Dr. Francisco Ward Chief PM&R St. Agnes Hospital

Medical Director: Seton Pain & Rehabilitation Center Medical Advisor: Key Risk (a W.R. Berkley Company)

Co-Chair of Medchi’s Medical Economic Council Board Member: American College of Healthcare Trustees

Goals and Objectives

l  Improve strategies to limit the abuse of prescription opioids

l  Identify patients who abuse opioids l Mitigating risk of opioid overdose as well

as other adverse effects

Changing Theories l Opioids have no limits or ceilings l  Increase dosages for increased pain l As long as patient functioning better its

okay l The 5th vital sign

Measuring Pain

l  Any assessment of pain, particularly for chronic pain, must include behaviors and the relevant reinforcement contingencies.

l  Visual Analog Scales l  Functional scale to standardize l  Health related quality of life

Politics in Medicine

l  PAIN ASSESSMENT: THE FIFTH VITAL SIGN –  Assembly Bill 791 (Thomson) was signed into law by

Governor Gray Davis on September 15, 1999, Section 1254.7 was added to the Health and Safety Code (HSC) as part of this bill.

HSC 1254.7 reads: l  (a) It is the intent of the Legislature that pain

be assessed and treated promptly, effectively, and for as long as pain persists.

l  (b) Every health facility licensed …. shall, as a condition of licensure, include pain as an item to be assessed at the same time as vital signs are taken. The health facility shall insure that pain assessment is performed in a consistent manner that is appropriate to the patient. The pain assessment shall be noted in the patient’s chart in a manner consistent with other vital signs.

DAWN Studies

DAWN Studies

Drug Abuse Warning Network (DAWN)

l Number of ED visits for non-medical uses of opioids –  2004-2008, increased 111% & continue to rise

l  From 144,600 to 305,900 visits +++

l Number of ED visits for non-medical uses of benzodiazepines –  2004-2008 increased 89%

l  From 143,500 to 271,700 visits

Opioids: a Public Health Crisis

l In 2009, 39,147 Americans died from drug poisonings –  Nearly 14,800 deaths involved prescription opioid analgesics

Warner M, et al. Drug poisoning deaths in the United States, 1980-2008. NCHS data brief, no 81. Hyattsville, MD: National Center for Health Statistics. 2011. National Center for Injury Prevention and Control. Division of Unintentional Injury Prevention. Policy Impact. Prescription Painkiller Overdoses. Nov 2011.

Opioid-related deaths

l The largest increase in number of heroin-related deaths between 2012 and 2013 occurred among African Americans. Heroin deaths in this group increased from 100 to 131, a 31% increase, while heroin deaths among Whites increased 285 to 321, a 13% increase. Oxycodone & methadone deaths declined >2011

l  ages 25-34 years 50% increase in the number of deaths, ages 55 years of age and older, with a 40% increase

l 27% of heroin-related deaths occurred in combination with alcohol, and 20% in combination with cocaine. Fentanyl x 4

Current State of Opiate Affairs: Rampant Addiction

Governor Hogan’s Taskforce

- Heroin and Opioid Emergency Task Force - Lieutenant Governor Boyd K. Rutherford,

Chair Recommendations: December 1, 2015 33 recommendations to tackle this emergency

Task Force Final Recommendations

–  Expanding Access to Treatment –  Enhancing Quality of Care –  Boosting Overdose Prevention Efforts –  Escalating Law Enforcement Options –  Reentry and Alternatives to Incarceration –  Promoting Educational Tools for Youth,

Parents, and School Officials –  Improving State Support Services

Task Force Final Recommendations

–  Expanding Access to Treatment l  More buprenorphine access

–  Enhancing Quality of Care l  Mandating PDMP usage

–  Boosting Overdose Prevention Efforts l  Allowing naloxone Rx for caretakers / parents

–  Reentry and Alternatives to Incarceration l  community resources (faith-based organizations,

peer support, and outpatient treatment programs

Clinical Due Diligence

l History: –  Social

l  Addiction behaviors (alcohol, tobacco, gambling) l  Prior CDS charges / gaps in story (incarceration)? l  Vocational Lapses or job instability

–  Family / Friends (gang affiliations) –  Medical / Psychiatric

l  Prior treatments / prior discharges / PDMP

Physical Exam

l Look for signs –  Track marks (hands, arms, neck, legs etc) –  Skin popping scars –  Gang tatoos –  Nasal septum defects –  Eyes (conjunctivitis, pupil size) –  Teeth (methamphetamine, methadone)

Work up

l  Take a medical history l  Review any medications you are using l  Conduct a physical examination to evaluate for

causes of pain l  Functional / Psychosocial History: How this pain

is affecting function l  Obtain blood and/or urine samples and necessary

laboratory work l  Consider appropriate imaging studies or

electrodiagnositic studies

What are you treating? l  Nociceptive pain Progressive l  Neuropathic pain Stable l  Visceral pain Continuous vs. l  Suffering intermittent pain l  Distress Sleep disturbance l  Depression Deconditioning/Obesity l  Anxiety Work issues l  Personality issues Family issues

Limited coping skills

Forms of physical pain

Acute Pain l  inflammation, or injury to tissues. It is

immediate and usually of a short duration. Acute pain is a normal response to injury and may be accompanied by anxiety or emotional distress. The cause of acute pain can usually be diagnosed and treated.

Benign Pain l Emotional (except depression) l Slow DJD / DDD l Lumbago / Cervicogenic / Growing pains l Myofascial hypoxia: smoking l Enthesitis / periosteal l Radiculitis/Neuritis l Modulation dysfunction

Heat Wraps

l Study comparing to OTC Acetaminophen or Ibuprofen 1200mg / day to Heat Wrap, n=113 patients, 40deg C, 8 hour/day –  Heat Wrap better, P=0.0001 day 1, 3&4.

Analgesic Balms

Emotional Component l  Emotion plays a role in determining illness

behavior l  Emotion is part of every conclusion drawn in the

illness experience and can itself cause physiologic arousal that may be perceived as illness

l  Higher intensity is accompanied by anxiety and the urge to escape or terminate the feeling

Semi-Malignant: Treat the Condition: Opioids often unnecessary l Depression l  Joint Overload / Fracture l  Ischemia l Radiculopathic / Axonopathic / Myelopathic l Tissue Toxic / Invasive / Infection l Myotubular obstruction

Malignant l  Ischemic (Acute, Intermittent, Chronic)

–  Cardiac, Brain, Bowel, Limb l Cancer l  Infection / Pronounced Inflammation l Myotubular Rupture

27 27 27 Note: Totals may not sum to 100% because of rounding or because suppressed estimates are not shown. Source: NSDUH 2008

Source Where Pain Relievers Were Obtained for Most Recent Non-medical Use among Past Year

Users Aged 12 or Older: 2008

0.4%

55.9%

4.3%

18.0%

5.4%

8.9%

Friend/Relative forFreeBought fromFriend/RelativeTook fromFriend/RelativePrescription fromOne DoctorFrom Drug Dealeror StrangerFrom Internet

81.7% of pain relievers obtained from friend/relative for free were obtained from one doctor. 1.6% were obtained from a drug dealer.

70% of Prescription Pain Relievers Used Non-Medically Come from Friends or Relatives

Opioid Myths

l Pain medicine = narcotics = opioids l Strong opioids work the best l Quick acting is better l Only opioids really work for pain l More is better , “Oxy” is the best l “It’s just Vicodin®” l “My narcotics work well for my fibromyalgia”

Risk of Addiction to Prescription Medications

l  2006 Passik et al, patients with SA history had more pain, distress, and problematic behaviors when given opiate Rx

l  TROUP study 2005-2009, patients with h/o SA and opiate therapy had increased ED visits and alcohol and drug complications

l  2008 11% older women misused prescription opiates, estimated by 2020 5 million older adults with substance abuse (Fleming, et al, 1999: Quinlan-Colwell,2011: Simoni-Wastala, et al, 2006: USDHHS,2005)

Aberrant Drug Behaviors

l Range from mildly problematic: Hoarding l Felony: Selling / Diverting l Misuse: Self escalating w/o clinician

approval for enhanced therapeutic effects l Abuse: Injection of any illicit drug or other

drug for non medical purpose

Risk Stratification

l Low: No addictions, no violations UDT, no untreated psychiatric conditions, not in $ jeopardy

l Medium: Presence of Addiction(s), prior evidence of misuse. + Psychiatric conditions

l High: Prior history of abuse + Hx of misuse, concurrent substance addiction. Dealer

Potential Predictors of Poor Outcome

l  Pain that does not fluctuate in intensity l  Low educational level l  History of other chronic pain l  History of physical/emotional/sexual abuse l  Significant premorbid mental illness l  Cigarette smoking l  Cognitive impairment l  Physically demanding occupation

How to improve Risk

l  Exercise: Studies show that people with glucose intolerance can decrease the development of diabetes by 58 % !! with 4 hours / week of exercise and 10 pounds of weight loss.

l  Lower cholesterol (size of cholesterol matters). Exercise increases HDL.

l  Quit smoking, minimize stress, inspect feet daily. l  Diet / nutrition supplements (vitamin C, E): See

a nutritionist

Patient Presentations

l  Professional Patient l  Desire for surgeries, procedures, interventions l  Negative outlook l  Client (vs patient) l  Workers’ Compensation l  Psychiatric illness l  Assistive devices

When Treating At Risk

l Be humane but skeptical – monitor closely for aberrant drug behaviors, Trial of CDS?

l Make sure Addictions in remission +/- Tx l PMDP prior to first Rx and periodically l Urine drug testing with instant feedback l Pill counts / avoid early refill drift l Avoid high value street preparations

Treatment: MSD

l Moist heat l Cold l Hydrotherapy (water therapy) l Mobilization therapies l TENS (transcutan electrical nerve stim) l Relaxation therapy l Acupuncture

Chronic Pain: Presentation

l Chronic pain is continuous pain that persists for more than 3 months, and beyond the time of normal healing. It ranges from mild to severe and can last weeks, months, or years to a lifetime. The cause of chronic pain is not always evident, although it can be brought on by chronic conditions such as arthritis and fibromyalgia. Beware of CDS

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Opioid Efficacy in Chronic Pain l  Most literature surveys & uncontrolled case series l  RCTs are short duration <4 months with small sample

sizes <300 pts l  Mostly pharmaceutical company sponsored l  Pain relief modest

–  Some statistically significant, others trend towards benefit –  One meta-analysis decrease of 14 points on 100 point scale

l  Limited or no functional improvement

Balantyne JC, Mao J. NEJM 2003 Martell BA et al. Ann Intern Med 2007; Eisenberg E et al. JAMA. 2005

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Can Opioids Worsen Pain ? l  Animal studies1 chronic opioid administration

results in increased pain sensitivity versus placebo

l  Methadone maintenance patients2 with enhanced pain sensitivity versus controls

l  ? Release of peptides “anti-opioids”, increase levels of dynorphin

l  ? Neuroadaptation to chronic opioids

Li X et al. Brain Res Mol Brain Res 2001 Doverty M et al. Pain 2001 Angst MS, Clark JD. Anesthesiology 2006

Hyperalgesia Syndrome l Occurs when prolonged administration of

opioids results in paradoxic increase in atypical pain that appears to be unrelated to the original stimulus.

l Down regulation of mu receptors l Frequent visits, opioid rotation with force

tapering of opioid. Diversity modalities

3 aspects of pain: Human sufferer

l  a) sensory / perceptual - discrimination of pain in time, space and intensity

l  b) emotional / motivational - negative feelings which motivate behavioral responses

l  c) cognitive / evaluative - quality of knowing, evaluating, interpreting and conceptualizing pain

l  perceptual experience often predominates in acute pain emotional aspects may pre-dominate with chronic pain

Potential Predictors of Poor Outcome

l  Significant work/legal issues l  Any substance abuse history, family history l  DUI l  Ill defined goals l  Limited control over the pain l  Desire for cure or complete pain relief l  Severely compromised function l  Limited social/family/financial support l  Frequent changes in venue for treatment l  High doses of opioids

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Opioid Options when appropriate

Short-acting l  Fentanyl l  Hydrocodone l  Hydromorphone l  Morphine l  Oxycodone l  Tapentadol

Long-acting l  Slow-release delivery system

–  Transdermal fentanyl –  Extended release morphine –  Extended release oxycodone

l  Intrinsic pharmokinetic property –  Methadone

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Emerging Opioid Formulations

l Abuse-resistant formulations –  Physical barriers –  If barriers defeated, drug becomes available

l Abuse-deterrent formulations –  Pharmacologic barriers –  If altered, antagonist or irritant released –  If not digested as intended, drug is inactive

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Abuse Deterrent Long Acting Opioids

Branded Products Oxycontin Hysingla Embeda

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Overdose Prevention

Do not mix opioids especially long acting with benzo’s especially long acting

Understand drug / drug and metabolism variables When tolerance wanes recidivism to abuse can be fatal Educate family members on use of Naloxone or

(EVZIO auto – injector) Identify sleep apnea risk and / or pulmonary disease Check UDT for alcohol Pharmacogenic testing consideration

Questions??