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©2015 MFMER | slide-1 The Opioid Epidemic: Current State and the Path Forward Teresa Rummans, MD Jenna K Lovely, Pharm D, BCPS Julie Cunningham, Pharm D, BCPP Halena Gazelka, MD
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The Opioid Epidemic: Current State and the Path Forward › sites › ce.mayo.edu › files › PGR... · Teresa Rummans, MD Jenna K Lovely, Pharm D, BCPS Julie Cunningham, Pharm

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Page 1: The Opioid Epidemic: Current State and the Path Forward › sites › ce.mayo.edu › files › PGR... · Teresa Rummans, MD Jenna K Lovely, Pharm D, BCPS Julie Cunningham, Pharm

©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

Page 2: The Opioid Epidemic: Current State and the Path Forward › sites › ce.mayo.edu › files › PGR... · Teresa Rummans, MD Jenna K Lovely, Pharm D, BCPS Julie Cunningham, Pharm

©2015 MFMER | slide-2

Disclosures• No relevant financial disclosures

Page 3: The Opioid Epidemic: Current State and the Path Forward › sites › ce.mayo.edu › files › PGR... · Teresa Rummans, MD Jenna K Lovely, Pharm D, BCPS Julie Cunningham, Pharm

©2015 MFMER | slide-3

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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©2015 MFMER | slide-4

Opioids and Addition: Origin of the Myth

https://www.youtube.com/watch?v=DgyuBWN9D4w

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©2015 MFMER | slide-5

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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©2015 MFMER | slide-6

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

Page 7: The Opioid Epidemic: Current State and the Path Forward › sites › ce.mayo.edu › files › PGR... · Teresa Rummans, MD Jenna K Lovely, Pharm D, BCPS Julie Cunningham, Pharm

©2015 MFMER | slide-7

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

Page 8: The Opioid Epidemic: Current State and the Path Forward › sites › ce.mayo.edu › files › PGR... · Teresa Rummans, MD Jenna K Lovely, Pharm D, BCPS Julie Cunningham, Pharm

©2015 MFMER | slide-8

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

Page 9: The Opioid Epidemic: Current State and the Path Forward › sites › ce.mayo.edu › files › PGR... · Teresa Rummans, MD Jenna K Lovely, Pharm D, BCPS Julie Cunningham, Pharm

©2015 MFMER | slide-9

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

Page 10: The Opioid Epidemic: Current State and the Path Forward › sites › ce.mayo.edu › files › PGR... · Teresa Rummans, MD Jenna K Lovely, Pharm D, BCPS Julie Cunningham, Pharm

©2015 MFMER | slide-10

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

Page 11: The Opioid Epidemic: Current State and the Path Forward › sites › ce.mayo.edu › files › PGR... · Teresa Rummans, MD Jenna K Lovely, Pharm D, BCPS Julie Cunningham, Pharm

©2015 MFMER | slide-11

http://www.health.state.mn.us/news/pressrel/2016/drugoverdoses051316.html

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©2015 MFMER | slide-12

https://www.ag.state.mn.us/Office/PressRelease/20161123OpioidReport.pdf

Page 13: The Opioid Epidemic: Current State and the Path Forward › sites › ce.mayo.edu › files › PGR... · Teresa Rummans, MD Jenna K Lovely, Pharm D, BCPS Julie Cunningham, Pharm

©2015 MFMER | slide-13

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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©2015 MFMER | slide-14

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

Page 15: The Opioid Epidemic: Current State and the Path Forward › sites › ce.mayo.edu › files › PGR... · Teresa Rummans, MD Jenna K Lovely, Pharm D, BCPS Julie Cunningham, Pharm

©2015 MFMER | slide-15

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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©2015 MFMER | slide-16

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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©2015 MFMER | slide-17

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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©2015 MFMER | slide-18

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.

Page 19: The Opioid Epidemic: Current State and the Path Forward › sites › ce.mayo.edu › files › PGR... · Teresa Rummans, MD Jenna K Lovely, Pharm D, BCPS Julie Cunningham, Pharm

©2015 MFMER | slide-19

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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©2015 MFMER | slide-20

Opioid use in Chronic pain: Controversial

Page 21: The Opioid Epidemic: Current State and the Path Forward › sites › ce.mayo.edu › files › PGR... · Teresa Rummans, MD Jenna K Lovely, Pharm D, BCPS Julie Cunningham, Pharm

©2015 MFMER | slide-21

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

Page 22: The Opioid Epidemic: Current State and the Path Forward › sites › ce.mayo.edu › files › PGR... · Teresa Rummans, MD Jenna K Lovely, Pharm D, BCPS Julie Cunningham, Pharm

©2015 MFMER | slide-22

• 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

Page 23: The Opioid Epidemic: Current State and the Path Forward › sites › ce.mayo.edu › files › PGR... · Teresa Rummans, MD Jenna K Lovely, Pharm D, BCPS Julie Cunningham, Pharm

©2015 MFMER | slide-23

• 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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©2015 MFMER | slide-24

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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©2015 MFMER | slide-25

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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©2015 MFMER | slide-26

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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©2015 MFMER | slide-27

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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©2015 MFMER | slide-28

• 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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©2015 MFMER | slide-29

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©2015 MFMER | slide-30

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

Page 31: The Opioid Epidemic: Current State and the Path Forward › sites › ce.mayo.edu › files › PGR... · Teresa Rummans, MD Jenna K Lovely, Pharm D, BCPS Julie Cunningham, Pharm

©2015 MFMER | slide-31

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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©2015 MFMER | slide-32

Goal• Describe opioid prescribing practices across

surgical specialties at our three main sites with the ultimate goal of optimizing post-operative prescription practice.

Page 33: The Opioid Epidemic: Current State and the Path Forward › sites › ce.mayo.edu › files › PGR... · Teresa Rummans, MD Jenna K Lovely, Pharm D, BCPS Julie Cunningham, Pharm

©2015 MFMER | slide-33

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

Page 34: The Opioid Epidemic: Current State and the Path Forward › sites › ce.mayo.edu › files › PGR... · Teresa Rummans, MD Jenna K Lovely, Pharm D, BCPS Julie Cunningham, Pharm

©2015 MFMER | slide-34

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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©2015 MFMER | slide-35

Opioids Prescribed at DischargeOral Morphine Equivalents (OME):

• Range: 0-3000+• Mean 675• Median 450

• Interquartile range (225,750)

Page 36: The Opioid Epidemic: Current State and the Path Forward › sites › ce.mayo.edu › files › PGR... · Teresa Rummans, MD Jenna K Lovely, Pharm D, BCPS Julie Cunningham, Pharm

©2015 MFMER | slide-36

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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©2015 MFMER | slide-37

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.

Page 38: The Opioid Epidemic: Current State and the Path Forward › sites › ce.mayo.edu › files › PGR... · Teresa Rummans, MD Jenna K Lovely, Pharm D, BCPS Julie Cunningham, Pharm

©2015 MFMER | slide-38

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)

Page 39: The Opioid Epidemic: Current State and the Path Forward › sites › ce.mayo.edu › files › PGR... · Teresa Rummans, MD Jenna K Lovely, Pharm D, BCPS Julie Cunningham, Pharm

©2015 MFMER | slide-39

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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©2015 MFMER | slide-40

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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©2015 MFMER | slide-41

Learning Assessment Question #1• The rate of opioid related deaths has surpassed

then number of motor vehicle related deaths in the US.

• True• False

Page 42: The Opioid Epidemic: Current State and the Path Forward › sites › ce.mayo.edu › files › PGR... · Teresa Rummans, MD Jenna K Lovely, Pharm D, BCPS Julie Cunningham, Pharm

©2015 MFMER | slide-42

Learning Assessment Question #2• Proactive planning to optimize non-pharmacologic

and non-opioid options leads to reduced opioid use

• True• False

Page 43: The Opioid Epidemic: Current State and the Path Forward › sites › ce.mayo.edu › files › PGR... · Teresa Rummans, MD Jenna K Lovely, Pharm D, BCPS Julie Cunningham, Pharm

©2015 MFMER | slide-43

Learning Assessment Question #3• There is not good evidence to support reducing

opioids quantities for acute pain.• True• False

Page 44: The Opioid Epidemic: Current State and the Path Forward › sites › ce.mayo.edu › files › PGR... · Teresa Rummans, MD Jenna K Lovely, Pharm D, BCPS Julie Cunningham, Pharm

©2015 MFMER | slide-44

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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©2015 MFMER | slide-45

Questions & Discussion