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.

The association between nonmedical use of prescription drugs and extreme weight control behavior among adolescents.

Although extreme weight control behavior (EWCB) is associated with substance use, no research has examined the association between the nonmedical use of prescription drugs (NMUPD) and EWCB. Self-report data were collected from a sample of 4,148 students in Grades 9-12 enrolled in 5 high schools across the United States. Logistic regression models were constructed to examine the nonmedical use of prescription pain relievers, depressants, stimulants, and a composite measure for any NMUPD, and the EWCB of fasting, use of diet pills, powders, or liquids, and vomiting or laxative use. Models were estimated before and after controlling for key covariates for males and females. Approximately 16% of respondents reported any EWCB during the past 30 days, while 11% reported any NMUPD during the past 30 days. After covariate adjustment, any NMUPD was associated with any EWCB in both males and females (p < .05), and all EWCB remained significant in females who reported prescription pain reliever use (p < .01), with 2 out of 3 remaining significant for prescription stimulant and depressant use (p < .01). The only significant association detected for males was between prescription pain reliever use and using diet pills, powders, or liquids (OR = 2.2, p < .01). Results suggest significant associations between NMUPD and EWCB, with variations by sex. These findings provide directions for additional research and point to several potential identification and intervention efforts. (PsycINFO Database Record

Measures That Identify Prescription Medication Misuse, Abuse, and Related Events in Clinical Trials: ACTTION Critique and Recommended Considerations.

Accurate assessment of inappropriate medication use events (ie, misuse, abuse, and related events) occurring in clinical trials is an important component in evaluating a medication's abuse potential. A meeting was convened to review all instruments measuring such events in clinical trials according to previously published standardized terminology and definitions. Only 2 approaches have been reported that are specifically designed to identify and classify misuse, abuse, and related events occurring in clinical trials, rather than to measure an individual's risk of using a medication inappropriately: the Self-Reported Misuse, Abuse, and Diversion (SR-MAD) instrument and the Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS). The conceptual basis, strengths, and limitations of these methods are discussed. To our knowledge, MADDERS is the only system available to comprehensively evaluate inappropriate medication use events prospectively to determine the underlying intent. MADDERS can also be applied retrospectively to completed trial data. SR-MAD can be used prospectively; additional development may be required to standardize its implementation and fully appraise the intent of inappropriate use events. Additional research is needed to further demonstrate the validity and utility of MADDERS as well as SR-MAD. PERSPECTIVE: Identifying a medication's abuse potential requires assessing inappropriate medication use events in clinical trials on the basis of a standardized event classification system. The strengths and limitations of the 2 published methods designed to evaluate inappropriate medication use events are reviewed, with recommended considerations for further development and current implementation.

Secular trends in opioid prescribing in the USA.

Opioid abuse and misuse in the USA is a public health crisis. The use of prescription opioid analgesics increased substantially from 2002 through 2010, then plateaued and began to decrease in 2011. This study examined prescriptions of branded and generic immediate- and extended-release opioid analgesics from 1992 to 2016. This was juxtaposed against state and federal policies designed to decrease overutilization and abuse, as well as the launch of new opioid products, including opioids with abuse-deterrent properties (OADPs). The data indicate that these health policies, including the utilization and reimbursement of OADPs, have coincided with decreased opioid utilization. The hypothesis that OADPs will paradoxically increase opioid prescribing is not supported.

Opioids with abuse-deterrent properties: A regulatory and technological overview.

Three concurrent public health problems coexist in the United States: endemic nonmedical use/misuse of opioid analgesics, epidemic overdose fatalities involving opioid analgesics, and endemic chronic pain in adults. These intertwined issues comprise an opioid crisis that has spurred the development of formulations of opioids with abuse-deterrent properties and label claims (OADP). To reduce abuse and misuse of prescription opioids, the federal Food and Drug Administration (FDA) has issued a formal Guidance to drug developers that delineates four categories of testing to generate data sufficient for a description of a product's abuse-deterrent properties, along with associated claims, in its Full Prescribing Information (FPI). This article reviews the epidemiology of the crisis as background for the development of OADP, summarizes the FDA Guidance for Industry regarding abuse-deterrent technologies, and provides an overview of some technologies that are currently employed or are under study for incorporation into OADP. Such technologies include physical and chemical barriers to abuse, combined formulations of opioid agonists and antagonists, inclusion of aversive agents, use of delivery systems that deter abuse, development of new molecular entities and prodrugs, and formulation of products that include some combination of these approaches. Opioids employing these novel technologies are one part of a comprehensive intervention strategy that can deter abuse of prescription opioid analgesics without creating barriers to the safe use of prescription opioids. The maximal public health contribution of OADP will probably occur only when all opioids have FDA-recognized abuse-deterrent properties and label claims.

Caveat emptor: Erroneous safety information about opioids in online drug-information compendia.

BACKGROUND: Healthcare professionals and consumers refer to online drug-information compendia (eg, Epocrates and WebMD) to learn about prescription medications, including opioid analgesics. With the significant risks associated with opioids, including abuse, misuse, and addiction, any of which can result in life-threatening overdose, it is important for those seeking information from online compendia to have access to current, accurate, and complete drug information to help support clinical treatment decisions. Although compendia are informative, readily available, and user friendly, studies have shown that they may contain errors. OBJECTIVE: To review and identify misinformation in drug summaries of online drug-information compendia for selected opioid analgesic products and submit content corrections to the respective editors. METHODS: Between 2011 and 2013, drug summaries for Purdue's prescription opioid analgesic products from seven leading online drug-information compendia were systematically reviewed, and the requests for corrections were retrospectively categorized and classified. At least 2 months following requests, the same compendia were then reexamined to assess the degree of error resolution. RESULTS: A total of 859 errors were identified, with the greatest percentage in Safety and Patient Education categories. Across the seven compendia, the complete or partial resolution of errors was 34 percent; therefore, nearly two thirds of the identified errors remain. CONCLUSION: The results of this analysis, consistent with past studies, demonstrate that online drug-information compendia may contain inaccurate information. Healthcare professionals and consumers must be informed of potential misinformation so they may consider using multiple resources to obtain accurate and current drug information, thereby helping to ensure safer use of prescription medications, such as opioids.

Assessment of physical function and participation in chronic pain clinical trials: IMMPACT/OMERACT recommendations.

Although pain reduction is commonly the primary outcome in chronic pain clinical trials, physical functioning is also important. A challenge in designing chronic pain trials to determine efficacy and effectiveness of therapies is obtaining appropriate information about the impact of an intervention on physical function. The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) and Outcome Measures in Rheumatology (OMERACT) convened a meeting to consider assessment of physical functioning and participation in research on chronic pain. The primary purpose of this article is to synthesize evidence on the scope of physical functioning to inform work on refining physical function outcome measurement. We address issues in assessing this broad construct and provide examples of frequently used measures of relevant concepts. Investigators can assess physical functioning using patient-reported outcome (PRO), performance-based, and objective measures of activity. This article aims to provide support for the use of these measures, covering broad aspects of functioning, including work participation, social participation, and caregiver burden, which researchers should consider when designing chronic pain clinical trials. Investigators should consider the inclusion of both PROs and performance-based measures as they provide different but also important complementary information. The development and use of reliable and valid PROs and performance-based measures of physical functioning may expedite development of treatments, and standardization of these measures has the potential to facilitate comparison across studies. We provide recommendations regarding important domains to stimulate research to develop tools that are more robust, address consistency and standardization, and engage patients early in tool development.

Adolescent Nonmedical Use of Prescription Pain Relievers, Stimulants, and Depressants, and Suicide Risk.

BACKGROUND: Although the link between drug abuse and suicide risk is established, few studies have examined the relationship between the nonmedical use of prescription drugs (NMUPD) and suicide risk, particularly among adolescents. OBJECTIVES: To explore the relationship between NMUPD and suicide risk among 4,148 adolescents in grades 9-12 enrolled in five public high schools. METHODS: Logistic regression models were constructed for the nonmedical use of prescription pain relievers, depressants, stimulants, and a composite measure for any NMUPD. Models were estimated before and after controlling for key covariates. RESULTS: About 21% of respondents reported lifetime NMUPD. After covariate adjustment, students who had reported any NMUPD were between 1.7 and 2.3 times more likely to report suicidal ideation, but not a suicide attempt (p < .0001). When stratified by sex and drug, nonmedical use of pain relievers, stimulants, and depressants were significantly associated with greater odds of suicidal ideation and behavior for both males and females (p < .05). However, NMUPD of pain relievers were not associated with greater odds of suicide attempts for males or females or among males who reported nonmedical use of stimulants. Nonmedical use of depressants was associated with greater odds of suicide attempts for both males and females (OR = 1.61 and 2.25, respectively) and among females who reported nonmedical use of stimulants (OR = 2.06, p < .01). CONCLUSIONS/IMPORTANCE: Results suggest that some adolescents may be inappropriately self-medicating psychological distress with prescription medications or NMUPD may promote suicide risk, especially for males and females who use depressants and females who use stimulants.

Implementing a Process to Review Product-Specific Misinformation in Online Drug Information Compendia.

Health care professionals and consumers often use online drug information compendia, which are intended to be user-friendly, readily available, accurate, and up-to-date. While these resources can be valuable, it has been shown that some compendia contain inaccuracies and outdated information, motivating the Medical Services (medical information) Department at Purdue Pharma LP to implement a periodic, standardized review of select online drug information compendia. Monographs within compendia for up to 9 Purdue products were reviewed and compared to their current Full Prescribing Information, with a focus on identifying safety-related misinformation. Content correction requests for nearly 1000 errors were submitted to 7 compendia clinical editors. This surprisingly large number of errors highlights the need for compendia to better maintain accurate product monographs, as well as for pharmaceutical companies to proactively and periodically review them for misinformation. Based on these findings, an overview on how the pharmaceutical industry may implement a drug information compendia review process is provided.

Key Data Gaps Regarding the Public Health Issues Associated with Opioid Analgesics.

Most pharmaceutical opioids are used to treat pain, and they have been demonstrated to be effective medications for many. Their abuse and misuse pose significant public health concerns in the USA. Research has provided much insight into the prevalence, scope, and drivers of opioid abuse, but a holistic understanding is limited by a lack of available data regarding key aspects of this public health problem. Twelve data gaps were revealed during the creation of a systems-level computer model of medical use, diversion, nonmedical use, and the adverse outcomes associated with opioid analgesics in the USA. Data specific to these gaps would enhance the validity and real-world applications of systems-level models of this public health problem and would increase understanding of the complex system in which use and abuse occur. This paper provides an overview of these gaps, argues for the importance of closing them, and provides specific recommendations for future data collection efforts.

Voices that may not otherwise be heard: a qualitative exploration into the perspectives of primary care patients living with chronic pain.

BACKGROUND: Although psychometrically sound pain assessment tools are available, there is a paucity of research that comprehensively defines chronic pain from the perspective of patients. The purpose of this study was to examine the utility of a combination of qualitative methods (Photovoice, one-on-one interviews, and focus groups) in examining the daily experiences of primary care patients living with chronic pain. METHODS: A sample of English-speaking primary care patients aged 30 years or older, who had been prescribed an opioid for long-term, noncancer pain management, participated in the study. Each patient took photographs that best reflected both his/her experiences with chronic pain and what he/she would like his/her life to be without chronic pain. RESULTS: Patients submitted an average of 20.2±3.1 photographs (range =8-27 photographs). Analysis of one-on-one interviews illuminated five dominant themes: daily need for multiple medications, including opioids; difficulties climbing a flight of stairs; struggling to get out of bed in the morning; extreme challenges with participating in day-to-day life activities; and experiencing feelings of hopelessness and helplessness on a regular basis. Seven themes emerged from the focus groups: undesired effects/burdens of medications, loss of/striving for independence, effect on social interactions/relationships, pain effect on activities of daily living, constant search for convenience/a better situation, interactions with physicians, and frustration/depression with pain. CONCLUSION: The qualitative methods employed in this study provide deep insight into perceptions and experiences of patients living with chronic pain that is vital for informing future clinical interventions.

Modeling the impact of simulated educational interventions on the use and abuse of pharmaceutical opioids in the United States: a report on initial efforts.

Three educational interventions were simulated in a system dynamics model of the medical use, trafficking, and nonmedical use of pharmaceutical opioids. The study relied on secondary data obtained in the literature for the period of 1995 to 2008 as well as expert panel recommendations regarding model parameters and structure. The behavior of the resulting systems-level model was tested for fit against reference behavior data. After the base model was tested, logic to represent three educational interventions was added and the impact of each intervention on simulated overdose deaths was evaluated over a 7-year evaluation period, 2008 to 2015. Principal findings were that a prescriber education intervention not only reduced total overdose deaths in the model but also reduced the total number of persons who receive opioid analgesic therapy, medical user education not only reduced overdose deaths among medical users but also resulted in increased deaths from nonmedical use, and a "popularity" intervention sharply reduced overdose deaths among nonmedical users while having no effect on medical use. System dynamics modeling shows promise for evaluating potential interventions to ameliorate the adverse outcomes associated with the complex system surrounding the use of opioid analgesics to treat pain.

Development and validation of the Patient Opioid Education Measure.

BACKGROUND: Although there are screening tools to aid clinicians in assessing the risk of opioid misuse, an instrument to assess opioid-related knowledge is not currently available. The purpose of this study was to develop a content-valid, understandable, readable, and reliable Patient Opioid Education Measure (POEM). METHODS: Using concept mapping, clinicians caring for patients with chronic pain participated in brainstorming, sorting, and rating need-to-know information for patients prescribed opioids. Concept mapping analyses identified seven clusters addressing knowledge and expectations associated with opioid use, including medicolegal issues, prescribing policies, safe use and handling, expected outcomes, side effects, pharmacology, and warnings. RESULTS: The 49-item POEM was verbally administered to 83 patients (average age 51.3 ± 9.8 years, 77.1% female, 47.1% African American) taking opioids for chronic nonmalignant pain. Patients averaged in total 63.9% ± 14.3% (range 23%-91%) correct responses on the POEM. The POEM demonstrated substantial test-retest reliability (interclass correlation coefficient 0.87). The POEM had a mean readability Lexile (L) score of 805.9 ± 257.3 L (equivalent to approximately a US fifth grade reading level), with individual items ranging from 280 L to 1370 L. CONCLUSION: The POEM shows promise for rapidly identifying patients' opioid-related knowledge gaps and expectations. Correcting misunderstandings and gaps could result in safer use of opioids in a clinical care setting.

System dynamics modeling as a potentially useful tool in analyzing mitigation strategies to reduce overdose deaths associated with pharmaceutical opioid treatment of chronic pain.

OBJECTIVE: To illustrate a system-level, simulation-based approach for evaluating mitigation strategies to address the dramatic rise in abuse, addiction, and overdose deaths associated with the use of pharmaceutical opioid analgesics to treat chronic pain. SIMULATED INTERVENTIONS: Making available drug formulations with increased tamper-resistance, prescriber education programs, and programs that reduce rates of medical user-related abuse and addiction. SIMULATED OUTCOME MEASURE: Number of overdose deaths of medical users of pharmaceutical opioid analgesics, including those who abuse or have become addicted. METHODS: A demonstration system dynamics model is developed, tested, and used to evaluate the impact of candidate mitigation strategies on the outcome measures. RESULTS: Tamper-resistant drug products will likely reduce overdose death rates but may not reduce overall deaths if there is increased prescribing. Prescriber education would likely reduce deaths through a reduction in patient access to pharmaceutical opioid analgesics. CONCLUSIONS: The system dynamics approach may have potential for opioid-related policy evaluation. However, metrics must be carefully selected, and trade-offs may be involved. For example, it may be difficult to limit negative outcomes associated with pharmaceutical opioids without adversely affecting chronic pain patients' access to pharmaceutical treatment. Ultimately, a combination of metrics and value judgments will be needed to properly evaluate mitigation strategies.

Position paper: appropriate use of pharmacotherapeutic agents by the orofacial pain dentist.

Orofacial Pain Dentistry is concerned with the prevention, evaluation, diagnosis, treatment, and management of persistent and recurrent orofacial pain disorders. The American Dental Association, through the Commission on Dental Accreditation (CODA), now recognizes Orofacial Pain as an area of advanced education in Dentistry. It is mandated by CODA that postgraduate orofacial pain programs be designed to provide advanced knowledge and skills beyond those of the standard curriculum leading to the DDS or DMD degrees. Postgraduate programs in orofacial pain must include specific curricular content to comply with CODA standards. The intent of CODA standards is to assure that training programs develop specific educational goals and objectives that describe the student/resident's expected knowledge and skills upon successful completion of the program. A standardized core curriculum, required for accreditation of dental orofacial pain training programs, has now been adopted.Among the various topics mandated in the curriculum are pharmacology and, specifically, pharmacotherapeutics. The American Academy of Orofacial Pain (AAOP) recommends, and the American Board of Orofacial Pain (ABOP) requires, that the minimally competent orofacial pain dentist* be knowledgeable in the management of orofacial pain conditions using medications when indicated. Basic knowledge of the appropriate use of pharmacotherapeutics is essential for the orofacial pain dentist and, therefore, constitutes part of the examination specifications of the ABOP. The minimally competent orofacial pain clinician must demonstrate knowledge, diagnostic skills, and treatment expertise in many areas, such as musculoskeletal, neurovascular, and neuropathic pain syndromes; sleep disorders related to orofacial pain; orofacial dystonias; and intraoral, intracranial, extracranial, and systemic disorders that cause orofacial pain or dysfunction. The orofacial pain dentist has the responsibility to diagnose and treat patients in pain that is often chronic, multifactorial, and complex. Failure to understand pain mechanisms can lead to inaccurate diagnoses and ineffective, delayed, or harmful treatment. It is the responsibility of the orofacial pain dentist to accurately diagnose the cause(s) of the pain and decide if treatment should be dentally, medically, or psychologically oriented, or if optimal management requires a combination of all three treatment approaches. Management may consist of a number of interdisciplinary modalities including, eg, physical medicine, behavioral medicine, and pharmacology or, in rare instances, surgical interventions. Among the essential armamentarium is the knowledge and proper use of pharmacologic agents.

Opioid pharmacotherapy for chronic non-cancer pain in the United States: a research guideline for developing an evidence-base.

UNLABELLED: This document reports the consensus of an interdisciplinary panel of research and clinical experts charged with reviewing the use of opioids for chronic noncancer pain (CNCP) and formulating guidelines for future research. Prescribing opioids for chronic noncancer pain has recently escalated in the United States. Contrasting with increasing opioid use are: 1) The lack of evidence supporting long-term effectiveness; 2) Escalating misuse of prescription opioids including abuse and diversion; and 3) Uncertainty about the incidence and clinical salience of multiple, poorly characterized adverse drug events (ADEs) including endocrine dysfunction, immunosuppression and infectious disease, opioid-induced hyperalgesia and xerostomia, overdose, falls and fractures, and psychosocial complications. Chief among the limitations of current evidence are: 1) Sparse evidence on long-term opioid effectiveness in chronic pain patients due to the short-term time frame of clinical trials; 2) Insufficiently comprehensive outcome assessment; and 3) Incomplete identification and quantification of ADEs. The panel called for a strategic interdisciplinary approach to the problem domain in which basic scientists and clinicians cooperate to resolve urgent issues and generate a comprehensive evidence base. It offered 4 recommendations in 3 areas: 1) A research strategy for studying the effectiveness of long-term opioid pharmacotherapy; 2) Improvements in evidence-generation methodology; and 3) Potential research topics for generating new evidence. PERSPECTIVE: Prescribing opioids for CNCP has outpaced the growth of scientific evidence bearing on the benefits and harms of these interventions. The need for a strong evidence base is urgent. This guideline offers a strategic approach to creating a comprehensive evidence base to guide safe and effective management of CNCP.

Development and reliability of items measuring the nonmedical use of prescription drugs for the Youth Risk Behavior Survey: results from an initial pilot test.

BACKGROUND: The purpose of this study was to develop and test the reliability of self-report survey items designed to monitor the nonmedical use of prescription drugs among adolescents. METHODS: Eighteen nonmedical prescription drug items designed to be congruent with the substance abuse items in the US Centers for Disease Control and Prevention's (CDC's) Youth Risk Behavior Survey were constructed, reviewed by a panel of experts, and then examined to assess reliability using a test-retest survey design. RESULTS: Simple kappa (kappa) coefficients for 14 of the 18 items demonstrated "substantial" or "almost perfect" reliability. Three items had coefficients within the "fair" or "moderate" ranges and 1 item fell within in the "poor" range. Of the 10 items for which weighted kappa coefficients were calculated, 6 items fell within the "almost perfect" or "substantial" ranges. Three fell within the "moderate" range and 1 fell within the "poor" range. CONCLUSIONS: Based on the expert panel review and the findings from our study, most of the 18 items developed to measure nonmedical use of prescription drugs among adolescents appear valid and reliable. The nonmedical use of prescription drugs ranks fourth among the most abused class of drugs by adolescents after alcohol, tobacco, and marijuana, respectively. The CDC should consider expanding the surveillance of these specific health-risk behaviors that are assuming new importance by including the items described in this article in future national surveys.

RxPATROL: a Web-based tool for combating pharmacy theft.

OBJECTIVE: To report the incidence of pharmacy-related burglaries and robberies and characteristics of pharmacies where such crimes have occurred using recent data from Rx Pattern Analysis Tracking Robberies & Other Losses (RxPATROL), a national Web-based information clearinghouse on pharmacy-related theft of prescription medications and over-the-counter products. DESIGN: Descriptive, nonexperimental study. SETTING: United States between 2005 and 2006. PARTICIPANTS: Not applicable. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Number of pharmacy theft reports received; incident type, date, and location; point of entry; and pharmacy security features. RESULTS: Between 2005 and 2006, 202 pharmacy burglary and 299 pharmacy robbery reports from 45 different states were filed with RxPATROL. More than 70% of pharmacies reporting such crimes lacked a security camera. Among those reporting a burglary, 60% lacked dead bolt locks, a solid exterior door, a motion detector device, or a safe or vault for storage of controlled substances. Burglars most often obtained access to the pharmacy via the front door. CONCLUSION: RxPATROL is a Web-based tool that can assist pharmacies and law enforcement in collaborating more effectively to combat and prevent pharmacy-related crimes.