3/17/2016

Come Fully Hydrated -you will need to provide a specimen

Timothy J. Wiegand, MD, FACMT, FAACT, FASAM Director of Toxicology at Strong Memorial Hospital and the University of Rochester Medical Center Medical Director Huther Doyle Drug & Alcohol Treatment

Disclosures (and background):

• No financial Disclosures to make • X-waivered physician over 10 years • Practiced addiction medicine in variety of settings –Inpatient addiction med/toxicology Consultation Liaison –Detoxification facility –Intensive Outpatient Program (IOP) Medical Director –Methadone program (going back to residency)

Testing is part of a comprehensive program

• Probation letter –Completed treatment –Continues in clinic –Regular contact –Working –In stable relationship –Volunteering (AA, peer Counselor, hospital) –Urine screens

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Objectives –Addiction Part 1

• 1.) Describe how drug testing is a primary prevention, diagnostic and monitoring tool. • 2.) List important parts of the addiction treatment contract as it pertains to drug testing during opioid agonist therapy. • 3.) Describe the role of drug testing in opioid agonist treatment • 4.) Provide guidance related to the types of drug testing available the optimum frequency and monitoring of drug testing during addictions treatment

White paper on drug testing

• Drug testing is a primary prevention and diagnostic monitoring tool.

Military used drug testing to prevent substance abuse

• Military drug testing using Immunoassay (IA) technology started in 1971 in Vietnam • Methadone Maintenance Treatment programs maintained opiate negative rates indicated effectiveness. • 1981 crash of aircraft aboard the USS Nimitz led to recognition that illicit drug use prevalent among Navy personnel – DoD imparts mandatory random drug testing to all active-duty military. – Positive results  referral to substance use disorder treatment – Repeated use by enlisted personnel and any use by officers after the initial attempt at rehab lead to punitive actions (less than honorable d/c). – Lost of veterans’ benefits.

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“ABCs of Drug Testing

A – adulterant “An adulterant is defined as any substance that, when added to a urine specimen, alters it in such a way to yield a negative result (aka a "false negative"). Common adulterants like bleach, Visine, or glutaraldehyde, as well as many chemical oxidants such as nitrates are screened for by the drug testing industry and are readily identifiable. Nevertheless, "spiking" a sample still remains a viable option for those who are willing to risk it, as there is no shortage of new, alternative adulterants promising to "beat" a urine test while avoiding the watchful eye of the drug testers”

Motivation of patients

• Self referred • 22 year-old M with • Department of Social autoimmune hepatitis has Services progressive struggle with prescription drugs (that he • Criminal Justice has been getting for his – Probation flares of acute hepatitis), – Parole marijuana, sedatives and – Alternative To Incarceration heroin, when he is not able – Other drug court to obtain Rx opioids. • Professional –physician • He can’t get transplant health, SPAN (nursing until maintains 90 days monitoring program) sober (neg UDS)

B.) The testing drug detection windows

Most drugs or their metabolites can detected 1-3 days after single use Heavy use of some drugs (in particular cannabis) can detected longer (up to weeks to months) Detection time depends on limit of detection and cut-off levels (e.g. longer for GC/MS) Detection time depends on type of test and matrix used Savvy patients aware many drugs not detected (e.g. synthetics)

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Interpretation and clinical utility of drug testing

Not incorporated into standard medical training Clinicians often have little understanding of false- positive/false-negative results Clinicians are unaware of types of testing available, panels, cost of testing, limitations by testing type, drug metabolism and windows of detection “we’ve ruled out an overdose! The tox screen is negative.” “Wait a minute clonazepam isn’t detected by this screen?”

Case 1 –use of tests -diagnosis at detox

• 35 year-old M with long history of IVDU previous methadone maintenance (came off during incarceration) presents to detoxification facility. • Intake shows no withdrawal (used buprenorphine from the street earlier in the day). • Urine Drug Screen (UDS) done (dipstick) with subsequent confirmation.

Case 1 patient A continued

•Dip confirmatory test. • Urine Drug Screen (UDS) shows: – Opiates • MAM, morphine, codeine –THC – buprenorphine.

• Admitted to detoxification facility.

• Buprenorphine taper with attempt to link to maintenance.

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Drug Testing Immunoassay POC testing

• Detox Facility uses this Point of Care (POC) testing method as initial screen

Detoxification center case 2

• 22 year-old M has been calling • “Not able to void” local detoxification facility for a bed • Phone evaluation: – reports heavy daily heroin use along with marijuana (“a little weed”). – Family in area but he reports homelessness. • Bed opens up in 7 days. • Intake screen shows disheveled male with no distress. COWS score is with only subjective positives (8) is eating alot • States he is unable to void for intake Urine Drug Screen (UDS).

Case 2 –detoxification center case 2

• Urine dipstick shows only cocaine –sent for confirmation  still only cocaine

• Patient held for 24 hours no w/d develops. • He is then switched to non- medical bed for referral to outpatient/housing. • He walks out AMA when finds out he’s not getting buprenorphine Rx

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Immunoassay pro/con –depends on goals

• Sometimes simple is enough Inexpensive Overall fairly accurate although false positive and false negative* can occur if you know what the tests look for! Historically, false positives limited usefulness False negatives increasing issue**

Drug Testing Considerations

Specific Gravity (or urine creatinine level) Temperature of specimen Directly observed pH and volume of sample In forensic testing second sample (B sample) saved for GC-MS (confirmatory testing if needed) Can confront a patient with the results

Case –check temp, color (or directly observe)

• Andrew, a 38 year-old M with opioid dependence who has been very vocal about not wanting to stop using marijuana returns from the bathroom with the urine container –and there is no yellow. • He hands the bag with the urine container to me -it is clearly not warm. Temp strip confirms room temp

6 3/17/2016

Attempts to manipulate testing

• This is a drug testing course –need at least one whizzinator…

Urine adulteration and substitution

Adding oral swab to testing

I’m concerned about Andrew’s specimen being valid - I attempted to do an observed urine but he was unable to void (we’ll cover this some more in part 2). Options? Oral screen 2nd urine same day

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Specimen Validity Testing (SVT)

SVT is performed to assess whether substitution, adulteration or dilution occurred Substitution is submission of a specimen that is not human urine or is from another person (a ‘clean’ specimen) Temperature, creatinine and specific gravity help determine whether a specimen has been substituted or not Adulteration is the addition of chemicals to a urine specimen that will mask or destroy drugs or their metabolites (nitrates, acids, oxidizing/reducing agents) Dilution (in vivo vs ex vivo) may be intentional (drinking large amounts of water before providing a specimen) or the result of physiologic conditions (i.e. diabetes)

The confirmation test –GC/MS or LC/MS/MS

• Point of Care tests are not used in isolation (with some exceptions)

Mass Spectroscopy

• Provides a ‘fingerprint’ as a chemical is heated and broken apart –(e.g. methcathinone vs ephedrine)

8 3/17/2016

Drug Testing by Matrix -gold (yellow) standard

Easy to collect and most drugs and metabolites are easy to detect for longer periods of time than blood or saliva. Drugs and metabolites are concentrated in urine. Ideally sampling is directly observed. Need same sex observer/collector. Creatinine determination can be used to normalize drug concentrations for dilute urine.

Oral Fluid Testing

Can be analyzed both by point-of-care (immunoassay) tests and GC/MS (confirmatory) testing Drugs are found in much lower concentrations in saliva (compared to urine) Highly resistant to cheating (easy to observe) Relatively insensitive to marijuana (THC in very low concentrations in the body) in particular POC tests Limit of Detection for cocaine lower –more pos cocaines Used for post-accident or ‘reasonable’ suspicion testing. If sensitivity improves may be future standard

Case

• 27 year-old M with opioid and cocaine dependence has biweekly f/u in the MAT clinic. He is seen on a Wednesday evening and has been doing well. Screens negative, buprenorphine confirmed… • Oral test done randomly and it is positive for cocaine.

• He is very upset and reports, “my counselor told me my lab tests were negative.” He is very adamant that the urine screen is correct and the oral is not.

9 3/17/2016

Drug Testing Hair

Drugs and metabolites incorporated into hair as it is being formed Hair grows ½ an inch/month and average hair is 1.5 inches –detection is typically over 90 days It takes 7 days for hair to grow from base of follicle to point it can be snipped –hair does not detect use in preceding week Concentrations of drugs low with sporadic use and may go undetected (use < than 2 x/week of marijuana is often missed) Codeine and morphine from poppy seeds not enough to be detected in hair (compared to urine + for opiates) No on-site testing methods

Drug Testing Sweat Patch

Sweat testing patches are similar to nicotine replacement patches Patch usually removed after 1-2 weeks Testing is prospective compared to other matrices. No on-site method for sweat testing Resistant to cheating as the patch ‘puckers’ if removed and reapplied High interindividual (and intraindividual patch) variability Contamination possible (external and internal)

Drug Testing Blood -forensic/OD/death

Invasive testing. Not part of screening Forensic and legal (post accident/injury) some designer drug tests Results may be used to help interpret impairment in certain situations Used for acute use during intoxication More expensive than urine testing

10 3/17/2016

Drug Testing Breath

Breath alcohol is prototype. Drugs of abuse are present in breath as well (albeit at very low concentrations). If technology advances appropriately may eventually be gold standard Easier to collect than urine, saliva  or other matrices. Resistant to cheating

Advanced technology –smart phone apps

• “Breathometer™ can transform your smartphone into a breathalyzer within seconds — helping you monitor your alcohol consumption, giving you the power to make smarter decisions when drinking. A combination of a sleek and portable device that connects to your smartphone and an easy-to-use app estimates your blood alcohol level.”

Testing Matrix Summary

Blood and breath levels may correlate with impairment for alcohol testing in particular. Urine and hair testing indicate test for use or exposure NOT addiction or dependence. Oral fluid testing indicates recent use –levels low and drugs such as THC only detected 24-48 hours from use. Sweat patch testing prospective –contamination possible Urine, breath (EtOH) and oral test used in addiction treatment (some professional monitoring programs use hair/nail/sweat)

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Comparison of matrix and indication/window

Testing order form

• How do you set up a testing program? –Patient –Site (clinic, office, inpatient) –Resources (additional staff?) –Matrix’

Addiction Medicine testing born on back of workplace and forensic testing

• Addiction testing born on back of workplace and forensic testing • Sometimes confirming medications useful –Antabuse –Naltrexone

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We need some control at the testing buffet table

• Don’t need to confirm all prescribed Meds

Cost and utility

Patient example –use good clinical judgment

– Kava metabolite? – Kratom metabolites? – SNRIs/SSRIs – Out of date stimulants (e.g. first gen cathinones) …Probably not needed… • 40 year-old M homeless but now in halfway house. Just started opioid agonist (bup). History of heroin and cocaine. Occasional street methadone. Appears well. Attendance good. • Testing  qualitative for opiates, BZD, cocaine, THC, amphetamine(s)) and buprenorphine with confirmation (of bup and metabolites) with adulteration panel (Cr).

Testing will vary by program type

• Methadone Maintenance may offer more screening and less confirmatory tests (though trend is to confirm all positive at our methadone maintenance program)

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Patient tailored approach

• Testing based on • Image from the the patient population & environment, geographical nuances, phase in treatment, the substances used or available, clinical concerns, treatment priorities, therapies, and cost.

Optimum frequency and expense in addiction treatment

• Testing in other specialized settings, such as pain management, addiction treatment programs, and professional health monitoring programs also may necessitate the use of larger and more extensive drug testing panels that require more advanced and expensive testing technologies. Laboratory fees for larger panels vary widely between laboratories. With laboratory revenue and profit this high, not surprisingly, the number of laboratories providing specialized types of testing is increasing dramatically. Unfortunately, at this writing, competition between these laboratories has not yet had the same cost containment effect observed in workplace and other programs. In treatment populations with a high percentage of presumptive positive (and, often, negative) IA results requiring confirmation, the costs are higher than in other populations where the rate of presumptive positive results is lower and where presumptive negative IA results do not receive further analysis. Physicians requiring specialized testing need to select biological matrices and drug test panels that maximize the value of the tests and that produce clinically useful results. --ASAM White Paper 2013

• Similar to pain contract • May be tailored for the individual • Provides boundaries • Need to have plan for when it aspects violated • Patients may test contract • Conflict does NOT mean termination from treatment • Enhanced by standard documentation

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Contract is used to help guide therapy.

• 38 year-old M with stimulant use disorder and opioid dependence is in an intensive outpatient program and on a buprenorphine formulation. He is taking it appropriately, not using, UDS confirms compliance with buprenorphine and no opiate use. • Cocaine is consistently positive… Despite attendance with group, individual sessions, mental health, he cannot stop using. Seen weekly by physician. Recommended halfway house • Declines to move to halfway house. Patient told that the recommendation is set and if declines won’t be able to continue buprenorphine (“contract violation”). • Patient agrees to go to Halfway House.

Contract C -Case example

• 27 year-old M with opioid and • Contracts available at cocaine dependence is doing well in an IOP program. He is on SAMHSA website and Suboxone™ and taking it through Provider Clinical appropriately. After two months Support Series (PCSS) in the program has a positive for THC on a random screen. • Counselor and physician discuss the episode and encourage patient to bring this up in group. • Reviewed patient interest in marijuana and health effects related to THC use • No changes to program

SAMHSA -http://www.samhsa.gov/

• Treatment locator • Contracts • Resources • Announcements • Information on X waiver • Information on confidentiality • Patient resources

15 3/17/2016

Information about addiction and workplace testing

• Patient maintained on buprenorphine is interesting in obtaining his Commercial Truck Driving License

Comprehensive program testing at various levels

• 32 year-old M is referred to • A.) Urine dipstick* during treatment by the initial encounter sent to lab Department of Social for confirmatory testing. Services (DSS) he has • B.) after evaluation random daily marijuana use, urine screens intermittent alcohol binges • C.) Breathalyzer (increased and uses prescription frequency for DWI referred opioids and sedatives. clients) • D.) Oral tests (random) • E.) Confirm medication compliance (methadone or buprenorphine, naltrexone*)

IOP case 4 IA pos bup  quantification of metabolites (& norbup/Cr)

• 55 year-old M with opioid • Orientation screens dependence is maintained • Monitoring/compliance on buprenorphine as part of a comprehensive treatment program. • He is enrolled in group, has a counselor and individual sessions and is in Medication Assisted Treatment (MAT) • He takes Suboxone™ 8/2 mg SL BID

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Office Based (primary care or toxicology/addiction)

• A 30 year-old pregnant • Continue contract woman with a long history • Random screens of opioid dependence is • Call ins maintained on buprenorphine. • If able do directly observed if not add oral/buccal • She has completed an IOP intermittently. and has been referred to the SMH Toxicology Clinic • Combined with other for Office Based Opioid interventions –directly Treatment (OBOT) observed dosing, strip/pill counts

Legal considerations

1.) Billing inappropriately 2.) Referring to self (Stark law) 3.) Billing more than once for same test

Owning own testing Owning own materials (UA/UDS/oral) Owning some aspect of material related to testing.

Out and out cheating (testing samples stored/banked while waiting for new LC apparatus to be set up (to the point of patient’s having left practice)

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