Exploring the Reliability, Frequency, and Methods of Drug Testing: What is Enough To Ensure Compliance? Martha E. Brown, MD Assistant Medical Director PRN and UF Associate Professor Addiction Medicine Division Co-Authors Judy Rivenbark, MD-Medical Director PRN Debbie Troupe, LMHC, CAP-Chief Compliance Officer PRN Jean D’Aprix, BA, RN, CARN-Chief Operating Officer PRN 1 Disclosures Dr. Brown is a Medical Review Officer and Consultant to Fortes Labs through the University of Florida The other authors have no disclosures Overview of Drug Testing Drug testing is one of the few methodologies that we have to assure boards that a participant is at least clean In order to be minimally effective, drug testing should be based on DOT regulations PHPs and forensic evaluations should use a federally certified lab NOT associated with the MD or program and have GCMS confirmation 2 Overview of Drug Testing Federal chain of custody procedures should be followed Testing should be random (how to do this???) Drug testing may miss positives unless a complete professional panel, of a variety of addictive prescription medications, is done Hair testing and other types of testing should be considered and used Drug testing can help determine if a participant is taking the prescribed meds, using illicit drugs/alcohol, or is compliant Overview of Problems in Urine Drug Testing  Alcohol and drug testing can be beaten and is at best a deterrent http://www.thewhizzinator.com/ http://www.passyourdrugtest.com/  Most drugs can only be detected 1-3 days  Patients are able to obtain prescriptions from “helpful” colleagues and friends  Cut off levels vary as well as an individual’s metabolism for a drug  Poppy seed defense can work once 3 Overview of Problems in Testing  Works once for low level EtG- “I didn’t know hand sanitizer, Listerine, and nonalcoholic beer had alcohol in it”  If it is NOT OBSERVED, it has a good chance of being beaten if the person wants to beat it (i.e. not in good recovery)  If the Chain of Custody (COC) does not ORIGINATE at collection site, then there is a good chance of being beaten if the person wants to beat it (one can collect/ship one’s own urine-the lab doesn’t study each box)  Expensive to screen for every opiate/drug Test Panels The more drugs tested for, the more likely you will catch someone using or an early relapse The more drugs tested for, the more expensive the test panel Impossible to test for every drug (you have to be SPECIFIC about what you want) 4 Minimum Test Panels Drugs and Alcohol EtG/EtS Pot Cocaine Benzodiazepines (needs to include all with metabolites) Amphetamines Tramadol Spice ? Opiates Hydromorphone Hydrocodone Oxycodone Meperidine Methadone Suboxone Fentanyl ? Drug Testing Reliability The cutoff levels set by the lab are fairly standard and are where the lab feels comfortable confirming specimen GCMS is “gold standard” The level of a drug reported in a urine, however, only means IT IS ABOVE THE CUTOFF. No information can be determined about amount of use or necessarily when they used (can only make general guess based on knowledge of half-life of the drug, i.e., a positive cocaine is not from using a month ago) A negative drug screen means a drug was not detected at the cutoff. It doesn’t mean a person didn’t use, particularly, if the urine is dilute. 5 Drug Testing Reliability Urines that are not fully observed are probably worthless in a monitoring situation Urine can be brought into the bathroom, hiding in many unusual places on the body Masking agents can be put under nails, as well as there are a multitude of other ways to adulterate the urine Labs run an adulterant panel, however, as soon as they figure out one product, another appears on the market (labs marked invalid may or may not have an adulterating substance in it) Drug Testing Reliability The cutoff levels set by the lab are fairly standard and are where the lab feels comfortable confirming specimen GCMS is “gold standard” The level of a drug reported in a urine, however, only means IT IS ABOVE THE CUTOFF. No information can be determined about amount of use or necessarily when they used (can only make general guess based on knowledge of half-life of the drug, i.e., a positive cocaine is not from using a month ago) A negative drug screen means a drug was not detected at the cutoff. It doesn’t mean a person didn’t use, particularly, if the urine is dilute. 6 Dilute and Out of Range Urines It takes a large amount of consumed water to cause a dilute (on average a gallon of water consumed over 1-1.5 hours) Kidney function and creatinine are a very stable system (not easily changed by muscle mass/exercise/food/meat, etc) We quickly eliminate excessive fluids restoring balance to our system unless we have kidney disease (which can easily be determined by a nephrologist) Dilute and Out of Range Urines A decrease in the creatinine is the most important and reliable indication of dilution Out of range has only an abnormal specific gravity Dilute has a creatinine of greater than or equal to 2mg/dL and less than 20mg/dL AND a specific gravity greater than 1.001 but less than 1.003 7 Dilute and Out of Range Urines Very difficult to monitor an individual if they constantly have dilute urines Multiple dilutes are a strong indicator of relapse behavior Testing to “detection only” shows large number of dilute samples are positive (won’t hold up in court) Easy to dilute out an EtG positive Normal creatinine IS NOT 20 mg/dL (20 mg/dL is just the DOT cutoff for dilutes) Normal creatinine IS 100-150 mg/dL Current Dilute Policy at PRN 1st-notification of dilute 2nd-notification and additional urine 3rd-final notice, 2 added urines, PEth, hair 4th-referral for urology/nephrology workup, PEth test, and two additional urines 5th-evaluation, PEth, at least weekly urines for 3 months, and a hair test 6th-inpatient evaluation, PEth, and observed weekly urines for 6 months 8 Current Dilute Policy at PRN 7th-results in consideration of whether the case should be closed secondary to noncompliance and DOH notified Participants must have 6 months with no dilute or out of range urines for this policy to restart over for a participant Invalid Tests DOT calls an invalid test one where the lab: 1) detects an adulterant or interference they are unable to identify or 2) documents an interference with the GC/MS confirmation assay or 3) sample has abnormal physical characteristics or 4) sample has an endogenous substance at an abnormal concentration that prevents the laboratory from completing or obtaining a valid drug test result. 9 Substituted or Adulterated DOT calls a substituted urine one where the Creatinine is < 2mg/dL and the sg is < or = to 1.001 OR > or = to 1.020 DOT calls an adulterated specimen a specimen that contains a substance that is not expected to be present in human urine, or contains a substance expected to be present but is at a concentration so high that it is not consistent with human urine (one where the nitrite concentration is > or = to 500mcg/mL OR the pH is < 3 or greater than or equal to 11 ) Frequency Issues Most drugs and EtG have fairly short half lives, therefore many relapses are missed if the frequency of testing is low Consider testing “back to back” or extremely random patterns Programs that test on a routine pattern are often beaten NFL tests up to 10 times a month 10 Frequencies of State Programs Frequency Study When urine testing is performed at rate of 8 times a year, probability of testing positive in given month 50-50 even for daily use Infrequent drug use difficult to detect regardless of DT frequency Main purpose of urine drug screens is to identify patients in early relapse so interventions can be applied when most likely to be effective Ross Crosby, Gregory Carlson, Sheila Specker. Journal of Addictive Diseases, Vol. 22(3) 2003. 11 Frequency Study of 48 Hour Detection Window (Mean/SD to positive urine) Drug Use DT 2X a week DT 1X a week DT 2X a month DT 1X a month 8X a year Every Day 3 +/- 2 7 +/- 2 15 +/- 10 30 +/-13 46 +/- 40 Every other 5 +/- 3 day 9 +/- 5 21 +/- 14 41 +/- 24 61 +/- 52 2X a week 7 +/- 6 14 +/- 10 30 +/- 24 63 +/- 48 91 +/- 81 1X a week 12 +/- 12 25 +/- 22 56 +/- 47 111 +/- 92 168 +/- 158 2X a month 27 +/- 28 56 +/- 50 134 +/- 133 222 +/- 190 379 +/- 320 1X a month 53 +/- 56 102 +/- 96 212 +/- 190 463 +/- 474 806 +/- 817 Ross Crosby, Gregory Carlson, Sheila Specker. Journal of Addictive Diseases, Vol. 22(3) 2003. PRN Missed Tests and Check-ins Participants will not be required to call in or test during the following: – Vacations out of the country (excluding Hawaii and Alaska) – Inpatient hospitalizations Unexcused missed call-ins in 6 months period: – – – – 1st-warning notification 2nd-warning notification and extra test added 3rd-final warning notification/extra test added 4th-Evaluation of recovery status 12 PRN Missed Tests and Check-ins Unexcused missed tests: – 1st-Removal from practice/evaluation of recovery status – 2nd-Voluntary withdrawal from practice and inpatient evaluation. Will not return to practice until determined Fit For Duty and capable/willing to comply with requirements – 3rd-Closing of file and referral for noncompliance If a test scheduled on an unexcused missed call-in, consequences may include 2 additional tests up to and including removal from practice Unexcused missed tests after calling in and finding out a drug test is required-immediate removal from practice May be excused from calling in/testing with unusual and extenuating circumstances Beating the Test Direct observation doesn’t necessarily ensure an accurate test Multiple products on the market to adulterate urine Can buy urine on the internet or get it from your kid Catherization 13 Other Common Types of Drug Testing Saliva (screening test that does not have a wide range of panels and is only a screening) Blood (can be expensive) Breath using Evidential Breathalyzer (machines are expensive and must have alcohol in system to get positive test) Hair Nails PEth Hair and Nail Testing Hair grows on average ½ inch per month, but there is a lot of variation Still some issues of hair including dying, bleaching, straightening; dark hair binds drugs tighter Nail clipping can show drugs up to 8 months One time use usually doesn’t show in hair or nails Less research on hair and nail testing 14 PEth Test Alcohol biomarker (phosphatidylethanol) that exists as a component of red cell membrane Abnormal phospholipid formed in cell tissues following alcohol exposure Using LC/MS/MS can identify as little as one drink (12 grams of Etoh) per day over a week’s time or 7 drinks in a binge Measured for 2-3 weeks after use of alcohol USDTL has this blood spot assay EtG (Ethyl Glucuronide) Testing Often the urine is negative for ethanol and positive for EtG/EtS when someone has used alcohol recently Alcohol positive with a negative EtG is a result of fermentation Incidental use issues abound Clinical correlation is necessary when using EtG testing and the test should not stand alone in determining a relapse 15 The Take Home Message 16