The Opioid Industry Documents Archive: Advancing Public Health Through Industry Document Disclosure.

More than twenty-five years after the first signs of potential harm, the US remains locked in the grip of an opioid epidemic, with more Americans dying from overdoses than ever before.1 Diversion of prescription opioids plays an important role in opioid-related harms. Much of the scientific and public health focus on diversion has been on end-users, given how commonly non-medical prescription opioid use occurs, as well as the proportion of individuals who report that their source of non-medical opioids was friends or family. However, diversion of opioids, as well as their rampant oversupply, can be discerned higher up the supply chain, including among wholesalers, pharmacies and rogue prescribers whose behavior may trigger well-described "flags" warranting further evaluation and action.

Addressing Bioethical Implications of Implementing Diversion Programs in Resource-Constrained Service Environments.

The opioid epidemic demands the development, implementation, and evaluation of innovative, research-informed practices such as diversion programs. Aritürk et al. have articulated important bioethical considerations for implementing diversion programs in resource-constrained service environments. In this commentary, we expand and advance Aritürk et al.'s discussion by discussing existing resources that can be utilized to implement diversion programs that prevent or otherwise minimize the issues of autonomy, non-maleficence, beneficence, and justice identified by Aritürk et al.

Diverting Data and Drugs: A Narrative Review of the Mallinckrodt Documents.

U.S. law imposes strict recording and reporting requirements on all entities that manufacture and distribute controlled substances. As a result, the prescription opioid crisis has unfolded in a data-saturated environment. This article asks why the systematic documentation of opioid transactions failed to prevent or mitigate the crisis. Drawing on a recently disclosed trove of 1.4 million internal records from Mallinckrodt Pharmaceuticals, a leading manufacturer of prescription opioids, we highlight a phenomenon we propose to call data diversion, whereby data ostensibly generated or collected for the purpose of regulating the distribution of controlled substances were repurposed by the industry for the opposite aim of increasing sales at all costs. Systematic data diversion, we argue, contributed substantially to the scale of drug diversion seen with opioids and should become a focus of policy intervention.

Stigma Related to the Non-Medical Use and Diversion of Prescription Stimulant Drugs: Should We Care.

BACKGROUND: Non-medical use (NMU) and diversion of prescription stimulants are prevalent on college campuses. Diversion represents a primary source of acquisition for NMU among young adults. This study examined relationships between stigmatizing beliefs related to NMU and diversion of stimulant medications and engagement in these behaviors, as well as how such perceptions are associated with indicators of psychological distress among those who engage in these behaviors. METHODS: Young adults (N = 384) were recruited from a large US university to participate in this cross-sectional electronic survey-based study. Relationships between stigma variables and NMU and diversion were assessed. Among those who engage in NMU and diversion, we tested relationships between stigma variables and indicators of psychological distress, using validated instruments. RESULTS: Perceived social and personal stigmatic beliefs did not significantly predict NMU. However, perceived social and personal stigma of diversion significantly reduced diversion likelihood. For NMU, associations were found between stigma variables and indicators of psychological distress. Markedly, we found that as stigmatic perceptions of NMU increased, so did depressive, anxiolytic, and suicidal symptomatology among those who engage in NMU. CONCLUSIONS: Stigmatization does not deter NMU; however, stigmatization is positively associated with psychological harm among those who engage in NMU. Interventions should be developed to reduce stigmatization in order to improve psychological health among those who engage in NMU. Stigmatic perceptions of diversion were not predictive of psychological harm, though they are negatively associated with diversion behavior.

"It didn't hurt me": patients' and providers' perspectives on unsupervised take-home doses, drug diversion, and overdose risks in the provision of medication for opioid use disorder during COVID-19 in San Juan, Puerto Rico.

BACKGROUND: During the COVID-19 pandemic, clinics offering medication for opioid use disorder (MOUD) needed to rapidly introduce unsupervised take-home dosing, while relapsing patients and patients unable to enter treatment faced increased risks of fentanyl-related overdose deaths and other drug-related harms. Based on a qualitative study of people who inject drugs (PWID) receiving MOUD treatment and MOUD staff in Puerto Rico, this paper documents the lived experiences of patients and providers during this period and the risk perceptions and management strategies to address substance misuse and drug diversion attributable to unsupervised take-home-dose delivery. METHODS: In-depth qualitative interviews were conducted with patients (N = 25) and staff (N = 25) in two clinics providing MOUD in San Juan, Puerto Rico, during 2022. Patients and staff were receiving or providing treatment during the pandemic, and patients reported injection drug use during the past thirty days. RESULTS: Patients were overwhelmingly male (84%), unmarried (72%), and unemployed (52%), with almost half (44%) injecting one to three times a day. Mean time in treatment was 7 years. Staff had a mean age of 46 years with more than half of the sample (63%) female. The majority of patients believed that unsupervised take-home dosing had no significant effect on their treatment adherence or engagement. In contrast, providers expressed concerns over the potential for drug diversion and possible increased risks of patient attrition, overdose episodes, and poor treatment outcomes. CONCLUSION: This study underscores the importance of insider perspectives on harm-reduction changes in policy implemented during a health crisis. Of note is the finding that staff disagreed among themselves regarding the potential harms of diversion and changes in drug testing protocols. These different perspectives are important to address so that future pandemic policies are successfully designed and implemented. Our study also illuminates disagreement in risk assessments between patients and providers. This suggests that preparation for emergency treatment plans requires enhanced communication with patients to match treatments to the context of lived experience.

Mapping a moral panic: News media narratives and medical expertise in public debates on safer supply, diversion, and youth drug use in Canada.

The ongoing overdose and drug toxicity crisis in North America has contributed momentum to the emergence of safer supply prescribing and programs in Canada as a means of providing an alternative to the highly volatile unregulated drug supply. The implementation and scale-up of safer supply have been met with a vocal reaction on the part of news media commentators, conservative politicians, recovery industry representatives, and some prominent addiction medicine physicians. This reaction has largely converged around several narratives, based on unsubstantiated claims and anecdotal evidence, alleging that safer supply programs are generating a "new opioid epidemic", reflecting an emerging alignment among key institutional and political actors. Employing situational analysis method, and drawing on the policy studies and social science scholarship on moral panics, this essay examines news media coverage from January to July 2023, bringing this into dialogue with other existing empirical sources on safer supply (e.g. Coroner's reports, program evaluations, debates among experts in medical journals). We employ eight previously established criteria delineating moral panics to critically appraise public dialogue regarding safer supply, diverted medication, and claims of increased youth initiation to drug use and youth overdose. In detailing the emergence of a moral panic regarding safer supply, we trace historic continuities with earlier drug scares in Canadian history mobilized as tools of racialized poverty governance, as well as previous backlashes towards healthcare interventions for people who use drugs (PWUD). The essay assesses the claims of moral entrepreneurs against the current landscape of opioid use, diversion, and overdose among youth, notes the key role played by medical expertise in this and previous moral panics, and identifies what the convergence of these narratives materialize for PWUD and healthcare access, as well as the broader policy responses such narratives activate.

Prescription Opioid Diversion Sources Among African Americans: Implications for Overdose Prevention.

Recent data show that African Americans (AAs) experienced a greater increase in overdose deaths involving prescription opioids relative to other racial/ethnic groups. One possible mechanism through which elevated risk for overdose is conferred to AAs could be due to greater exposure to contaminated counterfeit pills. Unfortunately, prescription opioid diversion is understudied among AAs and less is known regarding which sources AAs use to access pharmaceutical opioids. The objective of this study, therefore, was to identify and describe the most commonly used diversion sources for prescription opioids among AAs. Qualitative interview data are also presented to contextualize the most prevalent sources. This study used data from the Florida Minority Health Study, a mixed-methods project that included online surveys (n = 303) and qualitative in-depth interviews (n = 30) of AAs. Data collection was conducted from August 2021 to February 2022 throughout Southwest Florida. Analyses revealed that the most widely used sources for prescription opioids were dealers (33.0%) and friends/relatives (34.7%). Additionally, interview data indicated that dealers are the access point where larger volume acquisitions are made and high potency formulations are accessed. These findings suggest that AAs may utilize nonhealthcare related sources at higher rates than healthcare related sources to acquire prescription opioids. This is concerning because opioid pills acquired through nonhealthcare related sources are especially susceptible to fentanyl adulteration. These findings invite further study using nationally representative data to determine if AAs disproportionately use nonhealthcare related sources compared to persons from other racial/ethnic groups.

Study to assess the impact of analytics software on operating room controlled substance management and drug diversion.

PURPOSE: This study investigated the impact of an advanced analytics software solution in the operating room (OR) on tracking and evaluating controlled substance discrepancies. The authors hypothesized that the software would increase identification of these discrepancies and improve the efficiency of the preexisting manual process. METHODS: In this evaluation comparing data from before to after implementation of the software, data were collected using the preexisting manual process for 50 days before implementation, followed by a 25-day period for acclimation to the new software, and ending with a 49-day postimplementation review period. Data collected included the total number of medication discrepancies, time required for discrepancy review and reconciliation by an OR analyst, types of discrepancies, and number of discrepancies leading to provider audits. RESULTS: Before implementation of the analytics software, there were 7,635 OR cases with a total of 674 charting discrepancies (8.83 discrepancies per 100 total OR cases) discovered across 439 OR cases. After implementation, there were 7,454 OR cases with a total of 930 charting discrepancies (12.48 discrepancies per 100 total OR cases; P < 0.0001) discovered across 680 OR cases. While discrepancies increased by 38%, the median review time for the OR analyst per case decreased (P < 0.0001) and the percentage of incidents resolved by the OR analyst increased by 14% while the number of cases requiring additional documentation by the provider decreased by 10%. CONCLUSION: Implementation of advanced analytics software in the OR significantly increased the number of controlled substance charting discrepancies identified compared to the preimplementation review process while increasing the efficiency of the OR analyst.

National Hospital and Health-System Controlled Substances Drug Diversion Prevention & Surveillance Program Assessment Survey - 2021.

PURPOSE: To present and discuss the results of the National Hospital and Health-System Controlled Substances Drug Diversion Prevention & Surveillance Program Assessment Survey. METHODS: The survey was emailed to 1,529 chief pharmacy officers utilizing the list of directors of pharmacy from the American Society of Health-System Pharmacists. The survey opened September 15, 2021, and closed October 4, 2021. Forty-nine questions were included in 5 different sections, and participants were also given the option to respond to 39 additional questions. RESULTS: The survey response rate was 12.75%, with the results showing consistencies in practice around drug security and human resource management. Sixty-two percent of sites had a formalized drug diversion committee, half of which had been implemented since 2018. Adoption of electronic controlled substance systems continues to increase, with 50% of sites having implemented such a system in the previous 3 years. At the time of the survey, 18% of organizations did not have an electronic system, but 90% of sites had implemented or intended to implement one by 2023. Over 40% of sites that utilized an electronic system were looking to upgrade to a next-generation system. Most organizations had 0.5 to 1 full-time equivalent dedicated to diversion prevention, and two-thirds of sites had a formalized diversion committee. The majority of sites defined "significant loss" by utilizing professional judgement, based on the scenario, as a percentage of inventory or as a range of units. Community practice consensus is needed around auditing adjustments to controlled substance inventory and for perpetual inventory processes. Respondents reported 1 to 2 (29%), 3 to 5 (26%), and more than 10 (26%) formal drug diversion investigations annually. CONCLUSION: This first-time survey provided significant insight into the realities of drug diversion prevention practices in hospitals and health systems nationally.

Turning gold into lead: The troubling fate of the police drug diversion initiative.

INTRODUCTION: This paper explores the fate of South Australia's highly regarded Police Drug Diversion Initiative over the past 10 years. METHODS: The paper uses historical and legal analysis, including publicly available data as to rates of drug use, arrests and diversions, media reports, legislation and Hansard debates. RESULTS: In the mid-2010s, amidst growing anxiety about levels of amphetamine-type stimulants use in Adelaide, a coroner's report became the poster child for what was seen by the Liberal opposition as the excessive leniency and 'waste of resources' of the Police Drug Diversion Initiative. Despite being universally praised for its efficacy, the Liberal government, when elected, passed amendments to the legislation which 'capped' diversions at two. This ended the period in which diversions from criminal to social justice systems was mandatory for all persons charged with simple drug possession. But since then, the diversion rate in South Australia has plummeted in ways that cannot be explained merely because of these amendments. DISCUSSION AND CONCLUSIONS: The most highly regarded scheme for diversion of minor drug offenders to treatment is no longer effective. Indeed, the best scheme in the country may now be the worst. The essay draws attention to a catastrophe whose extent is not yet fully appreciated and suggests ways in which we can begin to explain why such a small change has had such dramatic and unforeseen consequences. Like some sort of perverse alchemy, Australia's gold standard for drug diversion has been turned into lead.

Prevention of drug diversion and substance use disorders among anesthesiologists: a narrative review

Abstract Diversion of substances from the care of the intended patient is a significant problem in healthcare. Patients are harmed by the undertreatment of pain and suffering, transmission of disease, as well as the risk associated with impaired vigilance. Healthcare providers may be harmed by the physical and mental impact of their addictions. Healthcare systems are placed in jeopardy by the legal impact associated with illegal routes of drug release including sanction and financial liability and loss of public trust. Healthcare institutions have implemented many measures to reduce diversion from the perioperative area. These efforts include education, medical record surveillance, automated medication dispensing systems, urine drug testing, substance waste management systems, and drug diversion prevention teams. This narrative review evaluates strengths, weaknesses, and effectiveness of these systems and provides recommendations for leaders and care providers.

Preventing controlled substance diversion in perioperative settings: a narrative review.

PURPOSE: Diversion of controlled substances in the perioperative setting is an ongoing challenge, with consequences for patients, anesthesiologists, perioperative staff, and health care facilities alike. Perioperative environments are at high risk for diversion, since controlled substances are frequently handled in these settings, with varying levels of oversight. In this narrative review, we summarize strategies for preventing diversion of controlled substances in perioperative settings (i.e., operating rooms, endoscopy suites, and postanesthesia recovery units). SOURCE: We performed a targeted literature search in PubMed MEDLINE, Embase, Scopus, Web of Science, the Cochrane Register of Controlled trials, and the Cochrane Database of Systematic Reviews, as well as a manual search for additional references. We used terminology related to drug diversion, drug abuse, anesthesiologists, pharmacists, physicians, operating room personnel, and controlled substances. PRINCIPAL FINDINGS: Many strategies have been described for preventing diversion in perioperative settings, and these are broadly categorized into: education, distribution, auditing, or provider screening. Some of these approaches may be time- and resource-intensive. There is limited evidence to inform anesthesia departments' choice of which strategies to adopt. CONCLUSION: Although awareness of perioperative controlled substance diversion has been improving, there are too few data to suggest an optimal approach. Anesthesia departments will need to work collaboratively with hospital pharmacies and actively select strategies that are reasonable given local resources.

RéSUMé: OBJECTIF: Le détournement des substances contrôlées en milieu périopératoire constitue un défi permanent qui a des conséquences pour la patientèle, les anesthésiologistes, le personnel périopératoire et les établissements de soins de santé. Les environnements périopératoires courent un risque élevé de détournement, car les substances contrôlées sont fréquemment manipulées dans ces milieux, avec divers niveaux de surveillance. Dans ce compte rendu narratif, nous résumons les stratégies de prévention du détournement des substances contrôlées dans les milieux périopératoires (c.-à-d. salles d'opération, salles d'endoscopie et salles de réveil). SOURCES: Nous avons réalisé une recherche documentaire ciblée dans les bases de données PubMed, MEDLINE, Embase, Scopus, Web of Science, le registre Cochrane des essais contrôlés et la base de données Cochrane des revues systématiques, ainsi qu'une recherche manuelle de références supplémentaires. Nous avons utilisé une terminologie liée au détournement de médicaments, à l'abus de substances, aux anesthésiologistes, aux pharmacien·nes, aux médecins, au personnel de salle d'opération et aux substances contrôlées. CONSTATATIONS PRINCIPALES: De nombreuses stratégies ont été décrites pour prévenir le détournement dans les milieux périopératoires, et celles-ci sont généralement classées en éducation, distribution, audit ou dépistage des fournisseurs et fournisseuses de soin. Certaines de ces approches peuvent exiger beaucoup de temps et de ressources. Il existe peu de données probantes pour éclairer le choix des départements d'anesthésie quant aux stratégies à adopter. CONCLUSION: Bien que la sensibilisation au détournement périopératoire de substances contrôlées se soit améliorée, il y a trop peu de données pour suggérer une approche optimale. Les départements d'anesthésie devront travailler en collaboration avec les pharmacies hospitalières et choisir activement des stratégies raisonnables qui tiennent compte des ressources locales.

Prevention of drug diversion and substance use disorders among anesthesiologists: a narrative review.

Diversion of substances from the care of the intended patient is a significant problem in healthcare. Patients are harmed by the undertreatment of pain and suffering, transmission of disease, as well as the risk associated with impaired vigilance. Healthcare providers may be harmed by the physical and mental impact of their addictions. Healthcare systems are placed in jeopardy by the legal impact associated with illegal routes of drug release including sanction and financial liability and loss of public trust. Healthcare institutions have implemented many measures to reduce diversion from the perioperative area. These efforts include education, medical record surveillance, automated medication dispensing systems, urine drug testing, substance waste management systems, and drug diversion prevention teams. This narrative review evaluates strengths, weaknesses, and effectiveness of these systems and provides recommendations for leaders and care providers.

Managing opioid waste, cost, and opportunity for drug diversion in the emergency department.

INTRODUCTION: Management of pain is a component of 80% of all emergency department (ED) visits, and intravenous (IV) opioids are most commonly used to treat moderate to severe pain. Since the dose of stock vials is rarely purchased based on provider ordering patterns, there is often a discrepancy between ordered doses and the dose of the stock vial, leading to waste. Here, waste is defined as the difference between the dose of the stock vials used to fill an order and the ordered dose. Drug waste is problematic as it increases the chance of administering the incorrect dose, it is a source of lost revenue, and in the context of opioids, it increases the opportunity for drug diversion. In this study, we sought to utilize real-world data to describe the magnitude of morphine and hydromorphone waste in the studied EDs. We also applied scenario analyses based on provider ordering patterns to simulate the effects of cost versus opioid waste minimization when making purchasing decisions for the dose of stock vial of each opioid. METHODS: This was an observational analysis of IV morphine and hydromorphone orders across three EDs within a health care system between December 1, 2014 and November 30, 2015. In the primary analysis we measured total waste and cost of all ordered hydromorphone and morphine, and we created logistic regression models for each opioid to estimate the odds that a given ordered dose would create waste. In the secondary scenario analysis we determined the total waste created and total cost to satisfy all written orders for both opioids with respect to prioritizing minimizing waste versus cost. RESULTS: Among a total of 34,465 IV opioid orders, 7866 (35%) of morphine orders created 21,767 mg of waste, and 10,015 (85%) of hydromorphone orders created 11,689 mg of waste. Larger dose orders were associated with a smaller likelihood of waste in both morphine and hydromorphone due to the doses of stock vials available. In the waste optimization scenario, relative to the base scenario, total waste, which included waste from both morphine and hydromorphone, was reduced by 97% and cost was reduced by 11%. In the cost optimization scenario, cost was reduced by 28% but waste increased by 22%. CONCLUSION: As hospitals continue to seek strategies to reduce costs and mitigate the harms of opioid diversion amidst the opioid epidemic, this study shows that optimizing the dose of the stock vial to minimize waste using provider ordering patterns, could mitigate risk while also reducing cost. Limitations included the use of data from EDs within a single health system, drug shortages that affected stock vial availability, and finally, the actual cost of stock vials, used for cost calculations, can differ based on a variety of factors.

Centralizing a controlled substance compliance and drug diversion prevention program within a multihospital health system.

PURPOSE: Challenges with monitoring and detecting drug diversion in healthcare facilities continue to be a trending topic amid the opioid epidemic. This article aims to provide insight into the expansion of an academic medical center's drug diversion and controlled substances compliance program. The justification and structure of a multihospital, centralized program are discussed. SUMMARY: Establishing dedicated controlled substances compliance and drug diversion resources has become increasingly common as awareness of the widespread healthcare impact has grown. One academic medical center recognized the value in expanding from 2 dedicated full-time equivalents (FTEs) with a scope of one facility to multiple FTEs with a scope of 5 facilities. The expansion included considering current practices at each facility, establishing the centralized team's scope, gaining organizational support, recruiting a diverse team, and forming an effective committee structure. CONCLUSION: There are multiple organizational benefits from establishing a centralized controlled substances compliance and drug diversion program, including standardization of processes, associated efficiencies, and effective risk mitigation by identifying inconsistent practices across the multifacility organization.

Signs and Behaviors to Identify Impairment and Drug Diversion.

Substance use disorder in health care professionals may adversely affect patient care. To reduce the risks of harm, raising awareness among all staff for early identification and response is a primary goal. Knowledgeable co-workers play an essential role to identify signs and behaviors indicating at-risk substance use by observed impairment or suspicion of drug diversion and report to a supervisor. Response protocol for a timely, confidential, safe and non-punitive intervention can help connect the clinician to needed assessment and treatment help and potentially save a life and provide a hopeful outcome to retain their license and career.

Uncommon and preventable: Perceptions of diversion of medication for opioid use disorder in jail.

INTRODUCTION: Correctional officials often cite diversion of medication for opioid use disorder (MOUD) treatment (e.g., buprenorphine) as a reason for not offering MOUD treatment in jails and prisons, but it is poorly understood whether these fears are justified. We aimed to understand staff perceptions of medication diversion from jail-based MOUD programs and the factors that contribute to and prevent diversion. METHODS: We conducted qualitative analyses of semi-structured in-depth interviews and focus groups performed in 2019-20 with 61 administrative, security, behavioral health, and clinical staff who implement MOUD programming in seven Massachusetts jails. RESULTS: Contrary to staff expectations, buprenorphine diversion was perceived to occur infrequently during MOUD program implementation. The MOUD program changed staff views of buprenorphine, i.e., as legitimate treatment instead of as illicit contraband. Also, the program was perceived to have disrupted the illicit buprenorphine market in jail and reduced related coercion. Proactive strategies were essential to prevent and respond to buprenorphine diversion. Key components of diversion prevention strategies included: staff who distinguished among different reasons for diversion; comprehensive and routinized but flexible dosing protocols; communication, education, and monitoring; patient involvement in assessing reasons for diversion; and written policies to adjudicate diversion consequences. CONCLUSION: With appropriate protocols, buprenorphine diversion within correctional programs designed to provide MOUD treatment is perceived to be uncommon and preventable. Promising practices in program design help limit medication diversion and inform correctional officials and lawmakers as they consider whether and how to provide MOUD treatment in correctional settings.

Detecting drug diversion in health-system data using machine learning and advanced analytics.

PURPOSE: The theft of drugs from healthcare facilities, also known as drug diversion, occurs frequently but is often undetected. This paper describes a research study to develop and test novel drug diversion detection methods. Improved diversion detection and reduction in diversion improves patient safety, limits harm to the person diverting, reduces the public health impact of substance use disorder, and mitigates significant liability risk to pharmacists and their organizations. METHODS: Ten acute care inpatient hospitals across 4 independent health systems extracted 2 datasets from various health information technology systems. Both datasets were consolidated, normalized, classified, and sampled to provide a harmonious dataset for analysis. Supervised machine learning methods were iteratively used on the initial sample dataset to train algorithms to classify medication movement transactions as involving a low or high risk of diversion. Thereafter, the resulting machine learning model classified the risk of diversion in a historical dataset capturing 8 to 24 months of history that included 27.9 million medication movement transactions by 19,037 nursing, 1,047 pharmacy, and 712 anesthesia clinicians and that included 22 known, blinded diversion cases to measure when the model would have detected the diversion compared to when the diversion was actually detected by existing methods. RESULTS: The machine learning model had 96.3% accuracy, 95.9% specificity, and 96.6% sensitivity in detecting transactions involving a high risk of diversion using the initial sample dataset. In subsequent testing using the much larger historical dataset, the analytics detected known diversion cases (n = 22) in blinded data faster than existing detection methods (a mean of 160 days and a median of 74 days faster; range, 7-579 days faster). CONCLUSION: The study showed that (1) consolidated datasets and (2) supervised machine learning can detect known diversion cases faster than existing detection methods. Users of the technology also noted improved investigation efficiency.