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Opioid Risk Management June 26-27, 2008 Ways to Deceive Drug Testing Theodore F. Shults, JD, MS Chairman American Association of Medical Review Officers Durham, NC 1 The Smoking Thoroughbred 2 1. 2. 3. 4. 5. 6. 7. Eliminate the evidence – substitution, dilution Attack the immunoassay – pH, interfering substances Attack the drug metabolite – oxidation, pH Avoid the test Hire a lawyer Find another doctor Deny, deny, deny… Basic Strategies to Beat the Test 3 y y Drug addicts and users have always had methods and practices to beat a drug test Common approaches ◦ ◦ ◦ ◦ Drink vinegar Dilute your urine Drink “Health Inca Tea” Adulterate your specimen x Bleach; soap; battery acid ◦ Self-catheterization ◦ Substitution Drug Culture: Mythology and Practices 4 Death Investigations y Criminal Investigations (DUI, DWI) y Court ordered: y x Custody x Parole x Probation y Doping Control (Sports) y y y y y y Life Insurance Underwriting Drug Deterrence and Control (workplace/schools) Emergency Medicine Pain Management “Wellness” Fitness for Duty Drug Testing Environments 5 y 1990s: Workplace Drug Testing and the Internet come of age. y Small cottage industry festers into multi-million-dollar industry to assist drug users in beating the test. y Selling hope. Commercialization of “Beating the Drug Test” 6 ◦ Lab profits are based on rapid negative test results ◦ Everyone loves negative tests ◦ Regulatory emphasis on costs of regulations ◦ Technical mistakes and leadership failures – x The substituted-specimen fiasco ◦ Privacy concerns prohibit observed collection without “individualized suspicion” ◦ HHS Mandatory Guidelines – All adulterated tests are now “invalids” Fostering the Growth of the Beat-the-Test Industry 7 Explosion of Products 8 The media breakout product for the “beat the drug test” industry has clearly been the Whizzinator. y Minnesota Vikings running back Onterrio Smith was caught in possession of this device in May 2005 at the Minneapolis-St. Paul International Airport, which resulted in his suspension. y Actor Tom Sizemore has also brought the Whizzinator into the public eye after having been caught with one attempting to evade drug tests. y The United States Congress held hearings on the Whizzinator on May 17, 2005. y Mr. Whizzinator Goes to Washington (Under Subpoena) 9 Rep. Bart Stupak (D-Mich.) bemoans the Whizzinator while holding an advertisement for the device. At left is Ed Whitfield (R-Ky.), the subcommittee chairman. Photo Credit: By Robert A. Reeder -The Washington Post 10 y “The sheer number of these products, and the ease with which they are marketed and distributed through the Internet, present formidable obstacles to the integrity of the drug testing process.” ◦ GAO-05-653T: “Drug Tests: Products to Defraud Drug Use Screening Tests Are Widely Available.” 11 12 13 “Number 1 is a disposable urinating device with enough premixed synthetic urine for 2 complete tests. It has been irradiated in order to destroy all bacteria giving Number 1 a one-year shelf life.” 14 $49.95 ORDER NOW! •Contains everything you need for 2 tests! •Highest quality synthetic urine available! •Adjustable belt included! •No mixing required! •Male & Female usage! •Most advanced heating system! •1 year shelf life! •No need to freezing or refrigeration! •Satisfaction Guaranteed! 15 Where does this go? 16 y High-Tech Meets Low-Tech The Three Amigos 17 Chemical Warfare: The Adulterants 18 19 20 in vitro Adulterants Available Commercially Adulterant Class Identity Mary Jane SuperClean 13 Surfactant Lemon Scented Detergent UrinAid Fixative Glutaraldehyde Amber-13 Acid 1.7 N HCI THC-Free Acid 2.1 N HCI 21 in vitro Adulterants Available Commercially Adulterant Class Identity Klear Oxidant Potassium Nitrite* Whizzies Oxidant Sodium Nitrite* Randy’s Clear Oxidant Nitrite 22 in vitro Adulterants Available Commercially Adulterant Class Identity Urine Luck Oxidant Pyridinium chlorochromate* LL418 Oxidant Pyridinium chlorochromate* Sweet Pee’s Spoiler Oxidant Pyridinium chlorochromate* Randy’s Klear II Oxidant Pyridinium chlorochromate* 23 Nitrites: Conclusions and Interpretation 1. Testing for Nitrite; Nitrate is different and does not interfere 2. Normal and medical nitrite concentrations in urine well below 500 mcg/mL 3. Nitrite is oxidizing agent and may deteriorate with time in unpreserved urine 4. Concentrations of nitrite in adulterated urine are high 5. Cutoff distinguishes normal from adulterated urine 24 Chromium: Conclusions and Interpretation 1. Cr+6 extremely toxic — not to be confused with Cr+3 2. Urine concentrations in adulterated urine generally 1000 times greater than normal 3. Cr+6 not expected in urine of an asymptomatic individual 4. Urine concentrations found in adulteration cases exceed highest toxic case reported 5. No established cutoff — 20 mcg/mL Limit of Detection required by new regulations 25 in vitro Adulterants Available Commercially Adulterant Class Identity Mary Jane SuperClean 13 Surfactant Lemon Scented Detergent UrinAid Fixative Glutaraldehyde Amber-13 Acid 1.7 N HCI THC-Free Acid 2.1 N HCI 26 in vitro Adulterants Available Commercially Adulterant Class Identity Klear Oxidant Potassium Nitrite* Whizzies Oxidant Sodium Nitrite* Randy’s Clear Oxidant Nitrite 27 in vitro Adulterants Available Commercially Adulterant Class Identity Urine Luck Oxidant Pyridinium chlorochromate* LL418 Oxidant Pyridinium chlorochromate* Sweet Pee’s Spoiler Oxidant Pyridinium chlorochromate* Randy’s Klear II Oxidant Pyridinium chlorochromate* 28 Strategies to Manage the Integrity of Drug Testing in Pain Management Who is fooling who here? 29 y y y y y y Drug Testing in Pain Management presents different legal framework than workplace/forensic drug testing Doctor-Patient Relationship Diagnostic / Management Goals Patients cooperation is “voluntary” Cooperation is a condition of treatment This allows for: ◦ ◦ ◦ ◦ Expanded panel of drugs to test Lower cutoffs Expanded panel of methods Observed collections for urine Different Legal Framework 30 y Policy Considerations ◦ Make integrity violation more serious than positive drug test. ◦ Patients need to know that integrity testing and validation of specimens is being done. ◦ Clearly define what constitutes a “refusal to test” (e.g., missing a test). ◦ Patients should have opportunity to selfdisclose changes in medications (legal and illegal) ◦ Test your collectors Counter-Strategies: Policy Considerations 31 ◦ Multiple specimen testing needed ◦ NOT JUST URINE! ◦ Oral fluid ◦ Sweat Patch Tests ◦ Hair (beard shaving may give short-term window) ◦ Understand the limits and trade-offs ◦ Randomly change methods Counter-Strategies: Alternative Tests Needed 32 y y y Gown patient Observed collection Grab two separate voids ◦ (compare creatinine/specific gravity between voids) (no need for large volumes here) y y Dipstick adulteration test Two collectors present Urine Testing Control Options 33 y On-Site Screening for Adulterants ◦ Simple dipstick sufficient to screen for all adulterants Counter-Strategies 34 The effects of adulterants and selected ingested compounds on drugs-of-abuse testing in urine. Dasgupta A : Am J Clin Pathol. 2007 Sep;128(3):491503 35 y y These adulterants can successfully mask drug testing if the concentrations of certain abused drugs are moderate. Several spot tests have been described to detect the presence of such adulterants in urine. Urine dipsticks are commercially available for detecting the presence of such adulterants, along with performance of tests for creatinine, pH, and specific gravity. 36 y y y How do you manage positive test results? How do you manage negative results? How do you manage the pain patient who is a substance abuser? How do you manage medical marijuana patient? Open Questions 37 38