The Drug Testing Process. Employer or Practice

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2 Disclosures Clinical Professor, Jefferson Medical College BOD MROCC [Medical Review Officer Certification Council] BOD National Sleep Foundation BOD POEMS [Pennsylvania Occupational & Environmental Medicine Society] Opioid Advisory Committee, American Academy of Pain Management Medical Director, Wellness Corporate Solutions Laboratory Director, Life Line Screening Laboratory Director, Promerica Health Medical Director, OMEGA Laboratories

3 The Drug Testing Process Employer or Practice?

4 Screening test is positive for a category: confirmation test - each category with a positive screen Laboratory Procedure Presumptive [Screening] Testing Adulteration checks are performed Specimen screened for categories [5, 10, more] of drugs and metabolites Testing determines whether a drug metabolite is present at or above a defined cutoff level Screening test is negative for a category: no further testing for that category

5 Laboratory Procedure

6 Presumptive [Screening] Test

7 Presumptive [Screening] Test

8 Immunoassay Formats 7 Homogeneous methods have generally been applied to the measurement of small analytes such as abused and therapeutic drugs.

9 Presumptive [Screening] Test

10 Presumptive [Screening] Test

11 Presumptive [Screening] Test

12 Know What You re Getting [ordering] 11

13 Definitive Test [Confirmation] D o Definitive Te st [Confirmation] if Acc uracy is What You Want [ w hen do you not want it??]. 12

14 Screening/Presumptive Tests That s ASAM, not me 13

15 Presumptive [Screening] Test Urine Specimen Collection

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17 Reporting Presumptive [Screening] Results

18 Why Cutoffs are Important Laboratory

19 POCT Immunoassay? Reliability While immunoassay, point of care (POC) testing has its utility in the making of temporary and on the spot changes in clinical management, its limitations with regard to accuracy have recently been the subject of study. These limitations are such that point of care testing may not be appropriate for making definitive changes in medication management in populations at high risk for adverse outcomes until the results of confirmatory testing with more accurate methods such as liquid chromatography tandem mass spectrometry (LC-MS/MS) are obtained. A recent study on LC-MS/MS results following immunoassay POC testing in substance use disorder treatment settings found very high rates of false negatives and positives. Federation of State Medical Boards. Guidelines for the Chronic Use of Opioid Analgesics. April 2017

20 qualitative Immunoassay at POC are known to be flawed with false positive and false negative results Passik S, Heit H, Rzetelny A, Pesce A, Mikel, C, et al. (2013) Trends in drug and illicit use from urine drug testing from addiction treatment clients. Proceedings of the International Conference on Opioids. Boston, MA.

21 Introduction to Mass Spectrometry Sample introduction Ionization Separate masses Count ions Minimize collisions, interferences Collect results

22 Introduction to Mass Spectrometry 21

23 Liquid chromatography Mass Spectrometry 22

24 Liquid Chromatography Mass Spectrometry 23

25 Adulteration Try it yourself!! [the search, not the product]

26 Role of the Laboratory: Pain, Addiction, Workplace Opportunity or Need

27 My View of the Drug Testing World Employee Drug Testing Federal mandated Non-mandated International Addictions Pain

28 The Drug Testing Process

29 The Drug Testing Process

30 Requirements to be MRO Eligible 49 CFR Licensed Physician (MD or DO) In a U.S., Canadian or Mexican Jurisdiction Cannot be a nurse practitioner, physician s assistant or chiropractor

31 MRO Certification Good for 5 Years

32 Pain Management Data urine data Total: 374,409 Inconsistent 229,371 Percentage Inconsistent: 61%

33 Drug Classes Surprises

34 Total # Inconsistent by Class

35 Drug Testing: Things to Consider Cutoffs Matter LOD & LOQ

36 Drug Testing: Things to Consider

37 TOOLS of the TRADE BREATH ORAL FLUID URINE SWEAT ONSITE HAIR LAB

38 Drug Testing: Things to Consider

39 Drug Detection Times: Urine Mayo Clinic Proceedings January 2008 vol. 83 no

40 [Benefits of] Alternative Testing Methods Hair sample analysis Hair testing offers the longest window of detection (90 days standard test) Hair specimens difficult to adulterate or substitute Collection is safe and simple (no handling hazardous bodily fluids) No observed collection concerns (gender) Hair testing is valid and admissible in court Offers many different panels to meet different needs Laboratory-based Oral fluid analysis Oral Fluid testing offers recent usage detection (approximately 4 hrs to 3 days) Oral Fluid specimens are very difficult to adulterate or substitute Collection is safe and simple (no handling hazardous bodily fluids) No observed collection concerns (gender) Oral fluid testing is valid and admissible in court Offers many different panels to meet different needs

41 Oral Fluid

42 Drug Testing: Things to Consider 41

43 Why Different Matrices are of Interest Cone. Oral fluid testing: New technology enables drug testing without embarrassment. CDA Journal. 34: (2006).

44 Relative Detection Times Period of Detection Drugs of Abuse Level of Usage Urine Saliva Hair Single Use 3-5 Days minutes - 14 Hours 90 Days Marijuana Cocaine Moderate Use 8-12 Days minutes - 14 Hours 90 Days Heavy 21 Days - 11 Weeks minutes - 14 Hours 90 Days Single Use 2-5 Days 15 minutes - 24 Hours 90 Days Regular Use 10 Days - 2 Weeks 15 minutes - 24 Hours 90 Days Opiates Any 2-4 Days 3-6 Hours 90 Days PCP Any 3-8 Days Unknown (may be similar to cocaine) 90 Days Amphetamines (Amphetamine, Ecstasy, Methamphetamine) Barbiturates (Depends on Drug) Single Use 2-4 Days 30 minutes - 16 Hours 90 Days Regular Use 10 Days - 2 Weeks 30 minutes - 16 Hours 90 Days Any 2-30 Days N/A 90 Days Benzodiazepines Any 1-6 Weeks N/A 90 Days

45 Drug Testing: Things to Consider

46 Drug Testing: Things to Consider

47 Drug Testing: Things to Consider 46

48 Drug Testing: Things to Consider

49 What s the Best Tool? While hair affords the ability to detect a pattern of use over time of select substances, urine testing provides a recent view of use that hair may not, and allows for testing of a broader range of substances. When used together, hair and urine testing serve as complements and provide information about an individual s drug use that neither test alone provides. An Analysis of Paired Hair-Urine Drug Test Results Over a 5½ Year Period. R. H. Barry Sample, Lenox B. Abbott, Ted D. Johnson SOFT abstract

50 Drug Testing: Things to Consider? How Often to Test

51 Principles of Drug Testing Pain & Addiction how far back do you want to look? I m soliciting

52 What s Available? Hair & Oral Fluid example Menus Many panels available to meet different testing needs Amphetamine Methamphetamine Methamphetamine, MDMA, MDA, MDEA Benzodiazepines Alprazolam, Diazepam, Midazolam, Oxazepam, Temazepam, Nordiazepam, Nitrazepam Cannabinoids Carboxy-THC Cocaine Cocaine, Benzoylecgonine, Norcocaine, Cocaethylene Opiates & Oxycodone Codeine, Morphine, 6-AM, Hydrocodone, Hydromorphone, Oxycodone, Oxymorphone PCP (Phencyclidine) Hair Test Panel Barbiturates Butalbital, Amobarbital, Pentobarbital, Phenobarbital, Secobarbital Methadone Methadone, EDDP Propoxyphene Propoxyphene, Norpropoxyphene Meperidine Meperidine, Normeperidine Tramadol Fentanyl Fentanyl, Norfentanyl Ketamine Ketamine, Norketamine Buprenorphine Buprenorphine, Norbuprenorphine Zolpidem Amphetamine Methamphetamine Methamphetamine, MDMA, MDA, MDEA Benzodiazepines Nitrazepam, Lorazepam, Triazolam, Flunitrazepam, Alprazolam, Clonazepam, Diazepam, Midazolam, Oxazepam, Temazepam, Nordiazepam Cannabinoids THC Cocaine Cocaine, Benzoylecgonine, Norcocaine, Cocaethylene Opiates & Oxycodone Codeine, Morphine, 6-AM, Hydrocodone, Hydromorphone, Oxycodone, Oxymorphone, Norhydrocodone, Noroxycodone PCP (Phencyclidine) Oral Fluid Test Panel Barbiturates Butalbital, Amobarbital, Pentobarbital, Phenobarbital, Secobarbital Methadone Methadone, EDDP Propoxyphene Propoxyphene, Norpropoxyphene Meperidine Meperidine, Normeperidine Tramadol Fentanyl Fentanyl, Norfentanyl Ketamine Ketamine, Norketamine Buprenorphine Buprenorphine, Norbuprenorphine Zolpidem

53 Smarter Drug Testing This is ASAM but applies to ALL

54 It s Hair Shaft Testing 53

55 Hair: Variable Growth Rates 54

56 Testing Frequency Notice that 5 years is also in the DOT federally mandated testing.

57 Drug Testing: Things to Consider Resources Choosing a Laboratory 56

58 Drug Testing: Things to Consider urine alcohol This is urine, not breath, blood, saliva

59 Examples of Cross-Reactivity [false positives] in Presumptive [immunoassay screening] Tests Michael White; Dept. Of Pharmacy Practice, UConn School Of Pharmacy

60 Examples of Cross-Reactivity [false positives] in Presumptive [immunoassay screening] Tests

61 Federally Mandated DOT Testing Recent Changes Expanded Opioid Testing Policy Issues New Federal CCF Specimen Collection Issues MRO Process Changes DOT Agency Changes Blind specimens, Part 40 definitions, ODAPC List-serve

62 DOT Panel January 2018 DOT drug testing continues to be identified as a 5-drug panel, although drugs/analytes have been added to the basic 5 drug classes THC, COC, OPI, PCP, AMP Initial Test Analyte Initial test cutoff ng/ml Confirmatory test analyte Confirmatory test cutoff ng/ml Marijuana metabolites 50 THCA 15 Cocaine metabolite 150 Benzoylecgonine 100 Codeine/morphine 2000 Codeine Morphine Hydrocodone/hydromorphone 300 Hydrocodone Hydromorphone Oxycodone/oxymorphone 100 Oxycodone Oxymorphone Acetylmorphine 10 6-acetylmoorphine 10 Phencyclidine 25 Phencyclidine 25 Amphetamine/methamphetamine 500 Amphetamine Methamphetamine MDMA/MDA 500 MDMA MDA

63 Initial Test Analyte Initial test cutoff ng/ml Confirmatory test analyte Confirmatory test cutoff ng/ml Marijuana metabolites 50 THCA 15 Cocaine metabolite 150 Benzoylecgonine 100 Codeine/morphine 2000 Codeine Morphine Hydrocodone/hydromorph one 300 Hydrocodone Hydromorphone Oxycodone/oxymorphone 100 Oxycodone Oxymorphone Acetylmorphine 10 6-acetylmoorphine 10 Phencyclidine 25 Phencyclidine 25 Amphetamine/methamphe tamine 500 Amphetamine Methamphetamine MDMA/MDA 500 MDMA MDA

64 Clinical Urine Cutoffs Example

65 Opiate Biotransformation [heroin] [6 MAM]

66 Simplified Benzodiazepine Biotransformation

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68 Available Guidelines Appropriate Use of Drug Testing in Clinical Addiction Treatment American Society of Addiction Medicine, March 27, 2017 Federation of State Medical Boards. Guidelines for the Chronic Use of Opioid Analgesics. April 2017 LABORATORY MEDICINE PRACTICE GUIDELINES Using Clinical Laboratory Tests to Monitor Drug Therapy in Pain Management Patients. AACC/CAP/AAPM SAMHSA

69 Happy to hear from you: Benjamin Gerson MD