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Grand Rounds
Lehigh Valley Hospital
February 23, 2005
James Patrick Murphy, M.D.
*
Medical Director
Murphy Pain Center
*
Assistant Clinical Professor
University of Louisville School of Medicine
*
Chair, Controlled Substances Taskforce
Jefferson County (KY) Medical Society
*
Board of Directors
Kentucky Pain Society
C O M P L I A N C E
 ONE
opioid.
 ONE pill
 3 DOSES
 as often as
PDR allows.
Impact of Chronic Pain

35% of Americans suffer from chronic pain

50 million workdays are lost per year

$100 billion is the estimated annual cost in lost
productivity, medical costs, and lost income
Diversion is Big Business

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A close second to cocaine
More than heroin and marijuana
Growing by 27% per year.
Ref: ASAM Common Threads V, p. 272
Definitions

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Narcotic = Opioid ?
Tolerance
Dependence
Addiction
DSM-IV “Dependence”
( 3 or more in 12 months )
TOLERANCE
WITHDRAWAL
LARGER AMOUNTS THAN INTENDED
UNSUCCESSFUL ATTEMPT TO QUIT
TIME & ENERGY SPENT OBTAINING
SOCIAL /OCCUPATIONAL SUFFERS
USE DESPITE KNOWLEDGE OF HARM
Addiction
primary
chronic
Factors:
genetic
psychosocial
environmental factors
One or more:
impaired control over drug use
compulsive use
continued use despite harm
craving
(ref: Principles of Addiction Medicine, 3rd ed.)
neurobiologic
Risk Factors for Addiction
Environment
occupation, peer group, culture, social instability
Patient
genetics, multiproblem family, psychiatric disorder
Drug
Availability
 Cost
 Speed reaching the brain
 Efficacy as a tranquilizer

DRUG ABUSE WARNING NETWORK

From 1995 – 2002 Narcotic mentions rose by
163 %
From 1994 – 2001
Oxycodone increased
 Morphine increased
 Hydrocodone increased

230 %
210 %
131 %
The Four D’s
 Dated
 Duped
 Disabled
 Dishonest

The 5th D …
DEFIANT
High Maintenance
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Credentials posted
NADDI posted
Location of office
CME
Join Organizations
Police newsletter
Police relationship
Licensed personnel
Screening patients
No CS first visit
KASPER
UDT
Pill counts
Background checks
Typed dictation
Articles posted
Pain School
Support group
Psychologist in office
Complete records
CS compliance flow chart
Treatment agreements
Fellowship training
ASAM
Addiction board certification
Must come to office to make appmt
No CS on premises
Flow sheet in chart
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KBML guidelines posted
Speaking engagements
Work with pharmaceutical reps
Task force
Media interviews
Frequent follow ups
Consultations
Full evaluations
FCE
Goals
DAST
PAS
Communication with primary care
Only take referrals/no walk ins.
100 mile radius
Team meetings
MPC ladder
SAFE score
MPC aberrancy rating
Write numerals on Rx
Copy all rx
Letter to pharmacies
One pharmacy
Non reproducible rx pad
Lock rx pads in safe
Two signatures on rx
No call in of rx
Numbered rx
Fill date on rx
Read three FAQs ?
...NOT SO FAST !
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www.medsch.wisc.edu/
painpolicy
www.usdoj.gov/dea
www.Stoppain.org
The Murphy Pain Center
Therapeutic Ladder for Chronic
Non-Malignant Pain
W.H.O. CANCER PAIN
MANAGEMENT LADDER
Adapted from the World Health Organization
Is there a “ceiling” to
opioid dosing ?
Concerns: addiction, diversion, pain,
tolerance, toxicity, immunity, endocrine
( and the “RADAR SCREEN” )
ONE opioid.
 ONE pill per dose.
 3 DOSES per day (or less)
as often as PDR allows.

Name: Ima Hurtin
Date: today
____________________________________________
Rx:
most appropriate opioid
Mgm:
as determined by careful titration
Sig:
ONE, per PDR recommendation
Dispense: one month supply (no refills)
Name: Ima Hurtin
Date: today
____________________________________________
Rx:
Percocet
Mgm:
5 mgm / 325
Sig:
ONE q. 4 – 6 hours prn
(maximum of 3 per day)
Dispense: 90 (one month supply)
Name: Ima Hurtin
Date: today
____________________________________________
Rx:
Avinza
Mgm:
30 mgm
Sig:
ONE p.o. daily
Dispense: # 30
Step 3
What if they “need” more?
PPPP
 P athological
New disease
 Progression of disease
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 P harmacological
Tolerance
 Toxicity
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 P sychological
Depression
 Addiction
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 P olice
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Diversion
Advantages
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“Acceptable” pain control
Less OPIOCENTRIC regimen
Fewer pills (with your name on them)
Less addiction, tolerance, toxicity, & diversion
Less time on the “RADAR SCREEN”
Disadvantages

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Some patients truly need a “designer” regimen.
Higher doses may be needed.
Some patients will need “breakthrough” meds.
Solutions:
Team meeting
Specialty consultation
Avinza
Spheroidal Oral Drug Absorption System
15. AVINZA® prescribing information. San Diego, CA: Ligand Pharmaceuticals Incorporated; March 2002.
Pharmacokinetics of AVINZA® (morphine sulfate
extended-release capsules) vs Immediate-release
Morphine Solution (IRMS)*15
Morphine Concentration
(ng/mL)
18
AVINZA
once daily
IRMS
6 times
daily
16
14
12
10
8
6
4
2
0
0
2
4
6
8
10
12
14
16
18
20
22
24
Time (hours)
*Eliot L, Loewen G, Butler J, et al. 17th Annual Meeting of the American Academy of Pain Medicine;
February 16, 2001; Miami, FL. Abstract and poster.
15. AVINZA® prescribing information. San Diego, CA: Ligand Pharmaceuticals Incorporated; March 2002.
Pharmacokinetics of AVINZA®
(morphine sulfate extended-release
capsules) vs MS Contin (MSC)18
Morphine Concentration
(ng/mL)
24
AVINZA
once daily
MSC
twice daily
20
16
12
8
4
0
0
4
8
12
16
20
24
Time (hours)
*Dose-normalized to a 100-mg daily dose.
18. Portenoy RK, Sciberras A, Eliot L, Loewen G, Butler J, Devane J. Steady-state pharmacokinetic comparison of a new,
extended-release, once-daily, morphine formulation, AVINZA®, and a twice-daily controlled release morphine
formulation in patients with chronic moderate-to-severe pain. J Pain Symptom Manage. 2002;23:292-300.
Steady-state Pharmacokinetics of
AVINZA® (morphine sulfate extendedrelease capsules) vs OxyContin®19
% Maximum Concentration
100
AVINZA
once daily
OxyContin
twice daily
80
60
40
20
0
5
10
15
20
25
Time (hours)
19. Eliot L, Geiser R, Loewen G. Steady-state pharmacokinetic comparison of a new, once-daily, extended-release
morphine formulation (Morphelan™) and OxyContin® twice daily. J Oncol Pharm Pract. 2001;7:1-8.
AVINZA® (morphine sulfate extendedrelease capsules) “Sprinkle-dose”
Pharmacokinetics21
Morphine Concentration
(ng/mL)
8
7
6
5
Sprinkle
Dose
Intact
Capsule
4
3
2
1
0
0
4
8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72
Time (hours)
21. Eliot L, Butler J, Devane J, Loewen G. Pharmacokinetic evaluation of a sprinkle-dose regimen of a once-daily,
extended-release morphine formulation. Clin Ther. 2002;24:260-268.
Avinza
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A capsule is not preferred on the “street”
30 pills per month (fewer DAWN mentions?)
No bolus effect (fewer side effects?)
Enters brain slowly (less euphoria / addiction?)
Level steady state (less tolerance?)
Easy to titrate slowly (less risk of overmedication)
Pearls

Sell the patient on the drug.
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Don’t try to go from a handful of short actings
to Avinza.
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Use the “aberrancy moment” to make the
change to Avinza.
COMPLIANCE
Model Policy for the
Use of Controlled Substances
for the Treatment of Pain
May 2004
Federation of State Medical Boards
of the United States
www.fsmb.org
The Board will judge the
validity of the physician’s
treatment based on
available documentation
C ompliance monitored
O ften assessed
M edical Records
P lan of treatment
L egitimate diagnosis
I nformed consent
A ddiction assessment
N on-addictive medications
C onsultation(s)
E valuation (History and Physical)
Compliance
“The Board expects that
physicians incorporate
safeguards into their practices to
minimize the potential for abuse
and diversion”
Drug screens / pill counts / PMP
Often Assessed
o
c mpliance
AAAA
The Four A’s
Analgesia
Activities of daily living
Adverse effects
Aberrant drug-related behaviors
Ref: Passik SD, et al. Clin Ther. 2004;26:552-561
Medical Records
coMpliance
Up to date / Accessible
Plan
comPliance
“…should state objectives
that will be used
to determine success”
L egitimate
comp
Liance
“Physicians will not be sanctioned for prescribing opioid
analgesics for legitimate medical purposes.”
“Legitimate… if based on sound clinical judgment”
“Document one or more recognized medical
indications for the use of a controlled substance”
Informed Consent
complIance
“The physician should discuss the risks and
benefits of the use of controlled substances”
Addiction Screen
Ance
compli
“Special attention should be given to those
patients with pain who are at risk for medication
misuse, abuse or diversion.”
Prevalence of Illicit Drug Use in KY
%
Third Party
Medicare
M/M
Medicaid
Illicit
17
10
24
39
Other opioid
2
2
3
6
Absence
26
24
36
56
Total
30
26
40
60
Ref: Manchikanti KMA Feb 2005
Non-Addictive Trial
complia
Nce
“The Board will refer to current
clinical practice guidelines….”
WHO PAIN
MANAGEMENT
LADDER
Adapted from the World Health Organization
Consultation
complianCe
“The physician should be willing to refer
the patient as necessary for additional
evaluation and treatment.”
Evaluation
compliancE
“A medical history and physical must be obtained.”
Content reflects the complexity of case.
Substance abuse history.
C ompliance monitored
O ften assessed
M edical Records
P lan of treatment
L egitimate diagnosis
I nformed consent
A ddiction assessment
N on-addictive medications
C onsultation(s)
E valuation (History and Physical)
C O M P L I A N C E
 ONE
opioid.
 ONE pill
 3 DOSES
 as often as
PDR allows.
Websites
 www.legalsideofpain.com
 www.murphypaincenter.com
 [email protected]