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Concept: Drug Enforcement Administration

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In March and October 2015, the Drug Enforcement Administration (DEA) and CDC, respectively, issued nationwide alerts identifying illicitly manufactured fentanyl (IMF) as a threat to public health and safety (1,2). IMF is unlawfully produced fentanyl, obtained through illicit drug markets, includes fentanyl analogs, and is commonly mixed with or sold as heroin (1,3,4). Starting in 2013, the production and distribution of IMF increased to unprecedented levels, fueled by increases in the global supply, processing, and distribution of fentanyl and fentanyl-precursor chemicals by criminal organizations (3). Fentanyl is a synthetic opioid 50-100 times more potent than morphine (2).* Multiple states have reported increases in fentanyl-involved overdose (poisoning) deaths (fentanyl deaths) (2). This report examined the number of drug products obtained by law enforcement that tested positive for fentanyl (fentanyl submissions) and synthetic opioid-involved deaths other than methadone (synthetic opioid deaths), which include fentanyl deaths and deaths involving other synthetic opioids (e.g., tramadol). Fentanyl deaths are not reported separately in national data. Analyses also were conducted on data from 27 states(†) with consistent death certificate reporting of the drugs involved in overdoses. Nationally, the number of fentanyl submissions and synthetic opioid deaths increased by 426% and 79%, respectively, during 2013-2014; among the 27 analyzed states, fentanyl submission increases were strongly correlated with increases in synthetic opioid deaths. Changes in fentanyl submissions and synthetic opioid deaths were not correlated with changes in fentanyl prescribing rates, and increases in fentanyl submissions and synthetic opioid deaths were primarily concentrated in eight states (high-burden states). Reports from six of the eight high-burden states indicated that fentanyl-involved overdose deaths were primarily driving increases in synthetic opioid deaths. Increases in synthetic opioid deaths among high-burden states disproportionately involved persons aged 15-44 years and males, a pattern consistent with previously documented IMF-involved deaths (5). These findings, combined with the approximate doubling in fentanyl submissions during 2014-2015 (from 5,343 to 13,882) (6), underscore the urgent need for a collaborative public health and law enforcement response.

Concepts: Drug, Opioid, Morphine, Drug addiction, Heroin, Naloxone, Opioids, Drug Enforcement Administration

84

To provide an update on prescription of naloxone as a harm-reduction strategy, PubMed was searched to identify publications relevant to naloxone prescribing for reversal of opioid overdose. Opportunities now exist to expand naloxone use, although evidence suggests these are often missed or underexploited. The US FDA has approved an intranasal naloxone spray and an autoinjector naloxone formulation for community use. Effective use of naloxone in community settings requires screening to identify patients at risk of opioid overdose, discussing naloxone use with patients and their relatives, and providing appropriate training. The tools exist to expand the use of naloxone more widely into the community, thereby creating an opportunity to reduce opioid overdose fatalities.

Concepts: Prescription drug, Morphine, Heroin, Naloxone, Over-the-counter drug, Food and Drug Administration, Drug overdose, Drug Enforcement Administration

39

In March and October 2015, the Drug Enforcement Administration (DEA) and CDC issued nationwide alerts identifying fentanyl, particularly illicitly manufactured fentanyl (IMF), as a threat to public health and safety (1,2). IMF is pharmacologically similar to pharmaceutical fentanyl (PF), but is unlawfully produced in clandestine laboratories, obtained via illicit drug markets, and includes fentanyl analogs. Fentanyl is a synthetic opioid 50-100 times more potent than morphine and approved for the management of surgical/postoperative pain, severe chronic pain, and breakthrough cancer pain.* DEA’s National Forensic Laboratory Information System (NFLIS) collects drug identification results from drug cases analyzed by federal, state, and local forensic laboratories throughout the United States.(†) In 2014, 80% of fentanyl submissions (i.e., drug products obtained by law enforcement that tested positive for fentanyl) in NFLIS were identified from 10 states, including Florida and Ohio (2), and seven of these 10 states reported sharp increases in fentanyl-related overdose deaths (fentanyl deaths) (3). This report presents findings of increased fentanyl deaths during 2013-2015 from investigations conducted by the University of Florida and the Ohio Department of Public Health, in collaboration with CDC. Analyses examined the association between trends in fentanyl-related law enforcement submissions and fentanyl deaths and describes groups at risk for fentanyl death using medical examiner and coroner reports. The marked increases in fentanyl death in Florida and Ohio during 2013-2015 were closely associated with parallel increases in fentanyl submissions, with the largest impact on persons who use heroin, consistent with reports that IMF is commonly mixed with or sold as heroin (1,4). In Ohio, circumstances associated with fentanyl deaths included a current diagnosed mental health disorder(§) and recent release from an institution such as a jail, rehabilitation facility, or hospital.

Concepts: Opioid, Morphine, Heroin, Controlled Substances Act, MDMA, Illegal drug trade, Federal Bureau of Investigation, Drug Enforcement Administration

28

Herbal smoking mixtures which are sold as incense or potpourri and often referred to as ‘Spice’ are actually inactive plant matter adulterated with alkylamino indole based synthetic cannabinoids such as JWH-018 and JWH-073. Due to the inclusion of five synthetic cannabinoids, including JWH-018 and JWH-073, as Schedule I drugs by the Drug Enforcement Agency (DEA) in March 2011, it has become necessary for forensic laboratories to develop analytical methods to test for the presence of metabolites of synthetic cannabinoids. When a new analyte of interest emerges, most laboratories strive to develop a sample preparation procedure and validate an analytical method as quickly as possible and therefore, rely on effective but time consuming traditional protocols such as solid phase and liquid-liquid extraction. This research focuses on the examination of all aspects of sample preparation and analytical method development to streamline the analysis of four urinary metabolites of JWH-018 and JWH-073. A detailed evaluation of the β-glucuronide hydrolysis step lead to the reduction of time required for hydrolysis from 1h at 50°C to only 10min at room temperature. By utilizing a salting-out assisted liquid-liquid extraction (SALLE) in place of traditional liquid-liquid extraction with a volatile solvent, processing time was saved and waste was reduced. The analysis run time was also shortened to one-third of a typical published run time by utilizing UPLC with isocratic conditions in place of conventional HPLC running a gradient method.

Concepts: Solubility, Benzene, Analytical chemistry, Diethyl ether, Cannabinoid, Cannabinoids, HU-210, Drug Enforcement Administration

27

OBJECTIVE.: Anti-obesity drugs have been marketed illicitly by “no prescription” online pharmacies after approval and scheduling by the Drug Enforcement Agency. We wished to assess whether anti-obesity drug Belviq® (locaserin HCl) was available from illicit online vendors before DEA-scheduling when sales are unauthorized. DESIGN AND METHODS.: Online searches of “buy Belviq no prescription” examining first five result pages marketing the drug. Searches were performed from 11/5/2012-12/8/2012, prior to DEA scheduing. RESULTS.: Belviq® is actively marketed by “no prescription” online vendors despite official unavailability and prescription requirements. Approaches included direct-to-consumer advertising using descriptive website URLs; linking to illicit marketers; and directing customers to other weight-loss websites for additional marketing.Finally, large quantities were marketed by business-to-business vendors. CONCLUSION.: Illicit online “no prescription” pharmacies are marketingunauthorized, suspect anti-obesity drugs before DEA scheduling and permitted marketing. Regulators must legally intercede to ensure patient safety and providers must educate patients about online-sourcing risks.

Concepts: Advertising, Sales, Marketing, Drug Enforcement Administration, Marketing research, Business-to-business

21

US FDA guidance recommends measuring the degree of effort needed to manipulate abuse-deterrent (AD) opioids. The ALERRT(®) instrument (PinneyAssociates; Bethesda, MD) uses visual analog scales to assess the labor, effort, and resources necessary to physically compromise AD product candidates in standardized settings.

Concepts: Prescription drug, Energy, Measurement, Psychometrics, Over-the-counter drug, Quantity, Food and Drug Administration, Drug Enforcement Administration

12

As Massachusetts prepares to implement its new medical-marijuana law, agents of the federal Drug Enforcement Administration (DEA) have reportedly visited at least seven Massachusetts physicians at their homes or offices and told them they must either give up their DEA registration or sever formal ties with proposed medical-marijuana dispensaries. These encounters were meant to intimidate the physicians and to discourage them from taking an active role in medical-marijuana dispensaries, and they have apparently succeeded. But there are differences between state and federal law, between talking to patients and selling drugs, and between acting as a physician and acting as a marijuana . . .

Concepts: Medicine, Patient, Hospital, United States, Physician, Law of the United States, Federal Bureau of Investigation, Drug Enforcement Administration

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Consideration by the US Drug Enforcement Administration and Food and Drug Administration of placing kratom into Schedule I of the Controlled Substances Act (CSA) requires its evaluation of abuse potential in the context of public health.

Concepts: Public health, Health, Addiction, Controlled Substances Act, Food and Drug Administration, MDMA, Drug Enforcement Administration, Act of Congress

4

Dextromethorphan is a safe, effective cough suppressant, available without a prescription in the United States since 1958. Due to a perceived prevalence of abuse of dextromethorphan by teens, in 2007 the Drug Enforcement Administration requested the Food and Drug Administration evaluate whether dextromethorphan should be recommended for scheduling under the Controlled Substances Act. The Food and Drug Administration held an Advisory Committee meeting in 2010 to provide a scientific and medical evaluation of dextromethorphan and its abuse potential.

Concepts: Cough, United States, Controlled Substances Act, Food and Drug Administration, Latin, Codeine, Drug Enforcement Administration, Cough medicine

1

To examine how an October 2014 Drug Enforcement Administration policy reclassified hydrocodone product from schedule III to II has affected older adults, who are among the largest consumers of prescription opioids in the United States.

Concepts: United States, U.S. state, Opioid, Controlled Substances Act, Recreational drug use, Codeine, Federal Bureau of Investigation, Drug Enforcement Administration