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Drug Testing Integrity

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Opioid Risk Management<br />

June 26-27, 2008<br />

Ways to Deceive <strong>Drug</strong><br />

<strong>Testing</strong><br />

Theodore F. Shults, JD, MS<br />

Chairman<br />

American Association of Medical Review Officers<br />

Durham, NC<br />

1


The Smoking Thoroughbred<br />

2


1. Eliminate the evidence – substitution,<br />

dilution<br />

2. Attack the immunoassay – pH, interfering<br />

substances<br />

3. Attack the drug metabolite – oxidation, pH<br />

4. Avoid the test<br />

5. Hire a lawyer<br />

6. Find another doctor<br />

7. Deny, deny, deny…<br />

Basic Strategies to Beat the Test<br />

3


• <strong>Drug</strong> addicts and users have always had<br />

methods and practices to beat a drug test<br />

• Common approaches<br />

◦ Drink vinegar<br />

◦ Dilute your urine<br />

◦ Drink “Health Inca Tea”<br />

◦ Adulterate your specimen<br />

• Bleach; soap; battery acid<br />

◦ Self-catheterization<br />

◦ Substitution<br />

<strong>Drug</strong> Culture:<br />

Mythology and Practices<br />

4


• Death<br />

Investigations<br />

• Criminal<br />

Investigations<br />

(DUI, DWI)<br />

• Court ordered:<br />

• Custody<br />

• Parole<br />

• Probation<br />

• Doping Control<br />

(Sports)<br />

• Life Insurance<br />

Underwriting<br />

• <strong>Drug</strong> Deterrence<br />

and Control<br />

(workplace/schools)<br />

• Emergency<br />

Medicine<br />

• Pain Management<br />

• “Wellness”<br />

• Fitness for Duty<br />

<strong>Drug</strong> <strong>Testing</strong> Environments<br />

5


• 1990s: Workplace <strong>Drug</strong> <strong>Testing</strong> and<br />

the Internet come of age.<br />

• Small cottage industry festers into<br />

multi-million-dollar industry to assist<br />

drug users in beating the test.<br />

• Selling hope.<br />

Commercialization of “Beating the<br />

<strong>Drug</strong> Test”<br />

6


◦ Lab profits are based on rapid negative test<br />

results<br />

◦ Everyone loves negative tests<br />

◦ Regulatory emphasis on costs of regulations<br />

◦ Technical mistakes and leadership failures –<br />

• The substituted-specimen fiasco<br />

◦ Privacy concerns prohibit observed collection<br />

without “individualized suspicion”<br />

◦ HHS Mandatory Guidelines – All adulterated<br />

tests are now “invalids”<br />

Fostering the Growth of<br />

the Beat-the<br />

the-Test<br />

Industry<br />

7


Explosion of Products<br />

8


• The media breakout product for the “beat the drug<br />

test” industry has clearly been the Whizzinator.<br />

• Minnesota Vikings running back Onterrio Smith was<br />

caught in possession of this device in May 2005 at the<br />

Minneapolis-St. Paul International Airport, which<br />

resulted in his suspension.<br />

• Actor Tom Sizemore has also brought the Whizzinator<br />

into the public eye after having been caught with one<br />

attempting to evade drug tests.<br />

• The United States Congress held hearings on the<br />

Whizzinator on May 17, 2005.<br />

Mr. Whizzinator Goes to<br />

Washington (Under Subpoena)<br />

9


Rep. Bart Stupak (D-Mich.) bemoans<br />

the Whizzinator while holding an<br />

advertisement for the device. At left is<br />

Ed Whitfield (R-Ky.), the subcommittee<br />

chairman.<br />

Photo Credit: By Robert A. Reeder --<br />

The Washington Post<br />

10


• “The sheer number of these<br />

products, and the ease with which<br />

they are marketed and distributed<br />

through the Internet, present<br />

formidable obstacles to the integrity<br />

of the drug testing process.”<br />

◦ GAO-05-653T: “<strong>Drug</strong> Tests: Products to Defraud<br />

<strong>Drug</strong> Use Screening Tests Are Widely Available.”<br />

11


“Number 1 is a disposable urinating device<br />

with enough premixed synthetic urine for<br />

2 complete tests. It has been irradiated in<br />

order to destroy all bacteria giving Number 1<br />

a one-year shelf life.” 14


$49.95<br />

ORDER NOW!<br />

•Contains everything you need for 2 tests!<br />

•Highest quality synthetic urine available!<br />

•Adjustable belt included!<br />

•No mixing required!<br />

•Male & Female usage!<br />

•Most advanced heating system!<br />

•1 year shelf life!<br />

•No need to freezing or refrigeration!<br />

•Satisfaction Guaranteed!<br />

15


Where does this go?<br />

16


• High-Tech Meets Low-Tech<br />

The Three Amigos<br />

17


Chemical Warfare:<br />

The Adulterants<br />

18


in vitro Adulterants Available<br />

Commercially<br />

Adulterant Class Identity<br />

Mary Jane<br />

SuperClean 13<br />

Surfactant<br />

Lemon Scented<br />

Detergent<br />

UrinAid Fixative Glutaraldehyde<br />

Amber-13 Acid 1.7 N HCI<br />

THC-Free Acid 2.1 N HCI<br />

21


in vitro Adulterants Available<br />

Commercially<br />

Adulterant Class Identity<br />

Klear Oxidant Potassium Nitrite*<br />

Whizzies Oxidant Sodium Nitrite*<br />

Randy’s Clear Oxidant Nitrite<br />

22


in vitro Adulterants Available<br />

Commercially<br />

Adulterant Class Identity<br />

Urine Luck Oxidant Pyridinium<br />

chlorochromate*<br />

LL418 Oxidant Pyridinium<br />

chlorochromate*<br />

Sweet Pee’s<br />

Spoiler<br />

Oxidant<br />

Pyridinium<br />

chlorochromate*<br />

Randy’s Klear II Oxidant Pyridinium<br />

chlorochromate*<br />

23


Nitrites:<br />

Conclusions and Interpretation<br />

1. <strong>Testing</strong> for Nitrite; Nitrate is different and<br />

does not interfere<br />

2. Normal and medical nitrite concentrations<br />

in urine well below 500 mcg/mL<br />

3. Nitrite is oxidizing agent and may<br />

deteriorate with time in unpreserved urine<br />

4. Concentrations of nitrite in adulterated<br />

urine are high<br />

5. Cutoff distinguishes normal from<br />

adulterated urine<br />

24


Chromium:<br />

Conclusions and Interpretation<br />

1. Cr +6 extremely toxic — not to be confused with Cr +3<br />

2. Urine concentrations in adulterated urine generally<br />

1000 times greater than normal<br />

3. Cr +6 not expected in urine of an asymptomatic<br />

individual<br />

4. Urine concentrations found in adulteration cases<br />

exceed highest toxic case reported<br />

5. No established cutoff — 20 mcg/mL Limit of<br />

Detection required by new regulations<br />

25


in vitro Adulterants Available<br />

Commercially<br />

Adulterant Class Identity<br />

Mary Jane<br />

SuperClean 13<br />

Surfactant<br />

Lemon Scented<br />

Detergent<br />

UrinAid Fixative Glutaraldehyde<br />

Amber-13 Acid 1.7 N HCI<br />

THC-Free Acid 2.1 N HCI<br />

26


in vitro Adulterants Available<br />

Commercially<br />

Adulterant Class Identity<br />

Klear Oxidant Potassium Nitrite*<br />

Whizzies Oxidant Sodium Nitrite*<br />

Randy’s Clear Oxidant Nitrite<br />

27


in vitro Adulterants Available<br />

Commercially<br />

Adulterant Class Identity<br />

Urine Luck Oxidant Pyridinium<br />

chlorochromate*<br />

LL418 Oxidant Pyridinium<br />

chlorochromate*<br />

Sweet Pee’s<br />

Spoiler<br />

Oxidant<br />

Pyridinium<br />

chlorochromate*<br />

Randy’s Klear II Oxidant Pyridinium<br />

chlorochromate*<br />

28


Strategies to Manage the<br />

<strong>Integrity</strong> of <strong>Drug</strong> <strong>Testing</strong><br />

in Pain Management<br />

Who is fooling who here?<br />

29


• <strong>Drug</strong> <strong>Testing</strong> in Pain Management presents<br />

different legal framework than<br />

workplace/forensic drug testing<br />

• Doctor-Patient Relationship<br />

• Diagnostic / Management Goals<br />

• Patients cooperation is “voluntary”<br />

• Cooperation is a condition of treatment<br />

• This allows for:<br />

◦ Expanded panel of drugs to test<br />

◦ Lower cutoffs<br />

◦ Expanded panel of methods<br />

◦ Observed collections for urine<br />

Different Legal Framework<br />

30


• Policy Considerations<br />

◦ Make integrity violation more serious than<br />

positive drug test.<br />

◦ Patients need to know that integrity testing<br />

and validation of specimens is being done.<br />

◦ Clearly define what constitutes a “refusal to<br />

test” (e.g., missing a test).<br />

◦ Patients should have opportunity to selfdisclose<br />

changes in medications (legal and<br />

illegal)<br />

◦ Test your collectors<br />

Counter-Strategies:<br />

Policy Considerations<br />

31


◦ Multiple specimen testing needed<br />

◦ NOT JUST URINE!<br />

◦ Oral fluid<br />

◦ Sweat Patch Tests<br />

◦ Hair (beard shaving may give short-term<br />

window)<br />

◦ Understand the limits and trade-offs<br />

◦ Randomly change methods<br />

Counter-Strategies:<br />

Alternative Tests Needed<br />

32


• Gown patient<br />

• Observed collection<br />

• Grab two separate voids<br />

◦ (compare creatinine/specific gravity between<br />

voids) (no need for large volumes here)<br />

• Dipstick adulteration test<br />

• Two collectors present<br />

Urine <strong>Testing</strong> Control Options<br />

33


• On-Site Screening for Adulterants<br />

◦ Simple dipstick sufficient to screen for all<br />

adulterants<br />

Counter-Strategies<br />

34


The effects of adulterants and<br />

selected ingested compounds<br />

on drugs-of<br />

of-abuse testing in<br />

urine.<br />

Dasgupta A : Am J Clin Pathol. 2007 Sep;128(3):491-<br />

503<br />

35


• These adulterants can successfully<br />

mask drug testing if the concentrations<br />

of certain abused drugs are moderate.<br />

Several spot tests have been described<br />

to detect the presence of such<br />

adulterants in urine.<br />

• Urine dipsticks are commercially<br />

available for detecting the presence of<br />

such adulterants, along with<br />

performance of tests for creatinine, pH,<br />

and specific gravity.<br />

36


• How do you manage positive test results?<br />

• How do you manage negative results?<br />

How do you manage the pain patient who<br />

is a substance abuser?<br />

• How do you manage medical marijuana<br />

patient?<br />

Open Questions<br />

37

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