Designer Drugs Is Your Drug Testing Program Keeping Up? 2

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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. 2

3 Substance abuse the challenges of today Since the Federal Analogue Act became law in 1986, users and dealers of analogue drugs substances whose chemical formulas are substantially similar to traditional drugs such as amphetamines, methamphetamines, cocaine, opiates, marijuana and PCP have sidestepped prosecution by selling or using drugs whose molecular construction has been modified enough to create something technically new. And while recent legislation and advances in tests for substance abuse have been initiated, State and Federal law enforcement agencies continue to struggle with users and dealers of these designer analogue drugs. The tremendous toll substance abuse has taken in the United States directly impacts nearly 24 million Americans aged 12 or older. 1 Every year, abuse of illicit drugs and alcohol contributes to more 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 of those who abuse drugs dramatically affects families, friends, and communities. Substance abuse also causes a substantial financial burden impacting an estimated $510.8 billion in societal costs and making it one of the most costly health problems amongst Americans. 4 Today, nearly 20% of all Medicaid hospital costs and about $1 of every $4 Medicare spends on inpatient care is associated with substance abuse. 5 It is understandable why substance abuse is regarded as one of the most important illnesses of our time. The introduction of designer drugs The creation, manufacture and distribution of designer drugs have been an on-going problem for decades. Since the 1970s, a small number of clandestine chemists began domestically manufacturing synthetic alternatives to fentanyl which were targeted to heroin users. One hundred to 500 times more potent, drug abusers unknowingly became test subjects with this uncontrolled experimentation resulting in a series of deaths throughout the country. Many of these mortalities were not caused by strength of the drug but by the toxic contaminants introduced during processing. These synthesized substances were non-controlled and monetarily profitable for the drug trade further hindering law enforcements ability to respond effectively. Then in 1986, the enactment of the Controlled Substance Analogue Enforcement Act provided law enforcement with the ammunition they needed to combat these clandestine labs. 6 The introduction of the Analogue Act provided law enforcement the ability to size drugs and laboratory 3

4 paraphernalia along with the authority to arrest and prosecute the chemists/violators. The outcome eventually dismantled the manufacturing and distribution networks. 6 However, a new onset of non-controlled synthetic drugs appeared such as benzylpiperazine (BZP) and trifloromethylphenylpiperazine (TFMPP) in combination designed to mimic the effects of MDMA (ecstasy), along with 5-MeO-AMT (an amphetamine substitute) which presented a whole new set of challenges for law enforcement. The manufacturing of these new synthetic drugs shifted overseas while smuggling operations for distribution in the United States began. 6 Manufacturing transfer to large-scale foreign entities limits the effects of the Analogue Act as well as hinders law enforcement s effectiveness to thwart potential designer drug threats proactively. The consequences expose unsuspecting abusers and youths to suffer further adverse health occurrences and even death from these dangerous uncontrolled substances which is where we are today. 6 Synthetic cannabinoids - K2, Spice Synthetic cannabinoids are a large family of compounds that are functionally similar to marijuana (THC). Plant materials are coated with chemicals designed to mimic the effects of marijuana when it is smoked or steeped for a hot drink. 6,7 Packaged to attract a wide range of users, these products are actively marketed over-the-counter and over the internet as a natural herbal marijuana alternative. Further chemical analyses of the active ingredients have confirmed that these are synthetic (designer) cannabinoid compounds. These synthetic cannabinoids in herbal incense products were first detected in the United States in November 2008, by the Drug Enforcement Administration (DEA) forensic laboratory. To avoid prosecution under the Analog Act, the packaging included statements such as Not for Human Consumption, For Novelty Use, or Use as Directed but without directions for use provided. 6,12 Synthetic cannabinoids are known by a variety of brand names which include: Spice, K2 Blaze, Red X Dawn, Paradise, Black Magic, Zohai, Genie, Yucatan, Fire, Crazy Clown, or Bombay Blue to name a few. The chemical analyses of these various products has revealed varied composition and concentrations of synthetic cannabinoids laced on the plant materials found in the 3 ounce packages rendering the effects unpredictable to the user while increasing the adverse health risks. 6,12 Popularity for these drugs has increased over the last five years due to the psychoactive properties and the misperception that these drugs are legal alternatives to the most widely abused drug marijuana. 6 4

5 DRUG USE AMONG HIGH SCHOOLERS 6,7 The 2012 annual Monitoring the Future survey conducted by the Federal Government confirmed continued and widespread use of these compounds by high schoolers Past Year Use of Illicit Drugs by High School Seniors (percent) 7 Among the three grades surveyed, the perceived risks with trying synthetic marijuana once or twice was quite low (23% to 25%). The over-the-counter availability of these drugs is believed to have communicated its safety to the teen population. 8 Marijuana/Hashish 36.4 Synthetic Marijuana 11.3 Hallucinogens Salvia MDMA (Ecstasy) Cocaine EMERGENCY DEPARTMENT VISITS 9 In 2010, the Drug Abuse Warning Network (DAWN) reported an estimated 11,406 emergency department (ED) visits which involved a synthetic cannabinoid. The majority (59%) of these visits were among 12 to 29 year olds with no other combined substances unlike marijuana and other drugs of abuse. 9 By 2011, the number of ED visits rose to 28,531 or 2.35% of all ED visits involving illicit drugs. 6 ED Visits per 100,000 Population Emergency Department Visits Marijuana* ana* a* Heroin** Cocaine** Illicit Stimulants** ts Synthetic ti Cannabinoids** Persons Aged 12 to 17 Persons Aged 18 to 20 Persons Aged 21 to * 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. 5

6 FEDERAL GOVERNMENT RESPONSE 6 In response to the growing onslaught of new designer drugs, an amendment to the CSA was approved giving the Attorney General the authority to temporarily place a substance into Schedule I of the CSA for one year without the requirements of 21 U.S.C. 811 (b) if such action avoids an imminent hazard to the public safety. The President subsequently signed into law the Synthetic Drug Abuse Prevention Act of 2012 extending the provision to 24 months. This law placed 15 cannabinoids into schedule I which included: JWH-018 JWH-073 JWH-200 CP-47,497 CP-47,497 C8 homologue AM-2201 AM-694 JWH-081 On May 16, 2013, the DEA added three more compounds to the growing list: UR fluoro-UR-144, XLR11 APINACA, AKB48 JWH-019 JWH-250 JWH-122 JWH-203 JWH-398 SR-19 SR-18 While 18 synthetic compounds have been controlled through legislation or regulatory action, the DEA has identified over 75 additional cannabinoids that have begun to appear in the domestic marketplace. 6 Laboratories, like the Federal Government, are having difficulty keeping up with detection of the new synthetic compounds. To illustrate this ever-changing problem, NMS Labs presented recent data illustrating this dramatic shift within just 2 years. 11 RCS-4 2% JWH-203 6% 2010 SYNTHETIC MARIJUANA COMPOUNDS JWH % JWH % JWH % 2012 SYNTHETIC MARIJUANA COMPOUNDS JWH-007 1% JWH-073 Methy Butyl/Homolog 2% AM % JWH-022 8% AM694 11% UR-144 3% JWH-210 9% XLR 11 3% JWH % JWH % JWH-073 4% JWH-250 2% JWH-081 2% Many of the assays, particularly the rapid tests, will no longer detect the latest trends in synthetic cannabinoids. 6

7 Synthetic cathinones - bath salts Synthetic cathinones known as bath salts are one of the latest additions to the growing list of substances that attract young people. Bath salts is a powder laced with a mixture of chemicals that are available in capsules or in loose form. Users either swallow the capsules or use the powder for inhalation or mixed with liquid for intravenous injection. The effect is similar to cocaine or ecstasy. 12 Synthetic cathinones are related to the parent compound cathinone and formerly sold legally online or over-the-counter. Many contained various amphetamine-like chemicals such as methylenedixoypyrovalerone (MPDV), mephedrone and pyrovalerone.6 Like the synthetic cannabinoids, bath salts are target marketed to youth and adolescents with brand names such as: Ivory Wave, Purple Wave, Red Dove, Blue Silk, Zoom, Vanilla Sky, and Hurricane Charlie. They too are labeled 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 unclear but had been mentioned in internet drug forums as early as DRUG USE AMONG HIGH SCHOOLERS 8 The 2012 survey for prevalence of bath salts use among high schoolers was found to be relatively low compared to other synthetic compounds (0.8%, 0.6%, and 1.3%) in grades 8, 10, and 12, respectively. 8 The data from the national poison control centers relating to bath salts also suggests a lower prevalence with the decline of cases from 6,136 in 2011 peak year to 2,676 in As of Aug. 31, 2013, 690 cases have been reported. 13 These lower bath salts rate of incidences may be attributed to the highly publicized adverse reactions and overdose episodes with users combined with recent legislation and law enforcement s successful efforts to crack down on sales and distribution. 7

8 EMERGENCY DEPARTMENT VISITS 14 In 2011, the Drug Abuse Warning Network (DAWN) reported that over 20,000 drug-related emergency department visits occurred. Of nearly 2.5 million ED visits involving drug misuse or abuse, bath salts contributed to nearly 1%. However, unlike synthetic marijuana, bath salts were found in a combination of other drugs more frequently than bath salts alone, 67% vs. 33%, respectively EMERGENCY DEPARTMENT VISITS INVOLVING BATH SALTS the DEA s temporary controlled substance list in October Most of the confiscated shipments were found to contain methylone originating from China and were to be delivered throughout the U.S. As of April 13, 2013, methylone is now part of the permanent controlled list of drugs along with its salt isomers.6 Following Federal Government guidelines, as of August 2013, 45 states and Puerto Rico have also banned these substances. 6 More recently, a shift in newer drugs within this class has appeared which are not currently on the DEA s controlled substance list which include 6 : 52% Bath Salts and Other Drug Combinations 11,987 33% Bath Salts Only 7,578 15% 4-MEC 4-EMC buphedrone butylone ethylone flephedrone The DEA continues to monitor these new compounds for determination of their classification. Bath Salts with Marijuana/Synthetic Marijuana 3,339 FEDERAL GOVERNMENT RESPONSE 6 Initially, three compounds, MDPV (3, 4- methylenedioxypyrovalerone), mephedrone (4-methylmethcathinone), and methylone (3,4- methylenedioxymethathinone) were the most frequently found in the U.S. marketplace and placed on Other designer drugs While synthetic cannabinoids and synthetic cathinones continue to dominant the drug trade, newer classes of sythethics are finding their way into the marketplace as well. The following is a brief description of some of these designer alternative drugs. Phenethylamines Phenethylamines are a large class of substances that stimulate the central nervous system creating hallucinogenic effects. There are over 170 different 8

9 compounds of phenethylamines 15 of which the Federal Government has place 9 of the 2C compounds under Schedule I. 6, 17 These include: 20,000 Emerging Drug Categories Reporting to NFLIS, C-E 2C-D 2C-D 2C-I 2C-T-2 2C-T-4 2C-H 2C-N 2C-P The National Forensic Laboratory Information System (NFLIS) is a program of the DEA that collects drug identification results from drug cases analyzed by Federal, State, and local forensic laboratories. From 2006 to 2010, reports of 2C-phenethylamines increased from and estimated 28 in 2006 to 228 in 2010 or 8 fold encounters. 16 Incidence of 2-C phenethylamines have also been linked to at least 14 deaths in and yet to be confirmed 13 additional deaths attributed to 251-NBOMe (another compound of phenethylamine). 6 Number of Reports 18,000 16,000 14,000 12,000 10,000 8,000 6,000 4,000 2,000 0 Synthetic Cathinones Synthetic Cannabinoids Piperazines Tryptamines 2C-Phenethylamines 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). These are alternative synthetic drugs to MDMA and sold as Ecstasy, Legal E or Legal X. 6 BZP is a Schedule I drug. 17 The NFLIS indicates that piperazines reports have escalated from an estimated 16 in 2006 to 11,012 in 2010, a 650% increase. 16 Tryptamines Tryptamine acts as a serotonin releasing agent which is associated with hallucinogenic effects. A number of these compounds have been encountered by law enforcement. To date, the following are listed on Schedule 1 6 : αet 5-MeO-DMT AMT DET DMT 5-MeO-DIPT Although the majority of reports for tryptamine in 2010 were DMT (28 reports), 5-MeO-DIPT (126 reports) was the most frequent tryptamine reported in the first 6 months of

10 Designer Drugs Don t Trust The Label The difficulty with determining drug abuse is that drug tests combined with new legislation are trailing behind the manufacturing and distribution of the latest designer drugs while the problem continues to grow. The District of Columbia s criminal justice system reports that 25-33% of young men tested positive for synthetic marijuana use while negative for other traditional 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 now obsolete in detecting the newest onslaught of compounds that have entered the market. This is particularly true of rapid point-of-care tests claiming detection of some these synthetics. As the need to broaden the spectrum of testing for designer drugs of abuse grows with each new analogue introduced, staying reasonably current is most effective with only lab-based assays that have the capability to identify these mimicked drugs of abuse. While many of the drug testing devices look alike and may claim detection of these newer compounds, it s important to take a closer look. OraSure s Intercept Oral Fluid Drug Test Intercept Oral Fluid Drug Test, by OraSure is a labbased oral fluid collection device. A saliva sample can be provided virtually anywhere using the Intercept device. One of the attractive conveniences of oral fluid testing is that the collection process is very simple. A typical collection using the OraSure Intercept device takes less than 15 minutes. The entire collection process is easily observable eliminating virtually all concerns about drug test cheating. Once the specimen is collected it is shipped overnight to a laboratory just as in the case of a lab-based urine test. An accurate analysis of the specimen is typically available in less than 24 hours. Choosing Intercept Oral Fluid Collection Device can help strip away the false façade of designer drug labels and help identify them for what they are drugs of abuse. In response to this growing trend, OraSure Technologies has partnered with major testing laboratories across the country that have broadened their range of assays to address existing designer drugs as well as the constantly evolving analogues that enter the marketplace. Education and technology will be the best tools drug testing programs can utilize to help stay ahead of synthetic drug battle. 10

11 References / Resources 1. SAMHSA. Results from 2012 National Survey on Drug Use and Health: Summary of National Findings, September, National Institute on Drug Abuse. The Science of Drug Abuse Addiction. downloaded 10/17/ Mokdad, A. PhD, etal. Actual Causes of Death in the United States, JAMA, March 10, 2004, Vol. 291, No. 10, pp SAMHSA. Substance Abuse and Prevention Dollars and Cents: A Cost-Benefit Analysis National Council for Community Behavioral Healthcare. Preventing and Trating Substance Use Disorders: A Comprehensive Approach, downloaded 10/7/ Dept. of Justice. Statement of Joseph T. Rannazzisi, Deputy. Assistant Administration, Office of Diversion Control Drug Enforcement Administration. Hearing entitled, Dangerous Synthetic Drugs, presented on September 25, Office of National Drug Control Policy. Synthetic Drugs (a.k.a. K2, Sice, Bath Salts, etc.). downloaded 10/14/ The National Institute on Drug Abuse. Monitoring the Future, National Survey Results on Drug Use, 2012 Overview, Key Findings on Adolescent Drug Use, February SAMHSA. The Dawn Report, Drug-Related Emergency Department Visits Involving Synthetic Cannabinoids, December 4, SAMHSA. The Dawn Report, Highlights of 2011 Drug Abuse Warning Network (DAWN) Findings on Drug Related Emergency Department Visits, February 22, NMS Labs. Designer Drug Testing, March g%testing%20march% pdf, downloaded 10/8/ UCLA Integrated Substance Abuse Programs/Gulf Coast ATTC Addiction Technology Transfer Center Network. Will They Turn You into a Zombie? What Clinicians Need to Know About Synthetic Drugs. Synthetic Drug Training Package Presentation, Sept. 25, American Association of Poison Control Centers. Synthetic Marijuana Data, August 31, Marijuana_Data_for_Website_ pdf SAMHSA. The Dawn Report, Bath Salts Were Involved in Over 20,000 Drug-Related Emergency Department Visits in 2011,September 17, Shulgin, Alexander and Ann. PihKal, A Chemical Love Story. The Vaults of Erowid. al.shtml 16. National Forensic Laboratory Information. Special Report: Emerging 2C-Phenethylamines, Piperazines, and Tryptamines in NFLIS, ging_2012.pdf 17. List of Schedule I Drugs (U.S.). Wikipedia.org. US) 11

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