Howard Chilcoat

Abuse Rates and Routes of Administration of Reformulated Extended-Release Oxycodone: Initial Findings From a Sentinel Surveillance Sample of Individuals Assessed for Substance Abuse Treatment

UNLABELLED Oxycodone hydrochloride controlled-release, also known as extended-release oxycodone (ER oxycodone), was reformulated with physicochemical barriers to crushing and dissolving intended to reduce abuse through nonoral routes of administration (ROAs) that require tampering (eg, injecting and snorting). Manufacturer shipments of original ER oxycodone (OC) stopped on August 5, 2010, and reformulated ER oxycodone (ORF) shipments started August 9, 2010. A sentinel surveillance sample of 140,496 individuals assessed for substance abuse treatment at 357 U.S. centers between June 1, 2009, and March 31, 2012, was examined for prevalence and prescription-adjusted prevalence rates of past-30-day abuse via any route, as well as abuse through oral, nonoral, and specific ROAs for ER oxycodone and comparators (ER morphine and ER oxymorphone) before and after ORF introduction. Significant reductions occurred for 8 outcome measures of ORF versus OC historically. Abuse of ORF was 41% lower (95% CI: -44 to -37) than historical abuse for OC, with oral abuse 17% lower (95% CI: -23 to -10) and nonoral abuse 66% lower (95% CI: -69 to -63). Significant reductions were not observed for comparators. Observations were consistent with the goals of a tamper resistant formulation for an opioid. Further research is needed to determine the persistence and generalizability of these findings. PERSPECTIVE This article presents preliminary findings indicating that 8 outcome measures of abuse of a reformulated ER oxycodone were lower than that for original ER oxycodone historically, particularly through nonoral ROAs that require tampering (ie, injection, snorting, smoking), in a sentinel sample of individuals assessed for substance use problems for treatment planning.

Reduced Abuse, Therapeutic Errors, and Diversion Following Reformulation of Extended-Release Oxycodone in 2010

UNLABELLED This study evaluated changes in abuse exposures, therapeutic error exposures, and diversion into illegal markets associated with brand extended-release oxycodone (ERO) following introduction of reformulated ERO. Original ERO and reformulated ERO street prices also were compared. Data from the Poison Center and Drug Diversion programs of the Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System were used. Quarterly rates 2 years prior to introduction of reformulated ERO (October 2008 through September 2010) were compared to quarterly rates after introduction (October 2010 through March 2012) using negative binomial regression. Street prices were compared using a mixed effects linear regression model. Following reformulated ERO introduction, poison center ERO abuse exposures declined 38% (95% confidence interval [CI]: 31-45) per population and 32% (95% CI: 24-39) per unique recipients of dispensed drug. Therapeutic error exposures declined 24% (95% CI: 15-31) per population and 15% (95% CI: 6-24) per unique recipients of dispensed drug. Diversion reports declined 53% (95% CI: 41-63) per population and 50% (95% CI: 39-59) per unique recipients of dispensed drug. Declines exceeded those observed for other prescription opioids in aggregate. After its introduction, the street price of reformulated ERO was significantly lower than original ERO. PERSPECTIVE This article indicates that the abuse, therapeutic errors, and diversion of ERO declined following the introduction of a tamper-resistant reformulation of the product. Reformulating abused prescription opioids to include tamper-resistant properties may be an effective approach to reduce abuse of such products.

The impact of a reformulation of extended-release oxycodone designed to deter abuse in a sample of prescription opioid abusers

BACKGROUND Prescription opioid abuse is a significant public health concern that requires strategies to reduce its impact, including development of abuse deterrent formulations. OxyContin, an extended-release oxycodone (ERO) formulation, has been widely abused. This study assessed the effects of reformulated ERO, designed to be more difficult to manipulate for purposes of intranasal and intravenous abuse, on patterns of opioid abuse among a sample of individuals from rural Appalachia with a history of ERO abuse. METHODS Structured interviews assessing opioid abuse (past 30-day abuse and retrospectively reported abuse prior to the reformulation in August 2010) were completed by 189 individuals between December 2010 and September 2011. RESULTS The past 30-day prevalence and frequency of reformulated ERO abuse through any route (33%, 1.9 days/month), snorting (5%, 0.2 days/month), and injecting (0.5%, <0.1 days/month) were low and infrequent compared to that of IR oxycodone (any route: 96%, 19.5 days/month; snorting: 70%, 10.3 days/month; injecting: 51%, 10.5 days/month) and retrospectively reported abuse of original ERO in August 2010 (any route: 74%, 13.4 days/month; snorting: 39%, 6.0 days/month; injecting: 41%, 8.6 days/month). After the reformulation, the prevalence of original ERO abuse significantly declined while abuse of reformulated ERO remained steadily low. Heroin abuse was rare in this sample. CONCLUSIONS In this sample, abuse of reformulated ERO was low, and lower than abuse of original ERO retrospectively and IR oxycodone concurrently, particularly through injecting and snorting routes of administration. There was no evidence to suggest that reformulated ERO became a substitute for original ERO.

Do socio-economic gradients in smoking emerge differently across time by gender? Implications for the tobacco epidemic from a pregnancy cohort in California, USA

Understanding current patterns of population smoking by socioeconomic position (SEP) can be substantially enhanced by research that follows birth cohorts over long periods of time, yet such data in the US are rare. Information from birth cohorts followed during critical time periods when the health consequences of smoking became widely known can inform the ways in which current smoking prevalence has been shaped by the historical processes that preceded it. The present study utilizes data from a substudy of the Child Health and Development Study pregnancy cohort (N = 1612). Women were queried about smoking status in 1959-1962, 1971-1972 and 1977-1980. Women were divided into three cohorts based on date of birth. Offspring represented another birth cohort assessed for smoking in 1977-1980. Results indicated that the overall prevalence of smoking exhibited cohort-specific patterns that persisted across time. Notably, the youngest maternal cohort (born 1937-1946) had high smoking prevalence throughout and showed no appreciable decrease (44.7%, 41.4%, 40.1% for 1959-1962, 1971-1972, and 1977-1980). Results also indicated that the relation of smoking to SEP exhibited cohort-specific patterns over time. Among the oldest birth cohort (born 1914-1930), no inverse relation of SEP to smoking was observed at any time; in contrast, an inverse relation emerged by 1959-1962 among the youngest cohort of mothers. Among the adolescent offspring, there was a strong SEP gradient (OR = 2.0, 95% CI = 1.4-3.0) that was stronger than in any maternal birth cohort at any assessment (β = 0.40, SE = 0.1, p<0.01). We conclude that SEP gradients in smoking emerge across birth cohorts rather than time alone, with increasingly strong gradients across time especially among younger cohorts.

Understanding opioid overdose characteristics involving prescription and illicit opioids: A mixed methods analysis

BACKGROUND Opioid abuse and misuse are significant public health issues. The CDC estimated 72% of pharmaceutical-related overdose deaths in the US in 2012 involved opioids. While studies of opioid overdoses have identified sociodemographic characteristics, agents used, administration routes, and medication sources associated with overdoses, we know less about the context and life circumstances of the people who experience these events. METHODS We analyzed interviews (n=87) with survivors of opioid overdoses or family members of decedents. Individuals experiencing overdoses were members of a large integrated health system. Using ICD codes for opioid overdoses and poisonings, we identified participants from five purposefully derived pools of health-plan members who had: 1) prescriptions for OxyContin(®) or single-ingredient sustained-release oxycodone, 2) oxycodone single-ingredient immediate release, 3) other long-acting opioids, 4) other short-acting opioids, or 5) no active opioid prescriptions. RESULTS Individuals who experienced opioid overdoses abused and misused multiple medications/drugs; experienced dose-related miscommunications or medication-taking errors; had mental health and/or substance use conditions; reported chronic pain; or had unstable resources or family/social support. Many had combinations of these risks. Most events involved polysubstance use, often including benzodiazepines. Accidental overdoses were commonly the result of abuse or misuse, some in response to inadequately treated chronic pain or, less commonly, medication-related mistakes. Suicide attempts were frequently triggered by consecutive negative life events. CONCLUSIONS To identify people at greater risk of opioid overdose, efforts should focus on screening for prescribed and illicit polysubstance use, impaired cognition, and changes in life circumstances, psychosocial risks/supports, and pain control.

Poster 99 Difference in Rates of Abuse Following Reformulation of Extended Release Oxycodone Using Data from the Radars® System Poison Center Program

Results or Clinical Course: After 6 months of conservative management with physical therapy for range of motion and strengthening, the patient was able to return to work with full functional use of his right upper extremity. Discussion: According to the literature, there has not been a previously reported case of successful conservative management for an occupational injury of recurrent shoulder dislocation with Bankart lesion and Hill-Sachs deformity. A Bankart lesion is a soft tissue tear in the glenoid labrum. It is often associated with Hill-Sachs deformity in recurrent anterior shoulder dislocations, which results in a posterolateral humeral head compression fracture due to the humeral head resting against the anteroinferior part of the glenoid. Conclusions: Recurrent shoulder dislocation with Bankart lesion and Hill-Sachs deformity can be managed conservatively with great success, functional outcome, and patient satisfaction.