4 Reasons for Drug Testing - WHY? act as a deterrent to future drug useidentify participants who are maintaining abstinenceidentify participants who have relapsedrapid interventionefficient utilization of limited resourcesprovides incentive, support and accountability for participantsadjunct to treatment & frames sanction decisions
5 Drug Testing Specimens urine - current specimen of choicegenerally readily available - large quantitiescontains high concentrations of drugsgood analytical specimenprovides both recent and past usagealternative specimensbreathhairsweat - patch testsaliva - oral fluids
6 Characteristics of a Good Drug Test: scientifically validemploys proven methods & techniquesaccepted by the scientific communitylegally defensibleable to withstand challengeestablished court track recordscrutinized by legal/judicial reviewtherapeutically beneficialprovides accurate profile of client’s drug useprovides rapid results for appropriate response
7 When to Test? KEEP ‘EM GUESSING ! effective drug testing must be randomunexpected, unannounced, unanticipatedlimit time between notification & testingtest as often as possible - twice weeklyconsider use of multiple specimens (hair, saliva, sweat)testing frequency remains constant throughout phase progression
8 Drug Testing Reality Check When developing and administering your drug testing program assume that the participants you are testing know more about urine drug testing than you do!Sources:InternetHigh Times magazineother court clients
10 The Importance of “Specificity” in a Client Contract: “I understand ”I will be tested for the presence of drugs in my system on a random basis according to procedures established by the Drug Court Team and/or my treatment provider.I understand that I will be given a location and time to report for my drug test.I understand that it is my responsibility to report to the assigned location at the time given for the test.
11 The Importance of “Specificity” in a Client Contract: I understand that if I am late for a test, or miss a test, it will be considered as a positive test for drugs/alcohol and that I may be sanctioned.I understand that if I fail to produce a urine specimen or if the sample provided is not of sufficient quantity, it will be considered as a positive test for drugs/alcohol and that I may be sanctioned.I understand that if I produce a dilute urine sample it will be considered as a positive test for drugs/alcohol and that I may be sanctioned.
12 The Importance of “Specificity” in a Client Contract: I have been informed that the ingestion of excessive amounts of fluids can result in a diluted urine sample and I understand that my urine sample will be tested to ensure the sample is not dilute.I understand that substituting or altering my specimen or trying in any way to modify my body fluids for the purposes of changing the drug testing results will be considered as a positive test for drugs/alcohol and will result in sanctioning and may be grounds for immediate termination from drug court.
14 “Witnessed” collection (for urine) single most important aspect of effective drug testing programurine collections not witnessed are of little or no assessment valuedenial component of substance abuse requires “direct observation” collections of participantsThe importance of witnessed collection (for urine monitoring) can not be over-emphasized. As indicated on the slide, urine collections which are not witnessed are of little or no assessment value because of the propensity of drug court participants not to provide a legitimate sample (denial; efforts to hide relapse). The definition of “witnessed collections” is direct line-of-sight observation – basically staring at a participants genitals. Difficult? - yes! Uncomfortable? - no doubt! Necessary? - absolutely critical. Put another way; if drug courts don’t directly observe urine collections, they should not waste their time and money on testing efforts! It’s THAT important!The success of monitoring depends on a legitimate specimen for testing. The most likely guarantor that a legitimate specimen will be produced is with direct-observation collections. Remember, a drug court can employ the absolute best testing methods available, but that testing is worthless if the sample has been tampered with (by the participant) prior to the testing process.
15 Sample Collection: pre-collection preparation site selection minimize access to water sourcesuse an area with a scant floorplanfind privacy & securitygather supplies beforehandobtain proper collection receptacleremoval of outer clothing
16 Sample Collection: (continued) wash hands prior to donation“witness” collectionadditional clothing removalbody inspectionsquat and coughlabel sample correctly
17 Sample Collection: (continued) accept sample & inspecttemperature (90-100˚ F)color (no color diluted ?)odor (bleach, sour apples, aromatics, vinegar, etc.)solids or other unusual particulatesstore sample properlyforensic sample - custody & control
18 Developing control strategies to prevent sample tampering is critical Developing control strategies to prevent sample tampering is critical. Once clients understand that they cannot beat the system, they are much more likely to engage in the therapeutic process toward recovery.
20 Two-Step Testing Approach screening test – designed to separate negative samples from samples that are “presumptively” positiveconfirmation test – follow-up procedure designed to validate positive test resultsdistinctly different analytical techniquemore specific and more sensitive
21 Step One – Screening often based on immunoassay technology more drug – more binding - more “color” produced – more instrument detector responsenumerous commercial manufacturersdesigned for high throughput instrumentation or on-site devices
22 On-site DOA screening often based on immunoassay technology concept of color “switch”“dynamic” versus “static” calibrationhand-held cassettes or test-cup devicesone test at a time - no batchingavailable in DOA panels or single drugsnumerous commercial manufacturersdifferential sensitivity & selectivity
23 On-site Drug Detection: Follow package insert guidance exactly!
24 On-site Drug Detection: Intensity of band is NOT quantitative!
25 Step Two - Confirmation gas chromatography-mass spectrometry (GC/MS) or LC/MSdrug molecules separated by physical characteristicsidentified based on chemical “finger-print”considered “gold standard”other chromatographic techniques
26 Why confirm ?Is it really necessary to confirm drugs that tested positive by initial screening tests?Why can’t the court adjudicate cases based on the screening test results?FALSE POSITIVES
27 Drug tests & cross reactivity: screening tests can and do react to “non-target” compoundsamphetaminesbenzodiazepinesobtain list of interfering compounds from lab or on-site test vendorinitial screening (“instant” tests) may only be 60-70% accurateconfirm positive results
29 Negative or None Detected Results indicates that no drugs or breakdown products (metabolites), tested for, were detected in the sample testedno such thing as “zero” tolerance or “drug free”negative does not mean NO drugs present
30 Negative/None Detected Interpretation client is not using a drug that can be detected by the testOther possible explanationsclient not using enough drugclient’s drug use is too infrequentcollection too long after drug useurine is tamperedtest being used not sensitive enoughclient using drug not on testing list
31 Negative/None Detected Interpretation no need to second-guess every “negative” resultnot suggesting withholding positive reinforcement & rewards for positive behaviorsdrug testing is a monitoring toolassess none detected drug testing results in the context of your client’s overall program compliance (or non-compliance) and their life’s skills success (or lack thereof)
32 Positive Test Result Interpretation indicates that drug(s) or breakdown products (metabolites), tested for, were detected in the sample testeddrug presence is above the “cutoff” levelgreatest confidence achieved with confirmationALWAYS confirm positive results in original sample
34 What is a “cutoff” level ? cutoffs are not designed to frustrate CJ professionalsa drug concentration, administratively established for a drug test that allows the test to distinguish between negative and positive sample - “threshold”cutoffs provide important safeguards:scientific purposes (detection accuracy)legal protections (evidentiary admissibility)measured in ng/mL = ppb
36 Drug Tests are Qualitative screening/monitoring drug tests are designed to determine the presence or absence of drugs - NOT their concentrationdrug tests are NOT quantitative
37 Drug concentrations or levels associated with urine testing are, for the most part, USELESS ! cannabinoids ng/mLopiates negativecocaine metabolite negativeamphetamines negative
38 The Twins A B 200 mg Wonderbarb @ 8:00 AM Collect urine 8:00 PM 12 hours laterAB
39 The Twins - urine drug test results ABWonderbarb = 638 ng/mLWonderbarb = 3172 ng/mL
40 The Twins - urine drug test results physiological make upexact amount drug consumedexact time of ingestionexact time between drugexposure and urine collectionAND YETAB
41 The Twins - urine drug test results Twin B’s urine druglevel is 5 times higherthan Twin AABWonderbarb = 638 ng/mLWonderbarb = 3172 ng/mL
42 Are any of the following questions being asked in your court? How positive is he/she?Are his/her levels increasing or decreasing?Is that a high level?Is he/she almost negative?Is this level from new drug use or continued elimination from prior usage?What is his/her baseline THC level?Does that level indicate relapse?Why is his/her level not going down? (or up?)
43 THE ISSUEUrine drug concentrations are of little or no interpretative value. The utilization of urine drug test levels by drug courts generally produces interpretations that are inappropriate, factually unsupportable and without a scientific foundation. Worst of all for the court system, these urine drug level interpretations have no forensic merit.
45 Scientific Rationale Technical Issues Physiological testing not linear tests measure total drug concentrationsPhysiologicalvariability of urine outputdifferential elimination of drug components
46 THIS ? 432 indicates he going up, right? is 22 above the cutoff? does 219 mean new use?307 – well she’s almostnegative, correct?639 is really high for THC, isn’t it?I think 1200 is a newrecord, isn’t it?115 is down from yesterday,probably continued elimination?515 is much higher thanlast week, right?don’t we need to considerrelapse at 57?
49 Drug Detection Times - by Drug (this is general guidance!) amphetamines: up to 4 dayscocaine: up to 72 hoursopiates: up to 5 daysPCP: up to 6 daysbarbiturates: up to a weekbenzodiazepines: up to a week. . then there’s alcohol & cannabinoidsDetection time in urine is based on an average of the most commonly tested drugs of abuse. It is important to stress that these estimates can vary significantly depending on client-specific parameters (such as those listed as variables in the notes for the preceding slide). In addition to those variables, the cutoff concentration of each drug test will have an impact on detection times. For example, a cannabin test with a 20 ng/mL cutoff level is 2.5 times more sensitive than a cannabinoid test with a 50 ng/mL threshold – accordingly, the 20 ng/mL test will have a detection window that is considerably longer (maybe several days) than the 50 ng/mL cannabinoid test.Again, the general estimates provided on this slide are just that – estimates.Alcohol elimination is rapid – being removed from the body in only a few hours. Cannabinoids (marijuana), being fat-soluble, can be detected in urine for up to a couple of weeks with testing performed at the 20 ng/mL cutoff level – however 30-day elimination rates often quoted would be considered extremely rare (if not physiologically highly unlikely).
50 Cannabinoid Detection in Urine Conventional wisdom has led to the common assumption that cannabinoids will remain detectable in urine for 30 days or longer following the use of marijuana.RESULT:delay of therapeutic interventionhindered timely use of judicial sanctioningfostered denial of marijuana usage by clients
52 Cannabinoids - Recent/Relevant Research 30+ day detection window often exaggerates duration of detection windowreasonable & pragmatic court guidancedetection time: at 50 ng/mL cutoffup to 3 days for single event/occasional useup to 10 days for heavy chronic usedetection time: at 20 ng/mL cutoffup to 7 days for single event/occasional useup to 21 days for heavy chronic use
53 Recent Cannabinoid Use versus Non-recent use (double sanction issue): How do drug courts discriminate between new drug exposure and continued elimination from previous (chronic) use ?an issue only in first phase of programonly drug that poses concern is cannabinoids“two negative test” rule – two back-to-back negative drug tests post clean out
54 EtG & EtS – Strategy for Monitoring Alcohol Abstinence
55 Alcohol is the most commonly abused substance by drug court clients and the most difficult substance to detect in abstinence monitoring.
56 Advantages of Ethyl Glucuronide & Ethyl Sulfate unique biological marker of alcohol use (no false positives)direct marker indicating recent uselonger detection window than alcoholstable in stored specimens (non-volatile)is not formed by fermentationis not detected in the urine of abstinent subjects
58 Advantages of Ethyl Glucuronide & Ethyl Sulfate unique biological marker of alcohol use (no false positives)direct marker indicating recent uselonger detection window than alcoholstable in stored specimens (non-volatile)is not formed by fermentationis not detected in the urine of abstinent subjects
59 Disadvantages of EtG/EtS testing available at relatively few laboratoriesEtG testing more costly than abused drugsexpensive LC/MS/MS technologyintroduction of new testing approachesmost significant concern – casual, inadvertent, environmental alcohol exposure causing positive results
60 Sources of “Incidental” Alcohol Exposure OTC medications (Nyquil, Vicks Formula 44)mouthwashes (Listermint & Cepacol)herbal/homeopathic medications (i.e., tincture of gingko biloba - memory)foods containing alcohol (such as vanilla extract, baked Alaska, cherries jubilee, etc.)“non-alcoholic” beers (O’Doul’s, Sharps)colognes & body spraysinsecticides (DEET)alcohol-based hand sanitizers (Purell, GermX)
61 Is a positive urine EtG/EtS test result a definitive indicator of relapse or prohibited drinking? Is a positive urine EtG/EtS test result sufficient justification for client sanctioning?
62 Consensus Cutoffs:EtG minimum of 500 ng/mLEtS minimum of 100 ng/mL
63 Positive EtG Result (500 ng/mL): a result reported as EtG positive in excess of the 500 ng/mL cutoff is consistent with the recent ingestion of alcohol-containing products (1-2 days prior to specimen collection) by a monitored clientstudies examining “incidental” exposure widely conclude that results in excess of the 500 ng/mL cutoff are not associated with inadvertent or environment ethanol sources
64 Negative EtG Result (500 ng/mL): a result reported as EtG negative is indicative of a client who has not ingested beverage alcohol within 1-2 days prior to specimen collectiona negative result is not proof of abstinenceadvertised “80-hour” window of detection not “real-world” applicable
67 Best Practices for EtG/EtS Testing: provide those being monitored with an alcohol use advisory document - EtG/EtS specific contract - mandatoryuse appropriate cutoffs:EtG ng/mLEtS ng/mLtest for EtS (ethyl sulfate) - biomarker of choice
69 The Effective Use of Urine Creatinine Measurements in Abstinence Monitoring
70 The most common form of specimen tampering is sample dilution The most common form of specimen tampering is sample dilution. Creatinine testing is a specimen validity issue!
71 EVERY urine sample collected for drug detection should be tested for creatinine! You can’t intervene to change behavior if you don’t know a client has relapsed!
72 What is creatinine ?creatinine is produced as a result of muscle metabolismcreatinine is produced by the body at a relatively constant rate throughout the daycreatinine is a compound that is unique to biological material (i.e. urine, other body fluids)creatinine measurements can:determine the “strength” or concentration of a urine sampleensure the sample being tested IS urine
73 Two Types of Urine Specimen Dilution pre collection dilutionconsumption of large quantities of fluids prior to collectionpost collection dilutionadding fluid to specimen post collection
74 Pre-Collection Dilution high-volume ingestion of fluids (water loading, flushing, hydrating, etc.)may be in conjunction with products designed to “enhance” drug elimination or removal of drugs (Gold Seal, Clean ‘n Clear, Test-Free, Naturally Klean, etc.)no evidence these products have any additional effect on drug elimination
75 DILUTION GOAL Client has a bladder full of urine with a drug concentration of greater thanthe cutoff level of the test - thusproducing a positive result.Urine in the bladder is diluted bythe consumption of large amounts ofnon-drug containing fluid; whichresults in a drug concentration thatis less than the cutoff level of the test -thus producing a negative result.
76 Water contains no drugs! easiest, cheapest, simplesturines with a creatinines of less than 20 mg/dL are considered “dilute” and rarely reflect an accurate picture of recent drug usedilute samples are more like water than like urineincidence of low creatinines in a population undergoing random drug testing is significantly (up to 10 times) greater than a non-drug tested population
77 The “Normal” Urine Creatinine normal urine creatinine: study “Urinary Creatinine Concentrations in the U.S. Population” determine the mean (based upon 22,245 participants) was 130 mg/dLstudy was not associated with drug testingsubjects came from a variety of ethnic groupssamples were collected AM, mid-day, and PMless than 1% below 20 mg/dLless than 1% greater than 400 mg/dL
78 Creatinine Facts some diseases that produce low urinary creatinines muscle wasting disease - RAREsome kidney aliments - RARElow creatinines ARE NOT routinely associated with:pregnancydiabetesobesityexercisehigh-blood pressurebeing vegetarian
79 More Creatinine Issues rapid ingestion (90 minutes) of 2-4 quarts of fluid will almost always produce low creatinines & negative urine drug tests within one hourrecovery time of urine creatinine and drug concentrations can take up to 10 hours
80 “Dilute” Result Interpretation: negative or none detected results should never be interpreted as indicating no drug use (abstinence), because if, in fact, drugs were present, they probably could not be detected by the testpositive drug test results from a dilute sample however, are considered valid (donor was not able to dilute the sample sufficiently to deceive the test)
81 Two final thoughts about dilute urine samples . . . . . a creatinine of less than 20 mg/dL (associated with a drug test) is nearly always an attempt by the donor to avoid drug use detection - REGARDLESS of how much liquid was consumed in order to achieve this resultplace a dilute sample prohibition in your client contract and sanction for repeat dilute samples
82 SUMMARY TEST FOR CREATININE! incorporate creatinine guidance in your SOPs and client contractinstitute a dilute sample prohibitionunderstand very low urine creatinine levels are NOT normal occurrencesdilute samples are nearly always an attempt by the donor to avoid drug use detectionsanction for repeat dilute testsfollow urine creatinine patterns
83 Ten Principles of Drug Testing 1. Design an effective drug detection program, place the policies and procedures into written form & communicate to court staff and clients alike.2. Develop a client contract that clearly enumerates the responsibilities and expectations of the court’s drug detection program.3. Select a drug testing specimen & testing methodology that provides results that are scientifically valid, forensically defensible and therapeutically beneficial.
84 Ten Principles of Drug Testing 4. Ensure that the sample collection process supports effective abstinence monitoring practices; (random/unannounced selection & witnessed/direct observation sample collection)5. Confirm of all positive screening results using alternative testing methods.6. Determine the creatinine concentrations of all urine samples to identify tampering.7. Eliminate of the use of urine levels for the interpretation of client drug use behavior.
85 Ten Principles of Drug Testing 8. Establish drug testing result interpretation guidelines that have a sound scientific foundation and that meet a strong evidentiary standard.9. In response to drug testing results, develop therapeutic invention strategies that promote behavioral change and support recovery.10. Understand that drug detection represents only a single supervision strategy in an overall abstinence monitoring program.
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