Transcript The Medical Review Officer: An Addiction Medicine Perspective

The Medical Review Officer: An
Addiction Medicine Perspective
CSAM October 9, 2004
By David E. Smith, M.D.
Past President, CSAM
Past President, ASAM
Addiction- Scope of the Problem
• In 1998 6.6% of employees reported current
drug use
• Absent from the job 100 hours per year
• 3.5 times as likely to be involved in an accident
• 5 times as likely to file a Workman’s Comp claim
• 3 times as likely to be fired
• Alcohol- $ 120 billion
• Nicotine- $ 60 billion
• Illicit drugs- $ 60 billion
The Drug Free Workplace Act
• 1996 Executive Order 12564
• A comprehensive program prohibiting workplace
drug use
• Employees will be educated about drug use
• Supervisors will be trained regarding their
responsibility
• EAP helping hand programs will be available
• Ability to identify drug users including urine
testing
Civil and Criminal Aspects of Addiction
and the Expert Witness
The Role of the Medical Review
Officer
• A positive test does not always identify and illicit
drug user
• Must be a licensed Medical Doctor
• Knowledgeable of substance abuse disorders
• Knowledgeable about how to interpret positive
tests
• Verify is there is a legitimate medical explanation
• Gatekeeper (Narrow) vs. Addiction Medicine
Specialist (Expanded) Role
Types of Tests
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Pre-employment
For Cause
Return to Duty and Follow-up
Random- Most controversial
– Not triggered by workplace impairment
Toxicological Considerations
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Screening and Confirmatory tests
Types of Samples- Urine, Hair, etc.
Detection Windows
Screening levels and cutoffs
Drug testing technologies
Validity testing- dilution, temperature,
contaminants
• New Regs- Stand downs and PIE’s and NOPE’s
Scope of Addiction Expert Witness
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Criminal and civil cases
Family custody disputes
Return to work
Appeals evaluations
Professional re-entry evaluations
Complicated workplace situations
– Following an accident
• Interpretation of toxicological test results
• Compliance with governmental regulations
Workplace Issues
• Case may be criminal followed by civil
– Employer often becomes the deep pocket
• Post Accident
- Exxon Valdez Case
Criminal Issues
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Toxicity
Developmental Model Issues
Recall
Amnesia
Non-toxic psychiatric co-morbidities
Intent issues
– New Brain, Old Brain dilemma
Validity Testing
• Verify a urine specimen is consistent with
normal human urine
– Adulterated
– Diluted
– Substituted
Validity (2)
• Treated the same as a confirmed positive
– The adulterant got there by physiologic
means
– Employee can produce the dilute specimen by
physiologic means
– MRO must use best professional judgment
– Employee may be directed to get a medical
evaluation by another MD
Americans with Disabilities Act
• What is covered
– Illicit drugs are not covered under ADA
• A using heroin addict is not covered
• A heroin addict stabilized on methadone is covered
• A recovering (abstinent) addict is covered
**Alcohol is covered under ADA
– However, if there are other federal regulations re: alcohol
the employer must comply i.e. B.A. > .02
**A person falsely accused is also covered
The HHS Certified Laboratory
HHS CERTIFIED LAB
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Introduction
Chain of Custody Procedures
Overview of Testing Procedures
Drugs Included in the Testing
Adulterant Testing
Summary
Chain of Custody
• Custody and Control Form
• Tamper Evident Bag and Tamper Evident
Bottle
• Secured Laboratory
• Internal Chain of Custody
Introduction
• HHS Certified Lab Procedures
• Two Step Testing Procedure
– Screening Test
--Confirmation Test
• HHS Drugs or Drug Metabolites
• HHS Specimen Validity Testing
Overview of Testing Procedures
• Screening Test or First Test
– Immunoassay
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Enzyme Multiple Immunoassay (EMIT)
Florescent Polarization Immunoassay (FPIA)
Kinetic Immunoassay (KIM)
Radio Immunoassay (RIA)
Overview of Testing Procedures
• Confirmation Testing
– Separate aliquot of the Specimen
– Gas Chromatography Mass Spectrometry
(GC/MS)
Quality Controls
• Open Quality Controls
• B Quality Controls for the Analyst
• Minimum 10% Quality Controls
Overview of Testing Procedures
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Review all the Chain of Custody
Review the Quality Controls
Review the Blind Controls
Review the Screening Test Data
Review the Confirmation Test Data
DHHS Drugs
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Cannabinoids
Cocaine
PCP
Opiates
Amphetamines
Marijuana metabolites
• Screening
50 ng/ml
• Confirmation 15 ng/ml
Cocaine Metabolites
• Screening 300 ng/ml
• Confirmation 150 ng/ml
Phencyclidine (PCP)
• Screening 25 ng/ml
• Confirmation 25 ng/ml
Opiates
• Screening 2000 ng/ml
Opiates
Codeine
• Confirmation
2000 ng/ml
• Quantitation if Concentration ≥ 1500 ng/ml
• Codeine Metabolites to Morphine
Opiates
Morphine
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Confirmation 2000 ng/ml
Quantitation if Concentation ≥ 15000 ng/ml
Heroin Metabolites to Morphine
Coedeine Metabolites to Morphine
Morphine as a drug
Opiates – Heroin
6- Monoacetyl Morphine
• An Intermediate Metabolite of Heroin
• Confirmation 10 ng/ml
• Heroin Metabolites to 6- Monoacetyl
Morphine and also to Morphine
Amphetamines
Amphetamine
• Screening
1000 ng/ml
Amphetamine
• Confirmation
500 ng/ml
• Methamphetamine Metabolites to
Amphetamine
Methamphetamine
• Confirmation
500 ng/ml
• Note: In addition 200 ng/ml Amphetamine
present
• Methamphetamine Metabolites to
Amphetamine
• D- isomer or L-isomer
Amphetaimes
D & L Isomers
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D- Amphetamine
L- Amphetamine
D- Methamphetamine
L- Methamphetamine
Adulterant Testing
• Creatinine: Normal- greater than 19.9 mg/dl
• Specific Gravity: Normal – greater than 1.001 or
less than 1.020
• pH: Normal 4.5-9
• Nitrite and Other Oxidants
• Soap
• Bleach
• Others
Reporting Adulterants
• Adulterated: Nitrite 500 mcg/ml or greater.
pH 3 or less; pH 11 or greater. Chromium
VI 20 mcg/ml or greater (Lab has the
option for cut off)
• Substituted: Creatinine 5.0 mg/dl or less
Creatine 5.0 mg/dl or less and Specific
Gravity 1.020 or greater. Challenge 3.8
Invalid Result
• Creatinine ≤ 5.0 mg/dl; Sp. Gr. Sp. Gr. ≥ 1.003 &
< 1.020
• Specific Gravity ≤ 1.001; Creatinine > 5.0 mg/dl
• Abnormal pH (outside 4-10)
• Possible (Characterize as Oxidant, Halogen,
Aldehyde, or Surfactant) Activity
• Immunoassay Interference
• GC/MS Interference
• Abnormal Physical Characteristics – (Specify)
• Bottle A and Bottle B – Different physical
Appearance
Rejected for Testing
Fatal Flaw
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Specimen ID number mismatch / missing
No collector printed name & no signature
Tamper- evident seal broken
Insufficient specimen volume
Wrong CCF used
Collector signature not recovered
Conclusion
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Chain of Custody
Two Step Testing Protocol
Five HHS Drugs
Adulterant Testing
Reviewed and Certified Results