Meeting the Challenge of the Opioid
Epidemic
-UC Irvine Medical Grand RoundsJan 29, 2013
GARY M. FRANKLIN, MD, MPH
MEDICAL DIRECTOR
WA DEPT OF LABOR AND INDUSTRIES
RESEARCH PROFESSOR
DEPTS OF ENVIRONMENTAL & OCCUPATIONAL
HEALTH SCIENCES, NEUROLOGY, AND HEALTH
SERVICES
UNIVERSITY OF WASHINGTON
"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”
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
4
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 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…”
Pain champions, Pharma surrogates, and
Astroturf organizations led the way
7
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 scores
More 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
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
8
Dentists and Emergency Medicine Physicians were the
main prescribers for patients 5-29 years of age
5.5 million prescriptions were prescribed to children and teens (19 years and under) in 2009
900
800
Rate per 10,000 persons
700
600
GP/FM/DO
500
IM
400
DENT
ORTH SURG
300
EM
200
100
0
0-4
5-9
10-14
15-19
20-24
Age Group
Source: IMS Vector ®One National, TPT 06-30-10 Opioids Rate 2009
25-29
30-39
40-59
60+
Opioid-Related Deaths,
Washington State Workers’ Compensation, 1992–2005
14
Definite
12
Probable
Possible
Deaths
10
8
6
4
2
0
‘95
‘96
‘97
‘98
Year
Franklin GM, et al, Am J Ind Med 2005;48:91-9
10
‘99
‘00
‘01
‘02
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
Age-adjusted rate per
100,000 population
National Vital Statistics System, http://wonder.cdc.gov
11
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: 85-92
 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
Unintentional Overdose Deaths Involving
Opioid Analgesics Parallel Opioid Sales
United States, 1997–2007
 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
800
Opioid sales *
(mg/person)
700
600
500
627%
increase
400
300
200
100
0
'97
'98
'99
'00
'01
'02
'03
'04
'05
'06
'07
Year
14000
 Overdose deaths
 2,901 in 1999
 11,499 in 2007
12000
Opioid deaths
10000
296%
increase
8000
6000
4000
2000
0
'99
'00
'01
'02
'03
Year
15
National Vital Statistics System, multiple cause of death data
set and Drug Enforcement Administration ARCOS system;
2007 opioid sales figure is preliminary
'04
'05
'06
'07
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 longterm/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
 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

18
http://www.guideline.gov/content.aspx?id=23792&search=wa+opioids
www.agencymeddirectors.wa.gov
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
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
20
http://www.agencymeddirectors.wa.gov/opioiddosing.asp
MED, Morphine equivalent dose
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
Available as mobile app:
http://www.agencymeddirec
tors.wa.gov/opioiddosing.as
p
21
http://www.agencymeddirectors.wa.gov/opioiddosing.asp#DC
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.
22
Washington State Primary Care Survey
2009: Adherence to State Guidelines
Never or
almost
never
Sometime
s
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%
Guidance
Morse JS et al, J Opioid Management 2011; 7: 427-433.
23
2009 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/pois
ion-issue-brief.pdf
Recent state policies
Connecticut WC policy-7/1/2012
The 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)-4/1/2012
Total 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
Number of Opioid Prescriptions
Yearly Trend of Scheduled Opioids
(Franklin et al, Am J Ind Med 2012; 55: 325-31 )
100,000
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
Opioids
Highdose Opioids
2010Q4
2010Q3
2010Q2
2010Q1
2009Q4
2009Q3
2009Q2
2009Q1
2008Q4
2008Q3
2008Q2
2008Q1
2007Q4
2007Q3
2007Q2
2007Q1
2006Q4
2006Q3
2006Q2
2006Q1
2005Q4
2005Q3
2005Q2
2005Q1
2004Q4
2004Q3
2004Q2
2004Q1
2003Q4
2003Q3
2003Q2
2003Q1
2002Q4
2002Q3
2002Q2
2002Q1
2001Q4
2001Q3
2001Q2
2001Q1
2000Q4
2000Q3
2000Q2
2000Q1
Percent of Timeloss Claimants on Opioids
2000 - 2010
40.0%
35.0%
30.0%
25.0%
20.0%
15.0%
10.0%
5.0%
0.0%
10-Q3
10-Q1
2010 Q1
09-Q3
2009 Q3
09-Q1
2009 Q1
08-Q3
2008 Q3
08-Q1
2008 Q1
07-Q3
2007 Q3
07-Q1
2007 Q1
06-Q3
2006 Q3
06-Q1
2006 Q1
05-Q3
2005 Q3
05-Q1
2005 Q1
04-Q3
2004 Q3
04-Q1
2004 Q1
Year/Quarter
03-Q3
2003 Q3
03-Q1
2003 Q1
02-Q3
2002 Q3
02-Q1
2002 Q1
01-Q3
2001 Q3
01-Q1
00-Q3
00-Q1
99-Q3
99-Q1
98-Q3
98-Q1
97-Q3
97-Q1
96-Q3
20
2001 Q1
96-Q1
Short-acting opioids
40
2000 Q3
2000 Q1
1999 Q3
1999 Q1
1998 Q3
1998 Q1
1997 Q3
1997 Q1
1996 Q3
28
1996 Q1
0
Long-acting opioids
100
80
60
MED (mg/day)
Average Daily Dosage for Opioids,
Washington Workers’ Compensation, 1996–2010
140
120
WA Workers' Compensation Opioid-related Deaths 19952010
Opioid-related Death
35
30
25
20
15
10
5
0
Possible
Probable
Definite
Unintentional Prescription Opioid Overdose Deaths
Washington 1995-2010
600
420
400
300
200
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
10
09
08
07
06
05
04
03
02
01
00
99
98
97
0
24
96
100
95
Number of deaths
500
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 opioidrelated 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 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 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
 Use 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)
Nov, 2012 WA Workers Compensation
Opioid Guideline*
35
 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 injuries
DOH 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
Proper and
Necessary Care
for
Opioid
Prescribing
Clinically Meaningful
Improvement in
Function
Managing
Surgical Pain in
Workers on COT
Case Definition
&
Algorithms
for
Discontinuing
COT
Addiction
Treatment
36
Stop and Take a Deep
Breath at 6 weeks and
before COT
Disability Prevention is the Key Health
Policy Issue
% of cases on
time loss
100
80
60
40
20
0
0
1
2
3
4
5
6
7
8
9
10
11
Time loss duration (months)
Adapted from Cheadle et al. Am J Public Health 1994; 84:190–196.
12
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
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.
THANK YOU!
For electronic copies of this
presentation, please e-mail
Laura Black
ljl2@uw.edu
For questions or feedback,
please
e-mail Gary Franklin
meddir@uw.edu