Designer Drugs – Is Your Drug Testing Program …redplanettesting.com/docs/designerdrugs001.pdfDesigner Drugs – Is Your Drug Testing Program Keeping Up? 3 Substance abuse – the

Designer Drugs – Is Your Drug Testing Program Keeping Up?2

The challenges detecting the latest advent of

designer drugs has become a moving target.

With the increasing number of new compounds

entering the United States every year, law

enforcement and treatment programs are

overwhelmed and resource constrained. Many

laboratories are struggling to keep up with the

newest trends in analogue drug detection.

Here’s some important facts you should know

when evaluating your drug testing programs.

INT00279 1013 Designer Drugs _Is Your Program Keeping Up_Layout 1 10/22/13 10:30 AM Page 2


Substance abuse – the challenges of todaySince the Federal Analogue Act became law in 1986,users and dealers of analogue drugs — substanceswhose chemical formulas are substantially similar totraditional drugs such as amphetamines,methamphetamines, cocaine, opiates, marijuana andPCP — have sidestepped prosecution by selling or usingdrugs whose molecular construction has beenmodified enough to create somethingtechnically new. And while recentlegislation and advances in tests forsubstance abuse have beeninitiated, State and Federal lawenforcement agencies continueto struggle with users anddealers of these “designeranalogue drugs”.

The tremendous toll substanceabuse has taken in the United Statesdirectly impacts nearly 24 millionAmericans aged 12 or older.1 Every year,abuse of illicit drugs and alcohol contributes tomore than 100,000 deaths making it among the top leading preventable causes of death and disease.2,3

To further compound the problem, the outcome ofthose who abuse drugs dramatically affects families,friends, and communities.

Substance abuse also causes a substantial financialburden impacting an estimated $510.8 billion in societalcosts and making it one of the most costly healthproblems amongst Americans.4 Today, nearly 20% of all

Medicaid hospital costs and about $1 of every $4Medicare spends on inpatient care is associated withsubstance abuse.5

It is understandable why substance abuse is regarded asone of the most important illnesses of our time.

The introduction of designer drugs

The creation, manufacture and distribution ofdesigner drugs have been an on-going

problem for decades. Since the 1970s, asmall number of clandestine chemists

began domestically manufacturingsynthetic alternatives to fentanylwhich were targeted to heroin users.One hundred to 500 times morepotent, drug abusers unknowingly

became test subjects with thisuncontrolled experimentation resulting

in a series of deaths throughout thecountry. Many of these mortalities were not

caused by strength of the drug but by the toxiccontaminants introduced during processing. These

synthesized substances were non-controlled andmonetarily profitable for the drug trade furtherhindering law enforcements ability to respondeffectively. Then in 1986, the enactment of theControlled Substance Analogue Enforcement Actprovided law enforcement with the ammunition theyneeded to combat these clandestine labs.6

The introduction of the Analogue Act provided lawenforcement the ability to size drugs and laboratory


paraphernalia along with the authority to arrest andprosecute the chemists/violators. The outcomeeventually dismantled the manufacturing anddistribution networks.6

However, a new onset of non-controlled synthetic drugs appeared such as benzylpiperazine (BZP) andtrifloromethylphenylpiperazine (TFMPP) in combinationdesigned to mimic the effects of MDMA (ecstasy), alongwith 5-MeO-AMT (an amphetamine substitute) whichpresented a whole new set of challenges for lawenforcement. The manufacturing of these new syntheticdrugs shifted overseas while smuggling operations fordistribution in the United States began.6

Manufacturing transfer to large-scale foreign entitieslimits the effects of the Analogue Act as well as hinderslaw enforcement’s effectiveness to thwart potentialdesigner drug threats proactively. The consequencesexpose unsuspecting abusers and youths to sufferfurther adverse health occurrences and even death fromthese dangerous uncontrolled substances which iswhere we are today.6

Synthetic cannabinoids - K2, Spice

Synthetic cannabinoids are a largefamily of compounds that arefunctionally similar to marijuana(THC). Plant materials are coatedwith chemicals designed to mimicthe effects of marijuana when it issmoked or steeped for a hotdrink.6,7 Packaged to attract awide range of users, these products areactively marketed over-the-counter and over theinternet as a ‘natural herbal marijuana alternative’.

Further chemical analyses of the active ingredients haveconfirmed that these are synthetic (designer)cannabinoid compounds.

These synthetic cannabinoids in herbal incenseproducts were first detected in the United States inNovember 2008, by the Drug EnforcementAdministration (DEA) forensic laboratory. To avoidprosecution under the Analog Act, the packagingincluded statements such as “Not for Human

Consumption”, “For Novelty Use”, or “Use as Directed” butwithout directions for use provided.6,12

Synthetic cannabinoids are known by a variety of brandnames which include: Spice, K2 Blaze, Red X Dawn,Paradise, Black Magic, Zohai, Genie, Yucatan, Fire, CrazyClown, or Bombay Blue to name a few. The chemicalanalyses of these various products has revealed variedcomposition and concentrations of syntheticcannabinoids laced on the plant materials found in the3 ounce packages rendering the effects unpredictableto the user while increasing the adverse health risks.6,12

Popularity for these drugs hasincreased over the last five

years due to the psychoactiveproperties and themisperception that thesedrugs are legal alternativesto the most widely abuseddrug marijuana.6



DRUG USE AMONG HIGH SCHOOLERS6,7

The 2012 annual Monitoring the Future surveyconducted by the Federal Government confirmedcontinued and widespread use of these compounds byhigh schoolers.

Among the three grades surveyed, the perceived riskswith trying synthetic marijuana once or twice was quitelow (23% to 25%). The over-the-counter availability ofthese drugs is believed to have communicated its safetyto the teen population.8


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Marijuana/Hashish

Synthetic Marijuana

Hallucinogens

Salvia

MDMA (Ecstasy)

Cocaine

2012 Past Year Use of Illicit Drugs by High School Seniors (percent)7

EMERGENCY DEPARTMENT VISITS9

In 2010, the Drug Abuse WarningNetwork (DAWN) reported anestimated 11,406 emergencydepartment (ED) visits whichinvolved a synthetic cannabinoid.The majority (59%) of these visitswere among 12 to 29 year olds withno other combined substancesunlike marijuana and other drugs of abuse.9

By 2011, the number of ED visitsrose to 28,531 or 2.35% of all EDvisits involving illicit drugs.6

Marijuana* Heroin** Cocaine** Illicit Stimulants** Synthetic Cannabinoids**

MMMaMaririijjj anana*a**jujuaa ss****nn******** e**e****** lllanantsts iiccHeHeroroooiinin CCCoCocacaiiininee iciittIll tt SttStiiimimmmuu SSSySyntttnthhhhhehetiti

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* The differences between those 12 to 17 and the two older age groups were statistically significant at the .05 level.

** All differences between groups were statiscally significant at the .05 level.

2011 Emergency Department Visits10


FEDERAL GOVERNMENT RESPONSE6

In response to the growing onslaught of new designerdrugs, an amendment to the CSA was approved givingthe Attorney General the authority to temporarily placea substance into Schedule I of the CSA for one yearwithout the requirements of 21 U.S.C.§ 811 (b) if suchaction avoids an imminent hazard to the public safety.The President subsequently signed into law theSynthetic Drug Abuse Prevention Act of 2012 extendingthe provision to 24 months. This law placed 15 cannabinoids into schedule I which included:

On May 16, 2013, the DEA added three morecompounds to the growing list:

UR-1445-fluoro-UR-144, XLR11APINACA, AKB48

While 18 synthetic compounds have been controlledthrough legislation or regulatory action, the DEA hasidentified over 75 additional cannabinoids that havebegun to appear in the domestic marketplace.6

Laboratories, like the Federal Government, are havingdifficulty keeping up with detection of the newsynthetic compounds. To illustrate this ever-changingproblem, NMS Labs presented recent data illustratingthis dramatic shift within just 2 years.11

Many of the assays, particularly the rapid tests, will nolonger detect the latest trends in syntheticcannabinoids.


JWH-018 JWH-073JWH-200 CP-47,497 CP-47,497 C8 homologueAM-2201 AM-694JWH-081

JWH-019JWH-250JWH-122JWH-203JWH-398SR-19SR-18

JWH-25011%

JWH-07326%

JWH-07863%

2010 SYNTHETIC MARIJUANA COMPOUNDS

2012 SYNTHETIC MARIJUANA COMPOUNDS

AM220127%

JWH-2109%

JWH-12219%

JWH-0812%

JWH-2502%

JWH-0734%

XLR 113%

UR-1443%JWH-073 Methy

Butyl/Homolog2%

RCS-42%

AM69411%

JWH-2036%

JWH-0071%

JWH-01811%

JWH-0228%


Synthetic cathinones - bath salts

Synthetic cathinones known as bath salts are one of thelatest additions to the growing list of substances thatattract young people. Bath salts is a powder laced with amixture of chemicals that are available in capsules or inloose form. Users either swallow the capsules or use thepowder for inhalation or mixed with liquid forintravenous injection. The effect is similar to cocaine or ecstasy.12

Synthetic cathinones are related to the parentcompound cathinone and formerly sold legally online or over-the-counter. Many contained variousamphetamine-like chemicals such asmethylenedixoypyrovalerone (MPDV), mephedrone and pyrovalerone.6

Like the synthetic cannabinoids, bath salts are targetmarketed to youth and adolescents with brand namessuch as: Ivory Wave, Purple Wave, Red Dove, Blue Silk,Zoom, Vanilla Sky, and Hurricane Charlie. They too arelabeled with similar disclaimers – “Not for Human

Consumption” in an effort to avoid the CSA.6,12

The first entry of bath salts into the drug trade is unclearbut had been mentioned in internet drug forums asearly as 2007.12

DRUG USE AMONG HIGH SCHOOLERS8

The 2012 survey for prevalence of bath salts use amonghigh schoolers was found to be relatively low comparedto other synthetic compounds (0.8%, 0.6%, and 1.3%) ingrades 8, 10, and 12, respectively.8 The data from thenational poison control centers relating to bath saltsalso suggests a lower prevalence with the decline ofcases from 6,136 in 2011 peak year to 2,676 in 2012. As of Aug. 31, 2013, 690 cases have been reported.13

These lower bath salts rate of incidences may beattributed to the highly publicized adverse reactionsand overdose episodes with users combined with recentlegislation and law enforcement’s successful efforts tocrack down on sales and distribution.



EMERGENCY DEPARTMENT VISITS14

In 2011, the Drug Abuse Warning Network (DAWN)reported that over 20,000 drug-related emergencydepartment visits occurred. Of nearly 2.5 million EDvisits involving drug misuse or abuse, bath saltscontributed to nearly 1%. However, unlike syntheticmarijuana, bath salts were found in a combination ofother drugs more frequently than bath salts alone, 67%vs. 33%, respectively.14

FEDERAL GOVERNMENT RESPONSE6

Initially, three compounds, MDPV (3, 4-methylenedioxypyrovalerone), mephedrone(4-methylmethcathinone), and methylone (3,4-methylenedioxymethathinone) were the mostfrequently found in the U.S. marketplace and placed on

the DEA’s temporary controlled substance list inOctober 2011. Most of the confiscated shipments werefound to contain methylone originating from China andwere to be delivered throughout the U.S. As of April 13,2013, methylone is now part of the permanentcontrolled list of drugs along with its salt isomers.6

Following Federal Government guidelines, as of August2013, 45 states and Puerto Rico have also banned thesesubstances.6

More recently, a shift in newer drugs within this classhas appeared which are not currently on the DEA’scontrolled substance list which include6:

The DEA continues to monitor these new compoundsfor determination of their classification.

Other designer drugs

While synthetic cannabinoids and synthetic cathinonescontinue to dominant the drug trade, newer classes ofsythethics are finding their way into the marketplace aswell. The following is a brief description of some ofthese designer alternative drugs.

Phenethylamines

Phenethylamines are a large class of substances thatstimulate the central nervous system creatinghallucinogenic effects. There are over 170 different


2011 EMERGENCY DEPARTMENT VISITS INVOLVING BATH SALTS

52%Bath Salts

and Other DrugCombinations

11,987

33%Bath Salts Only

7,578

15%

Bath Salts withMarijuana/Synthetic

Marijuana3,339

4-MEC 4-EMCbuphedrone

butyloneethyloneflephedrone


compounds of phenethylamines15 of which the FederalGovernment has place 9 of the 2C compounds underSchedule I.6, 17 These include:

The National Forensic Laboratory Information System(NFLIS) is a program of the DEA that collects drugidentification results from drug cases analyzed byFederal, State, and local forensic laboratories. From 2006to 2010, reports of 2C-phenethylamines increased fromand estimated 28 in 2006 to 228 in 2010 or 8 foldencounters.16 Incidence of 2-C phenethylamines havealso been linked to at least 14 deaths in 2012-2013 andyet to be confirmed 13 additional deaths attributed to251-NBOMe (another compound of phenethylamine).6

Piperazines

Piperazines present yet another class of compounds that share a core benzylpiperazine chemical structure. The two most common encountered by law enforcement include N-Benzylpiperazine (BZP) and 1-(3-trifluoromethylphenyl) piperazine (TFMPP). Theseare alternative synthetic drugs to MDMA and sold asEcstasy, Legal E or Legal X.6 BZP is a Schedule I drug.17

The NFLIS indicates that piperazines reports haveescalated from an estimated 16 in 2006 to 11,012 in 2010, a 650% increase.16

Tryptamines

Tryptamine acts as a serotonin releasing agent which isassociated with hallucinogenic effects. A number ofthese compounds have been encountered by lawenforcement. To date, the following are listed onSchedule 16:

Although the majority of reports for tryptamine in 2010were DMT (28 reports), 5-MeO-DIPT (126 reports) wasthe most frequent tryptamine reported in the first 6months of 2011.16


2006 2007 2008 2009 2010

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Synthetic Cathinones

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Emerging Drug Categories Reportingto NFLIS, 2006 - 2010

2C-E2C-D2C-D2C-I2C-T-2

2C-T-42C-H2C-N2C-P

αET5-MeO-DMTAMT

DETDMT5-MeO-DIPT



“Designer Drugs” – Don’t Trust The Label

The difficulty with determining drug abuse is that drugtests combined with new legislation are trailing behindthe manufacturing and distribution of the latestdesigner drugs while the problem continues to grow.The District of Columbia’s criminal justice systemreports that 25-33% of young men tested positive forsynthetic marijuana use while negative for othertraditional drugs [Washington Times, D.C. Drug Users

Turn to Synthetic Marijuana to Skirt Drug Tests, Sept. 24,2013]. Assays made as early as last year are nowobsolete in detecting the newest onslaught ofcompounds that have entered the market. This isparticularly true of rapid point-of-care tests claimingdetection of some these synthetics.

As the need to broaden the spectrum of testing for“designer” drugs of abuse grows with each newanalogue introduced, staying reasonably current is mosteffective with only lab-based assays that have thecapability to identify these mimicked drugs of abuse.While many of the drug testing devices look alike andmay claim detection of these newer compounds, it’simportant to take a closer look.

In response to this growing trend, OraSure Technologieshas partnered with major testing laboratories across thecountry that have broadened their range of assays toaddress existing “designer drugs” as well as theconstantly evolving analogues that enter themarketplace. Education and technology will be the besttools drug testing programs can utilize to help stayahead of synthetic drug battle.

OraSure’s Intercept® Oral Fluid Drug Test

Intercept® Oral Fluid Drug Test, by OraSure is a lab-based oral fluid collection device.

A saliva sample can be provided virtually anywhereusing the Intercept® device. One of the attractiveconveniences of oral fluid testing is that the collectionprocess is very simple. A typical collection using theOraSure Intercept® device takes less than 15 minutes.The entire collection process is easily observableeliminating virtually all concerns about drug testcheating.

Once the specimen is collected it is shipped overnightto a laboratory just as in the case of a lab-based urinetest. An accurate analysis of the specimen is typicallyavailable in less than 24 hours.

Choosing Intercept® Oral Fluid Collection Device canhelp strip away the false façade of designer drug labelsand help identify them for what they are – “drugs ofabuse”.



References / Resources1. SAMHSA. Results from 2012 National Survey on DrugUse and Health: Summary of National Findings,September, 2013.

2. National Institute on Drug Abuse. The Science of DrugAbuse Addiction.http://www.drugabuse.gov/publicatoins/media-guide/science-drug-abuse-addiction, downloaded10/17/13.

3. Mokdad, A. PhD, etal. Actual Causes of Death in theUnited States, 2000. JAMA, March 10, 2004, Vol. 291, No.10, pp 1238-1245.

4. SAMHSA. Substance Abuse and Prevention Dollars andCents: A Cost-Benefit Analysis. 2008.

5. National Council for Community Behavioral Healthcare.Preventing and Trating Substance Use Disorders: AComprehensive Approach, 2013.http://www.thatnationalcouncil.org/wp-content/uploads/2013/05/Substance-Use-Disorders.pdf,downloaded 10/7/13.

6. Dept. of Justice. Statement of Joseph T. Rannazzisi,Deputy. Assistant Administration, Office of DiversionControl Drug Enforcement Administration. Hearingentitled, “Dangerous Synthetic Drugs”, presented onSeptember 25, 2013.

7. Office of National Drug Control Policy. Synthetic Drugs(a.k.a. K2, Sice, Bath Salts, etc.).http://whitehouse.gov/ondcp/ondcp-fact-sheets/synthetic-drugs-k2-spice-bath-salts, downloaded10/14/13.

8. The National Institute on Drug Abuse. “Monitoring the

Future”, National Survey Results on Drug Use, 2012Overview, Key Findings on Adolescent Drug Use,February 2013.

9. SAMHSA. The Dawn Report, Drug-Related EmergencyDepartment Visits Involving Synthetic Cannabinoids,December 4, 2012.

10. SAMHSA. The Dawn Report, Highlights of 2011 DrugAbuse Warning Network (DAWN) Findings on DrugRelated Emergency Department Visits, February 22, 2013.

11. NMS Labs. Designer Drug Testing, March 2013.http://www.nmslabs.com/uploads/PDF/Designer%20Drug%Testing%20March%202013.pdf, downloaded 10/8/13.

12. UCLA Integrated Substance Abuse Programs/GulfCoast ATTC Addiction Technology Transfer CenterNetwork. Will They Turn You into a Zombie? What Clinicians

Need to Know About Synthetic Drugs. Synthetic DrugTraining Package Presentation, Sept. 25, 2012.http://www.uclaisap.org/slides/psatta/training-package/Synthetic%20Drugs%Guide_2012-09-25.pdf.

13. American Association of Poison Control Centers.Synthetic Marijuana Data, August 31, 2013.https://aapcc.s3.amazonaws.com/files/library/Synthetic_Marijuana_Data_for_Website_8.31.2013.pdf

14. 0. SAMHSA. The Dawn Report, “Bath Salts” WereInvolved in Over 20,000 Drug-Related EmergencyDepartment Visits in 2011,September 17, 2013.

15. Shulgin, Alexander and Ann. PihKal, A Chemical LoveStory. The Vaults of Erowid.http://www.erowid.org/library/books_online/pihkal/pihkal.shtml

16. National Forensic Laboratory Information. SpecialReport: Emerging 2C-Phenethylamines, Piperazines, andTryptamines in NFLIS, 2006-2011.http://www.deadliversion.usdoj.gov/nflis/spec_rpt_emerging_2012.pdf

17. List of Schedule I Drugs (U.S.). Wikipedia.org.http://en.wikipedia.org/wiki/List_of_Schedule_I_drugs_(US)


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Designer Drugs – Is Your Drug Testing Program …redplanettesting.com/docs/designerdrugs001.pdfDesigner Drugs – Is Your Drug Testing Program Keeping Up? 3 Substance abuse – the