Transcript 8.27.09 Chelminski Substance misuse-abuse

Opioid Prescribing For
Chronic Pain:
The Case For Universal
Precauations & The Role of Urine
Toxicologic Testing
Paul R. Chelminski, MD, MPH, FACP
Associate Professor of Medicine
Associate Residency Program Director
University of North Carolina at Chapel HIll
Objectives
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Provide the epidemiologic & clinical
context for rigorous substance misuse
monitoring (i.e. universal precautions)
Briefly discuss the elements of
universal precautions
Focus on UTS testing as component of
universal precautions
Chronic Pain Management
Objectives
1.
2.
3.
4.
Decrease pain
Improve functional status
Identify & treat depression
MONITOR FOR SUBSTANCE
MISUSE (Today’s Topic)
Pain Management
Process
Problem:
Chronic Pain
Outcome:
Improved Function
Mental Illness
Pain
Substance Misuse
Interventions
Case: 43 yo; chronic back
pain, on methadone
Society of General Internal
Medicine, 2006 Annual Meeting
Chronic Pain Workshop, Part 2:
The Dilemma Between
Treating Pain and
Endangering Public Health
In our nation’s war on drugs,
unscrupulous doctors who
traffic in narcotics are
prosecuted by the U.S.
Attorney and the federal Drug
Enforcement Administration.
These are their stories.
LAW & ORDER
INTENT TO DISTRIBUTE
LAW & ORDER
INTENT TO DISTRIBUTE
U.S. ATTORNEY
Paul Chelminski
LAW & ORDER
INTENT TO DISTRIBUTE
Assistant U.S. ATTORNEY
Mark Pletcher
LAW & ORDER
INTENT TO DISTRIBUTE
Medical EXPERT
Dr. Edna Sorlot
Heidi Coplin
LAW & ORDER
INTENT TO DISTRIBUTE
Also Starring:
Defense COUNSEL
Matthew Bair
LAW & ORDER
INTENT TO DISTRIBUTE
With:
Ian Chen as
Ignatz Dolophin
DEFENDANT
Dr.
LAW & ORDER
INTENT TO DISTRIBUTE
Peter Friedmann as
Reginald T. Pillholdyr
PHARMACIST
LAW & ORDER
INTENT TO DISTRIBUTE
Dan Alford as
Dr. M.D. Discipline, Member
STATE MEDICAL BOARD
LAW & ORDER
INTENT TO DISTRIBUTE
And Introducing:
Stacey Mollis as the JUDGE and
NARRATOR
LAW & ORDER
INTENT TO DISTRIBUTE
Producers
Paul Chelminski
Michael Picchioni
LAW & ORDER
INTENT TO DISTRIBUTE
Written By
Stefan Kertesz
Mina Madani
LAW & ORDER
INTENT TO DISTRIBUTE
Executive Producer
Dick Wolf
LAW & ORDER
INTENT TO DISTRIBUTE
The Patient, Mr. Igotnotoe
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Multiple toe amputations, PVD, Neuropathy
History of alcohol misuse
– Currently in Alcoholics Anonymous
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Discharged from surgeon’s care after amputation
Signed contract with Dr. Dolophin to receive pain meds
– 50 mg of methadone 3x/day, 3 Lortab/day for breakthrough pain
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Functional improvement - got a job
Occasionally tried to fill Rx early /ran out of meds early
Pt gave some pills to nephew for root canal pain
– Teenage nephew combined pills with alcohol and caused the
death of an elderly woman while driving
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Small time drug dealer with bottle of patient’s Lortab
prescribed by Dr. Dolophin
U.S. DISTRICT COURT
Part 13
Monday April 26
Opening Statement of the
Federal Prosecutor
The Charges
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Over 86 felony counts
– Drug trafficking
– Illegal distribution of Schedule II narcotics
– Prescription of medicine without a legitimate medical
purpose
– Conspiracy
– Health care fraud by billing Medicaid for his illegal
activities
– Mail fraud by use of the postal service for billing
– Repeated money laundering by depositing his illgotten gains into a U.S. bank
– Manslaughter
CHRONIC PAIN
MENTAL ILLNESS
SUBSTANCE MISUSE
PRESCRIPTION
SUBSTANCE MISUSE
Substance Abuse Disorders
•Addiction
•Dependence
Non-Medical Misuse
•Diversion for profit
•Barter for drug of choice
Street Value of Controlled
Substances
Drug
Value
Oxycontin
Oxycodone/APAP
$3-4/mg (40mg tab=$160)
$15/tab
Hydrocodone/APAP
Codeine/APAP
Propoxyphene/APAP
Hyrdomorphone
$6-12/tab
$2-4/tab
$2-20/tab
$15/mg
Morphine
$1/mg
Methadone
Alprazolam
$1-2/mg
$3-4/tab
Prescription Opioids &
Misuse: The Evolution of an
Epidemic
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1990’s: Opioids endorsed as appropriate for chronic pain
Per capita Rx of methadone, hydrocodone, oxycodone
increase 13X, 4X, 9X (1997-2007)
Non-medical use increases dramatically
ER visits increase
Unintentional drug OD’s increase 68% (1999-2004)
Prescription opioid overdose deaths greater than heroin
and cocaine combined
West Virginia has most dramatic rise: 550% & one of
highest per capita death rates
Substance Misuse/Abuse:
Prescription Drugs
Annual Numbers of New Non-Medical Users of Prescription-Type
Drugs, 1965-2000 (NHSDA)
Increase in Poisoning
Deaths: UTAH
Ascendance of
Prescription Drug Abuse
Physician Prescribing &
Opioid Deaths
Physicians & Public Health
Responsibility:
Minimizing Collateral Damage

Traditional: Infectious disease reporting (e.g.TB, syphilis,
hepatitis A)
– Not commonly criminal
– Not inherently adversarial
– Statutory requirement for reporting
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Substance Misuse/Diversion
– Potentially adversarial
– Empathy replaced by mistrust with therapeutic intent of physician
subverted
– Criminal implications
– No statutory requirement for reporting
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Opioids, warfarin, insulin: Considered top 3 “high alert
medications” Only opioids mandate public health in addition to
clinical vigilance to prevent harm to third parties
The Specter of Regulation
Can You Identify a Drug
Abuser?
Appearance
Reality
Chronic Pain & Substance
Abuse Disorders
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23% of 414 patients hospitalized with chronic pain
1995; 30: 919-927)
(Int J Addictions
60 to 70% of patients with depression; >50% anxiety.
Comorbid psychiatric conditions predict substance misuse
disorders and negative outcomes [Am J Psychiatry 2003; 160:5]
Substance and alcohol dependence and psychiatric disease (JAMA
1990;264:2511-18)
1. Major depression: 32%
2. Bipolar depression: 61%
3. Schizophrenia: 47%
4. Personality disorders 84%
5. Anxiety disorders: 24%
Substance Misuse/Abuse:
Prescription Drugs
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Substance Misuse Epidemiology in Pain Clinics:
–
3-18% “potential addicts” in subspeciatly setting (Int J
Addictions 1995; 30: 919-927, lnt J Pain & Subst Use Misuse
1996; 31:945-6 [Letter])
–
Substance misuse behaviors common in Yale University study
of VA and resident clinics (24% and 31% of patients receiving
opioids) (JGIM 2002;17:173-179)
–
32% in work by Ives, Chelminski, et al in primary care setting.
–
23% over 6 years [Chelminski and Ives]
Dilemma 1: History of drug, ETOH abuse, severe psychiatric
disease cited as contraindications to opioid use
Dilemma 2: Identifying pain patients at risk for substance
misuse with opioids a challenge (little literature).
Opioid Misuse*
*Ives, T. J.; Chelminski, P. R..et al. Predictors of Opioid Misuse in Patients with Chronic
Pain A Prospective Cohort Study. BMC Health Serv Res. 2006 Apr 4; 6(1)46.
Multivariate Predictors of
Substance Misuse
Model
Age
Drug or DUI Conviction
H/O Cocaine Use
H/O ETOH Abuse
Odds Ratio
(95% CI)
0.95
2.58
4.30
2.60
(0.90-0.99)
(1.01-6.59)
(1.76-10.4)
(1.12-6.26)
Fraudulent Promotion
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Shilling unproven and unsafe medications (e.g. Vioxx®,
Oxycontin®)
Iatrogenic Addictions= 1 in 10,000 (sic)
•Wrong clinical dilemma
•Too good to be true: Opioids would protect against
substance misuse
•
Substance Misuse Monitoring:
Universal Precautions*
Generally Available
 Meticulous, concrete documentation in EMR
(no “drug seeking behavior”)
 Medication contract
 Toxicological testing
Availability Depends
 Criminal background checks (as proxy for
history of substance misuse)
 Controlled substances surveillance system
*A “Hunch Free Approach”
Substance Misuse Defined
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Substance Misuse:
1. Cocaine or amphetamines on UTS
2. Doctor collecting/shopping
3. Adulteration/forgery of prescriptions
4. Diversion
5. Persistent (“clean”) negative urines
6. Inconsistent UTS
Opioid Therapy & Misuse
Substance Misuse Monitoring: A
“Hunch Free” Approach
Substance Abuse Proxy
The North Carolina
Controlled Substances
Reporting System
Forgery
Forgery
Urine Drug/Toxicologic
Testing
Applications/Settings
 Workplace
 Competitive sports
 Judicial (child custody, drug courts)
 Medical--Acute
– Intoxication
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Medical—Chronic Drug Abuse
– Harm reduction: Methadone/buprenorphine
– Substance abuse clinics
Urine Drug/Toxicologic
Testing
UTS & Chronic Pain Management
 Monitor illicit drugs of abuse
 Monitor non-prescribed controlled
substances (e.g. opioids and benzos)
 Adherence to Rx’ed opioids
Truth Serum: The “Straight
Shooter”
“Mexicans at the jobsite
smoking crack”
Patient Taking Diazepam &
Hydrocodone (i.e.
“Negative” Urine)
UTS Confirmation: Wrong
Opioid
Patient Prescribed Morphine
Inconsistent Urines
Patient Prescribed Oxycontin®
GCSF Confirmation
UTS Limitations
Known Cocaine Addict
Subsituted urine taken from lab dropoff area
UTS Limitations: Contamination
UNC: ~10% confirmed samples are “suspicious”
Directly Observed Urine
The Impact of Toxicologic
Testing
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113 of 488 (23%) patients followed in
UNC Internal Medicine Pain Program
with misuse
77% detected by UTS
Especially effective for early detection
of cocaine and negative urines
Duration of Universal
Precautions
Medication Contract Violations over 6 Year Period*
Signed Medication
Contract
NonViolators
375
Comments
Violators
113
(23%)
Time to Contract Violation,
Months, N (%)
<1
43 (38)
36 UTS+
cocaine
1-6
40 (35)
>6
30 (27)
13 cocaine;
12 negative
UTS
PR Chelminski, KB Hayes, TJ Ives, The medication contract & substance
misuse: 6-year outcomes in a primary care chronic pain program. Abstract
poster presentation, 2009 SGIM Annual Meeting, Miami, Florida.
The Potential of Oral
Fluids (vs. UTS)
Pros
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Ease of collection
No boundary violations
Faster for staff
?Less adulteration
Ease of sample
handling
Cons
 ½ life reflects serum
 Decreased window of
detection
 Less clinical data;
track reocrd
 ?Cost