Opioid Prescribing For Chronic Pain: The Case For Universal Precauations & The Role of Urine...

Opioid Prescribing For Opioid Prescribing For Chronic Pain:Chronic Pain:

The Case For Universal The Case For Universal Precauations & The Role of Precauations & The Role of Urine Toxicologic TestingUrine Toxicologic Testing

Paul R. Chelminski, MD, MPH, FACPPaul R. Chelminski, MD, MPH, FACPAssociate Professor of MedicineAssociate Professor of MedicineAssociate Residency Program Associate Residency Program DirectorDirectorUniversity of North Carolina at University of North Carolina at Chapel HIllChapel HIll

ObjectivesObjectives

Provide the epidemiologic & clinical Provide the epidemiologic & clinical context for rigorous substance context for rigorous substance misuse monitoring (i.e. universal misuse monitoring (i.e. universal precautions)precautions)

Briefly discuss the elements of Briefly discuss the elements of universal precautionsuniversal precautions

Focus on UTS testing as component Focus on UTS testing as component of universal precautionsof universal precautions

Chronic Pain ManagementChronic Pain Management

ObjectivesObjectives1.1. Decrease painDecrease pain2.2. Improve functional statusImprove functional status3.3. Identify & treat depressionIdentify & treat depression4.4. MONITOR FOR MONITOR FOR

SUBSTANCE MISUSE SUBSTANCE MISUSE (Today’s Topic)(Today’s Topic)

Pain Management ProcessProblem:

Chronic PainOutcome:

Improved Function

Interventions

Pain

Mental Illness

Substance Misuse

Case: 43 yo; chronic back pain, on methadone

Society of General Internal Society of General Internal Medicine, 2006 Annual Medicine, 2006 Annual MeetingMeeting

Chronic Pain Workshop, Part 2:Chronic Pain Workshop, Part 2:

The Dilemma Between The Dilemma Between Treating Pain and Treating Pain and Endangering Public Endangering Public HealthHealth

In our nation’s war on In our nation’s war on drugs, unscrupulous drugs, unscrupulous doctors who traffic in doctors who traffic in narcotics are prosecuted narcotics are prosecuted by the U.S. Attorney and by the U.S. Attorney and the federal Drug the federal Drug Enforcement Enforcement Administration.Administration.

These are their stories.

LAW & ORDERINTENT TO DISTRIBUTE


U.S. ATTORNEY

Paul Chelminski


Assistant U.S. ATTORNEY

Mark Pletcher


Medical EXPERT Dr. Edna Sorlot

Heidi Coplin


Defense COUNSEL

Matthew Bair

Also Starring:


Ian Chen as Dr. Ignatz Dolophin DEFENDANT

With:


Peter Friedmann as Reginald T. Pillholdyr

PHARMACIST


Dan Alford as Dr. M.D. Discipline, Member STATE MEDICAL BOARD


Stacey Mollis as the JUDGE and NARRATOR

And Introducing:


Producers

Paul Chelminski Michael Picchioni


Written By

Stefan KerteszMina Madani


Executive Producer Dick Wolf

The Patient, Mr. IgotnotoeThe Patient, Mr. Igotnotoe Multiple toe amputations, PVD, NeuropathyMultiple toe amputations, PVD, Neuropathy History of alcohol misuseHistory of alcohol misuse

– Currently in Alcoholics AnonymousCurrently in Alcoholics Anonymous Discharged from surgeon’s care after amputationDischarged from surgeon’s care after amputation Signed contract with Dr. Dolophin to receive pain Signed contract with Dr. Dolophin to receive pain

medsmeds– 50 mg of methadone 3x/day, 3 Lortab/day for 50 mg of methadone 3x/day, 3 Lortab/day for

breakthrough painbreakthrough pain Functional improvement - got a jobFunctional improvement - got a job Occasionally tried to fill Rx early /ran out of meds Occasionally tried to fill Rx early /ran out of meds

earlyearly Pt gave some pills to nephew for root canal painPt gave some pills to nephew for root canal pain

– Teenage nephew combined pills with alcohol and caused Teenage nephew combined pills with alcohol and caused the death of an elderly woman while drivingthe death of an elderly woman while driving

Small time drug dealer with bottle of patient’s Small time drug dealer with bottle of patient’s Lortab prescribed by Dr. DolophinLortab prescribed by Dr. Dolophin

U.S. DISTRICT COURTPart 13

Monday April 26

Opening Statement of the Federal Prosecutor

The ChargesThe Charges Over 86 felony countsOver 86 felony counts

– Drug traffickingDrug trafficking– Illegal distribution of Schedule II narcoticsIllegal distribution of Schedule II narcotics– Prescription of medicine without a legitimate Prescription of medicine without a legitimate

medical purposemedical purpose– ConspiracyConspiracy– Health care fraud by billing Medicaid for his Health care fraud by billing Medicaid for his

illegal activities illegal activities – Mail fraud by use of the postal service for Mail fraud by use of the postal service for

billingbilling– Repeated money laundering by depositing his Repeated money laundering by depositing his

ill-gotten gains into a U.S. bankill-gotten gains into a U.S. bank– ManslaughterManslaughter

CHRONIC PAIN

MENTAL ILLNESS

SUBSTANCE MISUSE

PRESCRIPTIONSUBSTANCE MISUSE

Substance Abuse Disorders•Addiction•Dependence

Non-Medical Misuse•Diversion for profit•Barter for drug of choice

Street Value of Street Value of Controlled SubstancesControlled Substances

Drug Value

Oxycontin $3-4/mg (40mg tab=$160)

Oxycodone/APAP $15/tab

Hydrocodone/APAP $6-12/tab

Codeine/APAP $2-4/tab

Propoxyphene/APAP $2-20/tab

Hyrdomorphone $15/mg

Morphine $1/mg

Methadone $1-2/mg

Alprazolam $3-4/tab

Prescription Opioids & Prescription Opioids & Misuse: The Evolution of Misuse: The Evolution of an Epidemican Epidemic

1990’s: Opioids endorsed as appropriate for 1990’s: Opioids endorsed as appropriate for chronic painchronic pain

Per capita Rx of methadone, hydrocodone, Per capita Rx of methadone, hydrocodone, oxycodone increase 13X, 4X, 9X (1997-2007)oxycodone increase 13X, 4X, 9X (1997-2007)

Non-medical use increases dramaticallyNon-medical use increases dramatically ER visits increaseER visits increase Unintentional drug OD’s increase 68% (1999-Unintentional drug OD’s increase 68% (1999-

2004)2004) Prescription opioid overdose deaths greater than Prescription opioid overdose deaths greater than

heroin and cocaine combinedheroin and cocaine combined West Virginia has most dramatic rise: 550% & West Virginia has most dramatic rise: 550% &

one of highest per capita death ratesone of highest per capita death rates

Substance Substance Misuse/Abuse: Misuse/Abuse: Prescription DrugsPrescription Drugs

Annual Numbers of New Non-Medical Users of Prescription-TypeDrugs, 1965-2000 (NHSDA)

Increase in Poisoning Increase in Poisoning Deaths: UTAHDeaths: UTAH

Ascendance of Ascendance of Prescription Drug Prescription Drug AbuseAbuse

Physician Prescribing Physician Prescribing & Opioid Deaths& Opioid Deaths

Physicians & Public Health Physicians & Public Health Responsibility:Responsibility:Minimizing Collateral Minimizing Collateral DamageDamage Traditional: Infectious disease reporting (e.g.TB, Traditional: Infectious disease reporting (e.g.TB,

syphilis, hepatitis A)syphilis, hepatitis A)– Not commonly criminalNot commonly criminal– Not inherently adversarialNot inherently adversarial– Statutory requirement for reportingStatutory requirement for reporting

Substance Misuse/DiversionSubstance Misuse/Diversion– Potentially adversarialPotentially adversarial– Empathy replaced by mistrust with therapeutic intent of Empathy replaced by mistrust with therapeutic intent of

physician subvertedphysician subverted– Criminal implicationsCriminal implications– No statutory requirement for reportingNo statutory requirement for reporting

Opioids, warfarin, insulin:Opioids, warfarin, insulin: Considered top 3 “high alert Considered top 3 “high alert medications” Only opioids mandate public health in addition medications” Only opioids mandate public health in addition to clinical vigilance to prevent harm to third partiesto clinical vigilance to prevent harm to third parties

The Specter of The Specter of RegulationRegulation

Can You Identify a Drug Can You Identify a Drug Abuser?Abuser?

Appearance Appearance

RealityReality

Chronic Pain & Chronic Pain & Substance Abuse Substance Abuse DisordersDisorders 23% of 414 patients hospitalized with chronic pain 23% of 414 patients hospitalized with chronic pain (Int J (Int J

Addictions 1995; 30: 919-927)Addictions 1995; 30: 919-927) 60 to 70% of patients with depression; >50% anxiety.60 to 70% of patients with depression; >50% anxiety. Comorbid psychiatric conditions predict substance misuse Comorbid psychiatric conditions predict substance misuse

disorders and negative outcomes disorders and negative outcomes [Am J Psychiatry 2003; 160:5][Am J Psychiatry 2003; 160:5]

Substance and alcohol dependence and psychiatric Substance and alcohol dependence and psychiatric disease (JAMA 1990;264:2511-18)disease (JAMA 1990;264:2511-18)

1.1. Major depression: 32%Major depression: 32%2.2. Bipolar depression: 61%Bipolar depression: 61%3.3. Schizophrenia: 47%Schizophrenia: 47%4.4. Personality disorders 84%Personality disorders 84%5.5. Anxiety disorders: 24%Anxiety disorders: 24%

Substance Misuse/Abuse: Substance Misuse/Abuse: Prescription DrugsPrescription Drugs Substance Misuse Epidemiology in Pain Clinics:Substance Misuse Epidemiology in Pain Clinics:

– 3-18% “potential addicts” in subspeciatly setting (Int J 3-18% “potential addicts” in subspeciatly setting (Int J Addictions 1995; 30: 919-927, lnt J Pain & Subst Use Addictions 1995; 30: 919-927, lnt J Pain & Subst Use Misuse 1996; 31:945-6 [Letter])Misuse 1996; 31:945-6 [Letter])

– Substance misuse behaviors common in Yale University Substance misuse behaviors common in Yale University study of VA and resident clinics (24% and 31% of study of VA and resident clinics (24% and 31% of patients receiving opioids) (JGIM 2002;17:173-179)patients receiving opioids) (JGIM 2002;17:173-179)

– 32% in work by Ives, Chelminski, et al in primary care 32% in work by Ives, Chelminski, et al in primary care setting.setting.

– 23% over 6 years [Chelminski and Ives]23% over 6 years [Chelminski and Ives]

Dilemma 1:Dilemma 1: History of drug, ETOH abuse, severe History of drug, ETOH abuse, severe psychiatric disease cited as contraindications to opioid usepsychiatric disease cited as contraindications to opioid use

Dilemma 2:Dilemma 2: Identifying pain patients at risk for substance Identifying pain patients at risk for substance misuse with opioids a challenge (little literature). misuse with opioids a challenge (little literature).

Opioid Misuse*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 Multivariate Predictors of Substance MisuseSubstance Misuse

ModelModel Odds Ratio Odds Ratio (95% CI)(95% CI)

AgeAge

Drug or DUI Drug or DUI ConvictionConviction

H/O Cocaine UseH/O Cocaine Use

H/O ETOH AbuseH/O ETOH Abuse

0.95 (0.90-0.95 (0.90-0.99)0.99)

2.58 (1.01-2.58 (1.01-6.59)6.59)

4.30 (1.76-4.30 (1.76-10.4)10.4)

2.60 (1.12-2.60 (1.12-6.26)6.26)

Fraudulent PromotionFraudulent Promotion

Shilling unproven and unsafe medications (e.g. Shilling unproven and unsafe medications (e.g. Vioxx®, Oxycontin®)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 Substance Misuse Monitoring: Universal Monitoring: Universal Precautions*Precautions*

Generally AvailableGenerally Available Meticulous, concrete documentation in Meticulous, concrete documentation in

EMR (no “drug seeking behavior”)EMR (no “drug seeking behavior”) Medication contractMedication contract Toxicological testingToxicological testingAvailability DependsAvailability Depends Criminal background checks (as proxy for Criminal background checks (as proxy for

history of substance misuse)history of substance misuse) Controlled substances surveillance Controlled substances surveillance

systemsystem*A “Hunch Free Approach”

Substance Misuse Substance Misuse DefinedDefined

Substance Misuse:Substance Misuse:

1.1. Cocaine or amphetamines on UTSCocaine or amphetamines on UTS

2.2. Doctor collecting/shoppingDoctor collecting/shopping

3.3. Adulteration/forgery of Adulteration/forgery of prescriptionsprescriptions

4.4. DiversionDiversion

5.5. Persistent (“clean”) negative urinesPersistent (“clean”) negative urines

6.6. Inconsistent UTSInconsistent UTS

Opioid Therapy & Opioid Therapy & MisuseMisuse

Substance Misuse Monitoring: Substance Misuse Monitoring: A “Hunch Free” ApproachA “Hunch Free” Approach

Substance Abuse Substance Abuse ProxyProxy

The North Carolina The North Carolina Controlled Controlled Substances Substances Reporting SystemReporting System

ForgeryForgery

Urine Drug/Toxicologic Urine Drug/Toxicologic TestingTestingApplications/SettingsApplications/Settings WorkplaceWorkplace Competitive sportsCompetitive sports Judicial (child custody, drug courts)Judicial (child custody, drug courts) Medical--AcuteMedical--Acute

– IntoxicationIntoxication Medical—Chronic Drug AbuseMedical—Chronic Drug Abuse

– Harm reduction: Methadone/buprenorphineHarm reduction: Methadone/buprenorphine– Substance abuse clinicsSubstance abuse clinics

Urine Drug/Toxicologic Urine Drug/Toxicologic TestingTesting

UTS & Chronic Pain UTS & Chronic Pain ManagementManagement

Monitor illicit drugs of abuseMonitor illicit drugs of abuse Monitor non-prescribed controlled Monitor non-prescribed controlled

substances (e.g. opioids and substances (e.g. opioids and benzos)benzos)

Adherence to Rx’ed opioidsAdherence to Rx’ed opioids

Truth Serum: The Truth Serum: The “Straight Shooter”“Straight Shooter”

““Mexicans at the jobsite Mexicans at the jobsite smoking crack”smoking crack”

Patient Taking Diazepam Patient Taking Diazepam & Hydrocodone (i.e. & Hydrocodone (i.e. “Negative” Urine)“Negative” Urine)

UTS Confirmation: Wrong UTS Confirmation: Wrong OpioidOpioid

Patient Prescribed Patient Prescribed MorphineMorphine Inconsistent Urines Inconsistent Urines

Patient Patient PrescribedPrescribed Oxycontin®Oxycontin®

GCSF ConfirmationGCSF Confirmation

UTS LimitationsUTS LimitationsKnown Cocaine AddictKnown Cocaine Addict

Subsituted urine taken from lab dropoff area

UTS Limitations: UTS Limitations: ContaminationContamination

Directly Observed Urine

UNC: ~10% confirmed samples are “suspicious”UNC: ~10% confirmed samples are “suspicious”

The Impact of The Impact of Toxicologic TestingToxicologic Testing 113 of 488 (23%) patients 113 of 488 (23%) patients

followed in UNC Internal Medicine followed in UNC Internal Medicine Pain Program with misusePain Program with misuse

77% detected by UTS77% detected by UTS Especially effective for early Especially effective for early

detection of cocaine and negative detection of cocaine and negative urinesurines

Duration of Universal Duration of Universal PrecautionsPrecautions

Signed Medication Signed Medication ContractContract

Time to Contract Violation, Time to Contract Violation, Months, N (%)Months, N (%)

Non-Non-ViolatorsViolators ViolatorsViolators < 1< 1 1-61-6 > 6> 6

375375 113 113 (23%)(23%)

43 (38)43 (38) 40 (35)40 (35) 30 (27)30 (27)

CommentsComments 36 UTS+ 36 UTS+ cocainecocaine

13 13 cocaine; cocaine; 12 12 negative negative UTSUTS

Medication Contract Violations over 6 Year Period*

PR Chelminski, KB Hayes, TJ Ives, The medication contract & substance misuse: 6-year outcomes in a primary care chronic pain program. Abstractposter presentation, 2009 SGIM Annual Meeting, Miami, Florida.

The Potential of Oral The Potential of Oral Fluids (vs. UTS)Fluids (vs. UTS)

ProsPros Ease of collectionEase of collection No boundary No boundary

violationsviolations Faster for staffFaster for staff ?Less adulteration?Less adulteration Ease of sample Ease of sample

handlinghandling

ConsCons ½ life reflects ½ life reflects

serumserum Decreased window Decreased window

of detectionof detection Less clinical data; Less clinical data;

track reocrdtrack reocrd ?Cost?Cost

Opioid Prescribing For Chronic Pain: The Case For Universal Precauations & The Role of Urine...

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