spinal Manipulation

How CBT/Exercise Helps

• CBT and exercise rewires the nervous system.

• Exercise promotes endorphins and positive mood changes.

• Exercise prevents or minimizes functional loss.

• CBT and exercise are evidence based conservative treatments (first line therapy).

• How many of your new patients referrals have not exhausted first line therapy?

Evidence for COT

• Short-term studies with well screened “pristine” population, poor outcome metrics, and large dropouts because of intolerable side effects. Not real world population.

• No long-term evidence.

• Recent Veteran Association study found no benefit of opioids over NSAIDs during a 2 year study. So why use them?

• Several epidemiological observations found opioid use associated with higher pain intensity, greater disability, and higher healthcare utilization. While this type of study cannot ID causation, these basic outcome metrics are not positive indicators for COT.

Risk of COT

• Adverse Side Effects (constipation, cognitive impairment)

• Endocrinopathies (low T, etc.)

• Increased risk of osteoporosis and spontaneous fractures

• Dosage dependent MVA

• Opioid induced mood disorders (depression)

• Opioid induced hyperalgesia

• Opioid induced central sleep apnea (death mechanism)

• Overdose

• Death, about 100 people per day. Drop in life expectancy.

Opioids

• Known risks outweighs any known benefit. Easy Risk/Benefit Calculation.

• Thus, COT is a non-evidence based high risk treatment.

• Unstable psychosocial issues are relative contraindication to use of opioids.

Opioids (cont.)

There is no safe dose of opioids:

• 20 Morphine Equivalent Daily Dosage (MEDD) to 50 MEDD doubles risk of overdose (OD).

• 20 MEDD to 90 MEDD has 9 times risk of OD.

• 91% of patients that survive an OD are prescribed opioids after the OD.

• 17% of lethal OD had survived a previous OD.

• Do not co-prescribe opioids with other sedatives (benzos/Soma). FDA black label warning!

COT

• In order to consider COT, conservative evidence based treatments need to be exhausted.

• When COT is used as a treatment, a reliable and clinically meaningful therapeutic benefit from COT must be achieved and documented. Pain reduction without functional improvement does not justify COT (Washington State Guides 2015).

• Without exhausting conservative evidence based treatments and/or without obtaining a reliable and clinically meaningful therapeutic benefit, medical necessity to treat with COT is not established.

• Without medical necessity, the prescription of a controlled substance is not legitimate.

COT (cont.)

In order to RX COT with minimal risk to your license or freedom, you must:

• Maintain the SOC• Adequate documentation (documentation requirements increase)• Establish medical necessity (i.e. obtain a therapeutic benefit and exhaust

conservative care)• Monitor for adverse effects of COT• Monitor for aberrant drug taking behaviors (PMP, UDT)• Comply with TMB rule 170.3• Avoid Willful Blindness (aka Deliberate Ignorance) and Condemned

Behaviors

Risk Mitigation Summary

• Exhaust Conservative Evidence Based Treatments

• Drug screens/Interpretation

• Prescription Monitoring programs

• Dosing per REMS blueprint (lowest possible dose)

• Informed Consent and PM Agreements

• Psychometric Screening Questionnaires

• Previous records (compliance, therapeutic benefit, aberrant behaviors)

• Naloxone for high risk

• Frequent follow-ups for high risk

How Many Ways Are There To Get Into Trouble?

• TMB/TBON:Sanctions (CME, Monitoring, Monetary Penalties)

Loss of Medical License (Reciprocity With Other States)

• TORTSued For Causing An Addiction (Supreme Court Ruling) (Monetary Penalties)

• District Attorney:Second Degree Murder Charges (Willful Blindness or Reckless Disregard For Human Safety) (Prison Time)

• DOJCriminal Charges (Prison, Fed Time Is Real Time)

Federal Tort (Monetary Penalties)

DEA Registration Revocation

Conclusions

• Non-pharmaceutical treatments should be the primary focus.

• Pharmaceutical treatments have small benefits.

• Opioids have greater risk than benefit.

• The risks increase with duration and dosage.

• Disability chronic pain intensity is driven by unstable behavioral issues (Suffering).

• Unstable behavioral issues are risk factors to chemical cope with controlled substances

• Family and personal history of substance use disorders and unstable behavioral issues are risk factors for developing a substance use disorder with COT.

• The vast majority of chronic pain patients on COT are chemically coping (best case) or will qualify for a substance use disorder (worst case).

• The patients with the greatest risk factors are the most likely to be prescribed opioids.

• Do not be cavalier in prescribing opioids.

Questions