Between Prohibitionism and Religious Freedom: The Legal Disputes Concerning an Ayahuasca Church and the United States Government

This article focuses on the legal disputes between the U.S. government and the Centro Espírita Beneficente União do Vegetal (UDV), as well as on the regulation of the religious use of ayahuasca by the Drug Enforcement Agency (DEA). Our aim is to present the main issues that were at stake throughout the dispute, especially the relationship between the limits of religious freedom when associated with the use of controlled substances.

The Identification of Gamma-Butyrolactone in JUUL Liquids

Gamma-Butyrolactone (GBL), a commonly used industrial solvent, is used recreationally as a central nervous system (CNS) depressant and, therefore, a United States Drug Enforcement Agency (DEA) List 1 chemical of the Controlled Substances Act. GBL was identified presumptively in the liquid from JUUL Virginia Tobacco flavored pods during routine untargeted screening analysis of e-cigarette products by gas chromatography–mass spectrometry (GC–MS). Methods for the confirmation and quantitation of GBL were developed for GC–MS and liquid chromatography–tandem mass spectrometry (LC–MS-MS) in the liquids and the aerosol generated from the liquid. Three flavors of JUUL pods available at the time of analysis were obtained by direct purchase from the manufacturer, purchase from a local vape shop, and via submission from a 3rd party. The only liquid flavor to contain GBL was Virginia Tobacco, with an average of 0.37 mg/mL of GBL, and it was detected in the aerosol. Studies evaluating the pharmacological effects of inhaling GBL do not exist, however a case report of chronic oral GBL ingestion indicates acute lung injury. The identification of GBL in an e-cigarette product purportedly compliant with federal regulation continues to demonstrate public health and public safety concerns.

The Current State of Opioid Prescribing and Drug Enforcement Agency (DEA) Action Against Physicians: An Analysis of DEA Database 2004-2017

Background: Prescribing opioids has become a challenge. The US Drug Enforcement Agency (DEA) and Centers for Disease Control and Prevention (CDC) have become more involved, culminating in the March 2016 release of the CDC’s “Guidelines for Prescribing Opioids for Chronic Pain.” Objectives: Given the new guidelines, we wanted to see if there have been any changes in the numbers, demographics, physician risk factors, charges, and sanctions involving the DEA against physicians who prescribe opioids, when compared to a previous DEA database review from 1998 to 2006. Study Design: This study involved an analysis of the DEA database from 2004 to 2017. Setting: The review was conducted at the Henry Ford Health System Division of Pain Medicine. Method: After institutional review board approval at Henry Ford Health System, an analysis of the DEA database of criminal prosecutions of physician registrants from 2004-2017 was performed. The database was reviewed for demographic information such as age, gender, type of degree (doctor of medicine [MD] or doctor of osteopathic medicine [DO]), years of practice, state, charges, and outcome of prosecution (probation, sentencing, and length of sentencing). An internet-based search was performed on each registrant to obtain demographic data on specialty, years of practice, type of medical school (US vs foreign), board certification, and type of employment (private vs employed). Results: Between 2004 and 2017, Pain Medicine (PM) had the highest percentage of in-specialty action at 0.11% (n = 5). There was an average of 18 prosecutions per year vs 14 in the previous review. Demographic risk factors for prosecution demonstrated the significance of the type of degree (MD vs. DO), gender, type of employment (private vs. employed), and board certification status for rates of prosecution. Having a DO degree and being male were associated with significantly higher risk as well as being in private practice and not having board certification (P < .001). In terms of type of criminal charges as a percent of cases, possession with intent to distribute (n = 90) was most prevalent, representing 52.3% of charges, with new charges being prescribing without medical purpose outside the usual course of practice (n = 71) representing 41.3% of charges. Comparison of US graduates (MD/DO) vs. foreign graduates showed higher rates of DEA action for foreign graduates but this was of borderline significance (P = .072). Limitations: State-by-state comparisons could not be made. Specialty type was sometimes selfreported, and information on all opioid prosecutions could not be obtained. The previous study by Goldenbaum et al included data beyond DEA prosecution, so direct comparisons may be limited. Conclusion: The overall risk of DEA action as a percentage of total physicians is small but not insignificant. The overall rates of DEA prosecution have increased. New risk factors include type of degree (DO vs. MD) and being in private practice with a subtle trend toward foreign graduates at higher risk. With the trend toward less prescribing by previously high-risk specialties such as Family Medicine, there has been an increase in the relative risk of DEA action for specialties treating patients with pain such as PM, Physical Medicine and Rehabilitation, neurology, and neurosurgery bearing the brunt of prosecutions. New, more subtle charges have been added involving interpretation of the medical purpose of opioids and standard of care for their use. Key words: Certification, CDC, criminal, DEA, opioid, prescribing, prosecution, sanctions

Drug Enforcement Agency 2014 Hydrocodone Rescheduling Rule and Opioid Dispensing after Surgery

Background In 2014, the U.S. Drug Enforcement Agency reclassified hydrocodone from Schedule III to Schedule II of the Controlled Substances Act, resulting in new restrictions on refills. The authors hypothesized that hydrocodone rescheduling led to decreases in total opioid dispensing within 30 days of surgery and reduced new long-term opioid dispensing among surgical patients. Methods The authors studied privately insured, opioid-naïve adults undergoing 10 general or orthopedic surgeries between 2011 and 2015. The authors conducted a differences-in-differences analysis that compared overall opioid dispensing before versus after the rescheduling rule for patients treated by surgeons who frequently prescribed hydrocodone before rescheduling (i.e., patients who were functionally exposed to rescheduling’s impact) while adjusting for secular trends via a comparison group of patients treated by surgeons who rarely prescribed hydrocodone (i.e., unexposed patients). The primary outcome was any filled opioid prescription between 90 and 180 days after surgery; secondary outcomes included the 30-day refill rate and the amount of opioids dispensed initially and at 30 days postoperatively. Results The sample included 65,136 patients. The percentage of patients filling a prescription beyond 90 days was similar after versus before rescheduling (absolute risk difference, −1.1%; 95% CI, −2.3% to 0.1%; P = 0.084). The authors estimated the rescheduling rule to be associated with a 45.4-mg oral morphine equivalent increase (difference-in-differences estimate; 95% CI, 34.2–56.7 mg; P &lt; 0.001) in initial opioid dispensing, a 4.1% absolute decrease (95% CI, −5.5% to −2.7%; P &lt; 0.001) in refills within 30 days, and a 37.7-mg oral morphine equivalent increase (95% CI, 20.6–54.8 mg; P = 0.008) in opioids dispensed within 30 days. Conclusions Among patients treated by surgeons who frequently prescribed hydrocodone before the Drug Enforcement Agency 2014 hydrocodone rescheduling rule, rescheduling did not impact long-term opioid receipt, although it was associated with an increase in opioid dispensing within 30 days of surgery. Editor’s Perspective What We Already Know about This Topic What This Article Tells Us That Is New

Cannabis Teratology Explains Current Patterns of Coloradan Congenital Defects: The Contribution of Increased Cannabinoid Exposure to Rising Teratological Trends

Rising Δ9-tetrahydrocannabinol concentrations in modern cannabis invites investigation of the teratological implications of prenatal cannabis exposure. Data from Colorado Responds to Children with Special Needs (CRCSN), National Survey of Drug Use and Health, and Drug Enforcement Agency was analyzed. Seven, 40, and 2 defects were rising, flat, and falling, respectively, and 10/12 summary indices rose. Atrial septal defect, spina bifida, microcephalus, Down’s syndrome, ventricular septal defect, and patent ductus arteriosus rose, and along with central nervous system, cardiovascular, genitourinary, respiratory, chromosomal, and musculoskeletal defects rose 5 to 37 times faster than the birth rate (3.3%) to generate an excess of 11 753 (22%) major anomalies. Cannabis was the only drug whose use grew from 2000 to 2014 while pain relievers, cocaine, alcohol, and tobacco did not. The correlation of cannabis use with major defects in 2014 (2019 dataset) was R = .77, P = .0011. Multiple cannabinoids were linked with summary measures of congenital anomalies and were robust to multivariate adjustment.

Genetic tools weed out misconceptions of strain reliability inCannabis sativa: Implications for a budding industry

Cannabis sativais listed as a Schedule I substance by the United States Drug Enforcement Agency and has been federally illegal in the United States since 1937. However, the majority of states in the United States, as well as several countries, now have various levels of legalCannabis. Products are labeled with identifying strain names but there is no official mechanism to registerCannabisstrains, therefore the potential exists for incorrect identification or labeling. This study uses genetic analyses to investigate strain reliability from the consumer point of view. Ten microsatellite regions were used to examine samples from strains obtained from dispensaries in three states. Samples were examined for genetic similarity within strains, and also a possible genetic distinction between Sativa, Indica, or Hybrid types. The analyses revealed genetic inconsistencies within strains. Additionally, although there was strong statistical support dividing the samples into two genetic groups, the groups did not correspond to commonly reported Sativa/Hybrid/Indica types. Genetic differences have the potential to lead to phenotypic differences and unexpected effects, which could be surprising for the recreational user, but have more serious implications for patients relying on strains that alleviate specific medical symptoms.