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.

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.

Drug Diversion: Best Practices and Support for a Staff Assessment Process.

The characteristics of opioid prescribing and administration in cancer centers include large quantities and less restrictive regulatory mandates governing cancer-related pain, which may increase the risk of drug diversion by staff members. The purpose of this article is to provide a framework for creating respectful investigative processes for staff suspected of drug diversion. Organizations, including cancer centers, need to engage in careful oversight of potential drug diversions while simultaneously promoting a psychologically safe work environment for individuals to successfully seek help.

Diversion of Controlled Drugs in Hospitals: A Scoping Review of Contributors and Safeguards.

Drug losses and theft from the healthcare system are accelerating; hospitals are pressured to implement safeguards to prevent drug diversion. Thus far, no reviews summarize all known risks and potential safeguards for hospital diversion. Past incidents of hospital drug diversion have impacted patient and staff safety, increased hospital costs, and resulted in infectious disease outbreaks. We searched MEDLINE, Embase, PsycINFO, CINAHL, Scopus, and Web of Science databases and the gray literature for articles published between January 2005 and June 2018. Articles were included if they focused on hospital settings and discussed either: (1) drug security or accounting practices (any drug) or (2) medication errors, healthcare worker substance use disorder, or incident reports (only with reference to controlled drugs). We included 312 articles and extracted four categories of data: (1) article characteristics (eg, author location), (2) article focus (eg, clinical areas discussed), (3) contributors to diversion (eg, factors enabling drug theft), and (4) diversion safeguards. Literature reveals a large number of contributors to drug diversion in all stages of the medication-use process. All health professions and clinical units are at risk. This review provides insights into known methods of diversion and the safeguards hospitals must consider to prevent them. Careful configuration of healthcare technologies and processes in the hospital environment can reduce the opportunity for diversion. These system-based strategies broaden the response to diversion beyond that of individual accountability. Further evidence is urgently needed to address the vulnerabilities outlined in this review and prevent harm.

The diversion of nonscheduled psychoactive prescription medications in the United States, 2002 to 2017.

PURPOSE: Systematic studies of the diversion of nonscheduled drugs, except for gabapentin, are not apparent. We searched diversion case reports of all other nonscheduled psychoactive prescription drugs in the Researched Abuse, Diversion, and Addiction-Related Surveillance (RADARS) System. METHODS: Case report data are drawn from a quarterly survey of prescription drug diversion completed by a national sample of law enforcement and regulatory agencies. Rates of diversion per 100 000 population were calculated for each year from 2002 to 2017 for prescription medications with greater than 400 reported cases during the period. RESULTS: Cyclobenzaprine, quetiapine, and trazodone met criteria for analysis. We found a significant and steady increase in the diversion of each drug over the period. The 2017 annual rates of diversion per 100 000 population for the three medications range from 0.0428 to 0.0726. Although these rates of diversion are much lower than the rate for total opioid analgesics, they are all more than five times higher in 2017 compared with 2002. While diversion rates for opioids have decreased in recent years, rates for cyclobenzaprine, quetiapine, and trazodone have continued to increase. CONCLUSIONS: A common attribute of the three nonscheduled drugs studied here is that all are used for the treatment and/or self-treatment of opioid withdrawal symptoms, and the increasing diversion of these drugs may be related to the ongoing opioid epidemic and to increasing levels of control over pharmaceutical opioid availability in the United States. Prescribers need to be aware of illicit markets for these medications and prescribe to their patients with appropriate caution.

Ensuring and Restoring Balance on Access to Controlled Substances for Medical and Scientific Purposes: Joint Statement from Palliative Care Organizations.

The central principle of "balance" represents the dual obligation of governments to establish a system of control that ensures the adequate availability of controlled substances for medical and scientific purposes while simultaneously preventing their nonmedical use, diversion, and trafficking, two primary goals of the international control system. On the one hand, although strong opioids, including morphine, are absolutely necessary for the relief of severe pain, legitimate access to opioids for pain treatment and palliative care is lacking in the majority of the world's countries. On the other hand, in a few high-income countries with higher consumption of prescription opioids, diversion and nonmedical use are increasingly prevalent. This report presents examples of unbalanced systems and a joint statement from global and regional palliative care organizations to promote development of balanced systems for optimal public health outcomes. Although nonmedical use of controlled substances poses a risk to society, the system of control is not intended to be a barrier to their availability for medical and scientific purposes, nor to interfere in their legitimate medical use for patient care. As representatives of palliative care organizations, we urge heads of state to act and to take measures to ensure and restore balanced systems in their countries and call on public health leaders and regulators to work together.

America's Opioid Epidemic: Supply and Demand Considerations.

America is in the midst of an opioid epidemic characterized by aggressive prescribing practices, highly prevalent opioid misuse, and rising rates of prescription and illicit opioid overdose-related deaths. Medical and lay public sentiment have become more cautious with respect to prescription opioid use in the past few years, but a comprehensive strategy to reduce our reliance on prescription opioids is lacking. Addressing this epidemic through reductions in unnecessary access to these drugs while implementing measures to reduce demand will be important components of any comprehensive solution. Key supply-side measures include avoiding overprescribing, reducing diversion, and discouraging misuse through changes in drug formulations. Important demand-side measures center around educating patients and clinicians regarding the pitfalls of opioid overuse and methods to avoid unnecessary exposure to these drugs. Anesthesiologists, by virtue of their expertise in the use of these drugs and their position in guiding opioid use around the time of surgery, have important roles to play in reducing patient exposure to opioids and providing education about appropriate use. Aside from the many immediate steps that can be taken, clinical and basic research directed at understanding the interaction between pain and opioid misuse is critical to identifying the optimal use of these powerful pain relievers in clinical practice.

Impact of the Hydrocodone Schedule Change on Opioid Prescription Patterns in South Dakota.

INTRODUCTION: Prescription opioid use is becoming increasingly common; consequently, opioid overdose deaths are increasing at an alarming rate. Hydrocodone, one of the most commonly abused opioids, was changed from a schedule III controlled substance to the more stringent schedule II to decrease abuse and diversion, effective Oct. 6, 2014. The objective of this study was to examine the impact of the hydrocodone schedule change on opioid prescribing in South Dakota. METHODS: Opioid prescription patterns were examined in the following six-month phases: the baseline phase before the change, the transition phase when existing hydrocodone prescriptions could still be refilled, and the final phase. The South Dakota Board of Pharmacy Prescription Drug Monitoring Program provided aggregate monthly data for South Dakota opioid prescriptions (i.e., total number of prescriptions and days supplied), including urban and rural stratification. T-tests were performed on the monthly values for each phase to determine the significance of differences in prescription features between phases. RESULTS: The number of hydrocodone prescriptions significantly decreased 14 percent from baseline to final phase, while the days supplied per prescription significantly increased 7.4 percent. These changes were greater in rural areas than in urban areas. Conversely, the number of other opioid prescriptions significantly increased by 6.5 percent over this timeframe. CONCLUSIONS: The number of hydrocodone prescriptions decreased, while the days supplied per prescription increased. These changes were greater in rural areas than in urban areas. In addition, the number of other opioid prescriptions increased. These trends may reflect some unintended effects of the schedule change.

Acceptability of the use of cellular telephone and computer pictures/video for "pill counts" in buprenorphine maintenance treatment.

OBJECTIVE: As part of a comprehensive plan to attempt to minimize the diversion of prescribed controlled substances, many professional organization and licensing boards are recommending the use of "pill counts." This study sought to evaluate acceptability of the use of cellular phone and computer pictures/video for "pill counts" by patients in buprenorphine maintenance treatment. SETTING AND INTERVENTION: Patients prescribed buprenorphine/naloxone were asked a series of questions related to the type(s) of electronic communication to which they had access as well as their willingness to use these for the purpose of performing a "pill/film count." RESULTS: Of the 80 patients, 4 (5 percent) did not have a phone at all. Only 28 (35 percent) had a "smart phone" with some sort of data plan and Internet access. Forty (50 percent) of the patients had a phone with no camera and 10 (12.5 percent) had a phone with a camera but no video capability. All patients said that they would be willing to periodically use the video or camera on their phone or computer to have buprenorphine/naloxone pills or film counted as long as the communication was protected from electronic tampering. CONCLUSIONS: With the advent of applications for smart phones that allow for Health Insurance Portability and Accountability Act of 1996-compliant picture/video communication, a number of things can now be done that can enhance patient care as well as reduce the chances of misuse/diversion of prescribed medications. This could be used in settings where a larger proportion of controlled substances are prescribed including medication assisted therapy for opioid use disorders and pain management programs.

The role of security in the prevention, detection and response to drug diversion by healthcare personnel.

Drug diversion by healthcare personnel poses substantial and growing risks to patients, staff, healthcare institutions and the community, the author reports. It is essential that clinical, pharmacy, and security personnel work together on diversion-related issues to reduce those risks, she says. In this article she spells out the critical roles of security personnel in the investigation of suspected diversion and the response to confirmed diversion.

Diversion of methadone and buprenorphine from opioid substitution treatment: the importance of patients' attitudes and norms.

AIMS: Methadone and buprenorphine diversion by patients in opioid substitution treatment (OST) is a poorly understood phenomenon. We study the norms and attitudes on diversion among OST patients, including the role these norms and attitudes play as diversion risk factors. We also study whether perceived quality of care, social bonds to treatment staff, and deterrence can be associated with diversion. METHODS: Structured interviews were conducted with 411 patients from eleven OST programs. In total, 280 interviews were done on site by the researchers, while 131 interviews were conducted through peer interviewing by specially trained patients. The data was analyzed through frequency- and averages-calculations, cross-tabulations, and logistic regression analysis. RESULTS: Most patients consider diversion as mostly positive (83.7%), morally right (76.8%), and without any significant risk of detection (66.9%). Individual differences in norms and risk perceptions may play a role in explaining variations in diversion; patients who consider it right to share medication with friends report higher treatment-episode diversion than other patients (OR 1.455, p = 0.016). Patients who perceive control measures as effective report lower diversion than other patients (OR = 0.655, p = 0.013). Furthermore, data indicate that patients who are satisfied with the care and service are less prone to engage in diversion. Social bonds with treatment staff seem to be less importance. CONCLUSIONS: The norm system described by patients resemble Bourgois' 'moral economy of sharing' concept-not sharing drugs with friends in withdrawal is considered unethical. Efforts to decrease diversion may focus on lifestyle-changing interventions, and reducing black market demand for illicit medications by expanding access to treatment.

Physician-pharmacist collaborative care model for buprenorphine-maintained opioid-dependent patients.

OBJECTIVES: To develop a physician-pharmacist collaborative practice for opioid-dependent patients designed to increase access to treatment, optimize patient care, reduce cost, minimize physician burden, and prevent diversion. SETTING: Suburban health department. PRACTICE DESCRIPTION: Physician-pharmacist buprenorphine/naloxone maintenance practice. PRACTICE INNOVATION: Traditionally, health department buprenorphine/naloxone patients have been referred to community physicians at considerable cost with varying outcomes. In this pilot project, patients were managed using a drug therapy management model. Intake assessments and follow-up appointments were conducted by the pharmacist. The pharmacist debriefed with the physician and documented each interaction, allowing for efficient assessment completion. The physician appended notes, when applicable, and cosigned each patient's record. The pharmacist prevented diversion by gathering data from outside providers, pharmacies, and laboratories. RESULTS: This health department program improved care by producing structure and expanding treatment options. A total of 12 patients completed full intakes with 135 follow-up appointments equating to an estimated savings of $22,000. The program demonstrated a 91% attendance rate, 100% 6-month retention rate, and 73% 12-month retention rate. Overall, 127 (98%) urine toxicology screens were positive for buprenorphine and 114 (88%) were positive for buprenorphine and negative for opioids. CONCLUSION: Physician and pharmacist collaboration optimized care of buprenorphine-maintained patients. Data from this pilot were used to develop a permanent physician-pharmacist program and to obtain approval for the first state-approved opioid use disorder drug therapy management protocol.

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.

Interprofessional pharmacy observation activity for third-year dental students.

Interprofessional learning is a key component of today's health sciences education. Within a two-course series in dental pharmacology and therapeutics, a dental curriculum was revised to provide an interprofessional activity to expose dental students to a community pharmacy setting. The objectives of this activity were to augment students' learning about drug laws and prescription writing, as well as to foster interprofessional relationships and collaboration between pharmacists and dentists. Dental students were scheduled for one-hour observations at community pharmacies on campus. Learning objectives to guide this activity focused on demonstrating community pharmacy operating procedures, identifying ways to minimize prescribing and dosing errors, and understanding how pharmacists can assist dentists in prescribing. Following the observation, students were required to submit a written assignment, which accounted for 14 percent of their course grade. All 119 dental students (100 percent) enrolled in the course for the summers of 2012 and 2013 completed the activity. The average grade on the written assignment was 96.2 out of 100. At the end of the course, students were asked to participate in an online course evaluation survey, for which response rates were 37 percent and 43 percent for 2012 and 2013, respectively. The students rated the pharmacy observation activity favorably on this course evaluation. The pharmacy observation activity provided a successful interprofessional component to the didactic pharmacy course and was well received by the dental students as well as the community pharmacists.

Reductions in prescription opioid diversion following recent legislative interventions in Florida.

PURPOSE: Florida has been at the center of the nation's ongoing prescription opioid epidemic, with largely unregulated pain clinics and lax prescribing oversight cited as significant contributors to the opioid problem in the state. METHODS: In an effort to mitigate prescription opioid abuse and diversion in Florida, legislative interventions were implemented during 2010 and 2011, which included two primary elements: (i) comprehensive legislation to better regulate the operation of pain clinics; and (ii) a statewide prescription drug monitoring program to promote safer prescribing practices. Using systematic longitudinal data collected on a quarterly basis from law enforcement agencies across Florida, this report examined changes in prescription opioid diversion rates following implementation of these regulatory initiatives. Quarterly diversion rates for buprenorphine, fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, and tramadol were calculated, and subsequently, hierarchical linear models were fit to test for differences in diversion rates over the 15 quarter period of interest. RESULTS: Significant declines in diversion rates were observed for oxycodone, methadone, and morphine; hydrocodone displayed a marginally significant decline. CONCLUSIONS: This study documented reductions in statewide opioid diversion rates following implementation of Florida's pain clinic and prescription drug monitoring program legislative interventions. Although these initial findings appear promising, continued surveillance of diversion is clearly warranted.

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

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.