Page 1

Substance Clarit y in Toxicolog y | v.7 i.2

The Options Issue

Choosing the right tests in Professional Health Monitoring programs

Summer

2016 4 The testing and technology of Professional Health Monitoring programs 14 Choosing the right test to find the best answer for your client 18 National positivity rates in fingernail and hair specimens


Letter from the editor

UNDERSTANDING YOUR OPTIONS The importance of choosing the right test and the right specimen.

Welcome to the Summer issue of Substance! We are enjoying great weather here in Chicagoland and hope that your summer has been equally as pleasant. For those of you that have been part of our publications for a while, you know that we talk a lot about the differences in drug testing and how important it is to choose the right test, and the right specimen. This is what we believe helps us stand out from the the drug testing laboratories that are not offering the most cutting edge technology and options. In this issue, our authors have done an excellent job explaining why understanding drug testing and drug testing options in their industries is crucial. Dr. David Martin, Science Team Director for the DEA Educational Foundation Global Adulterant Research Program, explains how historical perspective and knowledge of the science and ethics of the drug testing industry can bring success where other programs fail, not only to professional health programs, but to all recovery programs. His in depth article gives great insight into the differences of drug testing in Professional Health Monitoring (PHM) Programs and what different specimen types and biomarkers can be beneficial to use and why. Gary Patrone, CEO of ARCpoint Labs in Tempe, AZ, walks us through a real life case that he is involved in, giving an excellent example of why it it vital to understand what drug tests to use, and when to use them. Choosing the right test for your client can change their life. We are always looking for article submissions that would be beneficial to our readers. If you would like to tell your unique story about testing applications and outcomes, please feel free to contact us via editor@usdtl.com. Submissions are not guaranteed to be published. All thoughts are welcome. As always, we hope you find this issue valuable. If so, please consider sharing it online. This helps us reach even more people with our information. This, and past issues, are available under the Resources tab on our website.

Thanks for reading, Michelle Lach, Editor-in-Chief

2

Summer 2016 Substance


Substance Summer 2016 volume 7 issue 2 Editor-in-Chief

Michelle Lach, MSIMC Managing & Design Editor

Dru Wagner, MA Science Advisory Board

Douglas Lewis, D.Sc. Joseph Jones, MS NRCC-TC Adam Negrusz, Ph.D. F-ABFT Substance is a quarterly news magazine of toxicology science, data, and news. It is our mission to distill the technical world of toxicology, drug testing, and addiction science into plain words. If you have suggestions for topics you would like to know more about or are interested in contributing to our publication, let us know. editor@usdtl.com 1700 S. Mount Prospect Rd. Des Plaines, IL, 60018 847.235.2367

Table of Contents

4

DRUG TESTING, THE TECHNOLOGY OF RECOVERY FOR PROFESSIONAL HEALTH MONITORING PROGRAMS David M. Martin, Ph.D.

Historical perspective and knowledge of the science and ethics of the drug testing industry can bring success where other programs fail, not only to professional health programs, but to all recovery programs.

14

A TESTIMONY FROM THE FIELD: USE THE RIGHT TEST TO FIND THE BEST ANSWER Gary Patrone

Choosing the right test for your client can make all the difference.

18

NATIONAL POSITIVITY RATES Quarterly positivity results for drug and alcohol testing in fingernail and hair specimens.

© 2016 USDTL All Rights Reserved.

www.USDTL.com

Original images from iStock.

USDTL

3


DRUG TESTING, THE TECHNOLOGY O F RECOVERY FOR PROFESSIONAL H EALTH MONITORING PROGRAMS Historical perspective and knowledge of the science and ethics of the drug testing industry can bring success where other programs fail, not only to professional health programs, but to all recovery programs. by David M. Martin, Ph.D.

use combinations of alcohol, herbs and plant materials to enhance performance and mask pain allowing them to compete. The use of drugs to improve sports performance continues today in amateur, professional and Olympic sports. The sporting world long suspected there was drug abuse in professional athletes such as Lance Armstrong, Barry Bonds, Alex Rodriguez, and scores of other amateur and Olympic athletes, yet they never failed a drug test. This was possible because drug experts at a team, federation and In order to have a successful PHM drug testing program, the program national level provided not only must: test for the right drugs, with the correct technologies, on the best performance enhancing drugs, but also sophisticated guidance specimen types. in the use of those drugs and how to avoid detection.1 may lead to misdiagnosis, compromised treatment Avoiding detection while using drugs is a growing and can have tragic consequences. multimillion dollar industry. As such, it was not surprising when the problem of drug abuse by health professionals first emerged, many of the The Challenges of Professional Health initial drug tests were negative. To this day, many Monitoring (PHM) Programs drug tests performed on active drug abusers still are reported as negative if the wrong technology The first documented group of professionals or wrong type of specimen is used. Health to abuse drugs were gladiators in ancient Rome professionals, such as doctors, nurses, pharmacists and athletes in the original Olympic games in and therapists hold advanced degrees, have studied Greece. Gladiators and Olympic athletes would Drug testing is the technology of drug abuse recovery, much the same way glucose testing is the technology of diabetic recovery. Both are chronic, deadly diseases but can be controlled with appropriate testing and lifestyle changes. Unlike glucose tests, not all drug tests are the same, nor do they use the same technology. Drug testing is one of the most important technologies in the new science of evidence-based medical diagnostics and monitoring of addictive disorders. If done wrong, it

4

Summer 2016 Substance


USDTL

5


pharmacology and are knowledgeable about drug testing. In order to have a successful PHM drug testing program, the program must: test for the right drugs, with the correct technologies, on the best specimen types. It was first believed that the access to prescription drugs by health professionals was the fundamental reason why so many health professionals were diagnosed with addictive disorder. In 2010, at the John P. Mc-Govern Award Lecture and Symposium on “The Future of International Drug Policy� in Washington, D.C., Dr. Robert DuPont, opened the conference with a frightening statement. He pointed out that the world today is threatened by an epidemic of drug abuse that has never been seen before in the history of medicine. This is because it is only within the past few decades that mankind has been exposed to such a broad spectrum of very powerful, addictive prescription drugs that are cheap, easily available by phone or internet, and can be confidentially delivered to your home by overnight express. The added peril, he predicted, is that the 21st century drug problem will not be simply defined by prescription drug abuse alone. Medical marijuana, legalization of drugs, and new synthetics will create a new spectrum of drug abuse we have never seen before. Dr. DuPont was prescient and right. Today we have unethical pain clinics, medical and legal marijuana, internet pharmacies, synthetic THC, and new designer drugs that hit the streets every day. Medical professionals do not have to steal drugs from work. They only need a cell phone and a credit card. All this makes a challenging environment for an effective PHM drug testing program.

6

A Short History of Modern Drug Testing May 27, 1981 was a clear, calm night off the east coast of Florida. At 11:51pm, after a training mission, a Northrop Grumman EA-6B Prowler military jet approached the flight deck of the U.S.S. Nimitz aircraft carrier to land. The pilot missed the arresting cable with his tail hook and collided with two Grumman F-14 Tomcat fighter jets, setting off a chain reaction of collisions with more than a dozen other jets and helicopters on the flight deck. Several of the war planes exploded, killing 14 crew men, injuring dozens more, and sending a fireball rolling across the flight deck. Post mortem drug tests found that some members of the flight deck and pilots were positive for drug use. As a result, a zero tolerance program was put into place in the military and the first drug testing program in the armed forces began. It revealed that as high as 40% of service members were positive for drugs. This resulted in a call for not only a drug free military, but a drug free federal workplace in sensitive areas that affect public safety, such as truck drivers, commercial pilots, and train engineers. In 1986, President Ronald Regan signed Executive Order 12564 establishing a Drug Free Federal Workplace that required drug testing to begin for over 20 million Federal Employees and covered industries beginning in 1988.2 This occurred at a time when there was great concern about the state of drug testing in the United States. Patients undergoing methadone maintenance therapy, whose drug test results were negative for drugs of abuse during weeks of monitoring, were dying from overdoses. Clinicians could not explain the mounting death toll. The CDC ran an extensive nationwide blind testing

Summer 2016 Substance


program on the hundreds of methadone clinic Fast Forward More Than 25 Years laboratories serving an expanding heroin-addicted population recently returned from Vietnam. The The typical PHM urine testing panel used today report was titled, Crisis in Drug Testing: Results of commonly includes many drug classes beyond CDC Blind Study. At that time, laboratories did not those in the initial NIDA 5 test panel. It can test have standardization of technologies, consistent for over 30 drugs including an expanded class of cutoffs, confirmation of positives, or licensure opiates, benzodiazepines, barbiturates, alcohol, standards to perform drug testing. Error rates as and the direct alcohol metabolite ethyl glucuronide high as 100% in some laboratories made drug (EtG). But there is no national standard for cutoffs testing unreliable and dangerous for patient health or confirmation levels for the drugs tested in the and safety.3 expanded PHM testing panels. As a result, a PHM After two years of planning, public hearings, specimen that is positive in one lab for any of these closed door meetings and technology evaluations, expanded panel drugs could be negative in another the National Institute on Drug Abuse (NIDA) lab, also known as a false negative. came up with the first standardization of drug This is a serious problem, because a false negative testing to be used for Federal Employee testing.4 drug test can compromise treatment, encourage For the first time, NIDA initiated the concept of non-compliance, and in some cases be deadly. nationwide standardized cutoffs, the levels of drugs The causes of false negatives can be biological or in a specimen above which a test is considered a result of the technology and cutoff levels the positive. NIDA also required positive confirmation PHM laboratory is using. Biologically, detection testing by an alternate method to insure initial of substance use is highly dependent on choosing screening results were accurate. Post mortem drug tests found that some members of the flight deck NIDA also instituted standards and pilots were positive for drug use. As a result, a zero tolerance drug for record keeping, personnel, methodology, and quality program was put into place in the military and the first drug testing control policies, which, if met, program in the armed forces began. would indicate a laboratory was “NIDA Certified” (now Health and Human the correct specimen type to test (e.g. hair, urine, Services Certified) and allowed to test federal breath, oral fluid or blood). Alcohol use detection employee samples. This meant that specimens using direct alcohol biomarkers offers an excellent tested for the ‘NIDA 5’ drugs: amphetamines, example of the benefits of different specimen cocaine, marijuana, PCP, and opiates, in any NIDA testing options. Certified lab, anywhere in the country, would Ethyl glucuronide (EtG) is a direct biomarker of produce standard and equivalent results. It was a alcohol use. EtG detection in oral fluid parallels historic event in the science of drug testing which blood alcohol testing and breathalyzer analysis, and set the stage for modern drug testing programs. is very useful for detecting very recent alcohol use, up to approximately three hours post-consumption.

USDTL

7


Typical PHM Urine Drug Testing Panel in 2015 • Amphetamines - Amphetamine - Methamphetamine - MDA - MDMA - MDEA • Cocaine • Marijuana • PCP • ETG • EtOH • Zolpidem • Soma • Meprobamate • Ketamine • Barbiturates - Butabital - Amobarb - Pentobarbital - Secobarb - Phenobarbital

• Opiates - Morphine - Codeine - 6-MAM - Hydrocodone - Hydromorphone - Oxymorphone - Oxycodone - Buprenorphine - Methadone - Meperidine - Propoxyphene - Tramadol - Fentanyl • Benzodiazepines - Oxazepam - Nordiazepam - Temazepam - Lorazepam - Flurazepam - Nitrazepam - Triazolam - Alprazolam - Flunitrazepam - Midazolam - Clonazepam

The drugs from the original NIDA 5-panel are still there, listed in white. Expanded opiates, Benzodiazepines, Barbiturates, Alcohol and EtG are common depending on the panel you order. However, there is no national standard for cutoffs or confirmation levels. In turn, one PHM sample that is positive in one lab for any of these drugs in white could be negative in another lab. False negative drug tests compromise treatment, encourages non-compliance and can be deadly.

8

EtG in urine is sensitive enough to detect low levels of alcohol ingestion for up to 2-3 days following consumption. Urine is considered, by some, to be the gold standard of drug testing as it will concentrate drugs, but it is highly susceptible to adulteration and difficult to collect under direct observation. Hair testing is now common in PHM programs and hair ETG offers a window of detection for alcohol use up to three months. Phosphatidylethanol (PEth) is the newest direct alcohol biomarker, which is measured in dried blood spots and has the ability to look back at heavy alcohol use for up to three weeks. Fingernail testing is emerging as the preferred sample for some tests and difficult cases. Like hair, fingernail is a keratin fiber and has a window of detection for EtG up to three months. Unlike hair, fingernail has a much longer window of detection for drugs of abuse, up to six months in many cases. The windows of detection for testing alcohol in the various specimens are easy to remember by using a rule-of-threes: oral fluid/breath can look back approximately three hours, urine for three days, PEth in blood for three weeks, and hair and fingernails for up to three months. But all this is dependent on what cutoff levels are used in the laboratory to indicate a positive test result.

Ask Your Drug Testing Lab: “What Are Your Cutoff Levels?” The entry of liquid chromatography tandem mass spectrometry instruments (LC-MS/MS) into the PHM and pain management laboratories has only occurred in the last ten years. Improved sensitivity of new specimen types, such as hair and nail, which have given us the ability to look back three months or more, have only occurred in the last five years. Confirmation testing with this instrumentation is done at the femtogram level, that is, a quadrillionth of a gram. This level of sensitivity was unheard of only a few years ago. LC-MS/MS instruments cost a quarter million dollars and require very specific expertise to run. It’s like buying a fighter jet, you

Summer 2016 Substance


specimens at both laboratories, different cutoff need an experienced pilot and highly trained levels means different results. This compromises ground crew to make it work properly. treatment by missing non-compliance and may Unfortunately, these instruments are now being actually encourage continued drug and alcohol use bought and placed in startup pain laboratories or as the participants realize the limitations of the physician offices as drug testing has now become testing. False negatives are dangerous to patient a profit center. Often, these new entities do not outcomes and can have tragic results. have the proper expertise and staff to operate these Why would Lab B have higher cutoffs? Chances highly sophisticated drug testing instruments. are, Lab B uses a less expensive, less sensitive, Therefore, they cannot produce consistent high throughput method and as such will have cutoff standardization and at times are reporting fewer specimens that test positive. Lab B can then questionable results, an eerie repeat of the CDC sell at a lower price, including confirmation, as report, Crisis in Drug Testing. This is part and parcel it will have less expensive presumptive positive to a new expansion of laboratories seen in the last confirmations. Does Lab B test for drugs with the few years, and comes with significant problems. right technology? Yes. Will they detect the drugs at Drug testing cutoffs determine if a test is positive levels needed for recovery? Sadly, no. or negative. If drugs or alcohol are detected at or above the cutoff level calibrated on the instrumentation, the test will report out positive. Then Ask Your Drug Testing Lab: If the levels of drug or alcohol are below the cutoff “When Was Your Lab Licensed and who level calibrated on the instrumentation, the test will are Your PHM Clients?” report out negative, not detected. How screening and confirmation cutoffs are established will make In the last 5 years there has been an explosion all the difference in the success of detection. of laboratories entering the drug testing industry, Let’s compare two different hypothetical changing it dramatically. In 1990, there were only laboratories with two different cutoffs for the 8 NIDA certified laboratories (now HHS). Over opioid analgesic Fentanyl, a frequently abused drug the next decade, one lab was certified every month with health professionals that How screening and confirmation cutoffs are established is very difficult to detect. Let’s the difference in the success of detection. say, Lab A has a confirmation cutoff level of 100 ng/ml for Fentanyl and Lab B has a confirmation cutoff level until a high was reached in the year 2000, when of 500 ng/ml. If the concentration of Fentanyl approximately 138 certified labs existed. After that, in a collected specimen is below 100 ng/ml, a decline occurred, and today there are only 30 both labs will report the specimen as negative. HHS certified labs in the U.S.5 These are important If concentration level of Fentanyl in a collected workplace specific certifications, but alone do not specimen is above 500 ng/ml, both labs will qualify a laboratory to perform PHM testing, as report the specimen as positive. However, if the this is a specific expertise developed over time by concentration levels of Fentanyl in a collected experienced professionals. specimen is between 100 ng/ml and 499 ng/ml, In 1990, the concept of PHM or pain Lab A will report the specimen as positive, while management lab testing was unknown, it was a new Lab B will report the specimen as negative, because science. In 2000, a best industry guess is that there the concentration level did not reach their cutoff were only six major laboratories conducting testing level of detection. This is what the industry calls a for expanded opiates and other extended PHM false negative. Herein lies the problem, although drug panels. Around 2010, two events occurred the same instrumentation is being used to test the in the drug testing industry that made a huge

USDTL

will make all

9


impact; the monetization of drug testing in pain management and addiction treatment programs; and ownership schemes by drug testing laboratories for prescribing physicians and facilities. This caused an explosion in labs offering PHM and pain management drug tests, some ethically, albeit with high cutoffs, and others unethically, with ownership and billing schemes that continue today. Today there are literally over a thousand laboratories offering drug tests of one form or another. New labs pop up every week, some with experienced staff and technologies, others without. Industry associations and government agencies, including the HHS, FDA and Justice Department, are monitoring this situation closely. Recently, Millennium Health settled a False Claims Act case with the federal government for $256 million dollars,6 Cigna Insurance sued Sky Toxicology and its affiliate laboratories for $20 million dollars,

and to contact their PHM client list for references.

Not All Instant Testing Technologies Are Created Equal

The ability to instantly drug test in a PHM treatment program, systematically during admission or randomly throughout treatment and recovery, is a powerful deterrent and essential part of any PHM program. It is important to remember that the professional health population is comprised of sophisticated consumers of drugs and drug testing products. As such, they know how to invalidate instant test cups and laboratory based testing, so direct observation might be required in some cases. In the last 20 years there has been a blizzard of instant drug testing products that have come and gone from the market. There are over 100 kits of various descriptions on the market, and they do A public PHM program was concerned about the low rate of positives, not all perform the same. Like laboratory based testing, they reported by its laboratory. A confidential research program was setup vary in the drugs tested, cutoff to compare the existing laboratory with another reference laboratory levels, and cost, all affecting by splitting samples. The exiting laboratory reported approximately 4% their performance. Urine instant positive rate while the reference laboratory reported more than double tests are the best sample and the rate of positives. When EtG was added to this comparison, the provide the ability to instantly positivity rate was close to 20% higher than the exiting laboratory. test the largest number of drugs versus newly launched oral fluid instant tests which have a limited menus of drugs. resulting in its closure and United Healthcare filed The instant results are clinically helpful, but only if a federal fraud case.7,8,9 A public PHM program was accurate and confirmed, when necessary. concerned about the low rate of positives, reported An instant drug test kit for urine should have by its laboratory. A confidential research program the most commonly abused drugs at clinically was setup to compare the existing laboratory with significant cutoff levels with validity tests. Most another reference laboratory by splitting samples. importantly, the kit should be designed for The exiting laboratory reported approximately 4% transport for confirmatory analysis under chain positive rate while the reference laboratory reported of custody to an experienced PHM laboratory for more than double the rate of positives. When EtG confirmation of positive findings. It is important to was added to this comparison, the positivity rate keep in mind that if the instant drug testing kits are was close to 20% higher than the exiting laboratory. to be used clinically they must be CLIA waived, the Clearly, there is a new “crisis in drug testing� facility must have a CLIA waived certificate and, in in the PHM and pain management drug testing some states, a laboratory license. Currently, there laboratories, and as reported over 30 years ago by are no CLIA waived oral fluid instant drug tests. the CDC, it is all driven by money. To determine Instant testing is an invaluable tool to PHM the experience and ethics of the laboratory it is recovery programs; however, like laboratory based imperative to ask how long they have been licensed

10

Summer 2016 Substance


testing, if done wrong, it may lead to misdiagnosis, compromised treatment and can have tragic consequences.

New Technologies and Sampling Strategies Hair, Fingernail and Toenail Testing Strategy Hair testing has become an important tool in modern PHM programs, but its value has been recognized in other medical disciplines for quite some time. Hair testing was evaluated in the American Journal of Transplantation for substance abusers seeking organ transplants.10 As expected, hair testing generated more drug-positive results than urine testing for all substances. For cocaine and opioids, 50% of positive hair samples were not corroborated by either self-report or urinalysis. Even larger discrepancies were observed for alcohol, with 64% of positive hair tests for EtG not confirmed with self-reports, and 88% not confirmed with breath testing. This is all due to the longer three month window of detection for hair testing vs. the shorter days or weeks window for urine testing. Hair testing is good for long-term monitoring retrospectively, but not for short-term or random testing to insure compliance. Additionally, hair may not be available universally with all patients, which makes the next set of unique specimens so important. The most intriguing new specimens in modern PHM testing are clippings of fingernails and toenails. The human nails are comprised of keratin and are very similar to hair. The principle structures of the human nail is the matrix (where the nail originates), the nail plate, and the nail bed. The nail that extends beyond the finger or toe tip is called the free edge or free margin. The nail plate lengthens at a rate of approximately 3mm per month. Capillary blood flow in the nail bed gives the nail plate its pinkish color and deposits drugs into the nail plate which traps the drug as the nail plate lengthens and thickens.

USDTL

Nails are approximated four (4) times thicker than hair, so more drug is captured in this specimen. A recent study done at the University of Wisconsin at Milwaukee compared 60 matched pairs of hair and fingernails for marijuana use. Carboxy-tetrahydrocannabinol (THCA), a biomarker of marijuana, was tested and found to be five (5) times more concentrated in fingernails than hair due to the thickness of nails.11 Toenails, as they are thicker, may provide even more of a concentration of drugs and can be tested for drugs and EtG if no fingernails are available.

Alcohol Testing Strategy: Rule of Three Alcohol is still the major substance of abuse worldwide and often used with other drugs. The social and economic consequences of drug abuse is a fraction of that of alcohol. For those in treatments for addictive disorders an effective and modern approach of alcohol testing is required. Testing for alcohol in breath, blood, saliva or urine samples can be limited to a detection window of just a few short hours following consumption. Urine alcohol testing is also problematic due to bacterial growth compromising the test. Collecting a blood sample requires a medical professional to draw the blood and has risk of infection. The “Rule of Three� for direct alcohol biomarker testing is emerging as an effective alcohol testing strategy: breath, blood, saliva or urine alcohol has a window of detection of three hours or more, urine EtG has a window of detection up to three days, phosphatidyethanol (PEth) up to three weeks, and EtG in fingernails or hair for up to three months. These tools provide an effective ensemble of testing strategies and a solid evidence-based combination to monitor abstinence from alcohol. EtG in urine has been in PHM testing since 2005, but only recently has EtG in hair been available. The Society of Hair Testing suggests a 20 pg/mg cutoff as a marker for binge drinking. A 2013 publication in the journal Addiction, by Dr. Lisa Berger and her group at the University of Wisconsin at Milwaukee, analyzed 606 matched

11


fingernail and hair samples tested for EtG.12 The results demonstrated that fingernails and hair are comparable alcohol testing specimens. Fingernails displayed an advantage in the study, eliminating a bias seen in the hair data that was likely due to naturally thin, colored or cosmetically treated hair. PEth is a unique direct alcohol biomarker for binge drinking. PEth is produced in, and incorporated into, the red blood cell membrane when an individual consumes alcohol. It is a unique blood test that does not require a blood draw, but can be simply accomplished using dried blood spots.

Case Studies Drug testing in PHM programs is invaluable, not only to identify drug abuse, but also to vindicate those accused of drug abuse or non-compliance. A few case studies are presented to illustrating the point. Case Study #1 A combative and disruptive 48-year-old male surgeon was reported for suspected drug use and asked to provide a urine drug screen. The test came back negative, and a subsequent hair test was ordered. The gentlemen defiantly showed up to work with head and body hair shaven. His finger nails where clipped short. He was given a choice: agree to be tested or be dismissed. He agreed to be tested, and his toenails were clipped for the testing specimen. The result was positive for cocaine at an astonishing 102,000 pg/mg. Case Study #2 A 38 year old female alcoholic internist presented with a history of relapse and heavy drinking. She began a trial of naltrexone to aid her sobriety. Yet, her work attendance and behavior began to deteriorate, and her sobriety compliance was questioned. A urine sample for naltrexone was ordered, and it was negative. A hair test for naltrexone was ordered, and it too was negative. This was a single mother with two children who

12

was going to lose her job on the basis of these lab tests. She reported weekly visits to the beauty parlor, a potentially confounding factor for the hair test, and agreed to a fingernail test. The fingernail test was positive for naltrexone, and her job was saved. Case Study #3 A semi-retired pharmacist working in a large manufacturing facility had been in Alcoholics Anonymous for more than ten years. The State licensing agency randomly selected him for hair testing. The hair sample was positive for oxycodone. He denied using. A series of tests were done. His fingernails were also positive, but his urine and oral fluid were negative. He, like the female surgeon earlier, was going to lose his livelihood on the basis of this test. He agreed to a toenail test, which came back with a negative result. As it turned out, he had been assigned to repackage thousands of oxycodone pills manually and had his finger nails and hair environmentally contaminated. His toenails were free of drug as his lawyer pointed out, because he did not count pills with his feet.

Conclusion This is only a brief view of just a few of the new drug testing technologies that are available. There are several lessons to learn here. The most important is to always ask the important, threepart question: “What are your cutoffs, when was your lab licensed and who are your clients?� For better testing data, vary your testing panels among different specimen types - urine, saliva, hair, blood, and nails. Nails are especially important, since they not only identify drug use, but abstinence and compliance as well, potentially saving careers and lives. Custom design testing programs to individual patients’ addiction profiles whenever possible, for example, testing more frequently for a drug of choice using different samples. Treat the patient not the drug test. Sometimes drug tests are wrong and need investigation. Your patients and their families will thank you.

Summer 2016 Substance


References 1. Baron, D.A., Martin, D. M. & Magd, S.A. (2007). Doping in Sports and its Spread to At-Risk Populations: an International Review. World Psychiatry, 6(2): 118-123. Retrieved from: http://www.ncbi.nlm.nih.gov/pmc/ articles/PMC2219897/ 2. Exec. Order No. 12564, 3 C.F.R. 224 (1986). Retrieved from: http://www.archives.gov/federalregister/codification/executive-order/12564.html 3. Hansen HJ, Caudill SP, & Boone DJ. (1985). Crisis in Drug Testing. Results of CDC blind study. JAMA, 253(16): 2382-7. Retrieved from: http://www.ncbi.nlm. nih.gov/pubmed/2984441 4. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration. (2008). Mandatory Guidelines for Federal Workplace Drug Testing Programs. Retrieved from: http://www.gpo.gov/fdsys/pkg/FR-2008-11-25/ pdf/E8-26726.pdf 5. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration. (2016). Current List of HHS-Certified Laboratories and Instrumental Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies. Retrieved from: http://www.samhsa.gov/sites/default/files/workplace/ certified-labs-list-march-2016.pdf 6. Department of Justice, Office of Public Affairs. (2015). Millennium Health Agrees to Pay $256 Million to Resolve Allegations of Unnecessary Drug and Genetic Testing and Illegal Remuneration to Physicians [Press Release]. Retrieved from: https://www.justice.gov/opa/ pr/millennium-health-agrees-pay-256-million-resolveallegations-unnecessary-drug-and-genetic 7. Alltucker, K. (2015). Labs, doctors scrutinized over lucrative drug tests for pain-pill abuse. Arizona Republic. Retrieved from: http://www.azcentral.com/story/news/arizona/ investigations/2015/12/26/labs-doctors-scrutinized-overlucrative-drug-tests-pain-pill-abuse/77181470/ 8. Connecticut General Life Insurance Company and Cigna Health and Life Insurance Company vs. Sky Toxicology, LTD., Sky Toxicology Lab Management, LLC, Frontier Toxicology, LTD., and Hill Country Toxicology LTD. United States District Court, Southern

USDTL

District of Florida, West Palm Beach Division. Case 9:15-cv-80994-WJZ. Retrieved from: https://www. documentcloud.org/documents/2189942-cigna-v-sky. html 9. Miller, J. (2016, May 2). UnitedHealth names labs, treatment center in federal fraud case. Behavioral Healthcare. Retrieved from http://www.behavioral. net/article/unitedhealth-names-labs-treatment-centersfederal-fraud-case 10. Haller, D. L., Acosta, M. C., Lewis, D., Miles, D. R., Schiano, T., Shapiro, P. A., Gomez, J., SabagCohen, S. and Newville, H. (2010). Hair Analysis Versus Conventional Methods of Drug Testing in Substance Abusers Seeking Organ Transplantation. American Journal of Transplantation, 10: 1305–1311. doi: 10.1111/j.1600-6143.2010.03090.x 11. Jones, J., Jones, M., Plate, C., & Lewis, D. (2013). The Detection of THCA Using 2-Dimensional Gas Chromatography-Tandem Mass Spectrometry in Human Fingernail Clippings: Method Validation and Comparison with Head Hair. American Journal of Analytical Chemistry, 4(10): 1-8. doi: 10.4236/ ajac.2013.410A2001 12. Berger, L., Fendrich, M., Jones, J., Fuhrman, D., Plate, C., & Lewis, D. (2013). Ethyl Glucuronide in Hair and Fingernails as a Long-Term Alcohol Biomarker. Addiction, 109(3), 425-431. doi: 10.1111/add.12402

Dr. Martin has authored over 100 publications in drug abuse treatment and testing. He established one of the first professional health drug testing programs in the nation and has been the founder of several drug testing laboratories including Psychiatric Diagnostic Laboratories of America, FirstLab and JMJ Technologies. He is currently the Science Team Director for the Drug Enforcement Administration (DEA) Educational Foundation Global Toxic Adulterant Research Program studying new cutting agents added to street drugs and instant technologies to test for them.

13


14

Summer 2016 Substance


A TESTIMONY FROM THE F IELD: USE THE RIGHT TEST T O FIND THE BEST ANSWER Choosing the right test for your client can make all the difference. by Gary Patrone

will likely ask the court for reciprocity and ask to There are a variety of tests available, and have her tested as well. We also suggested she cast a choosing the right test can make the difference wide net and ask for a 10-panel hair test with head between answering questions and creating more hair preferred, and body hair or fingernails as an of them for your client. One client, Sara (not her alternate. real name) contacted our office and explained how Sara agreed to the test, and we used USDTL she was in the middle of a divorce and planned for a quick turnaround time of three days from to curtail child visitation rights to her estranged the collection date in order to meet her court husband in an upcoming court appearance. She appearance. We reviewed the results with her when knows that he uses methamphetamine and does they arrived, and she was shocked to learn that she not want her 12-year-old son exposed to drugs. She showed positive for methamphetamine. wanted to know which tests would be best suited She was driving at the time and had to pull for her to have included in the court order for her over and stop the car as she was nearing a panic ex-husband. attack. She had never used meth and insisted a The window of detection for methamphetamine in urine and saliva is approximately four days. After She knows that he uses methamphetamine and does not want her which, we may not find it. Sara’s 12-year-old son exposed to drugs. She wanted to know which tests ex-husband has a history of would be best suited for her to have included in the court order for meth use but may abstain from ex-husband. using during the current legal discussions. Since a urine or mistake had to have happened either at my lab or saliva test would likely result in a negative result, we the testing facility, USDTL. I assured her that the recommended a head hair test which has a ~90 day chain of custody had been maintained throughout window of detection. the collection and testing process and, considering We also advised Sara that once she asks the it was allergy season, asked her if she was using any court to test her ex-husband, opposing counsel

USDTL

her

15


game-changing comment. She was perplexed by a statement her ex-husband made the day he left the house. There was a heated argument where Sara threatened to have him tested for drugs before granting joint custody and/or visitation rights to her 12 year old son. Her husband seemed unfazed and informed her that meth was in her system as well. She thought it was a preposterous statement since she would most certainly know if she smoked any illegal drugs and dismissed his comment as spiteful retaliation. She thought about that seemingly odd comment overnight and remembered the last thing he did before leaving the house for the last time was to change the water filter feeding the refrigerator. She asked me if it was possible for him to add crystal meth to the water filter providing contaminated water to the ice and water dispenser in the refrigerator door. Although I could barely wrap my mind around someone doing something so atrocious, even to his own son, I confessed it was indeed possible. Smoking or injecting methamphetamine puts the drug very quickly into the bloodstream and brain, causing an immediate, intense “rush” and amplifying the drug’s addiction potential and adverse health consequences. Such potentially devious and malicious cases are not the norm, The rush, or “flash,” lasts only a however we do see many complex cases that require a measure of few minutes and is described as judgement in which tests are chosen to best fit a particular set of extremely pleasurable. Snorting circumstances. or oral ingestion produces euphoria—a high, but not an intense rush. Snorting produces effects within I explained the difference between d- and l-meth three to five minutes, and oral ingestion produces and advised her that I would check with the lab effects within 15 to 20 minutes.2 So introducing to see if enough hair sample remained to run an isomer separation test to determine if the positive methamphetamine to the water supply to the test results were due to the d- or l-isomer. She refrigerator may produce only subtle effects barely understood and agreed to call me the following day. noticeable to anyone consuming the water or ice Sara indeed called me the next day and made a sourced from the refrigerator. cold medications. She could not remember using anything and avoids cold and flu medications as best she can. Methamphetamine is a stereoisomer drug and is available in two forms: d- and l-. The d- form can be a pharmaceutical grade methamphetamine (Desoxyn) used to treat ADHD, severe obesity, and narcolepsy, but usually indicates the street drug crystal meth. The l- form is available overthe-counter as the active ingredient of the Vicks inhaler and is a metabolite of certain prescription medications. Illegally produced methamphetamine may contain mixtures of both isomers, with a substantially higher amount of d-methamphetamine present than most commercial products. Both d- and l- forms can register a positive methamphetamine result by immunoassay, and the d- form is 20 times more sensitive at producing a positive. The antibodies used in the ELISA only react at 4% for the l-form. Standard LC/MS/MS confirmation techniques do not distinguish between the d- and l- forms. If, however, the special isomer report reveals more than 20% d-methamphetamine present, the result usually indicates illicit methamphetamine use.1

16

Summer 2016 Substance


With this new information, I changed our strategy of running a test to separate the d- and l- isomers in the remaining hair sample from Sara. Instead I asked her to come in for another hair sample for a 5-panel hair test using a second lab. This would eliminate any possible notion that chain of custody was breached or samples mixed and serve to corroborate the findings of the first lab. I also asked her to bring in her 12-year-old son for the same hair test as a simple (not conclusive) check regarding the d- vs l-isomer issue and possibly linking the source of the drug to the refrigerator water dispenser. She agreed with the strategy and both Sara and son came into the lab for hair testing. I made it exceedingly clear as I cleaned the utensils used in the collection process of her hair sample that I was eliminating any possibility of cross contamination and used a second set of utensils to collect the hair sample from her son. The samples were sent the same day and the answers would arrive in about a week. The results arrived a week later shocking my staff and leaving me with an uneasiness that’s difficult to describe. Both Sara and her son tested positive for methamphetamine in their hair samples. Are the results conclusive that d-meth was found in both hair samples? No. Is it conclusive that meth was introduced into the water source for the refrigerator water and ice dispensers? No. Does it suggest that Sara’s husband, or anyone else, may have added meth to the water filter feeding the water supply to the refrigerator? No. These events are fresh, however, and may be just the beginning of larger events to come. Questions still remain, and this event may likely find its way into a courtroom. Although the tests performed are not conclusive in several areas, it is

USDTL

a good start and provides a solid foundation in any likely dispute moving forward. Should additional confirmations be required, we have hair and nail samples available to us to test, and the d- and lisomer separation test is still a viable option on new test samples. Such potentially devious and malicious cases are not the norm, however we do see many complex cases that require a measure of judgment in which tests are chosen to best fit a particular set of circumstances. Our clients depend on our ability to get it right, and we do our level best to not disappoint them. References 1. How is methamphetamine abused? (2013, September). Retrieved from https://www.drugabuse.gov/ publications/research-reports/methamphetamine/howmethamphetamine-abused 2. Stockard, F. (2014, July 25). Meth Addiction Facts: What’s True and What’s False? Retrieved from http:// lighthouserecoveryinstitute.com/meth-addiction-facts/

Gary F. Patrone is CEO of ARCpoint Labs of Tempe and owns three labs operating within the Phoenix Valley. Gary serves both corporate and private clients in drug, alcohol, DNA, wellness and on-site testing services, creates workplace policies for both DOT and non-mandated companies and manages consortiums and random programs for corporate and private clients. Gary is an active member of the Tempe-South Rotary Club, an Ambassador of the Tempe Chamber of Commerce, member of the Business Development Committee, member of the Advisory Council for Brookline College and PIMA Medical Institute. Gary has authored articles for DATIA, the Arizona Small Business Association and writes a monthly column for the Arizona Republic.

17


USDTL NATIONAL POSITIVITY RATES* * These data report national positivity rates for forensic toxicology tests conducted by USDTL on behalf of external clients and are not reflective of systematic research results.

Fingernail Specimens

Amphetamines | 14.1% Cocaine | 6.1% Opiates | 7.4% Cannabinoids | 22.7% Barbiturates | 0.6% Methadone | 1.1% Benzodiazepines | 1.8% Oxycodone | 5.6% Tramadol | 1.4% Fentanyl | 0.0%

Buprenorphine | 32.0% Ketamine | 0% Ethyl Glucuronide | 20.1%

Not shown: Meperidine 0.0%, Phencyclidine 0.0%, Propoxyphene 0.0%

30

18

20

10

0

Summer 2016 Substance


Report date range: January 1, 2016 – March 31, 2016

Hair Specimens

Amphetamines | 16.6

%

Cocaine | 6.9% Opiates | 11.9% Cannabinoids | 20.8% Barbiturates | 0.4% Methadone | 2.1% Benzodiazepines | 3.0% Oxycodone | 11.3% Tramadol | 3.9% Fentanyl | 0.9% Buprenorphine | 32.0% Ketamine | 3.6% Ethyl Glucuronide | 13.2%

Not shown: Meperidine 0.0%, Phencyclidine 0.2%, Propoxyphene 0.0%

0

USDTL

10

20

30

19


®

United States Drug Testing Laboratories, Inc. 1700 S. Mount Prospect Road|Des Plaines, IL|60018 Main: 847.375.0770|www.USDTL.com|Fax: 847.375.0775

Like what we have to share? Follow us for more!

EVENTS & EXHIBITS • August 12-14 – National Child Welfare, Juvenile and Family Law Conference – Philadelphia, PA • October 5-7 – Illinois Association of Problem-Solving Courts – Normal, IL • October 7-11 – The Association for Addiction Professionals Annual Conference – Minneapolis, MN

®

1700 S. Mount Prospect Rd. | Des Plaines, IL 60018 | 800.235.2367 | www.USDTL.com

20

Summer 2016 Substance

Profile for USDTL

Substance | Summer 2016  

Substance | Summer 2016  

Profile for usdtl