Coordinating Multiple Stakeholders

April 10-12, 2012 Walt Disney World Swan Resort

Accepted Learning Objectives: 1. Describe the relationship between prescription drug morbidity and mortality and the under-treatment of pain. 2. Identify measurement-based care as standard of care in pain medicine and describe how to measure pain, mood and function in every clinical encounter. 3. Evaluate how new state and federal policy changes will likely allow more prudent and safer use of opioids for chronic, non-cancer pain.

Disclosure Statement

•  All presenters for this session, Dr. Alex Cahana and Dr. Gary M. Franklin, have disclosed no relevant, real or apparent personal or professional financial relationships.

Opioids: A public health emergency -National Rx Summit-

Orlando, FL April 10-12, 2012

Gary M. Franklin, MD, MPH Research Professor

Departments of Environmental Health, Neurology, and Health Services

University of Washington

Medical Director Washington State Department of

Labor and Industries

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

!

“We can’t solve problems by using the same kind of thinking we used when we created them”

 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 Code

7

Portenoy and Foley Pain 1986; 25: 171-186

 Retrospective case series chronic, non-cancer pain

 N=38; 19 Rx for at least 4 years  2/3 < 20 mg MED/day; 4> 40 mg MED/day  24/38 acceptable pain relief  No gain in social function or employment

could be documented  Concluded: “Opioid maintenance therapy

can be a safe, salutary and more humane alternative…”

 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 later

Ballantyne 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

9

10

Opioid-Related Deaths, Washington State Workers’ Compensation, 1992–2005

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

0

2

4

6

8

10

12

14

De

ath

s

Definite Probable Possible

Year

‘95 ‘97 ‘00 ‘02 ‘96 ‘98 ‘99 ‘01

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

12

Age-adjusted rate per 100,000 population

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

MD MA NH RI CT DE DC VT NJ

12.5 12.5 11.7 11.1 11.1

9.8 8.8 7.9 7.5

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

Evidence linking specific doses to morbidity and mortality

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

at 100 mg MED  Editorial-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: 1425-32 Opioid 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

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)

Opioid deaths

627% increase

296% increase

Year

Year

Paulozzi and Stier, J Publ Health Pol 2010; 31: 422-32 • Per capita usage of opioids in NY 2/3 that in PA • Drug overdose deaths 1.6 fold higher in PA compared to NY • PDMP in NY better funded and uses serialized, tamperproof Rx forms

But mortality rates probably not affected by mandatory education alone

State mortality varies by regulatory environment

Fitzgibbon et al, Anesthesiology 2010; 112: 948-56

ASOA Closed Claims Database-N=8954 – 50/295 medication management issues

for CNCP •  59% inappropriate medication management •  24% high risk of misuse •  57% death

Washington Agency Medical Directors’ Opioid Dosing Guidelines

•  Developed with clinical pain experts in 2006

•  Implemented April 1, 2007 •  First guideline to emphasize dosing

guidance •  Educational pilot, not new standard or rule •  National Guideline Clearinghouse

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

18 www.agencymeddirectors.wa.gov

•  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

19

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.asp MED, Morphine equivalent dose

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

CAGE, “cut down” “annoyed” “guilty” “eye-opener”

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

New CDC recommendations

 For practitioners, public payers, and insurers

 Seek help at 120 mg/day MED if pain and function not improving

 http://www.cdc.gov/HomeandRecreationalSafety/pdf/poision-issue-brief.pdf

0

10,000

20,000

30,000

40,000

50,000

60,000

70,000

80,000

90,000

100,000

Num

ber o

f Opi

oid

Pre

scrip

tions

Yearly Trend of Scheduled Opioids

(Franklin et al, Am J Ind Med Dec 27 2011)

Schedule II Schedule III Schedule IV

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

35.0%

40.0% 20

00Q

1

2000

Q2

2000

Q3

2000

Q4

2001

Q1

2001

Q2

2001

Q3

2001

Q4

2002

Q1

2002

Q2

2002

Q3

2002

Q4

2003

Q1

2003

Q2

2003

Q3

2003

Q4

2004

Q1

2004

Q2

2004

Q3

2004

Q4

2005

Q1

2005

Q2

2005

Q3

2005

Q4

2006

Q1

2006

Q2

2006

Q3

2006

Q4

2007

Q1

2007

Q2

2007

Q3

2007

Q4

2008

Q1

2008

Q2

2008

Q3

2008

Q4

2009

Q1

2009

Q2

2009

Q3

2009

Q4

2010

Q1

2010

Q2

2010

Q3

2010

Q4

Percent of Timeloss Claimants on Opioids 2000 - 2010

Opioids Highdose Opioids

25

0

20

40

60

80

100

120

140

1996 Q1

1996 Q3

1997 Q1

1997 Q3

1998 Q1

1998 Q3

1999 Q1

1999 Q3

2000 Q1

2000 Q3

2001 Q1

2001 Q3

2002 Q1

2002 Q3

2003 Q1

2003 Q3

2004 Q1

2004 Q3

2005 Q1

2005 Q3

2006 Q1

2006 Q3

2007 Q1

2007 Q3

2008 Q1

2008 Q3

2009 Q1

2009 Q3

2010 Q1

MED

(m

g/d

ay)

Average Daily Dosage for Opioids,

Washington Workers’ Compensation, 1996–2010

Long-acting opioids

Short-acting opioids

Year/Quarter

96-Q

1

96-Q

3

97-Q

1

97-Q

3

98-Q

1

98-Q

3

99-Q

1

99-Q

3

00-Q

1

00-Q

3

01-Q

1

01-Q

3

02-Q

1

02-Q

3

03-Q

1

03-Q

3

04-Q

1

04-Q

3

05-Q

1

05-Q

3

06-Q

1

06-Q

3

07-Q

1

07-Q

3

08-Q

1

08-Q

3

09-Q

1

09-Q

3

10-Q

1

10-Q

3

0

5

10

15

20

25

30

35

Opi

oid-

rela

ted

Dea

th

WA Workers' Compensation Opioid-related Deaths 1995-2010

Possible Probable Definite

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

0

100

200

300

400

500

600

95

96

97

98

99

00

01

02

03

04

05

06

07

08

09

10

Num

ber o

f dea

ths

Prescription Opioid + alcohol or illicit drug

Prescription Opioid +/- Other Prescriptions

24

420

 Repeals current regulation; new expected by June 2011

 Provides specific dosing guidance and guidance on consultations, assessments, and tracking

 Signed into law by Governor Gregoire March 25, 2010

28

Washington State Opioid Treatment Regulations Final 1/2/2011

•  Emphasize tracking patients for improved pain AND function

•  Emphasize widely agreed-upon best practices –  Screening for substance abuse and other comorbidities –  Prudent use of urine drug screens –  Opioid treatment agreement –  Single pharmacy and single prescriber

•  Encourage use of Prescription Monitoring Program-begins 1/1/2012 and Emergency Department Information Exchange, when available

29

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

  Opioid treatment agreement   Screen for prior or current substance abuse/

misuse (alcohol, illicit drugs, heavy tobacco use)   Screen for depression   Prudent use of random urine drug screening

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

benzodiazepines   Track pain and function to recognize tolerance   Seek help if MED reaches 120 mg and pain and

function have not substantially improved

Improving Physician Access to Pain Specialists in Washington State

•  Issue –  Moderate capacity problem: not enough pain

specialists –  Interventional anesthesiologists generally won’t see

these patients to assist with opioid issues •  Solution

–  Advanced training for primary care to increase proficiency

–  Telephonic or video consultation with experts [Project ECHO at UW (http://depts.washington.edu/anesth/care/pain/echo/index.shtml)]

–  Public payers working on payment codes to incentivize these activities

31

Components Being Developed for Community-based Treatment of Chronic Pain

•  Cognitive behavioral therapy

•  Graded exercise •  Activity coaching •  Interdisciplinary care •  Care coordination

32

Other new directions for chronic pain treatment

 Incentivize best practices for chronic pain care in community setttings, eg, medical home concept for chronic pain E.g., cognitive behavioral therapy to

Cautious Prescribing Practices When Considering Therapy With Opioids -Physicians for Responsible Opioid Prescribing-

Von Korff M et al. Ann Intern Med 2011;155:325-328

©2011 by American College of Physicians

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: e92-96 Upper quintile of frequent opioid prescribers associated with last opioid Rx in 62.7% of public plan beneficiary unintentional poisoning deaths

DLI will send letters to all prescribers with any patient on opioid doses at or above 120 mg/day MED

•  Call their attention to AMDG Guidelines and new WA state regulations

•  Associate medical director will meet with these docs personally

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

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

and at least 4 days lost time  Baseline interview within 18 days(median)  14% on disability at one year  Receipt 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

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 •  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)

Unfinished business •  Address low capacity in communities to

prevent/Rx chronic pain •  Guidelines for peri-operative use of

opioids •  Looming large population dependent/

addicted from Rx opioids •  Develop guidelines Re tapering

– PCP routine taper; Detox/pain clinic taper +/- buprenorphine

•  Rx of opioid use disorder/addiction

It’s an emergency, so move ahead gingerly

 If you do something effective to reverse a decade of bad public policy, you will get pushback: Fauber J. Follow the money: Pain, policy, and profit. 2/19/12.

 URL:http://www.medpagetoday.com/Neurology/PainManagement/31256

  But remember that the docs in the trenches welcome assistance, tools, and best practices -National survey of PCP network for low income

patients: 1/3 reported a severe outcome (death or life-threatening event); 1/3 do not initiate prescribing of opioids

Leverence RR, et al. J Am Board Fam Med 2011; 24: 551-561

For electronic copies of this presentation, please e-mail

Melinda Fujiwara vasudha@u.washington.edu For questions or feedback,

please e-mail Gary Franklin

meddir@u.washington.edu

THANK YOU!