Coordinating Multiple Stakeholders National Rx Drug Abuse Summit

1. Coordinating Multiple
Stakeholders
April 10-12, 2012
Walt Disney World Swan Resort

2. 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.

3. 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.

4. 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

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

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

7. Change in National Norms for Use of Opioids
for Chronic, Non-cancer Pain
 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
WAC-Washington Administrative Code
7

8. 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…

9. Limitations of Long-term (>3 Months)
Opioid Therapy
 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
9

10. Opioid-Related Deaths,
Washington State Workers’ Compensation, 1992–2005
14
Definite Probable Possible
12
10
8
Deaths
6
4
2
0
‘95 ‘96 ‘97 ‘98 ‘99 ‘00 ‘01 ‘02
Year
Franklin GM, et al, Am J Ind Med 2005;48:91-9
10

11. 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. Unintentional and Undetermined Intent Drug
Overdose Death Rates by State, 2007
MD 12.5
MA 12.5
NH 11.7
RI 11.1
CT 11.1
DE 9.8
DC 8.8
VT 7.9
NJ 7.5
Age-adjusted rate per
100,000 population
National Vital Statistics System, http://wonder.cdc.gov
12

13. 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
*

14. 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
 Distribution by drug
Opioid sales * (mg/
companies person)
 96 mg/person in 1997 627%
 698 mg/person in 2007 increase
 Enough for every
American to take 5 mg
Vicodin every 4 Year
hrs for 3 weeks
 Overdose deaths Opioid deaths
 2,901 in 1999 296%
 11,499 in 2007 increase
Year
National Vital Statistics System, multiple cause of death data
set and Drug Enforcement Administration ARCOS system;
15 2007 opioid sales figure is preliminary

16. State mortality varies by regulatory
environment
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

17. 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

18. 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

19. Washington Agency Medical Directors’
Opioid Dosing Guidelines
• 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
www.agencymeddirectors.wa.gov

20. Guidance for Primary Care Providers on Safe and
Effective Use of Opioids for Chronic Non-cancer Pain
 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
http://www.agencymeddirectors.wa.gov/opioiddosing.asp
MED, Morphine equivalent dose
20

21. Open-source Tools Added to June 2010
Update of Opioid Dosing Guidelines
 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
CAGE, cut down annoyed guilty eye-opener
21 http://www.agencymeddirectors.wa.gov/opioiddosing.asp#DC

22. 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

23. Yearly Trend of Scheduled Opioids
(Franklin et al, Am J Ind Med Dec 27 2011)
100,000
Number of Opioid Prescriptions
90,000
80,000
70,000
60,000
50,000
40,000
30,000
20,000
10,000
0
Schedule II Schedule III Schedule IV

24. 0.0%
5.0%
10.0%
15.0%
20.0%
25.0%
30.0%
35.0%
40.0%
2000Q1
2000Q2
2000Q3
2000Q4
2001Q1
2001Q2
2001Q3
2001Q4
2002Q1
2002Q2
2002Q3
2002Q4
2003Q1
2003Q2
2003Q3
2003Q4
2004Q1
2004Q2
Opioids
2004Q3
2004Q4
2005Q1
2005Q2
2005Q3
2005Q4
2000 - 2010
2006Q1
Highdose Opioids
2006Q2
2006Q3
2006Q4
2007Q1
2007Q2
2007Q3
2007Q4
Percent of Timeloss Claimants on Opioids
2008Q1
2008Q2
2008Q3
2008Q4
2009Q1
2009Q2
2009Q3
2009Q4
2010Q1
2010Q2
2010Q3
2010Q4

25. 10-Q3
2010 Q1
10-Q1
Washington Workers Compensation, 1996–
2009 Q3
09-Q3
2009 Q1
09-Q1
2008 Q3
08-Q3
Average Daily Dosage for Opioids,
2008 Q1
08-Q1
2007 Q3
07-Q3
2007 Q1
07-Q1
2006 Q3
06-Q3
2006 Q1
06-Q1
Long-acting opioids
2005 Q3
05-Q3
Short-acting opioids
2005 Q1
05-Q1
2004 Q3
04-Q3
2004 Q1
04-Q1
2003 Q3
03-Q3
2003 Q1
Year/Quarter
2010
03-Q1
2002 Q3
02-Q3
2002 Q1
02-Q1
2001 Q3
01-Q3
2001 Q1
01-Q1
2000 Q3
00-Q3
2000 Q1
00-Q1
1999 Q3
99-Q3
1999 Q1
99-Q1
1998 Q3
98-Q3
1998 Q1
98-Q1
97-Q3
1997 Q3
97-Q1
1997 Q1
96-Q3
1996 Q3
96-Q1
1996 Q1
140
120
100
80
60
40
20
0
25
MED (mg/day)

26. WA Workers' Compensation Opioid-related Deaths
1995-2010
35
30
Opioid-related Death
25
20
15
10
5
0
Possible Probable Definite

27. Unintentional Prescription Opioid Overdose Deaths
Washington 1995-2010
600
500
420
Number of deaths
400
300
200
100 24
0
95
96
97
98
99
00
01
02
03
04
05
06
07
08
09
10
Prescription Opioid + alcohol or illicit drug
Prescription Opioid +/- Other Prescriptions
* Tramadol only deaths included in 2009, but not in prior years.
Source: Washington State Department of Health, Death Certificates

28.  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

29. 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

30. 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

31. 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

32. Components Being Developed for
Community-based Treatment of Chronic Pain
• Cognitive behavioral
therapy
• Graded exercise
• Activity coaching
• Interdisciplinary care
• Care coordination
32

33. 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

34. 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

35. 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

36. 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

37. 38% Increase since 2001

38. 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)

39. 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

40. 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

41. THANK YOU!
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