GA RY M. F RA NKLI N, MD, MPH

MEDI CA L D IRE CTORWA DE PT OF L AB OR A ND IN DUSTR IE S

RESEA RC H PR OFE SSORDEP TS OF ENV I RONM ENTA L & OCCU PATION A L HE A LTH

SCIE NCE S, N EUR OLOGY, AN D HE A LTH SERV ICE SUNI V ERSITY OF WA SHI NGTON

Meeting the Challenge of the Opioid Epidemic

-UC Irvine Medical Grand Rounds-

Jan 29, 2013

"To write prescriptions is easy,but to come to an understanding with people is hard."-- Franz Kafka, “A Country Doctor”

By the late 1990s, at least 20 states passed new laws, regulations, or policies moving from near prohibition of opioids to use without dosing guidance WA law: “No disciplinary action will be taken

against a practitioner based solely on the quantity and/or frequency of opioids prescribed.” (WAC 246-919-830, 12/1999)

Laws were based on weak science and good experience with cancer pain

Change in National Norms for Use of Opioids for Chronic, Non-cancer Pain

WAC-Washington Administrative Code4

Similarities Between Illicit & Prescription Drugs

Portenoy and Foley Pain 1986; 25: 171-186

Retrospective case series chronic, non-cancer pain

N=38; 19 Rx for at least 4 years2/3 < 20 mg MED/day; 4> 40 mg MED/day24/38 acceptable pain reliefNo gain in social function or employment

could be documentedConcluded: “Opioid maintenance therapy can

be a safe, salutary and more humane alternative…”

7

Pain champions, Pharma surrogates, and Astroturf organizations led the way

Older falsehoods Opioids not as addicting as we used to think

(<1%)-”pseudoaddiction” coined No ceiling on dose-standard was to increase dose to address

tolerance Pain as the fifth vital sign Patients should leave the ER in comfort-drove satisfaction scoresMore recent falsehoods* Were it not for the heavy hand of law enforcement/gov’t, we’d be

fine It’s all a methadone problem It’s all abuse It’s just a cluster of pill mills and a few others

*http://www.huffingtonpost.com/radley-balko/prescription-painkillers_b_1240722.html

Overall, the evidence for long-term analgesic efficacy is weak

Putative mechanisms for failed opioid analgesia may be related to rampant tolerance

The premise that tolerance can always be overcome by dose escalation is now questioned

100% of patients on opioids chronically develop dependence More than 50% of patients on opioids for 3

months will still be on opioids 5 years laterBallantyne J. Pain Physician 2007;10:479-91; Martin BC et al. J Gen Intern Med 2011; 26: 1450-57

Limitations of Long-term (>3 Months) Opioid Therapy

8

Dentists and Emergency Medicine Physicians were the main prescribers for patients 5-29 years of age

0-4 5-9 10-14 15-19 20-24 25-29 30-39 40-59 60+0

100

200

300

400

500

600

700

800

900

GP/FM/DOIMDENTORTH SURGEM

Age Group

Rate

per

10,

000

pers

ons

5.5 million prescriptions were prescribed to children and teens (19 years and under) in 2009

Source: IMS Vector ®One National, TPT 06-30-10 Opioids Rate 2009

10

Opioid-Related Deaths, Washington State Workers’ Compensation,

1992–2005

Franklin GM, et al, Am J Ind Med 2005;48:91-9

1995

1996

1997

1998

1999

2000

2001

2002

02468

101214

Definite Probable Possible

Deat

hs

Year

‘95 ‘97 ‘00 ‘02‘96 ‘98 ‘99 ‘01

11

Age-adjusted rate per

100,000 population

Unintentional and Undetermined Intent Drug Overdose Death Rates by State, 2007

MDMANHRICTDEDCVTNJ

12.512.511.711.111.1

9.88.8 7.97.5

National Vital Statistics System, http://wonder.cdc.gov

Moore, et al. Serious Adverse Drug Events Reported to the Food and Drug Administration, 1998-2005 - Arch Intern Med. 2007;167(16):1752-1759

Evidence linking specific doses to morbidity and mortality

Dunn et al, Ann Int Med 2010; 152: 85-92Risk of morbidity and mortality increased 8.9 fold

at 100 mg MEDEditorial-McLellan-White House Office of National

Drug Control Policy “Smarter, more responsible (prescribing) practices are the

only hope to avoid tragic, avoidable deaths”Braden et al, Arch Int Med 2010; 170: 1425-

32Opioid doses >120 mg/day MED and use of long acting Schedule II opioids associated with incresed risk of alcohol- or drug- related ER visit

*

Evidence linking specific doses to morbidity and mortality

Bohnert et al, JAMA 2011; 305: 1315-21• Risk of mortality 7.18 (chronic pain), 6.64

(acute pain)

Gomes et al, Arch Int Med 2011; 171: 686-91• Risk of mortality 2.04 at 100 mg and 2.88 at

200 mg

0

100

200

300

400

500

600

700

800

'97 '98 '99 '00 '01 '02 '03 '04 '05 '06 '07

15

Unintentional Overdose Deaths Involving Opioid Analgesics Parallel Opioid Sales

United States, 1997–2007

National Vital Statistics System, multiple cause of death data set and Drug Enforcement Administration ARCOS system; 2007 opioid sales figure is preliminary

Distribution by drug companies 96 mg/person in 1997 698 mg/person in 2007

Enough for every American to take 5 mg Vicodin every 4 hrs for 3 weeks

Overdose deaths 2,901 in 1999 11,499 in 2007

Opioid sales * (mg/person)

0

2000

4000

6000

8000

10000

12000

14000

'99 '00 '01 '02 '03 '04 '05 '06 '07

Opioid deaths

627%increase

296% increase

Year

Year

Do function and QOL improve?

“Epidemiological studies are less positive, and report failure of opioids to improve QOL in chronic pain patients.”

Eriksen, J Pain 2006: 125: 172-179 “…it is remarkable that opioid treatment of long-

term/chronic non-cancer pain does not seem to fulfill any of the key outcome opioid treatment goals: pain relief, improved quality of life and improved functional capacity.”

Naliboff et al, J Pain, 2011: 12: 288-296 RCCT dose escalation vs “hold the line” No improvement in any primary outcome 27% misuse/non-compliance

Franklin et al, Natural History of Chronic Opioid Use Among Injured Workers with Low Back Pain-Clin J Pain, Dec, 2009

• 694/1843 (37.6%) received opioid early• 111/1843 (6%) received opioids for 1 yr• MED increased sign from 1st to 4th qtr• Only minority improved by at least 30%

in pain (26%) and function (16%)• Strongest predictor of long term opioid use

was MED in 1st qtr (40 mg MED had OR 6)• Avg MED 42.5 mg at 1 yr; Von Korff 55 mg

at 2.7 yrs

Washington Agency Medical Directors’ Opioid Dosing Guidelines

18

Developed with clinical pain experts in 2006Implemented April 1, 2007First guideline to emphasize dosing guidanceEducational pilot, not new standard or ruleNational Guideline Clearinghouse

http://www.guideline.gov/content.aspx?id=23792&search=wa+opioids

www.agencymeddirectors.wa.gov

19

Part I – If patient has not had clear improvement in pain AND function at 120 mg MED (morphine equivalent dose) , “take a deep breath” If needed, get one-time pain management consultation

(certified in pain, neurology, or psychiatry)Part II – Guidance for patients already on very

high doses >120 mg MED

Washington Agency Medical Directors’ Opioid Dosing Guidelines

www.agencymeddirectors.wa.gov

Establish an opioid treatment agreement Screen for

Prior or current substance abuse Depression

Use random urine drug screening judiciously Shows patient is taking prescribed drugs Identifies non-prescribed drugs

Do not use concomitant sedative-hypnotics Track pain and function to recognize tolerance Seek help if dose reaches 120 mg MED, and pain

and function have not substantially improved

Guidance for Primary Care Providers on Safe and Effective Use of Opioids for Chronic Non-

cancer Pain

20

http://www.agencymeddirectors.wa.gov/opioiddosing.aspMED, Morphine equivalent dose

Open-source Tools Added to June 2010 Update of Opioid Dosing Guidelines

21

Opioid Risk Tool: Screen for past and current substance abuse

CAGE-AID screen for alcohol or drug abuse Patient Health Questionnaire-9 screen for

depression 2-question tool for tracking pain and function Advice on urine drug testing

http://www.agencymeddirectors.wa.gov/opioiddosing.asp#DC

Available as mobile app: http://www.agencymeddirectors.wa.gov/opioiddosing.asp

22

Washington State Primary Care Survey 2009:Physician Concerns

Please check the statement that most accurately reflects

your experience when prescribing opioids for chronic, non-cancer pain

NO concerns about development of psychological dependence, addiction, or diversion

2%

OCCASIONAL concerns about development of psychological dependence, addiction, or diversion

45%

FREQUENT concerns about development of psychological dependence, addiction, or diversion

54%

Morse JS et al, J Opioid Management 2011; 7: 427-433.

23

Washington State Primary Care Survey 2009: Adherence to State Guidelines

GuidanceNever or almost never

Sometimes Often

Always or

almost always

Use treatment agreement 10% 22% 20% 49%

Screen for substance abuse <1% 3% 15% 81%

Screen for mental illness <1% 12% 30% 58%

Use random urine screen 30% 32% 18% 20%

Use patient education 34% 38% 19% 9%

Track pain 40% 31% 15% 15%

Track physical function 69% 20% 7% 5%Morse JS et al, J Opioid Management 2011; 7: 427-433.

2009 CDC recommendations

For practitioners, public payers, and insurersSeek help at 120 mg/day MED if pain and

function not improvinghttp://www.cdc.gov/HomeandRecreationalSafety/pdf/pois

ion-issue-brief.pdf

Recent state policies

Connecticut WC policy-7/1/2012The total daily dose of opioids should not be increased above 90mg oral MED/day (Morphine Equivalent Dose) unless the patient demonstrates measured improvement in function, pain or work capacity. Second opinion is recommended if contemplating raising the dose above 90 MED/day.

MaineCare (Medicaid)-4/1/2012Total 45 day maximum for non-cancer pain

New Mexico-Rule 16.10.14-Proposed rules Aug, 2012

A health care practitioner shall, before prescribing, ordering, administering or dispensing a controlled substance listed in schedule II, III or IV, obtain a patient PMP report for the preceding twelve (12) months

_x00

04_1

996

_x00

04_1

997

_x00

04_1

998

_x00

04_1

999

_x00

04_2

000

_x00

04_2

001

_x00

04_2

002

_x00

04_2

003

_x00

04_2

004

_x00

04_2

005

_x00

04_2

006

_x00

04_2

007

_x00

04_2

008

_x00

04_2

009

0

10,000

20,000

30,000

40,000

50,000

60,000

70,000

80,000

90,000

100,000

Yearly Trend of Scheduled Opioids(Franklin et al, Am J Ind Med 2012; 55: 325-31 )

Schedule II Schedule III Schedule IV

Num

ber o

f Opi

oid

Pre

scrip

tions

2000Q

1

2000Q

3

2001Q

1

2001Q

3

2002Q

1

2002Q

3

2003Q

1

2003Q

3

2004Q

1

2004Q

3

2005Q

1

2005Q

3

2006Q

1

2006Q

3

2007Q

1

2007Q

3

2008Q

1

2008Q

3

2009Q

1

2009Q

3

2010Q

1

2010Q

30.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

35.0%

40.0%

Percent of Timeloss Claimants on Opioids 2000 - 2010

Opioids Highdose Opioids

Average Daily Dosage for Opioids, Washington Workers’ Compensation, 1996–2010

28

1996 Q11996 Q31997 Q11997 Q31998 Q11998 Q31999 Q11999 Q32000 Q12000 Q32001 Q12001 Q32002 Q12002 Q32003 Q12003 Q32004 Q12004 Q32005 Q12005 Q32006 Q12006 Q32007 Q12007 Q32008 Q12008 Q32009 Q12009 Q32010 Q1

020406080

100120140

MED

(mg/

day)

Long-acting opioids

Short-acting opioids

Year/Quarter

96-

Q1 96-

Q3 97-

Q1 97-

Q3 98-

Q1 98-

Q3 99-

Q1 99-

Q3 00-

Q1 00-

Q3 01-

Q1 01-

Q3 02-

Q1 02-

Q3 03-

Q1 03-

Q3 04-

Q1 04-

Q3 05-

Q1 05-

Q3 06-

Q1 06-

Q3 07-

Q1 07-

Q3 08-

Q1 08-

Q3 09-

Q1 09-

Q3 10-

Q1 10-

Q3

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

2010

0

5

10

15

20

25

30

35

WA Workers' Compensation Opioid-related Deaths 1995-2010

Possible Probable Definite

Opi

oid-

rela

ted

Dea

th

Unintentional Prescription Opioid Overdose Deaths Washington 1995-2010

* Tramadol only deaths included in 2009, but not in prior years.

Source: Washington State Department of Health, Death Certificates

95 96 97 98 99 00 01 02 03 04 05 06 07 08 09 10

0

100

200

300

400

500

600

Prescription Opioid + alcohol or illicit drug

Prescription Opioid +/- Other Prescriptions

Num

ber o

f dea

ths

24

420

There is substantial clustering among providers on dosing and mortality

CA CWCI study-Swedlow et al, March, 2011: 3% of prescribers account for 55% of Schedule II opioid Rxs:http://www.cwci.org/research.html

Dhalla et al, Clustering of opioid prescribing and opioid-related mortality among family physicians in Ontario. Can Fam Physician 2011; 57: e92-96Upper quintile of frequent opioid prescribers associated with last opioid Rx in 62.7% of public plan beneficiary unintentional poisoning deaths

DLI sent letters to all prescribers with any patient on opioid doses at or above 120 mg/day MED-ONLY N=60• Call their attention to AMDG Guidelines and new WA state

regulations• Associate medical director will meet with these docs personally

What can PCP do to safely and effectively use opioids for CNCP?

Opioid treatment agreementScreen for prior or current substance

abuse/misuse (alcohol, illicit drugs, heavy tobacco use)

Screen for depressionPrudent use of random urine drug screening

(diversion, non-prescribed drugs)Do not use concomitant sedative-hypnotics or

benzodiazepinesTrack pain and function to recognize toleranceSeek help if MED reaches 120 mg and pain and

function have not substantially improvedUse PDMP!

Concrete steps to take Track high MED and prescribers Reverse permissive laws and set dosing and best practice

standards for chronic, non-cancer pain Implement AMDG Opioid Dosing Guidelines (

http://www.agencymeddirectors.wa.gov/opioiddosing.asp) Implement effective Prescription Monitoring Program;

check the PDMP on every new injured worker who receives opioid Rx

Encourage/incent use of best practices (web-based MED calculator, use of state PMPs)

DO NOT pay for office dispensed opioids ID high prescribers and offer assistance Incent community-based Rx alternatives (activity coaching

and graded exercise early, opioid taper/multidisciplinary Rx later)

Offer assistance (academic detailing, free CME,ECHO)

35

Nov, 2012 WA Workers CompensationOpioid Guideline*

Adoption of the 2010 AMDG Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain

This Supplement provides additional information and guidance for treating work-related injuriesDOH pain management rules, 2010 AMDG

Guideline and this Supplement are reflective of the practice standard for prescribing

opioids for a work-related injury or occupational disease.

*www.lni.wa.gov/ClaimsIns/Files/OMD/MedTreat/FINALOpioidGuideline010713.pdf

36

Clinically Meaningful

Improvement in Function

Case Definition

&

Algorithmsfor

Discontinuing COT

Managing Surgical Pain

in Workers on

COT

Stop and Take a Deep Breath at 6 weeks and before

COT

Proper and Necessary Care for Opioid

Prescribing

Addiction Treatment

Disability Prevention is the Key Health Policy Issue

Adapted from Cheadle et al. Am J Public Health 1994; 84:190–196.

12111098765432100

20

40

60

80

100

Time loss duration (months)

% o

f ca

ses

on t

ime

loss

Early opioids and disability in WA WC. Spine 2008; 33: 199-204

Population-based, prospective cohortN=1843 workers with acute low back injury

and at least 4 days lost timeBaseline interview within 18 days(median) 14% on disability at one yearReceipt of opioids for > 7 days, at least 2

Rxs, or > 150 mg MED doubled risk of 1 year disability, after adjustment for pain, function, injury severity

38% Increase since 2001

Opioid Use in Workers’ Compensation

1

Measuring the Impact of Opioid Use Beyond acute phase, effective use should result in

clinically meaningful improvement in function (CMIF) CMIF is an improvement in function of at least 30%

compared to start of treatment or in response to a dose change

Evaluation of clinically meaningful improvement should occur at 3 critical phases (acute, subacute and during COT)Continuing to prescribe opioids in the absence of CMIF or after

the development of a severe adverse outcome is not proper and necessary care. In addition, the use of escalating doses to the

point of developing opioid use disorder is not proper and necessary care.

For electronic copies of this presentation, please

e-mail Laura Blackljl2@uw.edu

For questions or feedback, please

e-mail Gary Franklinmeddir@uw.edu

THANK YOU!