Real or fake? Sourcing and marketing of non-prescribed benzodiazepines amongst two samples of people who regularly use illicit drugs in Australia.

INTRODUCTION: There is concern around non-prescribed benzodiazepine use, particularly with increasing detections of counterfeit products containing high-risk novel compounds. The aims of this study were to investigate how and which non-prescribed benzodiazepines are being sourced; forms, appearance and packaging; and awareness of risks associated with non-prescribed benzodiazepines. METHODS: Data were collected from a sample of Australians who inject drugs or use ecstasy and/or other illicit stimulants on a monthly or more frequent basis, and who reported past 6-month use of non-prescribed benzodiazepines (n = 235 and n = 250, respectively). Data were collected on source, diversion from a known/trusted prescription, product name and aesthetic characteristics for the last non-prescribed benzodiazepine obtained. RESULTS: Amongst participants who injected drugs, 71% reported that their last non-prescribed benzodiazepines were diverted from a known/trusted prescription, compared to 59% of participants who used ecstasy/other stimulants. Sourcing via cryptomarkets was rare. Across both samples, the majority reported last obtaining substances sold/marketed as diazepam or alprazolam. Participants sourcing via non-diverted means were twice as likely to obtain alprazolam. Known sourcing of novel compounds was rare. Amongst participants who used ecstasy/other stimulants, 36% reported confidence in the content/dose of non-prescribed benzodiazepines even when the source is unknown. DISCUSSION AND CONCLUSIONS: Most participants obtained substances sold as classic/registered benzodiazepines, mostly via diverted prescriptions, with a substantial minority potentially unaware of counterfeits circulating. While diverted use undeniably presents risks, tightening of prescriptions in Australia could inadvertently lead to greater supply of novel benzodiazepines as seen internationally, reinforcing prioritisation of demand and harm reduction strategies.

Incremental Effect of the Addition of Prescriber Restrictions on a State Medicaid's Pharmacy-Only Patient Review and Restriction Program.

BACKGROUND: Patient review and restriction programs (PRRPs), used by state Medicaid programs to limit potential abuse and misuse of opioids and related controlled medications, often restrict members to a single pharmacy for controlled medications. While most states use a restricted pharmacy access model, not all states include restricted prescriber access. Oklahoma Medicaid (MOK) added a restricted prescriber access feature to its PRRP in July 2014. OBJECTIVE: To evaluate the incremental effect that the addition of a prescriber restriction to MOK's pharmacy-only PRRP had on the pharmacy and resource utilization of the enrolled members. METHODS: MOK members with at least 6 months of enrollment in the pharmacy-only PRRP were restricted to a maximum of 3 prescribers for controlled substances in July 2014 and were identified as "cases." Using a propensity score method, cases were matched to controls from the MOK non-PRRP enrolled population based on demographics and baseline health care utilization. Data from January 1, 2014, through December 31, 2014, were evaluated. Each member's monthly health care resource utilization, defined in terms of medical and pharmacy costs, prescription counts, and opioid use per member per month (PMPM), was analyzed. A difference-indifferences (DID) regression estimated the change in resource utilization following the July 2014 policy change. RESULTS: This study included 378 controls and 126 cases after propensity matching. No differences were noted for daily morphine equivalents, benzodiazepine prescriptions, or maintenance prescriptions. There were decreases in mean PMPM use for both groups for short-acting opioid (SAO) claims (P < 0.001), overall opioid claims (P = 0.007 for controls and P < 0.001 for cases), prescribers (P = 0.01 for controls and P < 0.001 for cases), and number of pharmacies for cases (P < 0.001). DID analyses indicated that cases had a larger decrease in mean SAO claims (difference: -0.15, 95% CI: -0.25 to -0.04, P = 0.008); prescribers (difference: -0.25, 95% CI: -0.36 to -0.15, P < 0.001); and pharmacies (difference: -0.20, 95% CI: -0.28 to -0.13, P < 0.001) relative to controls. The difference for overall opioid claims was greater for cases than controls but did not reach statistical significance (difference: -0.12, 95% CI: -0.25 to 0.00, P = 0.050). CONCLUSIONS: Although there was no evidence that overall opioid claims were affected, the addition of prescriber restrictions may have resulted in an incremental change to SAO, prescriber, and pharmacy use in the PRPP population. Use of PRRPs may be an effective tool in reducing inappropriate use of prescription opioids within payer systems. The question remains whether these changes result in long-term changes to behavior outside the payer system. Future research into the effects of PRRPs on patient behavior beyond the payer system is needed. DISCLOSURES: No outside funding supported this research. All authors disclose either employment by the Oklahoma Health Care Authority or contractual work for this employer. In addition, Keast discloses unrelated funding through unrestricted research grants from Gilead Sciences and Purdue Pharma. Study concept and design were contributed by Keast and Pham, along with Teel and Nesser. Keast and Pham collected the data, along with Teel, and data interpretation was provided by Keast and Pham, with assistance from Teel and Nesser. The manuscript was written primarily by Keast, along with Pham and Teel, and revised by all the authors.

Association of a Controlled Substance Scoring Algorithm with Health Care Costs and Hospitalizations: A Cohort Study.

BACKGROUND: Patients often misuse a combination of prescription drugs including opioids; however, the relationship between a controlled substance (CS) score and health outcomes is unknown. OBJECTIVE: To examine the association between a CS scoring algorithm and health care use, specifically total cost of care, hospitalizations, and emergency room (ER) visits. METHODS: This analysis was a retrospective cohort study using administrative claims data from a large U.S. health insurer. Included in the analysis were 999,852 members with a minimum CS score of 2.5 in the fourth quarter (4Q) of 2012, who were continuously enrolled from January 1, 2012, to December 31, 2013, and who were aged 18 years or older. A CS score was calculated using 4Q 2012 (3 months) prescription claims data and divided into 3 components: (1) number of CS claims, (2) number of unique pharmacies and unique prescribers, and (3) evidence of increasing CS use. The primary outcomes were total cost of care (pharmacy and medical costs), all-cause hospitalizations, and ER visits in 2013. We also quantified what a 1-point change in CS score meant for the primary outcomes. RESULTS: 47% of members had a CS score of 2.5, indicating a single CS claim, and 51% of members had a score between 3 and less than 12. The remaining 2% (20,858 members) had a score of 12 or more. There was a statistically significant and consistently increasing association between the 4Q 2012 CS score and hospitalizations, ER visits, and total costs of care in 2013. A 1-point change in CS score was associated with a $1,488 change in total cost of care, 0.9% change in the hospitalization rate, and 1.5% change in the ER visit rate. CONCLUSIONS: There is a linear association between increasing CS score and negative health outcomes. Insurers should consider interventions to lower member CS scores. DISCLOSURES: This study was funded internally by Prime Therapeutics. Starner, Qiu, and Gleason are employees of Prime Therapeutics, a pharmacy benefits management company. Karaca-Mandic is an employee of the University of Minnesota and did not receive any compensation related to this work. The results of this study were presented as a poster at the Academy of Managed Care Pharmacy's 27th Annual Meeting and Expo; San Diego, California; April 7-10, 2015. Study concept and design were contributed by Starner, Gleason, and Qiu. Qiu took the lead in data collection, assisted by Starner and Gleason. Data interpretation was performed by all the authors. Starner primarily wrote and revised the manuscript, along with the other authors.

Underbanked: Cooperative Banking as a Potential Solution to the Marijuana-Banking Problem.

Numerous states have recently legalized recreational marijuana, which has created a burgeoning marijuana industry needing and demanding access to a variety of banking and financial services. Due, however, to the interplay between the federal criminalization of marijuana and federal anti-money laundering laws, U.S. financial institutions cannot handle legally the proceeds from marijuana activity. As a result, most financial institutions are unwilling to flout federal anti-money laundering laws, and so too few marijuana-related businesses can access banking services. This Note argues that the most viable policy option for resolving this "underbanking" problem is a financial cooperative approach such as a cannabis-only financial cooperative. Even in light of federal anti-money laundering laws, this Note contends that the Federal Reserve is legally authorized to grant some cannabis-only financial cooperatives access to its payment system services under the Monetary Control Act of 1980.

Medicare Letters To Curb Overprescribing Of Controlled Substances Had No Detectable Effect On Providers.

Inappropriate prescribing is a rising threat to the health of Medicare beneficiaries and a drain on Medicare's finances. In this study we used a randomized controlled trial approach to evaluate a low-cost, light-touch intervention aimed at reducing the inappropriate provision of Schedule II controlled substances in the Medicare Part D program. Potential overprescribers were sent a letter explaining that their practice patterns were highly unlike those of their peers. Using rich administrative data, we were unable to detect an effect of these letters on prescribing. We describe ongoing efforts to build on this null result with alternative interventions. Learning about the potential of light-touch interventions, both effective and ineffective, will help produce a better toolkit for policy makers to improve the value and safety of health care.

Identification of Challenges to the Availability and Accessibility of Opioids in Twelve European Countries: Conclusions from Two ATOME Six-Country Workshops.

BACKGROUND: Access to many controlled medicines is inadequate in a number of European countries. This leads to deficits in the treatment of moderate to severe pain as well as in opioid agonist therapy. OBJECTIVE: The study objective was to elaborate the reasons for this inadequacy. The work plan of the Access to Opioid Medication in Europe (ATOME) project included two six-country workshops. These workshops comprised a national situational analysis, drafting tailor-made recommendations for improvement and developing action plans for their implementation. METHODS: In total, 84 representatives of the national Ministries of Health, national controlled substances authorities, experts representing regulatory and law enforcement authorities, leading health care professionals, and patient representatives from 13 European countries participated in either one of the workshops. The delegates used breakout sessions to identify key common challenges. Content analysis was used for the evaluation of protocols and field notes. RESULTS: A number of challenges to opioid accessibility in the countries was identified in the domains of knowledge and educational, regulatory, legislative, as well as public awareness and training barriers that limit opioid prescription. In addition, short validity of prescriptions and bureaucratic practices resulting in overregulation impeded availability of some essential medicines. Stigmatization and criminalisation of people who use drugs remained the major impediment to increasing opioid agonist program coverage. CONCLUSIONS: The challenges identified during outcomes of the workshops were used as the basis for subsequent dissemination and implementation activities in the ATOME project, and in some countries the workshop proceedings already served as a stepping-stone for the first changes in regulations and legislation.