1. The Medical Review Officer: An Addiction Medicine Perspective CSAM October 9, 2004 By David E. Smith, M.D. Past President, CSAM Past President, ASAM

2. 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

3. 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

4. Civil and Criminal Aspects of Addiction and the Expert Witness

5. 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

6. Types of Tests Pre-employment For Cause Return to Duty and Follow-up Random- Most controversial –Not triggered by workplace impairment

7. 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

8. 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

9. Workplace Issues Case may be criminal followed by civil –Employer often becomes the deep pocket Post Accident - Exxon Valdez Case

10. Criminal Issues Toxicity Developmental Model Issues Recall Amnesia Non-toxic psychiatric co-morbidities Intent issues –New Brain, Old Brain dilemma

11. Validity Testing Verify a urine specimen is consistent with normal human urine –Adulterated –Diluted –Substituted

12. 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

13. 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

14. The HHS Certified Laboratory

15. HHS CERTIFIED LAB Introduction Chain of Custody Procedures Overview of Testing Procedures Drugs Included in the Testing Adulterant Testing Summary

16. Chain of Custody Custody and Control Form Tamper Evident Bag and Tamper Evident Bottle Secured Laboratory Internal Chain of Custody

17. Introduction HHS Certified Lab Procedures Two Step Testing Procedure –Screening Test --Confirmation Test HHS Drugs or Drug Metabolites HHS Specimen Validity Testing

18. Overview of Testing Procedures Screening Test or First Test –Immunoassay Enzyme Multiple Immunoassay (EMIT) Florescent Polarization Immunoassay (FPIA) Kinetic Immunoassay (KIM) Radio Immunoassay (RIA)

19. Overview of Testing Procedures Confirmation Testing –Separate aliquot of the Specimen –Gas Chromatography Mass Spectrometry (GC/MS)

20. Quality Controls Open Quality Controls B Quality Controls for the Analyst Minimum 10% Quality Controls

21. 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

22. DHHS Drugs Cannabinoids Cocaine PCP Opiates Amphetamines

23. Marijuana metabolites Screening 50 ng/ml Confirmation 15 ng/ml

24. Cocaine Metabolites Screening 300 ng/ml Confirmation 150 ng/ml

25. Phencyclidine (PCP) Screening 25 ng/ml Confirmation 25 ng/ml

26. Opiates Screening 2000 ng/ml

27. Opiates Codeine Confirmation 2000 ng/ml Quantitation if Concentration ≥ 1500 ng/ml Codeine Metabolites to Morphine

28. Opiates Morphine Confirmation 2000 ng/ml Quantitation if Concentation ≥ 15000 ng/ml Heroin Metabolites to Morphine Coedeine Metabolites to Morphine Morphine as a drug

29. Opiates – Heroin 6- Monoacetyl Morphine An Intermediate Metabolite of Heroin Confirmation 10 ng/ml Heroin Metabolites to 6- Monoacetyl Morphine and also to Morphine

30. Amphetamines Amphetamine Screening 1000 ng/ml

31. Amphetamine Confirmation 500 ng/ml Methamphetamine Metabolites to Amphetamine

32. Methamphetamine Confirmation 500 ng/ml Note: In addition 200 ng/ml Amphetamine present Methamphetamine Metabolites to Amphetamine D- isomer or L-isomer

33. Amphetaimes D & L Isomers D- Amphetamine L- Amphetamine D- Methamphetamine L- Methamphetamine

34. 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

35. 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

36. 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

37. Rejected for Testing Fatal 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

38. Conclusion Chain of Custody Two Step Testing Protocol Five HHS Drugs Adulterant Testing Reviewed and Certified Results