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.

Controlled substances in hospices after patient death: a cross-sectional survey of Ontario hospices.

Background Practices related to the handling of controlled substances (CS) in Ontario hospices have not been previously published and therefore, are unknown. Objective The objective of this study was to determine current practices, and policies, standard operating procedures (SOPs) and guidelines related to handling and disposal of CS at hospices across Ontario. Setting This study was a cross-sectional survey of hospices in Ontario. Method A list of all hospices in Ontario, 39 in total, was obtained from Hospice and Palliative Care Ontario. The Director at each hospice was contacted to request contact information on the person most likely to be knowledgeable about handling procedures related to CS. All participants who provided consent were asked to complete a telephone survey composed of 32 questions: 20 multiple-choice and 12 open-ended. Of the 20 multiple-choice, eight requested demographics of the hospice, nine were related to disposal and documentation practices. Main outcome measure Demographic information, disposal practices and patterns of care were summarized and presented as frequencies or means. Responses to open-ended questions were analyzed qualitatively to identify themes related to the handling and disposal of controlled substances in hospices. Results Twelve hospices (12/39; 31%) participated in the survey, 25 did not, and two were ineligible. Two (2/12, 17%) hospices served both pediatric and adult patients while 10 (83%) served adults only; 100% indicated that 76-100% of their patients were on CS at time of death. Eight (67%) had a policy for controlled substances handling, two had policy and SOPs and two had no policies, guidelines or SOPs. Qualitative analysis indicated variability in procedures for obtaining CS (patient's own supply, other patient's supply, hospice associated pharmacy), storage and dispensation of CS (location, secure lock, dispensing by staff or family), documentation (dispensing records, double signature, tracking returns and disposal), and disposal of CS (return to pharmacy, disposal at hospice, return to families). Conclusion Although most of the hospices have a policy, guideline or SOP on the handling of CS, there is considerable variation in practice of dispensing CS to patients, documentation and disposal of CS, which may provide an avenue for inappropriate use, abuse or diversion of CS.

Pharmacy-related theft of controlled substances: RxPATROL® findings.

OBJECTIVE: To characterize pharmacy-related theft data reported to the Rx Pattern Analysis Tracking Robberies and Other Losses (RxPATROL®) database during the time periods before (2007-2010) and after (2011-2016) the August 2010 switch to reformulated OxyContin® (oxycodone hydrochloride) extended-release tablets (Purdue Pharma L.P.). METHODS: The RxPATROL® database was queried to identify characteristics associated with theft of drug products. Variables analyzed included incident counts, drugs involved (OxyContin or other oxycodone products), pharmacy-security features, and other incident-related information. The data captured from 2007 to 2010, defined as the original formulation period, were compared with those captured from 2011 to 2016, defined as the post-reformulation period. RESULTS: A total of 6,905 incidents were reported from 2007 to 2016, with robbery (51.8 percent) and burglary (26.4 percent) being the most commonly reported incidents. The number of total robbery incidents reported peaked in 2010 and remained steady. Incidents reported as robberies that involved OxyContin initially increased from 2007 to 2010 and then steadily decreased from 296 in 2010 to 13 in 2016. Total burglary reports decreased from 2009 to 2015 and slightly increased from 2015 to 2016. Total burglary reports that involved OxyContin decreased after 2009. Total burglary reports that involved oxycodone remained steady from 2009 to 2014, decreased from 2014 to 2015, and remained steady from 2015 to 2016. The majority of reported incidents occurred on weekdays and involved suspects who entered and exited through the front door at pharmacies without security features such as alarms, dead bolts, and cameras. CONCLUSION: Following replacement of the original formulation of OxyContin with a new formulation that has abuse-deterrent properties in 2010, pharmacy thefts of OxyContin reported to the RxPATROL® database decreased. The decreases were not fully explained by concurrent trends in total robbery or burglary incidents reported to the RxPATROL® database over the same time period.

Big Data and the Opioid Crisis: Balancing Patient Privacy with Public Health.

Parts I through III of this paper will examine several, increasingly comprehensive forms of aggregation, ranging from insurance reimbursement "lock-in" programs to PDMPs to completely unified electronic medical records (EMRs). Each part will advocate for the adoption of these aggregation systems and provide suggestions for effective implementation in the fight against opioid misuse. All PDMPs are not made equal, however, and Part II will, therefore, focus on several elements - mandating prescriber usage, streamlining the user interface, ensuring timely data uploads, creating a national data repository, mitigating privacy concerns, and training doctors on how to respond to perceived doctor-shopping - that can make these systems more effective. In each part, we will also discuss the privacy concerns of aggregating data, ranging from minimal to significant, and highlight the unique role of stigma in motivating these concerns. In Part IV, we will conclude by suggesting remedial steps to offset this loss of privacy and to combat the stigma around SUDs and mental health disorders in general.

Controlled Substances Quotas. Final rule.

The Drug Enforcement Administration (DEA) is publishing this final rule to strengthen the process for setting controls over diversion of controlled substances and make other improvements in the quota management regulatory system for the production, manufacturing, and procurement of controlled substances.

Solution to Detect, Classify, and Report Illicit Online Marketing and Sales of Controlled Substances via Twitter: Using Machine Learning and Web Forensics to Combat Digital Opioid Access.

BACKGROUND: On December 6 and 7, 2017, the US Department of Health and Human Services (HHS) hosted its first Code-a-Thon event aimed at leveraging technology and data-driven solutions to help combat the opioid epidemic. The authors­an interdisciplinary team from academia, the private sector, and the US Centers for Disease Control and Prevention­participated in the Code-a-Thon as part of the prevention track. OBJECTIVE: The aim of this study was to develop and deploy a methodology using machine learning to accurately detect the marketing and sale of opioids by illicit online sellers via Twitter as part of participation at the HHS Opioid Code-a-Thon event. METHODS: Tweets were collected from the Twitter public application programming interface stream filtered for common prescription opioid keywords in conjunction with participation in the Code-a-Thon from November 15, 2017 to December 5, 2017. An unsupervised machine learning­based approach was developed and used during the Code-a-Thon competition (24 hours) to obtain a summary of the content of the tweets to isolate those clusters associated with illegal online marketing and sale using a biterm topic model (BTM). After isolating relevant tweets, hyperlinks associated with these tweets were reviewed to assess the characteristics of illegal online sellers. RESULTS: We collected and analyzed 213,041 tweets over the course of the Code-a-Thon containing keywords codeine, percocet, vicodin, oxycontin, oxycodone, fentanyl, and hydrocodone. Using BTM, 0.32% (692/213,041) tweets were identified as being associated with illegal online marketing and sale of prescription opioids. After removing duplicates and dead links, we identified 34 unique "live" tweets, with 44% (15/34) directing consumers to illicit online pharmacies, 32% (11/34) linked to individual drug sellers, and 21% (7/34) used by marketing affiliates. In addition to offering the "no prescription" sale of opioids, many of these vendors also sold other controlled substances and illicit drugs. CONCLUSIONS: The results of this study are in line with prior studies that have identified social media platforms, including Twitter, as a potential conduit for supply and sale of illicit opioids. To translate these results into action, authors also developed a prototype wireframe for the purposes of detecting, classifying, and reporting illicit online pharmacy tweets selling controlled substances illegally to the US Food and Drug Administration and the US Drug Enforcement Agency. Further development of solutions based on these methods has the potential to proactively alert regulators and law enforcement agencies of illegal opioid sales, while also making the online environment safer for the public.

State survey of medical boards regarding abrupt loss of a prescriber of controlled substances.

OBJECTIVES: The purpose of the study was to evaluate states' experiences with abrupt changes in controlled substances (CS) prescribing, to determine whether states have action plans in place to manage such situations, and describe the components of any such plans. METHODS: A survey of executive directors of 51 medical boards was conducted to evaluate states' experiences with abrupt changes in CS prescribing, the extent of consumer complaints attributed to these events, and the types of plans in place to manage these situations. RESULTS: Forty-six executive directors of medical boards responded. Twenty boards (43.5 percent) confirmed that their state had experienced abrupt loss of CS providers and 11 (55 percent) of these executive directors indicated that the loss resulted in increased consumer complaints. The majority of executive directors (86 percent) had no action plan. Six executive directors reported some type of action plan or process consisting of regulatory action, patient-provider connection, professional education, patient education, or public notice. CONCLUSIONS: Most states do not have operational plans in place. However, a few have key strategies that may be useful in addressing potential problems following abrupt loss of a CS prescriber. State medical boards can play a significant role in the development of comprehensive preparedness plans to mitigate damage from the loss of CS prescribers in the community.

How Drug Control Policy and Practice Undermine Access to Controlled Medicines.

Drug conventions serve as the cornerstone for domestic drug laws and impose a dual obligation upon states to prevent the misuse of controlled substances while ensuring their adequate availability for medical and scientific purposes. Despite the mandate that these obligations be enforced equally, the dominant paradigm enshrined in the drug conventions is an enforcement-heavy criminal justice response to controlled substances that prohibits and penalizes their misuse. Prioritizing restrictive control is to the detriment of ensuring adequate availability of and access to controlled medicines, thereby violating the rights of people who need them. This paper argues that the drug conventions' prioritization of criminal justice measures-including efforts to prevent non-medical use of controlled substances-undermines access to medicines and infringes upon the right to health and the right to enjoy the benefits of scientific progress. While the effects of criminalization under drug policy limit the right to health in multiple ways, we draw on research and documented examples to highlight the impact of drug control and criminalization on access to medicines. The prioritization and protection of human rights-specifically the right to health and the right to enjoy the benefits of scientific progress-are critical to rebalancing drug policy.

Drug Policy and Indigenous Peoples.

This paper identifies the principal concerns of indigenous peoples with regard to current international treaties on certain psychoactive substances and policies to control and eradicate their production, trafficking, and sale. Indigenous peoples have a specific interest in the issue since their traditional lands have become integrated over time into the large-scale production of coca, opium poppy, and cannabis crops, in response to high demand from the American and European markets, among others. As a consequence, indigenous peoples are persecuted because of their traditional use of these and other plant-based narcotics and hallucinogens. They are also victims of the drug producers who remove them from their lands or forcibly recruit them into the production process. As indigenous peoples are caught in the violent world of illicit drug production, law enforcement often targets them first, resulting in disproportionate rates of criminalization and incarceration.

Drugs down the drain: When nurses object.

The authors examine the nursing practice of disposing unaltered controlled substances into public water systems as an issue for nurses concerned with the environmental harm it can cause. A summary of the history of controlled substance management reveals inconsistencies in the interpretation of current regulations that have led to disposal policies that vary by institution, according to a benchmarking survey of regional hospitals. Much attention has been given to the phenomenon of conscientious objection in the context of patient care that conflicts with a nurse's moral integrity. Nurses who are compelled to dispose narcotics down drains may also face this struggle. The authors submit that this disposal method is based on a type of double effect logic where preventing diversion is viewed as a good effect of flushing unused controlled substances that outweighs any harm it may cause, though there is little evidence to support this conclusion. Consequently, the topic deserves further study so that nurse managers and administrators can support and offer alternatives to nurses who object to flushing drugs down the drain.

Controlled Substance Lock-In Programs: Examining An Unintended Consequence Of A Prescription Drug Abuse Policy.

Controlled substance lock-in programs are garnering increased attention from payers and policy makers seeking to combat the epidemic of opioid misuse. These programs require high-risk patients to visit a single prescriber and pharmacy for coverage of controlled substance medication services. Despite high prevalence of the programs in Medicaid, we know little about their effects on patients' behavior and outcomes aside from reducing controlled substance-related claims. Our study was the first rigorous investigation of lock-in programs' effects on out-of-pocket controlled substance prescription fills, which circumvent the programs' restrictions and mitigate their potential public health benefits. We linked claims data and prescription drug monitoring program data for the period 2009-12 for 1,647 enrollees in North Carolina Medicaid's lock-in program and found that enrollment was associated with a roughly fourfold increase in the likelihood and frequency of out-of-pocket controlled substance prescription fills. This finding illuminates weaknesses of lock-in programs and highlights the need for further scrutiny of the appropriate role, optimal design, and potential unintended consequences of the programs as tools to prevent opioid abuse.

Controlled Substance Reconciliation Accuracy Improvement Using Near Real-Time Drug Transaction Capture from Automated Dispensing Cabinets.

BACKGROUND: Accurate accounting of controlled drug transactions by inpatient hospital pharmacies is a requirement in the United States under the Controlled Substances Act. At many hospitals, manual distribution of controlled substances from pharmacies is being replaced by automated dispensing cabinets (ADCs) at the point of care. Despite the promise of improved accountability, a high prevalence (15%) of controlled substance discrepancies between ADC records and anesthesia information management systems (AIMS) has been published, with a similar incidence (15.8%; 95% confidence interval [CI], 15.3% to 16.2%) noted at our institution. Most reconciliation errors are clerical. In this study, we describe a method to capture drug transactions in near real-time from our ADCs, compare them with documentation in our AIMS, and evaluate subsequent improvement in reconciliation accuracy. METHODS: ADC-controlled substance transactions are transmitted to a hospital interface server, parsed, reformatted, and sent to a software script written in Perl. The script extracts the data and writes them to a SQL Server database. Concurrently, controlled drug totals for each patient having care are documented in the AIMS and compared with the balance of the ADC transactions (i.e., vending, transferring, wasting, and returning drug). Every minute, a reconciliation report is available to anesthesia providers over the hospital Intranet from AIMS workstations. The report lists all patients, the current provider, the balance of ADC transactions, the totals from the AIMS, the difference, and whether the case is still ongoing or had concluded. Accuracy and latency of the ADC transaction capture process were assessed via simulation and by comparison with pharmacy database records, maintained by the vendor on a central server located remotely from the hospital network. For assessment of reconciliation accuracy over time, data were collected from our AIMS from January 2012 to June 2013 (Baseline), July 2013 to April 2014 (Next Day Reports), and May 2014 to September 2015 (Near Real-Time Reports) and reconciled against pharmacy records from the central pharmacy database maintained by the vendor. Control chart (batch means) methods were used between successive epochs to determine if improvement had taken place. RESULTS: During simulation, 100% of 10,000 messages, transmitted at a rate of 1295 per minute, were accurately captured and inserted into the database. Latency (transmission time to local database insertion time) was 46.3 ± 0.44 milliseconds (SEM). During acceptance testing, only 1 of 1384 transactions analyzed had a difference between the near real-time process and what was in the central database; this was for a "John Doe" patient whose name had been changed subsequent to data capture. Once a transaction was entered at the ADC workstation, 84.9% (n = 18 bins; 95% CI, 78.4% to 91.3%) of these transactions were available in the database on the AIMS server within 2 minutes. Within 5 minutes, 98.2% (n = 18 bins; 95% CI, 97.2% to 99.3%) were available. Among 145,642 transactions present in the central pharmacy database, only 24 were missing from the local database table (mean = 0.018%; 95% CI, 0.002% to 0.034%). Implementation of near real-time reporting improved the controlled substance reconciliation error rate compared to the previous Next Day Reports epoch, from 8.8% to 5.2% (difference = -3.6%; 95% CI, -4.3% to -2.8%; P < 10). Errors were distributed among staff, with 50% of discrepancies accounted for by 12.4% of providers and 80% accounted for by 28.5% of providers executing transactions during the Near Real-Time Reports epoch. CONCLUSIONS: The near real-time system for the capture of transactional data flowing over the hospital network was highly accurate, reliable, and exhibited acceptable latency. This methodology can be used to implement similar data capture for transactions from their drug ADCs. Reconciliation accuracy improved significantly as a result of implementation. Our approach may be of particular utility at facilities with limited pharmacy resources to audit anesthesia records for controlled substance administration and reconcile them against dispensing records.

The Relationship Between Controlled Substances and Violence.

A causal relationship between controlled substances and firearm violence has been widely assumed in the United States, and federal law prohibits individuals who are "unlawful users of or addicted to any controlled substance" from purchasing or possessing firearms (68 FR 3750. 2003. Codified at 27 CFR §478.11). However, the law does a poor job of defining "unlawful users," resulting in recent calls for a revised, actionable definition. Such a definition should be informed by research evidence, but to date the epidemiologic research on the relationship between controlled substances and violence has not been comprehensively reviewed. The initial goal of this review was to summarize the best available evidence on the relationship between controlled substances and firearm violence, but only 1 study specific to firearm violence was identified. We therefore reviewed studies of this relationship using broader measures of interpersonal violence and suicide, all of which included but were not limited to firearm violence, and measures of illicit firearm carrying. Prospective longitudinal studies (n = 22) from 1990 to 2014 were identified by using searches of online databases and citation tracking. Information was extracted from each study by using a standardized protocol. Quality of evidence was independently assessed by 2 reviewers. Aggregate measures of controlled substance use were associated with increased interpersonal violence and suicide, but evidence regarding the relationship between specific substances and violence was mixed. Involvement in illegal drug sales was consistently associated with interpersonal violence. To effectively revise extant federal law and delineate appropriate prohibiting criteria, more research is needed to understand the relationship between controlled substances and firearm violence.

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.

Programas de monitoreo de medicamentos de prescripción en los Estados Unidos de América / Prescription drug monitoring programs in the United States of America

Desde finales de la década de los años noventa, el número de muertes por sobredosis que involucran analgésicos opioides se ha cuadriplicado en los Estados Unidos de América (de 4 030 muertes en 1999 a 16 651 en 2010). Los objetivos de este artículo son proporcionar una visión general del problema de sobredosis de medicamentos de prescripción en los Estados Unidos y discutir las acciones que podrían ayudar a reducir el problema, abordando en forma directa las características de los Programas de monitoreo de medicamentos de prescripción (PDMP). Estos programas están compuestos de bases de datos a nivel estatal que vigilan las sustancias controladas. La información recopilada en las bases de datos está a disposición de las personas autorizadas por el Estado (por ejemplo, los médicos, los farmacéuticos y otros proveedores de cuidado médico) y debe ser utilizada solo con propósitos profesionales. Los proveedores pueden utilizar dicha información para evitar la interacción con otros medicamentos, la duplicación terapéutica o la identificación de conductas de búsqueda de drogas. Las agencias del orden público pueden utilizar estos programas para identificar patrones de prescripción inadecuada, dispensación o desviación.

Since the late 1990s, the number of opioid analgesic overdose deaths has quadrupled in the United States of America (from 4 030 deaths in 1999 to 16 651 in 2010). The objectives of this article are to provide an overview of the problem of prescription drug overdose in the United States and to discuss actions that could help reduce the problem, with particular attention to the characteristics of prescription drug monitoring programs (PDMPs). These programs consist of state-level databases that monitor controlled substances. The information compiled in the databases is at the disposal of authorized persons (e.g., physicians, pharmacists, and other health-care providers) and may be used only for professional purposes. Suppliers can use such information to prevent interaction with other drugs or therapeutic duplication, or to identify drug-search behavior. Law enforcement agencies can use these programs to identify improper drug prescription or dispensing patterns, or drug diversion.