3Volume II ? – Fall 2014 drug testing data/evaluation role of the team ancillary servicescaseloadaddendum on legal
4Best Practices frequency of testing random testing witness collection & specimen integritycustody & controlaccurate results & confirmationrapid turn-around time
5The law is not black and white and neither is science. “. . there is a substantial gap between thequestions that the legal community would liketo have answered by drug testing and the answersthat the scientific community is able to provide.The real danger lies in the legal community’s failure to “mind the gap” by drawing unwarranted inferences from drug testing results.”
7Reasons 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
8Drug 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
9When 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 program participation
10Characteristics 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
11Drug 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
13The 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.
14The 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.
15The 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.
17The “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.
18Sample Collection: pre-collection preparation site selection minimize access to water sourcesuse an area with a scant floorplanfind privacy & securitygather supplies beforehandobtain proper collection receptacleconfirm IDremoval of outer clothing
19Sample Collection: (continued) wash hands prior to donation“witness” collectionadditional clothing removalbody inspectionsquat and coughlabel sample correctly61st District Court - Grand Rapids
20Sample 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 documents
22Two-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
23Step 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
24On-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
25On-site Drug Detection: Follow package insert guidance exactly!
26On-site Drug Detection: Intensity of band is NOT quantitative!
27Step 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
28Why 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
29Drug 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
30Choosing a Drug Testing Laboratory certifications – SAMHSACAP-FUDT (College of American Pathologists - Forensic Urine Drug Testing)methodology, SOP, staff qualifications, quality assurance, security, etc.turn-around time, result reporting formatscost - $$$$customer service (access to expert advice)ease of access - proximity, minimize sample handlingrequest current customer list
31Choosing an On-Site Testing Device FDA - approvedCLIA-waived (means nothing)cost - $$$$ (BUT - you get what you pay for)ease of useappropriate cutoff levelscustomer service (access to expert advice)request current customer listconfirmation required
33Negative 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
34Negative/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
35Negative/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)
36Positive 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
38What 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
40Drug Tests are Qualitative screening/monitoring drug tests are designed to determine the presence or absence of drugs - NOT their concentrationdrug tests are NOT quantitative
41Drug concentrations or levels associated with urine testing are, for the most part, USELESS ! cannabinoids ng/mLopiates negativecocaine metabolite negativeamphetamines negative
42The Twins A B 200 mg Wonderbarb @ 8:00 AM Collect urine 8:00 PM 12 hours laterAB
43The Twins - urine drug test results ABWonderbarb = 638 ng/mLWonderbarb = 3172 ng/mL
44The Twins - urine drug test results physiological make upexact amount drug consumedexact time of ingestionexact time between drugexposure and urine collectionAND YETAB
45The Twins - urine drug test results Twin B’s urine druglevel is 5 times higherthan Twin AABWonderbarb = 638 ng/mLWonderbarb = 3172 ng/mL
46Are 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?)
47THE 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.
49Scientific Rationale Technical Issues Physiological testing not linear tests measure total drug concentrationsPhysiologicalvariability of urine outputdifferential elimination of drug components
50THIS ? 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?
53Drug 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).
54Cannabinoid 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
56Cannabinoids - 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
57Recent 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
58Opiates - Results Interpretation screening tests - drug class assayspositive results indicate presence of opiatesmost assays not reactive toward synthetic narcotic analgesics; meperidine (Demerol), propoxyphene (Darvon), methadone, pentazocine (Talwin), fentanyl (Sublimaze)difficult to separate legitimate use from abusedetection time: up to 4 days following therapeutic use of codeine or morphine
59Alcohol - Results Interpretation screening tests specific for ethanol, ethyl alcoholpositive results indicate presence alcoholalcohol is rapidly cleared from the bodynegative results don’t necessarily document abstinencedetection time = hoursexample - person intoxicated at 11:00 PM, collect second urine sample of next day (11:00 AM), most likely test negative for alcohol
60EtG & EtS – Strategy for Monitoring Alcohol Abstinence
61Alcohol is the most commonly abused substance by court clients and the most difficult substance to detect in abstinence monitoring.
62Advantages 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
64Advantages 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
65Disadvantages 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
66Sources 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)
67Is 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?
68Consensus Cutoffs:EtG minimum of 500 ng/mLEtS minimum of 100 ng/mL
69Positive 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
70Negative 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
71EtG/EtS- Specific Contract: outlines the behavioral requirements and compliance standards necessary for continued participation in drug courteducate, alert and advise drug court clients of the potential (incidental) sources of alcohol that could produce a positive urine EtG/EtS test resultlisting the numerous commercial products that contain ethyl alcohol and provides a list of substances to avoid while in a drug court program
72Prohibited Items: OTC medications non-alcoholic beer & wine foods that contain alcoholalcohol-based mouthwashesalcohol-based hand sanitizersalcohol-based hygiene products
74Best 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
75EtG/EtS Admissibility? are EtG/EtS results legally admissibleKelly-Frye, Daubert, Rule 703use of proper cutoffs 500/100 ng/mLuse of appropriate methodologies (LC/MS/MS for confirmation of positives)use client contractinterpret results correctlyYES!
79Challenge with Prescription Drugs therapeutic use versus abusetherapeuticusevarious stages of misuseabuse
80Drug testing is an excellent tool for the abstinence monitoring of court clients, however it provides limited information for the differentiation between the appropriate therapeutic use of prescribed medications and the misuse/abuse of those same drugs - regardless of the specimen tested.
81Client Signed Releases doctorsdentistsother healthcare professionalspharmacies
82Healthcare Contact Form form used by clients to document contact with healthcare professionalsclients required to use contact form for each visit where medications are being used during a procedure or prescribed for usesanction for failure to use formplace requirement in client contractclient seek prior permission to see doctor
83I (client name), am a participant in drug court I (client name), am a participant in drug court. This program is a court monitored recovery program for addicts. As a result, I am subject to frequent and random drug testing. Therefore, I must report to the court my visit today. As I am in recovery, I would respectfully request that you take this into consideration and offer non-narcotic medications, if possible, when drugs are necessary for my medical treatment.Physician (Name) ______________________________________Physician (Signature) _______________________________________If you have any questions or concerns, please feel free to call the court and talk to my case specialists.If this patient fails to present this form to the nurse and physician prior to receiving medication or a prescription for medication, please notify the court.Please list the medications prescribed today:
84Other Control Strategies search & seizure (client contract)car, home, possessionspill countsno out-of-state prescriptionsuse of specified pharmaciesloss of completion credits/time while on certain prescription meds
85Ten 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.
86Ten 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.
87Ten 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.