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Objective The objective of this work was to develop a risk prediction model for opioid overdose and opioid use disorder for patients at first opioid prescription and compare the predictive accuracy of morphine equivalent total dosage with the predictive accuracy of daily dosage . Design Records from patients 18–79 years of age with opioid prescriptions between January 1, 2016, and June 30, 2019, no prior history of adverse outcomes, and no malignant cancer diagnoses were collected from the electronic health record system of a medium-sized central Ohio health care system (n = 219,276). A Cox proportional-hazards model was developed to predict the adverse outcomes of opioid overdose and opioid use disorder from patient sociodemographic, pharmacological, and clinical diagnosis factors. Results During the study time frame, 573 patients experienced overdoses, and 2,571 patients were diagnosed with opioid use disorder. Morphine equivalent total dosage of opioid prescriptions was identified as a stronger predictor of adverse outcomes (C = 0.797) than morphine equivalent daily dosage (C = 0.792), with the best predictions coming from a model that includes both predictors (C = 0.803). In the model with both daily and total dosage predictors, patients receiving a high total / low daily dosage experienced a higher risk (hazard ratio [HR] = 2.17) than those receiving a low total / high daily dosage (HR = 2.02). Those receiving a high total / high daily dosage experienced the greatest risk of all (HR = 3.09). Conclusions These findings demonstrate the value of including morphine equivalent total dosage as a predictor of adverse opioid outcomes and suggest that total dosage may be more strongly correlated with increased risk than daily dosage.

Objectives To determine the effect of one-click integration of a state’s prescription drug monitoring program (PDMP) on the number of PDMP searches and opioid prescriptions, stratified by specialty. Methods Our large health system worked with the state department of public health to integrate the PDMP with the electronic health record (EHR), which enabled providers to query the data with a single click inside the EHR environment. We evaluated Schedule II or III opioid prescriptions reported to the Massachusetts PDMP 6 months before (November 15, 2017-May 15, 2018) and 6 months after (May 16, 2018, to November 16, 2018) integration. Search counts, prescriptions, patients, morphine milligram equivalents, as well as prescriber specialty were compared. Results There were 3,185 unique prescribers with a record of a Schedule II and/or III opioid prescription in both study periods that met inclusion criteria. After integration, the number of PDMP searches increased from 208,684 in the pre-integration phase to 298,478 searches in the post-integration phase (+43.0%). The number of opioid prescriptions dispensed decreased by 4.8%, the number of patients receiving a prescription decreased by 5.1%, and the mean morphine milligram equivalents (MMEs) per prescriber decreased by 5.4%. There were some notable specialty-specific differences in these measures. Conclusions Integration of the PDMP into the EHR markedly increased the number of searches but was associated with modest decreases in opioids prescribed and patients receiving a prescription. Single click EHR integration of the PDMP, if implemented broadly, may be a way for states to significantly increase PDMP utilization.

ObjectiveTo evaluate abuse, misuse, and diversion of Xtampza ER, an extended-release (ER) abuse-deterrent formulation (ADF) of oxycodone.MethodsAbuse, misuse, and diversion of Xtampza ER were assessed using Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System data sources. Xtampza ER was compared with immediate-release (IR) oxycodone, other ADF ER products combined, and non-ADF ER products combined.ResultsXtampza ER prescriptions increased 50-fold during the study period. In contrast, cases from poison centers, substance abuse treatment centers, and diversion were infrequent and did not increase. Adjusted for prescriptions dispensed, poison center exposures were greater for IR oxycodone (rate ratio [RR] = 2.3, P = 0.008), other ADF ER opioids (RR = 5.2, P ConclusionXtampza ER abuse, misuse, and diversion and tampering are low relative to other prescription opioid analgesics. Abuse and diversion did not increase over the study period.

Objective To assess the generalizability of the overdose or serious opioid-induced respiratory depression risk index (VHA-RIOSORD), created by Zedler et al., using claims data from a large private insurer. Design A retrospective nested case–control analysis of health care claims data. Subjects Commercially insured individuals with a claim for an opioid prescription between October 1, 2014, and September 30, 2016 (N = 1,431,737). Methods An overdose or serious opioid–induced respiratory depression (OSORD) occurred in 1,097 patients. Ten controls were selected per case (N = 10,970). Items and the assignment of point values to predictors were consistent with those determined by Zedler et al. Modeling of risk index scores produced predicted probabilities of OSORD; risk classes were defined by the predicted probability distribution. Results All 15 items of the VHA-RIOSORD were used to determine a member’s risk of OSORD. The average predicted probability of experiencing OSORD ranged from 3% in the lowest risk decile to 90% in the highest, with excellent agreement between predicted and observed incidence across risk classes. The model’s C-statistic was 0.88. Conclusions Consistent with the findings of its developers, the VHA-RIOSORD performed well in identifying members of a large private insurance company who were medical users of prescription opioids at elevated risk of overdose or life-threatening respiratory depression, those most likely to benefit from preventive interventions.

Objectives No estimates exist regarding the extent of prescription opioid use among US adults who are the primary caregivers to children. Methods Data were from Wave IV of the National Longitudinal Study of Adolescent to Adult Health. Respondents were age 24 to 32 years. We compared the prevalence of prescription opioid use in the last four weeks and medical conditions with the potential to precipitate use among parents (i.e., one or more children living in the household) and nonparents. We then examined demographics and substance use behaviors among parents with and without recent prescription opioid use. Results A significantly higher percentage of parents (6.7%) compared with nonparents (3.9%) had taken a prescription opioid in the last four weeks, but a significantly lower percentage of parents compared with nonparents reported medical conditions with the potential to precipitate use such as an injury in the last four weeks (2.8% vs 4.0%). A higher percentage of parents with recent prescription opioid use reported financial hardship (44.1% vs 28.2%) and met criteria for risky substance use behaviors such as prescription opioid misuse (26.3% vs 11.8%) compared with parents without recent prescription opioid use. Conclusions Results suggest notable prescription opioid use among young parents in the United States and that parents with recent prescription opioid use are more likely to have a history of inappropriate use of substances. These results highlight the need for additional research regarding the effects of prescription opioid use on parenting behaviors.

Objective To review confidentiality requirements of prescribers who become aware of a forged prescription. Design A case is reviewed in which a prescriber believes that a prescription has been forged. Results The literature and law related to prescription forgery and confidentiality are reviewed. Although prescription forgery is a crime, the prescriber's responsibility for reporting to law enforcement is not clear under current state and federal law. Federal laws and regulations, including the Health Insurance Portability and Accountability Act (HIPAA), do not permit prescribers in all circumstances to disclose prescription fraud to law enforcement. Conclusions Under common circumstances, HIPAA may prohibit prescribers from reporting prescription forgery to law enforcement. However, collaborating with a dispensing pharmacist may offer a lawful pathway to reporting prescription forgery. State legislature may consider laws that clarify the reporting responsibilities of prescribers in cases of prescription forgery.

Objective. The present study builds on research to model abusers' perceptions of particular analgesics' attractiveness for abuse and extends these methods to derive an estimate of attractiveness for abuse of a not-yet-marketed abuse-deterrent formulation (ADF) of a prescription opioid (Remoxy®, Pain Therapeutics, Inc., San Mateo, CA, and King Pharmaceuticals, Inc., Bristol, TN). In a previous study, the Opioid Attractiveness Technology Scaling (OATS) method identified, from a drug abuser's point of view, the particular features of a prescription opioid relevant to its attractiveness for recreational use. A second online sample rated the extent to which these features applied to particular products they had actually used/abused. These data were used to model the abusers' overall preference for prescription opioids they had used/abused. Design. In the present study, this method was applied to a not-yet-marketed ADF using substance abuse counselors as proxies for prescription opioid abusers. Thirty-eight counselors were given materials describing the new ADF along with four known products. Results. Thirty-two counselors demonstrated sufficient agreement with abusers' ratings of the overall attractiveness of these drugs. The overall model yielded a significant pseudo R2 of 0.15 ( P < 0.001), with increasing model fit based on preferred route of administration, from swallowing whole (pseudo R2 = 0.06; P < 0.001) and best for those who preferred to inject (pseudo R2 = 0.40; P < 0.001). Data from a cross-validation group of 16 counselors/proxies were used to calculate the OATS scores for the five rated drugs and revealed significant differences between the ADF and OxyContin® (Purdue Pharma LP, Stamford, CT), Percocet® (Endo Pharmaceuticals, Chadds Ford, PA), and Vicodin® (Abbott Laboratories, Abbott Park, IL), but not Talwin® NX (Sanofi-aventis, Bridgewater, NJ), which was identified in the prior study as a highly unattractive drug for recreational purposes. Conclusions. The OATS method shows promise for providing pre-marketing estimates of attractiveness for abuse of not-yet-marketed ADFs.

Objective. Prescription opioids are the second most misused/abused drug in the United States behind only marijuana. Recreational prescription opioid users appear to prefer some products over others; however, the extent to which attributes of any particular formulation account for such preferences has yet to be determined. The Opioid Attractiveness Technology Scaling was developed to identify the particular features of a prescription opioid that are relevant to its attractiveness for recreational use, and to use these features to model attractiveness for recreational use of particular prescription opioid formulations. Design. Four hundred and ninety-one self-reported recreational prescription opioid users identified 43 product features as being relevant to determining whether a product is “attractive” or “unattractive” for recreational use. Average ratings were used to determine appropriate weights to be applied to the features. A factor analysis yielded 10, highly differentiated factors. Five hundred and sixty-four prescription opioid abusers were then asked to rate the extent to which the 43 features identified in Study 1 were relevant to specific prescription opioid products they had used. Results. Respondents provided an overall preference rating of these products and a model was created. A random intercept model yielded a significant pseudo R2 of 0.14 (chi-square = 310.02, degrees of freedom [df] = 10, P < 0.001). The model fit least well, albeit significantly, for abusers who preferred to swallow the drug (pseudo R2 = 0.06; chi-square = 55.52, df = 10, P < 0.001) and best for those who preferred to inject (pseudo R2 = 0.37; chi-square = 199.34, df = 10, P < 0.001). Conclusions. The relevance of the model is discussed along with possible modifications that might allow prediction of “attractiveness” of “abuse deterrent” formulations that have not yet been marketed.

Prescription opioid pain relievers play an essential role in improving the quality of life for millions of Americans each year. However, over the last decade, the legitimate use as well as the misuse and abuse of prescription opioids have increased dramatically. From 1997 to 2007, the milligram per person use of prescription opioids in the United States increased from 74 mg to 369 mg per person, an increase of 402% [1]. In addition, the health and economic consequences of opioid abuse are exacting a significant toll—with over five million Americans, 12 years of age and older, reporting nonmedical use of prescription opioids in 2009 [2]. From 2004 to 2008, there was a 111% increase in emergency room visits for misuse or abuse of prescription opioids [3], and this was paralleled with a fourfold increase in treatment admissions for abuse of opioids over the last decade [4]. Most alarming is a nearly 300% increase in opioid-related deaths between 1999 and 2007 [5]. Prescription drug abuse is a public health epidemic, and comprehensive policies must be developed to minimize abuse while ensuring legitimate access to these medications. Prescription drug monitoring programs (PDMPs) are a promising tool to assist health care providers in clinical decision-making and to identify patients who may be misusing or abusing prescription drugs. Although studies have shown that PDMPs shorten investigation times [6] and reduce the supply of certain Schedule II controlled …

Primary care providers (PCPs) should be well-positioned to deliver excellent care for patients with chronic pain. We specialize in the long-term care of the whole patient and are expert in the management of chronic disease. Chronic pain conditions are among the most common problems seen in primary care [1]. Furthermore, if opioid prescribing is a marker for attention to pain, we have good evidence that pain is increasingly on the primary care radar screen [2,3]. However, research has demonstrated deficits in the quality of primary care pain treatment [4]. Why do we often fall short in providing optimal pain management in primary care? In this issue, Dobscha et al. provide evidence that most often it is not because of a lack of interest or concern about treating pain [5]. In their survey of 45 PCPs practicing in five clinics affiliated with one Veterans Administration (VA) Medical Center, they found that a large majority believed skilled pain management was a high priority and were confident in their abilities to treat chronic pain. The study confirms that opioid prescribing has become a routine part of primary care practice; in the average provider panel, one of six patients had a current opioid prescription. Primary care providers …

This Supplement to Pain Medicine emerges from the editors' and authors' longstanding commitment to the primary axiom of Medicine: first do no harm (nonmaleficence). There is no question that opioids can and do have serious adverse effects, even when used correctly and for justifiable reasons. For that purpose alone, it is important to review the exigent literature on the effects of long-term opioid use and critically analyze outcomes in order to provide clarity and guidance for practitioners who care for patients with debilitating pain conditions. The burgeoning rate of prescription opioid misuse, …

The use of opioid analgesics for the management of chronic pain has come under increasing scrutiny for a variety of reasons. The paucity of studies on their efficacy is of most importance, but the potential adverse events associated with extended use of these medications are also of concern. One of these is the association between opioid use and coronary heart disease (CHD). Although the cardiotoxic effects of methadone have long been recognized and are often given as the primary reason why this drug should be avoided, less attention has been paid to whether other opioids should similarly be prescribed with marked caution, if at all, to patients with CHD. The finding by Khodneva et al. [1] that prescription opioid use may be associated with an increased risk of CHD and cardiovascular disease (CVD) deaths, especially … kingpain{at}gmail.com

The difficulty in evaluating patients on opioids and other centrally acting drugs has never been more prevalent. Though as noted below, the American Academy of Pain Medicine (AAPM) remains a credible source for information regarding pain. On January 28, 2015 the Coast Guard published a Federal Register notice requesting public comment on its proposed policy for evaluating merchant mariners who require the use of potentially impairing medications. https://www.federalregister.gov/articles/2015/01/28/2015-01623/request-for-public-comment-on-waiver-revisions-for-certain-medications-and-suggestions-for-risk Last month Adrienne Buggs, MD, FACEP, Medical Technical Advisor from the U.S. Coast Guard Headquarters, called me asking whether the American Academy of Pain Medicine was in a position to comment on the policy. Many of you are aware of the difficulty we all face evaluating patients on opioids and other centrally …

In his contribution, Dr. Cain has made an excellent point regarding the plight of primary care physicians (PCPs), the professionals who provide over half of all chronic pain care in the United States [1]. Only so much time can be spent in the classroom, particularly given their growing patient loads as the PCP shortage approaches crisis proportions. Dr. Cain also makes an astute observation that mandatory CME is not a panacea to the prescription opioid abuse crisis in the United States. Dr. Manworren expresses considerable concern regarding the quality of pain management in the United States, noting the research indicating that most PCPs feel neither prepared nor comfortable providing pain management. She also notes that the quality of pain education needs to improve, particularly given that issues of conflict …

Successful marketing of “designer” opioids (new formulations to either extend activity or speed onset) contributed appreciably to the vast increases in opioid prescribing for pain that occurred in the United States in the 1980s and 1990s [1]. Some in the medical community were persuaded that because the new formulations could produce a steady state, thus avoiding peak concentrations, they were less likely to cause addiction and could be used safely and effectively for long-term treatment of chronic pain [2]. Extending opioids to patients with chronic pain had clear advantages in terms of the market: chronic pain is commonplace, and it lasts forever. Regulations that require clinicians to be registered and monitored when prescribing controlled substances had countered misuse of prescription opioids fairly effectively throughout most of the 20th century. But with the recent precipitous rise in opioid prescribing, prescription opioid misuse increased in parallel [3]. Prescription opioid abuse, misuse, overdose, and death rates have all proliferated, often spreading from the individuals receiving treatment, to those around them [4]. Prescription opioids freely available in the community led to more misuse. Prescription opioid misuse is now seen by the regulatory authorities as a societal problem of enormous proportions and one that needs urgent intervention. Since immediate action is warranted, it has been decided that the Food and Drug Administration (FDA) should act under authority already in place given to it by the 2007 FDA Amendments Act. Under this authority, the FDA will require drug companies to develop, use, and continuously evaluate new Risk Evaluation and Mitigation Strategies (REMS). Previous REMS had focused on informing prescribers …