RESPONSIBLE OPIATE PRESCRIBING

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 1

THE OPIOID EPIDEMIC : US stats Opioid overuse/abuse is an epidemic Opioids 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 dispensed 3900 people initiate nonmedical use prescription opioids 580 people initiate heroin use hhs.gov/opioids 2

cdc.gov cdc.gov cdc.gov 3

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 4

They started with a prescription...and they are women. HOW DID THIS HAPPEN? Increased prescriptions 5

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 6

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 7

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 8

OPIATE PRESCRIBING GUIDELINES www.wisconsinmedicalsociety.org www.dsps.wi.gov www.painphysicianjournal.com www.cdc.gov 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 9

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 treat Ibuprofen 200mg/APAP 500 mg 1.6 Naproxen 2.7 Oxycodone 5mg/APAP 325 mg 2.7 Oxycodone 15 mg 4.6 Moore et al., 2015 10

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 treat Ibuprofen 200mg/APAP 500 mg 1.6 Naproxen 2.7 Oxycodone 5mg/APAP 325 mg 2.7 Oxycodone 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 11

Hill et al., 2017 Hill et al., 2017 Hill et al., 2017 12

Hill et al., 2017 71% of opioid pills prescribed were NOT taken!! 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 13

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 14

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. 15

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 16

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 17

www.pdmp.wi.gov WI epdmp training materials, pdmp.wi.gov 18

WI epdmp training materials, pdmp.wi.gov WI epdmp training materials, pdmp.wi.gov WI epdmp training materials, pdmp.wi.gov 19

WI epdmp training materials, pdmp.wi.gov WI CSB report, Oct 2016 Utilizing the PDMP Red flags: Inconsistent use vs. prescribed Multiple/overlapping prescriptions Dramatic changes in dose Frequent early refills Concurrent opiate and benzo prescribing 20

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 21

Avoid Opiates + Benzos Treatment Increase annualized mortality 100 morphine mg equivalents (MME) 880% 100 MME + benzodiazepines 2640% 200 MME 2400% 200 MME + benzodiazepines 7200% 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 22

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 23

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 24

OPTIMAL TREATMENT OF CHRONIC PAIN RISK/BENEFIT Exceptions to immediate cessation : Unstable angina Pregnancy 1 st trimester - miscarriage 3 rd 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 25

www.healthpartners.com Urine Drug Screening Medication Used Codeine Heroin (detected as morphine) Hydromorphone Methadone Morphine Oxycodone Time detected in Urine 48 hours 48 hours 2-4 days 3 days 48-72 hours 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 26

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 27

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 28

18. OPIOIDS AND ILLICIT DRUG USE Increase abuse, overdose, death Strongly discouraged Clear and compelling justification 19. INITIAL OPIOID TITRATION Re-evaluation 1-4 weeks Chronic 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 29

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) 30

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 31

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 32

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 33

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 34

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. 35

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. 36