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3/31/2017 1 RESPONSIBLE OPIATE PRESCRIBING CRESTA JONES MD DISCLOSURES No conflicts to report OBJECTIVES Understand the scope and extent of the opiate abuse crisis in the United States Demonstrate appropriate opiate prescribing for both acute and chronic pain Demonstrate appropriate use of prescription data monitoring programs (PDMPs), including as they apply to Wisconsin state law

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Page 1: RESPONSIBLE OPIATE PRESCRIBING · TREATMENT OF ACUTE PAIN Cochrane review – acu te postoperative pain Number needed to treat (NNT) 50% maximum pain relief 4-6 hours, all types of

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RESPONSIBLE OPIATE PRESCRIBINGCRESTA JONES MD

DISCLOSURES

No conflicts to report

OBJECTIVES

Understand the scope and extent of the opiate abuse crisis in the United States

Demonstrate appropriate opiate prescribing for both acute and chronic pain

Demonstrate appropriate use of prescription data monitoring programs (PDMPs), including as they apply to Wisconsin state law

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THE OPIOID EPIDEMIC : US stats

Opioid overuse/abuse is an epidemicOpioids – leading cause of injury death Continuing to increase

Economic impact

$55 billion – health and social costs related to prescription opioid abuse per year

$20 billion – emergency department and inpatient care for opioid poisonings

hhs.gov/opioids

Just another day in the US….....

650,000 opioid prescriptions dispensed3900 people initiate nonmedical use

prescription opioids580 people initiate heroin use

hhs.gov/opioids

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cdc.gov

cdc.gov

cdc.gov

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THE OPIOID EPIDEMIC : WI

163,000 opiate use disorder Leading cause of injury deaths in Wisconsin

Motor vehicle accidents, suicide, firearms Prescription opioids – more overdose deaths

than heroin + cocaine

dhs.wisconsin.gov/publications/p01129.pdf

dhs.wisconsin.gov

Who uses opiates?

JAMA Psychiatry 2014

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They started with a prescription….

…..and they are women.

HOW DID THIS HAPPEN?

Increased prescriptions

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HOW DID THIS HAPPEN?

Increased prescriptions

1991: 76 million RX

HOW DID THIS HAPPEN?

Increased prescriptions

1991: 76 million RX 2014:

HOW DID THIS HAPPEN?

Increased prescriptions

1991: 76 million RX 2014, 240 million RX =

Every US adult - 5 mg hydrocodone every 6 hours for 45 days

hhs.gov/opioids

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Opiate use disorder – United States

5% of the world population…..

…...80% of the world’s opiates!

www.samhsa.gov, March 2015

HOW DID THIS HAPPEN?

Increased social acceptability for use

HOW DID THIS HAPPEN?

Increased acceptability for use History – acute and cancer pain only 1996 – extended release for non – cancer pain

Oxycontin - ER “non addictive” Based on 1 year addiction rates 1%Postoperative IV narcotics

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HOW DID THIS HAPPEN?

Aggressive marketing by pharmaceutical companies

SINCE 1999, OPIOID PRESCIPTIONS HAVE QUADRUPLED….

BUT REPORTED PAIN REMAINS UNCHANGED!

McNett, M – Wisconsin Medical Society

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OPIATE PRESCRIBING GUIDELINES

www.wisconsinmedicalsociety.org

www.cdc.gov

www.dsps.wi.gov

www.painphysicianjournal.com

OPIATE PRESCRIBING GUIDELINES

www.dsps.wi.gov

OPIATE PRESCRIBING GUIDELINES Address acute and chronic pain Chronic – longer than 3 months, past expected

tissue healing Not for active cancer treatment, end-of-life,

palliative care Not designed for pediatric pain

www.dsps.wi.gov

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1. EVALUATING PAIN

Pain is subjective Patient reported measures We must accept the patient’s report of pain….

Commensurate with causative factors? Factors adequately evaluated?Already addressed with non-opioid therapy?

2. TREATMENT OF ACUTE PAIN

Consider non-opioid first Opioid – START LOW AND GO SLOW!

Most less than 3 days (MAX: 5 days) CDC = 7 days

Consider med you can refill (APAP/codeine)Consider 2 small Rx, specific refill dates

TREATMENT OF ACUTE PAIN

Cochrane review – acute postoperative pain Number needed to treat (NNT)

50% maximum pain relief 4-6 hours, all types of surgery

Medication Number needed to treatIbuprofen 200mg/APAP 500 mg 1.6Naproxen 2.7Oxycodone 5mg/APAP 325 mg 2.7Oxycodone 15 mg 4.6

Moore et al., 2015

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TREATMENT OF ACUTE PAIN

Cochrane review – acute postoperative pain Number needed to treat (NNT)

50% maximum pain relief 4-6 hours, all types of surgery

Medication Number needed to treatIbuprofen 200mg/APAP 500 mg 1.6Naproxen 2.7Oxycodone 5mg/APAP 325 mg 2.7Oxycodone 15 mg 4.6

Moore et al., 2015

Hill MV, et al, 2017 642 outpatient surgical procedures Partial mastectomies, laparoscopic cholecystectomy,

laparoscopic/open inguinal hernia repair Opiate naive patients

Hill et al., 2017

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Hill et al., 2017

Hill et al., 2017

Hill et al., 2017

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71% of opioid pills prescribed were NOT taken!!

Hill et al., 2017

What to do with all those extra meds?

Fire safe storage DEA National Drug Take-Back Days – April 29,

2017 Sealable plastic bag with water + dirt, cat

litter, coffee grounds Away from children Out of home for open house, social events

etc.

fda.gov

3. IDENTIFY AND TREAT THE CAUSE OF PAIN

Address the underlying condition as the primary objective

Avoid opiates if unwilling to obtain definitive treatment for condition causing pain

Avoid if medical condition present is not reasonably expected to cause pain severe enough for opioids Non-anatomic pain, residual pain at old surgical sites

Refer patient if needed

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4. OPIOIDS ARE NOT ALWAYS THE FIRST CHOICE : ACUTE PAIN

Evidence for opioids is weak Try first

Acetaminophen/NSAIDs Lidocaine gel, biofreeze PT/OT Manipulation, massage Cognitive behavioral therapy

If severe enough for opioids, ALWAYS use in combination with other treatments

OPIOIDS ARE NOT ALWAYS THE FIRST CHOICE : ACUTE EXTENDED PAIN

Look for complications of acute pain: Surgical complication Nonunion of fracture Constipation as side effect of treatment

Complication ruled out, transition to non-opioid treatment

OPIOIDS ARE NOT ALWAYS THE FIRST CHOICE : ACUTE EXTENDED PAIN

Weaning opioids for acute extended pain (more than one week)

Decrease 10-25% per week Non-narcotics for acute pain treatment Start treatment for chronic pain – refer if indicated

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OPIOIDS ARE NOT ALWAYS THE FIRST CHOICE : CHRONIC PAIN

Past expected healing >3 months Studies– few benefits, substantial increase mortality

72% INCREASE IN CARDIOVASCULAR MORTALITY No quality evidence to support use > 6 months Already initiated

Close monitoring, PDMP Refer for additional treatment Contract – no early fills, no other fills, urine drug screen

Patient obligations : opiate prescribing

I will not increase my dose or use without permission. I will not obtain opioids from other prescribers, or allow them to

adjust my dose. I will use the medication exactly as directed. I will never share, sell or allow others access to my medication. I will not receive early refills. I will not abuse other drugs or alcohol during my treatment. I will bring my pills and medication bottles to each appointment.

Patient obligations: opiate prescribing

I will call the office at least 2 business days before I need a refill. If I miss my appointment, I may not get a refill. I will not call for opioids during evenings, holidays or weekends. I will only use one pharmacy for my opioid prescriptions. I will give a urine drug screen anytime I am asked. I will notify the office as soon as possible of any new medical

condition. I will not drive or use heavy machinery while taking opioids. I will follow up as requested. I agree to allow my provider to contact all my other caregivers as

needed.

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wisconsinmedicalsociety.org, Opiate CME programming

OPIOIDS ARE NOT ALWAYS THE FIRST CHOICE : UNWILLING PATIENT

Patient unwilling to accept other treatments Questionable justification for non – use “nothing else works” Intolerance to all other treatments

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5. UTILIZE A SINGLE PROVIDER

Dedicated provider – primary care, pain specialist Check PDMP before start Ask about existing pain contracts Plan - acute pain outside office hours

Call immediately next office day Have ED contact primary prescriber

No early refills Fire safe

6. EXACERBATIONS OF CHRONIC PAIN

Avoid chronic pain treatment in the emergency dept.

Contact chronic pain doctor Avoid IV/IM opiates – preferred agent

hydromorphone Refer back to primary provider

7. UTILIZING THE PDMP

Patient history of controlled substance prescriptions

Prescription Data Monitoring Program (PDMP) Currently available in 49 states Prior/ongoing opioid prescriptions Dangerous combinations increasing overdose

risk

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www.pdmp.wi.gov

WI ePDMP training materials, pdmp.wi.gov

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WI ePDMP training materials, pdmp.wi.gov

WI ePDMP training materials, pdmp.wi.gov

WI ePDMP training materials, pdmp.wi.gov

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WI ePDMP training materials, pdmp.wi.gov

WI CSB report, Oct 2016

Utilizing the PDMP

Red flags: Inconsistent use vs. prescribedMultiple/overlapping prescriptionsDramatic changes in doseFrequent early refillsConcurrent opiate and benzo prescribing

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Utilizing the PDMP: WI Act 266 (2015)

April 1, 2017 Before prescribing monitored drug Exceptions –

Hospice 3 days or less prescribed Drug administered directly Emergency situation prevents review of PDMP PDMP not operational, technical issue – must notify CSB

Act 266 – opiate CME prior to license renewal

8. PAIN MANAGEMENT PRIOR TO SURGERY AFFECTS RESULTS

Avoid opiates for chronic pain prior to surgery Preop opiate use:

Higher complication rates More postoperative narcotics Lower satisfaction rates after surgery

Chronic dosing will not address acute postsurgical pain Pain will be perceived as more, but should not last longer

9. BEWARE OF BENZODIAZEPINES

AVOID OPIATES + BENZOS 3x increase respiratory depression and annual mortality Neither demonstrates effectiveness more than 2 months Have patient chose, wean the other Concurrent use needs clearly documented rationale Similar effects with alcohol

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Treatment Increase annualized mortality

100 morphine mg equivalents (MME) 880%

100 MME + benzodiazepines 2640%

200 MME 2400%

200 MME + benzodiazepines 7200%

Avoid Opiates + Benzos

10. AVOID OXYCODONE

No more effective than other oral opioids More qualities that promote addiction to a greater

degree 2x euphoria of equivalent doses of oral morphine,

hydrocodone Harder to d/c treatment

Wightman et al, 2012

AVOID OXYCODONE

More abused 16 million >12 yrs age – lifetime nonmedical use of

oxycodone Illicit value $1/mg ($0.15/mg if acetaminophen added) Most frequently encountered pharmaceutical Rx by law

enforcement 2x as potent as morphine

Natl Survey on Drug Use and Health, 2014

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AVOID OXYCODONE

Meta-analysis RCTs examining abuse liability 9 studies Oxycodone

High subjectiveness attractiveness Increased reinforcing characteristics Increased abuse liability profile

Increased vs. oral morphine and oral hydrocodone

Wightman et al, 2012

AVOID OXYCODONE

”the use of oxycodone is discouraged” Should not be considered first-line Indications

Intolerance of other opioids Evaluated for increased risk of abuse

Zachy 2008, Schoedel 2011

11. OPTIMAL TREATMENT OF CHRONIC PAIN – FIRST EVALUATE

Targeted history/examination – signs of abuse Nature/intensity of pain – baseline, challenge credibility Current/past treatment, response Co-existing diseases Effect of pain on function Substance abuse history (self and family) Psychiatric disorders – bipolar, ADHD, depression Medical indication for opioids documented

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drugabuse.gov

12. OPTIMAL TREATMENT OF CHRONIC PAIN – TRIAL OF OPIOIDS

Initiation is a trial, NOT a commitment Objective goals – symptoms and function – prior to start

30% improvement for success Agree on goals before treatment Not met after trial – wean/discontinue opioids

13. OPTIMAL TREATMENT OF CHRONIC PAIN – RISK/BENEFIT

Consider and start and with every refill Reassess risks/benefits Wean/discontinue with increased risk Risk of imminent danger or diverted – stop and treat for

withdrawal

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OPTIMAL TREATMENT OF CHRONIC PAIN – RISK/BENEFIT

Exceptions to immediate cessation : Unstable angina Pregnancy

1st trimester - miscarriage3rd trimester –preterm labor

OPTIMAL TREATMENT OF CHRONIC PAIN – Ongoing risk assessment

Review of the Prescription Drug Monitoring Program

Periodic urine drug testing - at least yearly Periodic pill counts – at least yearly Violation review

www.healthpartners.com

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www.healthpartners.com

Urine Drug Screening

Medication Used Time detected in UrineCodeine 48 hoursHeroin (detected as morphine) 48 hoursHydromorphone 2-4 daysMethadone 3 daysMorphine 48-72 hoursOxycodone 2-4 days

Healthpartners.com

14. OPTIMAL TREATMENT OF CHRONIC PAIN – INFORMED CONSENT

Adverse effects of treatment Addiction Overdose Death

Treatment agreement Behaviors required of patient to keep them safe from

adverse effects

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15. INITIAL OPIOID TREATMENT -SHORT ACTING OPIOIDS

Start low, go slow Titrate dose with short acting – acute and chronic Consider long acting as majority of dose

If stabilized on short acting Chronic therapy

No indication for extended release treatment for acute pain

16. INITIAL OPIOID TREATMENT –LOWEST EFFECTIVE DOSE

Lowest effective dose, shortest duration Convert to morphine milligram equivalents (MME) for risk

assessment 50 MME– additional precautions 90 MME– no evidence for higher doses Must have appropriate documentation to go higher

Agencymeddirectors.wa.gov/Files/2015AMDGOpioidGuideline.pdf

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Agencymeddirectors.wa.gov

Agencymeddirectors.wa.gov

17. AVOID METHADONE

Variable metabolism and sensitivity Days to steady state (accumulation) Drug interactions Stronger respiratory depressant Prolonged QTc effect Increased risk overdose and death Use only with extensive training/experience – MAT

program

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18. OPIOIDS AND ILLICIT DRUG USE

Increase abuse, overdose, death Strongly discouraged Clear and compelling justification

19. INITIAL OPIOID TITRATION

Re-evaluation 1-4 weeksChronic therapy: 3 months or less

20. HOME NALOXONE Indications for use;

History of overdose (should be contraindication to prescribe)

Opioid dose > 50 MME/day Clinical depression Other measured risk (behaviors, family history, PDMP,

UDS) 0.4 IM/intranasal, repeat if needed Can be prescribed to family members Available without prescription in Wisconsin

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HOME NALOXONE

Wisconsin Act 200 (2014) Standing naloxone order – trained WI Pharmacists Request by individual, family member, friend Screened by pharmacist, pharmacy tech

Chronic opioids > 3 months Medication assisted treatment 90 MME/day or higher Medical comorbidities

21. THE RESPONSIBILITIES OF PRESCRIBING

Must care for complications Assess for behaviors of opiate use disorder Assist with addiction treatment

Providing directly Referring to treatment center

Discharging a patient for opioid use disorder alone not acceptable

DAST-10 questionnaire (drugabuse.gov)

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22. DISCONTINUING TREATMENT Not effective:

Decrease 10% weekly Discontinue at 5-10 MME

Increased risk: Decrease 25% weekly Discontinue at 5-10 MME Clonidine 0.2 mg oral twice daily Tizanidine 2 mg oral three times daily

Imminent risk of overdose, addiction, or diversion Stop immediately, treat for withdrawal

cdc.gov/drugoverdose/pdf/clinical_pocket_guide_tapering-a.pdf

Opioid Taper Tips

Who should taper? Requests dose reduction No meaningful improvement pain/function (at least

30%) > 50 MME with no benefit Opioids with benzodiazepines Signs of opiate use disorder Early warning signs for overdose : confusion, sedation,

slurred speech

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Opioid Taper Tips

Adjust the rate and duration of the taper based on reponse Don’t reverse the taper Pause or slow and treat withdrawal

When reach smallest available dose Extended interval between doses Stop when taken less than once daily

Address increased overdose risk if revert to original dose

Agencymeddirectors.wa.gov, 2017

cdc.gov, Mar 2016

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1. Non-opioid treatment preferred – chronic pain 2. Establish goals of treatment before starting 3. Review risks, benefits and responsibilities before

starting 4. Initiate treatment with immediate release medication 5. Prescribe lowest effective dose 6. Acute pain – 3 days typical, 7 days max

cdc.gov, Mar 2016

7. Evaluate risk of opiate-related harms –start/periodically

8. Re-evaluate benefits and harms – 1-4 weeks, at least every 3 mos.

9. Utilize PDMP at start, at least every 3 mos. 10. Urine drug screen at start, at least annually 11. Avoid opiates and benzodiazepines 12. Offer or arrange evidence based treatment if opiate

use disorder is diagnosed

cdc.gov, Mar 2016

CAN WE MAKE A DIFFERENCE?

FLORIDA 2010

Regulated pain clinics No dispensing of prescription opioids from offices Established PDMP

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MORE PROOF! NEW YORK

2010: PDMP before prescribing opiates 75% drop in patients with multiple prescribers

TENNESSEE 2012: PDMP before prescribing opiates 36% decline in patients with multiple prescribers

OREGON Established PDMP, Medicaid pre-auth high-dose methadone,

naloxone education and distribution, provider education 38% decrease prescription opioid overdose 58% decrease methadone overdose

THE OPIOID EPIDEMIC : WI

Heroin, Opiate, Prevention and Education (HOPE) Agenda John Nygren WI Assemblyman 17 pieces of legislation ID to pick up prescriptions (199), drug disposal

programs (198), pilot programs for treatment for underserved populations (195)

legis.wisconsin.gov

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Special considerations – our patients

Reproductive plan review Risk of neonatal abstinence Pre-pregnancy consultation

Chronic pain Maternal – Fetal Medicine Neonatology

Effective contraception

Conclusion The United States is currently experiencing an

unprecedented crisis in opiate use disorders Although there is no easy fix, we can contribute to the

solution Progress is made through responsible management of

acute and chronic pain Patient and provider education is key to optimal pain

management while also minimizing unnecessary opiate prescribing

References Ossiander EM. Using textual cause-of-death data to study drug poisoning. Am J

Epidemiol. 2014 Apr 1:179(7).

Hill MV, et al. Wide variation and excessive dosage of opioid prescriptions for common general surgical procedures. Ann Surg. 2017 Apr; 265(4):709-714.

Manchikanti L et al., Responsible, safe, and effective prescription of opioids for chronic non-cancer pain: American Society of Interventional Pain Physicians (ASIPP) guidelines. Pain Physician 2017 Feb;20(2S): S3-S92.

Moore RA et al., Single dose oral analgesics for acute postoperative pain in adults. Cochrane Database of Systematic Reviews, Sept 2015.

CDC Guideline for Prescribing Opioids for Chronic Pain – United States 2016. Dowell D et al. JAMA 2016 Apr 19/315(15):1624-45.

Zachny J and Gutierrez S. Subjective, psychomotor, and physiological effects profile of hydrocodone/acetaminophen and oxycodone/acetaminophen combination products. Pain Medicine 2008; 9(4):433-443.

Schoedel K et al. Positive and negative subjective effects of extended-release oxymorphone versus controlled-release oxycodone in recreational opioid users. J Opioid Manag 2011; 7(3):179-192.

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References Manchikanti et al. Opioid epidemic in the United States. Pain Phys 2012; 15:ES9-ES38

Manchikanti et al. Therapeutic opioids: a 10 year perspective on the complexities and complications of the escalating use, abuse and nonmedical use of opioids. Pain Phys 2008; 11:S63-S88.

National Survey on Drug Use and Health. DEA diversion, March 2014.

Wightman R et al. Likeability and abuse liability of commonly prescribed opiates. J Med Toxicol 2012; 8:335-40.