Scheduling of new psychoactive substance the Swiss way: A review and critical analysis.

Since the introduction of the European Early Warning System in 2005, >700 new psychoactive substances (NPS) have been listed. This review article presents for the first time the Swiss narcotic law in perspective of scheduling of NPS, and compares it to the regulations of the German speaking neighbours Austria and Germany. The Swiss way is a fast and effective way for scheduling NPS, with the purpose to restrict drug trafficking and for controlling the NPS drug market: the legal basis for scheduling substances of abuse is the "Law about narcotics and psychotropic substances" (BetmG, SR 812.121), which includes the "narcotic law directory (BetmVV-EDI, SR 812.121.11) suitable for listing all controlled substances. The BetmVV-EDI, SR 812.121.11 contains seven indices, with index e specifically designed for the fast scheduling of NPS. Newly appearing NPS can either be controlled under a structure analogues definition or by listing single substances. The list of single substances is updated at least once per year, and structure analogues definitions can be implemented, in order to keep track with new developments on the NPS market. The latest version from November 30th 2018 contains ten different structure analogue definitions and 207 single substances. Requirements to list NPS are their appearance on the NPS market, suspected psychotropic effects and their suggestions by Forensic professionals. As soon as substances are newly placed, on Schedule I of the 1961 Convention or Schedule II of the 1971 Convention by the Commission on Narcotic Drugs of the World Health Organization they can easily be transferred from index e to index a-d of the BetmVV-EDI, SR 812.121.11. The Austrian law uses a structure analogue and single substances approach (introduced in 2012, one update in 2016), whereas the German NPS law (established in 2016, no update yet) only lists two structure-analogue-definitions. All three legislations have defined which core structures, kinds and sites of substitutions are regulated.

Regulating gabapentin as a drug of abuse: A survey study of Kentucky community pharmacists.

OBJECTIVES: As the number of gabapentin prescriptions has increased, so have reports of its misuse and diversion. This trend has led some states to closer monitoring of gabapentin dispensing through prescription drug monitoring programs (PDMPs). The objective of this study was to collect and analyze Kentucky community pharmacists' perceptions of gabapentin misuse and diversion, and their support or opposition to regulatory efforts to reclassify the drug as a controlled substance (CS). METHODS: Responses were collected using an online survey sent by e-mail to all pharmacists practicing in Kentucky in August 2016. The survey collected basic demographic characteristics and pharmacists' experience with gabapentin dispensing. Descriptive statistics were calculated using question response frequencies. Pearson's chi-squared statistics were calculated to examine the distribution of support for gabapentin as a CS in Kentucky across each of the categories of the individual variables. Logistic regression was used to estimate the effects of pharmacist demographic characteristics and experiences with gabapentin on their support of gabapentin reclassification as a CS. RESULTS: One thousand seven hundred sixty-nine surveys were collected (response rate = 34.2%). Responding community pharmacists (n = 1084) believe that the abuse and diversion of gabapentin are a problem in their communities, with 9 in 10 (89.6%) indicating that they agree or strongly agree. More than three-fourths (87.5%) indicated support for reclassifying gabapentin as a CS. Common reasons for opposition to gabapentin regulatory changes were that they would not reduce or eliminate abuse (45.8%) and that they would be an inconvenience to patients (17.0%). Pharmacists practicing in independent pharmacies and pharmacists in practice greater than 20 years were less likely to indicate support for gabapentin reclassification. CONCLUSION: Kentucky community pharmacists express considerable concern over the possible misuse and diversion of gabapentin and widely support regulatory changes reclassifying gabapentin as a CS.

The Scheduling of Kratom and Selective Use of Data.

Kratom is a traditional drug from Southeast Asia that has been an emerging new substance in the United States. On August 30, 2016, the DEA announced the intention to emergency schedule kratom into Schedule I. To support this decision, the DEA cited an increase in drug seizures of kratom and an increase in calls to poison control concerning kratom. However, a short time later, on October 12, 2016, the DEA withdrew the intent to schedule kratom after public and congressional backlash. The withdrawal by the DEA was somewhat unprecedented. To better understand both decisions, the current article examines the evidence the DEA cited to support their decision to emergency schedule kratom and the degree and type of media coverage of kratom to determine if a media-driven drug panic occurred.

The Effect of a Federal Controlled Substance Act Schedule Change on Hydrocodone Combination Products Claims in a Medicaid Population.

BACKGROUND: In 2012, hydrocodone combination products (HCPs) were the most prescribed medications in the United States. Under the Controlled Substance Act of 1970, hydrocodone alone was classified as a Schedule II drug, while HCPs were classified as Schedule III, indicating a lower risk for abuse and misuse. However, according to a Drug Enforcement Agency analysis, the addition of nonopioids has not been shown to diminish abuse potential of hydrocodone. In response to concerns for drug abuse and overdose, the Drug Enforcement Agency rescheduled HCPs to Schedule II in October 2014, with the intent of limiting overprescribing and increasing awareness of their abuse potential. However, it is unknown whether this has affected the overall claims for HCPs in a Medicaid population. OBJECTIVES: To (a) compare the trend in HCP prescription claims with select non-HCP (opioid and nonopioid) analgesic claims before and after the HCP schedule change in the Massachusetts Medicaid fee-for-service/Primary Care Clinician plan population and (b) identify if there was a change in HCP new start member and claim characteristics before and after the HCP schedule change. METHODS: This quasi-experimental, retrospective study used enrollment and pharmacy claims data to evaluate all members in the study population 1 year before and after the HCP schedule change. The number of claims for HCPs and select non-HCP analgesics was reported as the monthly rate per total population, and an interrupted time series analysis compared the change in the monthly rate of claims across groups. Members with 1 or more pharmacy claims for a new HCP prescription during a 5-month period before or after the HCP schedule change were analyzed to determine member demographics (age, gender, and number of claims) and claim characteristics (average daily dose, average quantity per claim, and days supply). RESULTS: The rate of HCP claims increased before and decreased after the HCP schedule change. Controlling for the trend during the period before the HCP schedule change, the rate of HCP claims per 1,000 members per month decreased at a greater rate than non-HCP analgesics in the period after the HCP schedule change (P < 0.001). The percentage of HCP claims for new start members decreased after the HCP schedule change (44.9% vs. 34.1% of all HCP claims pre- to post-schedule change; P < 0.001). In the group of new starts, there was not a significant difference in the average daily dose (26.3 mg vs. 26.4 mg; P = 0.69), while there was a decrease in average number of tablets dispensed per claim (from 37.1 to 20.3 tablets; P < 0.001) and an increase in the percentage of claims for a shorter days supply (from 57.7% to 81.6%; P < 0.001). CONCLUSIONS: The findings of this study suggest that the HCP schedule change may have contributed to the decrease in claims for HCPs in a Medicaid population. After the HCP schedule change, there was a trend towards decreased HCP use among new starts. DISCLOSURES: No outside funding supported this study. The authors have nothing to disclose. Study concept and design were contributed by all authors except for Arnold and Clements. Tran, Arnold, and Clements took the lead in data collection, along with Peristere, and data interpretation was performed by all the authors, except Arnold. The manuscript was written primarily by Tran, along with Lavitas, Stevens, and Greenwood, and revised by all the authors except Arnold and Peristere. A poster of this research project was presented at the Academy of Managed Care Pharmacy's 2016 Annual Meeting in San Francisco, California, April 2016.

Physicians' intention to prescribe hydrocodone combination products after rescheduling: A theory of reasoned action approach.

BACKGROUND: The U.S. Drug Enforcement Administration (DEA) rescheduled hydrocodone combination products (HCPs) in an attempt to mitigate the prescription opioid epidemic. Many in the medical and pharmacy community expressed concerns of unintended consequences as a result of rescheduling. OBJECTIVES: This study examined physicians' intentions to prescribe HCPs after rescheduling using the framework of the theory of reasoned action (TRA). METHODS: A cover letter containing a link to the online questionnaire was sent to physicians of the Texas Medical Association who were likely to prescribe opioids. The questionnaire assessed physicians' intentions to prescribe HCPs after rescheduling. Predictor variables included attitude toward rescheduling, subjective norm toward HCP prescribing, and past prescribing behavior of schedule II prescriptions. All variables were measured on a 7-point, Likert-type scale. Intention to prescribe as a dependent variable was regressed over TRA variables and respondent characteristics. RESULTS: A total of 1176 usable responses were obtained, yielding a response rate of 13.3%. Mean (M) age was 53.07 ± 11 and most respondents were male (70%) and Caucasian (75%). Physicians held a moderately positive intention to prescribe HCPs (M = 4.36 ± 2.08), held a moderately negative attitude towards rescheduling, M = 4.68 ± 1.51 (reverse coded). Subjective norm was moderately low, M = 3.06 ± 1.78, and past prescribing behavior M = 2.43 ± 1.21. The linear regression analysis indicated that attitude (ß = 0.10; P = 0.006), subjective norm (ß = 0.35; P < 0.0001) and past prescribing behavior (ß = 0.59; P < 0.0001) were significant predictors of intention to prescribe HCPs after rescheduling. CONCLUSIONS: TRA was shown to be a predictive model of physicians' intentions to prescribe HCPs after rescheduling. Overall, physicians held a moderately positive intention to prescribe HCPs. Past behavior concerning schedule II prescribing was found to be the most significant predictor of intention. Understanding the impact of federal rule changes on pain management care and patient satisfaction is necessary to determine whether this change has produced the intended consequences without harming patients in need of HCPs.

Development and evaluation of a record linkage protocol for Utah's Controlled Substance Database.

Utah's Controlled Substance Database prescription registry does not include master identifiers to link records for individual patients. We describe and evaluate a linkage protocol for Utah's Controlled Substance Database. Prescriptions (N = 22,401,506) dated 2005-2009 were linked using The Link King software and patient identifiers (e.g. names, dates of birth) for 2,232,725 patients. Review of 998 randomly selected record pairs classified 46 percent as definitely correct links and 54 percent as probably correct links. A correct link could not be confirmed for <1 percent. None were classified as probably incorrect links or definitely incorrect links. Record set reviews (N = 100 patients/set for 10 set sizes, randomly selected) classified 27-49 percent as definitely correct links and 39-63 percent as probably correct links. Fewer had too little information to confirm a link (5%-22%) or were probably incorrect (0%-6%). None were definitely incorrect. Overall, results suggest that Utah's Controlled Substance Database records were correctly linked. These data may be useful for cross-sectional and longitudinal studies of patient-controlled substance prescription histories.

Gabapentin: can it be misused?

Gabapentin, a gamma-aminobutyric acid analog drug, appears to be safe and efficacious for the treatment of alcohol dependence. Gabapentin is not a controlled drug, but there are anecdotal reports of its misuse and abuse as well as reports of withdrawal symptoms associated with abrupt discontinuation. The risk of gabapentin misuse is inconsistent, the magnitude of the risk is small, and the risk is not comparable to the much higher risks associated with alcohol use; benzodiazepine, opioid, and stimulant drug use; or illicit drug use. Reports of gabapentin misuse are not unique to this drug, as misuse of prescription medications not typically considered "drugs of abuse" can also occur.

Schedules of controlled substances: temporary placement of three synthetic cannabinoids into Schedule I. Final order.

The Deputy Administrator of the Drug Enforcement Administration (DEA) is issuing this final order to temporarily schedule three synthetic cannabinoids under the Controlled Substances Act (CSA) pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). The substances are (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (UR-144), [1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (5-fluoro-UR-144, XLR11) and N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide (APINACA, AKB48). This action is based on a finding by the Deputy Administrator that the placement of these synthetic cannabinoids and their salts, isomers and salts of isomers into Schedule I of the CSA is necessary to avoid an imminent hazard to the public safety. As a result of this order, the full effect of the CSA and the Controlled Substances Import and Export Act (CSIEA) and their implementing regulations including criminal, civil and administrative penalties, sanctions and regulatory controls of Schedule I substances will be imposed on the manufacture, distribution, possession, importation, and exportation of these synthetic cannabinoids.

Establishment of drug codes for 26 substances. Final rule.

On July 9, 2012, the President signed into law the Synthetic Drug Abuse Prevention Act of 2012 (SDAPA). SDAPA amends the Controlled Substances Act by placing 26 substances in Schedule I. DEA is publishing this rule to establish drug codes for these 26 substances, and to make technical and conforming amendments in accordance with SDAPA.