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MEDICATIONS OF CONTROVERSY
Challenges, Risks and Strategies
Alan Lembitz M.D.
COPIC
© 2006 Wotkyns Creative
Disclosure
I have no relevant
financial relationships
to disclose
Risks
OverviewToday we are going to talk about:
Scope of Problem
Safe prescribing practices
Tools- PDMP, Agreements, Consents,
Screening Tools, Diagnostic Tools,
Documentation
PART 1
 OPIOIDS
5
Being a medical caregiver means putting your
self in suffering’s way
Rita Charon M.D.
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CDC declares painkillers at epidemic levels
Opioids, Anxiolytics and Sedatives
Rates of prescription painkiller sales, deaths and substance abuse
treatment admissions (1999-2010)
SOURCES: National Vital Statistics System, 1999-2008; Automation of Reports and Consolidated Orders System
(ARCOS) of the Drug Enforcement Administration (DEA), 1999-2010; Treatment Episode Data Set, 1999-2009
Distribution of Opioid Users
Controlled
chronic pain
“All the rest”
uncontrolled pain
pseudo-addiction
Addiction
abuse
Overview
Top Reasons for paid claims in Primary Care:
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2
3
Delay or failure to diagnose (65+%)
Improper treatment of known medical
condition
Medication Errors
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Risk by diagnosis
 Heads
 Hearts
 Bellies
 Bugs- Severe Infectious
Diseases
 Failure to DX CA
 Underappreciated
severity of trauma
COPIC data
OxyContin in increasing doses beginning at ½ tab
TID (20 mg) and increasing to 80mg tabs 6 per day
in 4 doses – These are the complete notes
Opiates
 Opiates from poppies
 Sumerians isolated
opium from 3000 B.C.
 Given with hemlock to
put people to death
 China 800 AD Europe
1300
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Opiates
 In 1806 Serturner
isolated the morphine
alkaloid and named it
after the god of dreams,
Morpheus
 Heroin detailed for
cough medicine in 1898
 Works thru at least 4
receptors throughout the
body
 Profound effect is the
mu receptor CNS
 Controlled Substances
Act in 1970 DEA
enforces
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Be sure of the DX
 Pain out of proportion to
findings
 ? FX
 ? Necrotizing fasciitis
 Vascular, inc. mesenteric
 Compartment syndrome
 Don’t miss the CA
Pain diagrams
 Accuracy of diagnosis
 Symptom magnification
 Objective preprocedure, or pretreatment functionality
 Objective postprocedure or posttreatment assessment
of functionality
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Addiction vs. tolerance vs. dependence
Addiction
Tolerance
Physical dependence
 Compulsive use
causing personal
harm
 Decreased
effectiveness over
time
 Abstinence
syndrome think
French connection
 Psychological
dependence
 Actually rare - if
more needs there
may be a reason
 Not psychologic
addiction
 Rare in terminally
ill or pain
management
 Usually
preexisting abuse
 Don’t label a
tolerant patient
addicted
 Decrease dose 50%
Q 3 days
Addiction
A maladaptive pattern of substance use leading to
impairment or distress, but has not met the criteria
for Substance Dependence, having ≥ 1 of the
following:
 Recurrent substance use resulting in failure to
fulfill major role obligations at work, home, school
 Recurrent substance use in situations in which it
is physically hazardous
 Recurrent substance-related legal problems
 Continued substance use despite having
persistent or recurrent problems caused by the
substance use
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Opioid addiction risk factors
 Biggest risk factor is a
personal or family
history of drug/ETOH
abuse
 Psych problems
 Poor coping skills
 Sexual abuse
Journal of pain v109 pg 113-130 2009
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Faces of addiction
Criteria of chronic illness
 Genetics
 Pathogenesis
 Precipitants
 Environmental
determinants
 Gender specifics
 Complications
 Relapse-Remission
Key to identifying alcohol abuse
ASK
• CAGE: cut back, annoying, guilt,
eye opener
• Drinks per week: 7 or 14?
• Binge per year: 5 (4)?
SOAPP
 Biggest risk factor is a
personal or family
history of drug/ETOH
abuse
Journal of pain v109 pg 113-130 2009
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Overdose- accidental vs. intentional
 It’s about the
documentation
 Evaluate for coexisting
psych problem
 Tip of the iceberg potential
 ACTIONS MUST MATCH
THE DOCUMENTATION
DEA
 Responsible prescribing
 Regulation increasing
 Stings
 Documentation
 Pharmacist is the trigger
work with them
Street value
Drug
Estimated Street Cost
Oxycodone
$5-10/ pill
Oxycodone ER
$1/mg
Vicodin 5/500
$3-5/ pill
Percocet
$5-10/ pill
Methadone
$25
Xanax
$3-5/ pill
Fentanyl
$1/ mcg
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Dilaudid 4mg #240
No address
No date
Pm
No legitimate
purpose
Street value
of this Rx:
$7,000
plus
Prescription Drug Monitoring Program
 Powerful tool
 Use it don’t lose it
 Password sacred
 Notification
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Which of the following is NOT appropriate
for a pain agreement?
A) No diversion allowed
B) May request a tox screen at any time
C) Notify us by Thursday if scripts are lost or
destroyed
D) Can only go to 1 pharmacy
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Opioid agreements
 An Agreement not a
Contract
 May specify one
pharmacy
 Treaters may
discuss DX and RX
 No diversion
 Danger of abrupt
withdrawal
 Pregnancy
 Urine or Serum tox screens
may be a condition of the
agreement.
 Lost, wet, left, stolen not
acceptable excuses
 Compliance with scheduled
appointments and referrals
 Breach may result in
termination, cessation of
therapy or referral to
addiction specialist
Long-term consent
 Indications
 Withdrawal
 Risks
 Addiction definition and
potential
 Prohibition of activity
if impaired
 Physical Dependence
 Tolerance and Possible
Increases in dosages or
reduction in effect
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Align your partners
 Clear discussion of
philosophy
 Pain agreements help guide
your partners
 A covering prescriber on a
routine script- little risk
CMB – red flags
 Chronic narcotics without
cause
 No formal relationship
 No physical exam
 Suggest different pharmacies
 Prescribe for sex or sharing
 Prescribe to family
Example of the office visit notes
OxyContin 40mg 2-bid
Dilaudid 8mg qid
Soma 1 qid
DEA examples
New patient:
Prescribed Dilaudid
4 mg #240 plus
Xanax
Do you believe this
doctor
did an exam of the head,
heart and lungs?
Hassle factors
 HIPAA
 Records release
 Labeling addict can be an issue
 Weekend and night calls
Always
 Contact the previous physician
 Ask the patient about previous alcohol and
drug use, or psychiatric or drug related
hospitalizations.
 Document a thorough and thoughtful exam
 Consider a drug screen
PART 2
 MEDICAL MARIJUANA
 RECREATIONAL MARIJUANA
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SCOPE OF MMJ
 Numbers of registrants
 Characteristics of registrants
 Age
 Primary Dx
 The Dispensaries
MAJOR QUESTIONS TO CONSIDER
 Do I certify for MMJ?
Informed Consent
Screen for contraindications
Know and review the science
Following CMB regulations
 Bona fide physician patient relationship
 Diagnosis established by history and examination
 Documentation
 Recommendation for follow-up
Practical Logistics- forms and registry
MAJOR QUESTIONS TO CONSIDER
 My patient is on MMJ registry and
actively using, does this change my
practice and prescribing for them?
MAJOR QUESTIONS TO CONSIDER
 What if my patient was inappropriately
certified for the registry?
CMB unprofessional conduct- license and duty to report
Specific clinical examples
 Minors
 Psychiatric contraindications
 Occupations involving public safety
MAJOR QUESTIONS TO CONSIDER
 Do I have vicarious liability if I certify, or
if I know my patient is using MMJ, or if
they are taking opioids, etc?
Chart documentation of discussion
Informed consent is a process, but a form may be required if
significant risk and non-compliance with recommendations
DRIVING UNDER INFLUENCE
 Law Enforcement considerations
 Available testing and reliability
SPECIAL SITUATIONS
 Physicians who personally are on the
registry
 CPHP
 CMB
 COPIC
SUMMARY
 Certifying my own patients- how to do this
in compliance and consistent with sound
medical practice
 What to do about your patient who
someone else certified for the registry
 What about other physicians who certify
out of compliance with sound practice
 Vicarious liability
DUI is not just alcohol
Boundaries- Are your issue
 Boundary discussions
are often about your
own conflict
 Can be you or the
patient with the
problem
 Discuss what your
concern is
Boundaries—Providers role
 I don’t give unlimited narcotics
but I want to help you. What can
we work out….
Clarify boundaries
And negotiate
 My role is to help people not just
give out narcs…
 Can we come up with a short
term plan today and then work
on something long term?
Do you accept the challenge?
 Do you choose to work
with this patient?
 It is OK to say no
 Send a letter 30 days
 Taper schedule
 Withdrawal and ?
refer
The good news
 Most lawsuits result in defense judgments or
verdicts.
 Most patient complaints to plaintiffs’
attorneys do not result in lawsuits
 Most CMB complaints do not result in
discipline
 Pain assessments, agreements, consents,
documentation and consults help greatly
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Our challenge
"....in the sufferer, let me see
only the human being” –
Maimonides, 13th Century
Thank you
I appreciate
your feedback.
Any questions?
Alan Lembitz M.D.
VP, COPIC
Patient Safety and Risk
Management
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