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©2015 MFMER | slide-1
The Opioid Epidemic: Current State and the Path Forward
Teresa Rummans, MDJenna K Lovely, Pharm D, BCPSJulie Cunningham, Pharm D, BCPPHalena Gazelka, MD
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Disclosures• No relevant financial disclosures
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Objectives• Describe the current prevalence of opioid
misuse in the US.• Identify non-opioid alternatives for the treatment
of pain• Recognize the correlation with acute opioid
prescribing and chronicity of opioid use.• Describe current Mayo Clinic Enterprise
initiatives to curb opioid prescribing.
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Opioids and Addition: Origin of the Myth
https://www.youtube.com/watch?v=DgyuBWN9D4w
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Prevalence of Substance Misuse in General• Substance abuse now is as prevalent as
diabetes and 1.5 x more common than all the cancers combined
• 50% of those with substance misuse also have mental illness
• More are dying from substance abuse (opioids being the main one) than car accidents annually
• Yet only 10% get any help JAMA, 2016
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Opioid Misuse in US• Affects people of all ages, ethnicities, and all
socioeconomic groups• “2.1 million people in the United States suffering
from substance use disorders related to prescription opioid pain relievers in 2012 and an estimated 467,000 addicted to heroin.”
• Opioid abuse is increasing dramatically• 3,900 individuals start non-medical use of
prescription opioids each day • 580 individuals start using heroin each day
SAMHSA National Survey on Drug Use and Health, 2013
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0
10,000
20,000
30,000
40,000
50,000
60,000
70,000
1980 1985 1990 1995 2000 2005 2010 2015 2016
Drug Overdose Deaths, 1980-2016
deaths
59,000 to 65,000 people died fromoverdoses in the U.S. in 2016*
Peak car crash deaths (1972)
Peak HIV deaths (1995) *46,000
Peak gun deaths (1993) *39,000
• Katz J: Drug Deaths in American Are Rising Faster Than Ever (The Upshot), The New York Times; June 5, 2017.
• *Approximate Estimate per Data Obtained
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Prescription Trends
• Number of prescription opioids sold has nearly quadrupled since 1999
• More than 650,000 opioid prescriptions are filled everyday
• In Minnesota, there are 52-71 opioid prescriptions per 100 people
CDC
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Worldwide Statistics about Opioids
• 80% of all opioids in world are used in US with the fastest growing group of people in US using heroin being middle aged women
WHO,2016
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Opioid Misuse in Minnesota• In Minnesota, there were 2,273 opioid overdose
deaths between 2000-15 • In Olmsted County, there were 43 opioid deaths
between 2000-15 • 25 (~58%) of those were between 2012-15
MN Health Dept
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http://www.health.state.mn.us/news/pressrel/2016/drugoverdoses051316.html
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https://www.ag.state.mn.us/Office/PressRelease/20161123OpioidReport.pdf
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Unnecessary opioid exposure• Adolescents and adults reporting recent
nonmedical use of opioid medications obtain these medications through their family or friends
• Surgical meta-analysis • 42-71 % opioids prescribed went unused• Only 9 % met FDA recommended disposal methods
Bicket, Long, Provonost, et al JAMA Surg 2017
Substance Abuse and Mental Health Services Administration. Results from the 2013 National Survey on Drug Use and Health: mental health findings. http://www.samhsa.gov/data/sites/default/files/NSDUHmhfr2013
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Stop the cycle for each area you serveExample: ‘vicious cycle’ of opioid use in IBD- IBD pt paradoxical response of hyperalgesia
Loftus et al Am J Gastroenterology 2005
- Narcotic bowel syndrome (NBS) Drossman DA, Szigethy EM. Am J Gastroenterol. 2014
• Higher overall use in this patient population leading to a high preoperative use compared to other diseases
Submitted for publication: Lovely, Larson et al 2017
- Opioids 30 days prior to ostomy surgery had increased risk of postoperative complications (p=0.03, OR=2.57, 95 % CI=1.16–5.53) Hirsch et al DCR 2013
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How can we reduce opioid exposure?• Proactive plans for managing pain
• Maximize non-pharmacologic options• Ex: Counseling, Physical Therapy, Cognitive Behavior
Therapy, Surgery where indicated, etc.
• Maximize non-opioid options• Acetaminophen, NSAIDs, adjunct agents
• Systematic approach for dismissal• Paradigm shift for ‘just in case’ prescribing
• Systematic approach for patient calls/triage
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Myth/Myth buster• Myth: Surgery = Opioid
Myth Buster: Only subsets of patients need post operative opioids.• Examples:
• 24% require no post op opioids in CRS with Enhanced Recovery Pathway
• 25% require no post op opioids in Ortho with Total Joint Pathway
Larson, Lovely, et al JACS 2011; Horlocker et al 2013, Hebl, Pagnano et al J Bone Joint Surg Am. 2005
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Myth/Myth buster:• Myth: Prescribing more opioids on dismissal,
reduces call backs/additional RXs.Myth Buster: 4286 CRS patients 2012-14• 20% of patients received additional opioid
• Regardless of dismissal opioid amount (range zero to 30,000 MME)
• More opioids on dismissal did nothing to change the ‘call back’ rate.
Submitted for publication Lovely, Huang, Meyers, Larson et al 2017
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Paradigm shift of “just in case” prescribing
• Patients do not need an opioid• Extra scripts/more tabs do not help• Increasing dose, additional scripts don’t prevent calls• I don’t have time to explain. MAKE THE TIME!• I don’t want backlash from the patient.
Ebbert, Philpot, Clements, Lovely et al Pain Medicine 2017
Of survey responses, 37 % were NOT confident in their ability to manage chronic (non-cancer) pain.
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We need a Paradigm Shift• Proactively plan for non-pharm and opioid sparing • Deprescribe: focused ‘taper to off’ plan
• Currently only 6% have taper OFF Plan• Set patient and team expectations
• Define when and how to dispose properly
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Opioid use in Chronic pain: Controversial
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CDC: Goals for safer opioid prescribing
Reduce use to only when
benefit outweighs
risk.
For acute pain,
prescribe only for
expected duration of
pain.
Use the lowest
effective dose.
CDC: Vital Signs, July 2017
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• Chronic opioid use often begins with treatment of acute pain episode
• Random 10% sample 2006-2015 IMS Lifelink+ database
• Episode defined as: continuous use of opioids with a gap of not more than 30 days)
• Reviewed Opioid prescriptions in opioid naïve patients; • Defined as no opioid prescription in past 6 months
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• Characteristics of acute prescriptions
• Higher dose on initiation• First prescription supply
exceeded 10 days or 30 days
• Pt received 3rd prescription• Cumulative dose >700
MME• Long acting opioid
formulations• Initial treatment with
tramadol
• Characteristics of patients
• Older• Female• Pain diagnosis prior to
opioid initiation• Initiated on higher
doses
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Acute Opioid Use and Relationship to Chronicity of Use • Statewide retrospective cohort review
• Opioid naïve users 2012-2013 (no use in previous 365 days) n= 536,767
• Long term users: 6 or more subsequent fills in next year; n= 26,785 (5%)
• Correlation with long term users:• Number of refills (2 = 10.6%; 4 or more = 26.1%)
• Cumulative MME during initiation month• 120 MME or less = 2%; >400 MME=
10.6%; >800 MME = 18.6%
Deyo RA et al. J Gen Intern Med 32(1):21-7. 2016
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Acute Use for Chronic Opioid patient• CDC principles still apply:
• For acute pain, prescribe only for expected duration of pain.
• Use the lowest effective dose.• Tips:
• Continue home opioid medications if possible• Higher opioid doses will generally be necessary after
surgery compared to opioid naïve patients• Wean quickly thereafter back to home dose by 7
days• Consider alternative strategies: epidural, nerve
block, pain consultHuxtable CA et al. Anaesth Int Care 39:804-23. 2011
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Case: SB• 71 year old female on fentanyl 75 mcg/hr + prn
oral opioids (unknown frequency) with acute fracture of arm due to fall S/P shoulder arthroplasty. Post op course:
• Fentanyl 75 mcg/hr Q72 hrs• Acetaminophen 1gm qid• Baclofen 20 mg qid• Hydromorphone PCA transition to po 6-8 mg
q3hr prn• Day prior to DC = 56 mg hydromorphone
(224 MME)• Transition to SNF
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CDC Guidelines (2016)Recommendations
• Chronic Opioid Use• Prescribe dose of <50
morphine milligram equivalents (MME)/day
• Carefully justify an increase to 50-90 MME
• Should avoid increasing dosage to ≥90 MME/day
• Justifying a decision to titrate dosage to ≥90 MME
• Very few benefits past this dose
• Evaluate benefits and harms with patients within 1 to 4 weeks
• Starting opioid therapy• Dose Escalation
• Clinicians should evaluate benefits and harms of continued therapy at least every 3 months
• If benefits do not outweigh harm work with patients to taper
• Continue to optimize non-opioid and nonpharmacological therapies.
Dowell et al. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. Recommendations and Reports / March 18, 2016 / 65(1);1–49
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• Lack of solid evidence for tapering • Taper speed advice:
• 25% reduction of previous daily dose to prevent acute withdrawal
• Fast or ultrafast taper con be considered when inpatient taper is needed
• First reduce to smallest available dose unit and then increase time between doses
• Author center experience: decrease by 10% every 5-7days until 30% of original dose is reached, followed by weekly 10% reductions
Berna C et al. Mayo Clin Proc. 2015;90:828-842
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Opioid Work Group Formation
Formed by MCCPC (Dr. Mike Harper)
Charges• High level internal assessment of enterprise risk of overprescribing
and diversion• Review internal and external existing guidelines, policy, workflows,
and controls governing opioid prescription process• Review and document current state best practices• Identification of best practice (consider similar method developed
by drug diversion committee)• Define a standardization plan starting with areas of highest risk• Develop timeline and implementation plan for diffusing best
practices
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Wide Variation and Over-Prescription of Opioids following Elective Surgery
Thiels CA, Anderson SS, Ubl DS, Hanson KT, Bergquist WJ, Gazelka HM, Cima RR, Habermann EBAccepted by the American Surgical Association; Presented at the Department of Surgery’s Balfour Research Day
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Goal• Describe opioid prescribing practices across
surgical specialties at our three main sites with the ultimate goal of optimizing post-operative prescription practice.
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Methods
• Adults undergoing 25 common elective procedures 2013-2015• Mayo Clinic Rochester, Scottsdale, or Jacksonville
• ACS-NSQIP institutional data• Patient and procedural characteristics• Complications
• Pharmacy data• Opioids prescribed at discharge (outcome of interest)• Identification of opioid naïve patients
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Results• 7651 adults
underwent one of 25 common elective procedures 2013-2015 and were sampled for three-site institutional ACS-NSQIP data
46511408
1592
RST FL AZ
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Opioids Prescribed at DischargeOral Morphine Equivalents (OME):
• Range: 0-3000+• Mean 675• Median 450
• Interquartile range (225,750)
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Median OME Prescribed at Dischargeby Site
400
675
405
0
100
200
300
400
500
600
700
800
MCR MCF MCA
p< 0.001
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Response…• Standardized guidelines for ortho surg patients
• Enacted July 1, 2017
• Plan: survey patients to study • How much they are using• What do they do with the leftover opioid• How was their pain control/were they satisfied• Did they call for refills• Etc.
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Result• OWG developed:
Mayo Clinic Guidelines for Acute Opioid Prescribing
Mayo Clinic Guidelines for Chronic Opioid Prescribing
• These have now been endorsed by the CPC, leading to the next phase of the project:
Mayo Clinic Opioid Stewardship Program (OSP)
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Opioid Stewardship Program Timeline 2017-2018OCT ‘17 JAN ‘18MAY ‘17 JUL ‘17
EPIC Roll-out prescribing dashboards to provide real-time monitoring
RST: Iterative pilots & diffusion targeting improvement in acute prescribing
Ongoing Stewardship
Project Oversight Group Created & Sub-groups
Established
Project Oversight
Project Sub-groups
Transition to on-going program
RST ECH MCHS: Iterative pilots & diffusion of chronic guidelines
PMP interface planning & implementation
EPIC Roll-out Opioid registry & workflows
Inventory patient / staff education
needs & resources
Implementation Plan to meet immediate education needs
Patient / staff : close gaps in education resources
Planning & implementation of Opioid Stewardship Committee
Plan for site-specific oversight / structure Define site targets
Ongoing Stewardship
Create robust toolkits targeting roles; leadership
AME guidelines, care processes
Jun ‘18
Start: May, 2017
End: Transition to On-going Structure June 1, 2019
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Primary Goals of OSP• Consistent, safe approach to opioid prescribing throughout the enterprise
• Reduce risk: to patients, to providers, to institutions, to the public
• Educate: providers, patients, staff on appropriate use and monitoring of opioids – and on alternative therapies
• Monitor: the effects of changes on prescribing practices, pain management, patient and provider satisfaction, etc.
• Make the guidelines “do-able” – EMR, workflows, staffing, etc
• Empower each Mayo institution, clinic, hospital, department, and division to “self regulate” opioid prescribing/monitoring
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Learning Assessment Question #1• The rate of opioid related deaths has surpassed
then number of motor vehicle related deaths in the US.
• True• False
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Learning Assessment Question #2• Proactive planning to optimize non-pharmacologic
and non-opioid options leads to reduced opioid use
• True• False
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Learning Assessment Question #3• There is not good evidence to support reducing
opioids quantities for acute pain.• True• False
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Learning Assessment Question #4• Quantities of opioids prescribed at the Mayo
Clinic following elective surgical procedures are generally less than 200 MME for the total prescription.
• True• False
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Questions & Discussion