Trends in Urine Drug Monitoring Among Persons Receiving Long-Term Opioids and Persons with Opioid Use Disorder in the United States

BACKGROUND: Practice guidelines recommend urine drug monitoring (UDM) at least annually in the setting of chronic opioid therapy as an objective assessment of substance use. However, empirical evidence on who gets tested and how often testing occurs is lacking. OBJECTIVES: This study investigates 10-year UDM trends in the United States based on 2 factors: (1) the duration of prescription opioid treatment, and (2) having an opioid use disorder (OUD) diagnosis and medications for opioid use disorder (MOUD) prescriptions. STUDY DESIGN: Observational cross-sectional study. SETTING: Research was conducted using administrative claims data from Optum’s deidentified Clinformatics Data Mart Database for the period 2007 to 2016. The dataset contained information on the plan enrollment and health care claims from 50 states and the District of Columbia. METHODS: To examine trends in UDM based on the duration of prescription opioid treatment, persons receiving prescription opioid analgesics were categorized into 4 groups based on the number of days covered: (a) less than 90 days, (b) 90 to 179 days, (c) 180 to 269 days, and (d) at least 270 days. To examine trends based on an OUD diagnosis and MOUD prescriptions, persons diagnosed with OUD were identified and categorized based on the presence of MOUD prescriptions as follows: (a) OUD with buprenorphine (BPN) and naltrexone (NTX) in the same year; (b) OUD with BPN only; (c) OUD with NTX only; (d) OUD with chronic prescription opioid analgesics (≥ 90 days); (e) OUD without prescription opioid analgesics, BPN, or NTX; and (f) chronic prescription opioid analgesics (≥ 90 days) without an OUD diagnosis. For analysis, the percent receiving UDM was estimated per group per year. Then the data were restricted to those receiving at least one UDM to estimate the average number of UDM per person. RESULTS: Data included an average of 364,485 persons per year receiving prescription opioid analgesics for chronic use, and 10,277 per year receiving an OUD diagnosis. Among those receiving prescription opioid analgesics, less than 50% received UDM. For those receiving at least one UDM, one additional UDM was performed per person as the duration of opioids increased by 90 days. Among persons with OUD, the percent receiving UDM was the highest for those receiving both BPN and NTX (87%), followed by those receiving BPN only (80%), chronic opioids (79%), NTX only (72%), and those not receiving any MOUD/opioids (54%). LIMITATIONS: Methadone dispensing for OUD treatments was not captured in administrative claims data. CONCLUSIONS: Although recommended for patients with chronic pain, UDM is provided less than half of the time for these patients. However, once patients received at least one UDM, they would continue to receive it on a fairly regular basis. Compared with those with chronic pain, persons diagnosed with OUD are more likely to receive UDM at a more frequent interval. KEY WORDS: Urine drug monitoring, urine drug testing, urine drug screening, chronic pain, opioid use disorder, prescription opioid analgesic, buprenorphine, naltrexone, medications for opioid use disorder

Postmarketing Analysis of Misuse, Abuse, and Diversion of Xtampza ER

Objective To evaluate abuse, misuse, and diversion of Xtampza ER, an extended-release (ER) abuse-deterrent formulation (ADF) of oxycodone. Methods Abuse, 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. Results Xtampza 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 < 0.001), and non-ADF ER opioids (RR = 2.5, P = 0.004) than for Xtampza ER. In Treatment Center Programs Combined, past-month abuse prevalence for other ADF ER opioids (odds ratio [OR] = 7.4, P < 0.001) and non-ADF ER opioids (OR = 2.0, P = 0.002) was greater than Xtampza ER; IR oxycodone was not significantly different (OR = 1.2, P = 0.349). In the Drug Diversion Program, rates for IR oxycodone (RR = 3.7, P = 0.003), other ADF ER opioids (RR = 4.2, P = 0.002), and non-ADF ER opioids (RR = 3.4, P = 0.007) were greater than Xtampza ER. Adjustment using morphine equivalents provided similar results, except that IR oxycodone in Treatment Center Programs Combined became higher than Xtampza ER. Nonoral abuse cases involving Xtampza ER were infrequent; Web monitoring data support findings that Xtampza ER is difficult to abuse nonorally. Conclusion Xtampza 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.

National estimates of substance use, substance use disorders, and treatment among adolescent and young adult cancer survivors.

7042 Background: Adolescent and young adult (AYA) survivors of cancer are at an elevated risk of early-life morbidity and mortality due to the disease trajectory and treatment. Engagement in risk behaviors, including substance use, can exacerbate survivors’ vulnerabilities and place them at further risk for adverse health outcomes. This study provides national estimates of the prevalence of substance use and misuse, substance abuse or dependence (i.e., substance use disorders [SUD]), and receipt of treatment for SUD among AYA cancer survivors. Methods: We used 2015-2018 National Survey of Drug Use and Health data to identify a nationally-representative AYA sample (aged 12-34 years). Outcomes included past-year alcohol use, marijuana use, other illicit drug use, misuse of any prescription psychotherapeutic drugs (including opioid analgesics, stimulants, sedatives, or tranquilizers), and misuse of prescription opioid analgesics. Outcomes also assessed past-year SUD in aforementioned drug classes. Among those with SUD, we evaluated past-year receipt of SUD treatment. Multiple logistic regressions were estimated to compare outcomes between 846 AYAs who reported a cancer history and 142,870 AYAs who did not, adjusting for sociodemographic and need-related characteristics. Results: In bivariate analyses, AYAs with a cancer history were more likely than noncancer peers to use alcohol (78.6% vs. 63.4%; p< 0.001) and illicit drugs other than marijuana (11.2% vs. 7.8%; p= 0.02), misuse any prescription psychotherapeutic drugs (16.9% vs. 10.6%; p< 0.001) and prescription opioid analgesics (12.0% vs. 5.9%; p< 0.001), and have an illicit drug (other than marijuana) SUD (3.7% vs. 1.3%; p< 0.01) in the past year. In regression analyses, differences in past-year misuse of any prescription psychotherapeutic drug and prescription opioid analgesics persisted ( p= 0.02, p< 0.01, respectively). Among AYAs with SUD, those with a cancer history were more likely than noncancer peers to receive SUD treatment (21.0% vs. 8.1%; p= 0.01) in the past year; this difference persisted in regression analyses ( p= 0.03). Conclusions: AYAs with a cancer history had an elevated risk for misusing prescription psychotherapeutic medications, which was driven by misuse of prescription opioids; yet, only one in five AYAs with a cancer history and SUD received treatment. Our findings underscore the need for future interventions designed to reduce substance use and misuse and improve access to SUD treatment in AYA cancer survivors.

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.