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Emerging Pharmacy Issues in the Texas Workers’ Compensation System

Presented by

Suzanne Novak, MD, PhDCEO, Austin Outcomes Research, Inc.June 9, 2009 AustinOutcomesResearch

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Any reproduction of this material is prohibited without the author’s express written permissionCopyright 2008, Austin Outcomes Research

Presentation Outline

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DO WE HAVE A PROBLEM?- Current data- Adverse effects- Opioids and workers’ compensation- What is in the guidelines- Special issues

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Current Data

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What is the Current Data?

Americans consume 80% of the global supply of opioids

•This includes 99% of the world’s hydrocodone and 2/3s of the world’s illegal drugs

•They constitute 4% of the world’s population

•Number of new opioid users1990: 573,000 2000: 2.5 million

Manchikanti L. National drug control policy and prescription drug abuse: facts and fallacies. Pain Physician. 2007;10:399-424.

Opioid Abuse: Current Data

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Current data on Prescription Drug Abuse

•The reported range of patient’s exhibiting problematic opioid use ranges from 2.8% to 62.2%- Seeking prescriptions from multiple providers- Forging prescriptions- Preoccupation with obtaining more opioids despite evidence of pain relief- Unsanctioned dose escalations

•Abuse rose 71% between 1997 and 2002•Opioid misuse reports range from 20% to 40%

Turk DC, et al. Clinical Journal of Pain 2008;24:497-508.

Opioid Abuse: Current Data

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Overdose Deaths: West Virginia- 2006 Death Rate from unintentional overdose

16.2/100,000 population (295)- US average: 5.6/100,000- Rate of opioid prescribing from 2000 to 2005

increased at a higher rate in WV- Pharmaceutical diversion: 63.1%- Doctor shopping: 21.4%- Only 44.4% had been prescribed these drugs

Opioid Abuse: Current Data

Hall AJ et al. JAMA 2008

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Why am I telling you this?

Only 19% of surveyed physicians received any medical school training in identifying prescription drug diversion

Only 40% received any training in identifying prescription drug abuse and addiction

43% do not ask about prescription drug abuse and diversion

1/3 do not obtain old records before prescribing controlled drugs

Manchikanti L. National drug control policy and prescription drug abuse: facts and fallacies. Pain Physician. 2007;10:399-424.

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Adverse Effects

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1. Sedation2. Cognitive impairment3. Respiratory depression4. Nausea5. Constipation6. Edema7. Hypogonadism8. Hormonal changes9. Immunosuppression10. Hyperalgesia

Opioid Abuse: Side Effects

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1. Higher disability2. Higher rates of healthcare utilization3. Higher rates of tobacco and other substance

abuse4. Higher levels of depression

Opioid Abuse: Side Effects (psychosocial)

Dersch J et al. Spine 2008: 2219-27

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Opioids and Worker’s Compensation

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Opioids and Workers’ Compensation

Webster et al study

Controlling for age, gender, job tenure, and LBP severity, the receipt of higher amounts of morphine equivalent medications in early treatment was associated with:

Prolonged disability Higher medical costs Higher costs of surgery Late use of opioids

Webster BS, et al. Relationship between early opioid prescribing for acute occupational low back pain and disability duration, medical costs, subsequent surgery and late opioid use. Spine. 2007 Sep 1;32(19):2127-32.

Opioids and Workers’ Compensation

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Opioids and Workers’ CompensationThese findings suggest that the intensive use of opioids for the management of acute LBP may not be effective for:

• Long-term pain reduction

• Improving function

• May be counterproductive to recovery

Opioids and Workers’ Compensation

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Risk Factors

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Psychosocial factors may be better predictors of pain and disability than physical or diagnostic factors

Chronic pain patients have an increased prevalence of:

- Depression - Anxiety- Substance abuse/dependence- Somatization and personality disorders

Opioids and Workers’ Compensation

Dersch J, et al. Spine 2007;1917-25

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Substance abusers have a higher rate of:

- Psychiatric comorbidity: Depression; Anxiety; Personality disorders

- History of physical and sexual abuse- Use of other substances known for dependence- Tobacco dependence- Family history of substance abuse

Opioids and Workers’ Compensation

Dersch J, et al. Spine 2007;1917-25

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Evidence for use of Opioids for

Neuropathic Pain

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Opioids for Neuropathic Pain

Eisenberg et al. Cochrane 2006 The use of opioids for neuropathic pain remains

controversial Opioids have high side effect profiles Studies are small and have yielded equivocal

results There is no established long-term risk-

benefit ratio

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Opioids for Neuropathic Pain

Short-term studies only provided equivocal evidence regarding efficacy

Intermediate-term studies demonstrated significant efficacy of opioids over placebo

Further randomized controlled trials are need to establish long-term efficacy, safety (including addiction potential) and effects on quality of life.

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When to use Opioids

When moderate to severe pain is having an adverse impact on function or quality of life

Benefits outweigh risk

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What is in the Guidelines?

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APS/AAPM Guidelines

Prior to initiating treatment:

Conduct a H&P including assessment of risk of substance abuse, misuse, or addiction

Obtain Informed Consent: includes goals, expectations, potential risks, and alternatives to treatment

Consider a written management plan to document patient and clinician responsibilities

The initial treatment should be considered a trial.

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ODG: Indicators of Poor Outcomes

Little or no relief with acute or subacute treatment

There is evidence of psychiatric pathology such as conversion disorder, somatization disorder, pain associated with psych factors (depression, anxiety, or history of previous substance abuse)

Patient requests opioids and there are inconsistencies in the history, presentation, and physical findings.

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ODG: Steps Before the Trial

Obtain at least one physical and psychosocial assessment

“When subjective complaints do not correlate with imaging studies and/or physical findings and/or psychosocial concerns exist, a second opinion with a pain specialist and psychological assessment should be obtained.”

Sullivan 2006, Sullivan 2005, Wilsey 2008, Savage 2008, Ballyantyne 2007

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ODG: On-Going Management

Prescriptions from a single practitioner Lowest possible dose to improve pain and

function Maintain ongoing review of outcomesFour A’s: analgesia; activities of daily living;

adverse effects; aberrent drug-taking behavior. Urine drug screening for abuse, addiction or

poor pain control (Webster, 2008)

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ODG: On-Going Management

Document misuse Consult: multidisciplinary pain clinic

- Doses of opioids are required beyond that usually required for the condition- Pain does not improve in 3 months

Consider a psych consult if there is evidence of depression or anxiety.

Consider an addiction consult if there is evidence of substance abuse

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ODG: When to Discontinue

No overall improvement in function Continued pain with evidence of intolerable

adverse effects and lack of significant benefit (lack of improved function at high doses with persistent pain, i.e. > 120 mg MED)

Evidence of serious non-adherence

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ODG: When to Continue

The patient has returned to work The patient has improved function and pain

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Special Issues

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What about Patients at High Risk?

Closer monitoring Random urine drug screens Involvement of family/partner Consider a consultation with a mental Health or

addiction specialist

Urine drug screens are also recommended periodically for all patients to confirm adherence.

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What about those frequent escalations?

WHY? Is there evidence of disease progression? Is there evidence of another pain generator? Is there evidence of issues such as secondary

gain, exacerbation of underlying depression or anxiety?

Is there evidence of development of addiction?

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What about those frequent escalations?

HISTORY OF RESPONSE TO OPIOIDS Has the patient responded to opioids in the

past?

IF SO: IS THIS TOLERANCE? IS THIS OPIOID HYPERALGESIA?

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Opioid Hyperalgesia

Patients who receive opiate therapy sometimes develop unexpected changes in their response to opioids.

Development of abnormal pain (hyperalgesia) Change in pain pattern Persistence in pain at higher levels than expected.

Opioids in this case actually increase rather than decrease sensitivity to noxious stimuli.

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Diagnosis of Opioid Hyperalgesia

Opioid trial (assumes there has been previous improvement)

IMPROVEMENT Tolerance

NO IMPROVEMENT Possible opioid hyperalgesia A pain condition that is non-opioid responsive

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Treatment of Opioid Hyperalgesia

Wean the dose Rotate opioids Use of adjuvant pain medications Further evaluation by a specialist with additional

expertise in psychiatry, pain medicine, or addiction medicine

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What if the diagnosis is addictive disease?

YOU ARE GOING TO DO THE EXACT SAME THING

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How do we stop opioids?

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Thank Youcontact Info: snovak@austinor.com

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