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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
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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 • Pre-employment • For Cause • Return to Duty and Follow-up • Random- Most controversial • Not triggered by workplace impairment
Toxicological Considerations • 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 • 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 • 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
HHS CERTIFIED LAB • 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 • 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 • 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 • 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 • Confirmation 2000 ng/ml • Quantitation if Concentation ≥ 15000 ng/ml • Heroin Metabolites to Morphine • Coedeine Metabolites to Morphine • Morphine as a drug
Opiates – Heroin6- 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
AmphetaimesD & L Isomers • 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 TestingFatal Flaw • 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 • Chain of Custody • Two Step Testing Protocol • Five HHS Drugs • Adulterant Testing • Reviewed and Certified Results