Becki Bucher Bartelson

Do Prescription Monitoring Programs Impact State Trends in Opioid Abuse/Misuse?

OBJECTIVE Prescription monitoring programs (PMPs) are statewide databases containing prescriber and patient-level prescription data on select drugs of abuse. These databases are used by medical professionals or law enforcement officials to identify patients with prescription drug use patterns indicative of abuse or providers engaging in illegal activities. Most states have implemented PMPs in an attempt to curb prescription drug abuse and diversion. However, assessment of their impact on drug abuse is only beginning. This study aimed to evaluate the relationship between PMPs and opioid misuse over time in two drug abuse surveillance data sources. METHODS Data from the RADARS® System Poison Center and Opioid Treatment surveillance databases were used to obtain measures of abuse and misuse of opioids. Repeated measures negative binomial regression was applied to quarterly surveillance data (from 2003 to mid-2009) to estimate and compare opioid abuse and misuse trends. PMP presence was modeled as a time varying covariate for each state. RESULTS Results support an association between PMPs and mitigated opioid abuse and misuse trends. Without a PMP in place, Poison Center intentional exposures increased, on average, 1.9% per quarter, whereas opioid intentional exposures increase 0.2% (P = 0.036) per quarter with a PMP in place. Opioid treatment admissions increase, on average, 4.9% per quarter in states without a PMP vs 2.6% (P = 0.058) in states with a PMP. In addition to the time trend, population and a measure of drug availability were also significant predictors. A secondary analysis that classified PMP based upon ideal characteristic showed consistent though not significant results. CONCLUSIONS Two observational data sources offer preliminary support that PMPs are effective. Future efforts should evaluate what PMP characteristics are most effective and which opioids are most impacted.

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.

Nonmedical use of tapentadol immediate release by college students.

Objectives:Prescription opioid analgesics play an important role in managing moderate to severe pain. An unintended consequence of the availability of these drugs is nonmedical use. We report rates and methods of nonmedical use of the analgesic tapentadol immediate release (IR) and other commonly prescribed opioid analgesics among US college students following the launch of tapentadol IR in June 2009. Materials and Methods:The Researched Abuse, Diversion and Addiction-Related Surveillance System College Survey Program collects data from approximately 2000 self-identified college students throughout the United States during fall, spring, and summer terms using a web-based questionnaire. Responses from July 2009 through September 2011 were analyzed for the rate of nonmedical use of tapentadol IR. Results:Nonmedical use of prescription opioids was reported by 1626 of 13,514 respondents (12.0%); tapentadol IR use was reported by 101 respondents (0.7%). The rate of nonmedical tapentadol IR use per 100,000 population was highest in 4Q2009 (0.013 per 100,000 population) and decreased over the subsequent 2 years to 0.004 per 100,000 population. Similarly, the rate per 1000 unique recipients of dispensed drug (URDD) was highest in 4Q2009 (0.66 per 1000 URDD) and decreased to 0.06 per 1000 URDD. The primary route of administration endorsed for nonmedical tapentadol IR use was intact swallow (49.5%), chewed and swallowed (41.6%), followed by inhalation (20.8). Discussion:Since its launch, rates of nonmedical tapentadol IR use by college students have been low and have decreased over time. The initial levels of reported nonmedical use may represent a brief period of experimentation after introduction.

A Randomized, Double-Blind, Placebo-Controlled Trial of a Highly Purified Equine F(ab)2 Antibody Black Widow Spider Antivenom

STUDY OBJECTIVE Black widow spider antivenom has never been tested in a randomized clinical trial, to our knowledge. We explore various efficacy measures for a novel F(ab)2 antivenom in patients with moderate to severe pain caused by black widow spider envenomation. METHODS A randomized, placebo-controlled, double-blind, clinical trial was conducted in 12 academic emergency departments. We included patients at least 10 years old with moderate to severe latrodectism. Subjects received either a single intravenous infusion of antivenom or placebo. Pain was assessed with the visual analog scale. The primary efficacy outcome was the difference in pre- and posttreatment visual analog scale score. Prospectively defined secondary outcomes included treatment failures and time to clinically important decrease in pain. RESULTS Twenty-four subjects were enrolled between October 2005 and October 2006; 13 were randomized to antivenom and 11 to placebo. The median change in visual analog scale at 150 minutes posttreatment was -50.0 mm (Interquartile Range [IQR] -67, -41 mm) in the antivenom treatment group and -46.0 mm (IQR -51, 0 mm) in the placebo treatment group (P=.14). There were 7 treatment failures (64%; 95% confidence interval 35% to 92%) in the placebo group and 3 (23%; 95% confidence interval 0.2% to 46%) in the antivenom group (P=.06). The median time to a clinically important decrease in pain after treatment was shorter in the antivenom group compared with the placebo group (30 minutes [IQR 30, 60 minutes] versus 90 minutes [IQR 30, 90 minutes]; P=.03). No serious adverse events or deaths were reported. CONCLUSION Although the overall reduction in pain was similar for antivenom- and placebo-treated subjects, antivenom reduced pain more rapidly than placebo. No significant adverse events occurred in either group.

Medical outcomes associated with prescription opioid abuse via oral and non-oral routes of administration

BACKGROUND Prescription opioid abuse and misuse is a serious and growing public health issue. While the most common form of abuse is swallowing intact tablets/capsules, some abusers manipulate, or tamper with, these medications by altering the dosage form to allow for non-oral routes of administration (e.g., injection, inhalation) in order to achieve more rapid or enhanced psychoactive effects. Because administration of opioids via non-oral routes results in greater systemic availability and more rapid central nervous system penetration, we hypothesized that death and major medical outcomes occur more frequently with non-oral routes compared to oral route alone. METHODS This retrospective cohort study analyzed data from the Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System Poison Center Program to investigate relative risk of prescription opioid abuse via oral and non-oral routes. RESULTS While the oral route was the most commonly reported route of abuse (64.0%), non-oral routes were reported in 14.6% exposures and unknown routes in 21.4% exposures. The relative risk of an exposure resulting in death or major effect was 2.43 (95% CI 1.97, 2.99) if non-oral routes were reported compared to exposures involving oral route only. CONCLUSION Analysis of acute health events recorded by poison centers indicates that death or major effects are twice as likely to occur with intentional abuse of prescription opioids via non-oral routes of administration than ingestion alone. Effective interventions to prevent abuse via non-oral routes of solid dosage forms of prescription opioids, such as abuse-deterrent formulations could have a significant public health impact.

The Effect of a Statewide Smoking Ordinance on Acute Myocardial Infarction Rates

BACKGROUND Public smoking ordinances may reduce acute myocardial infarction events. Most studies assessed small communities with reported reductions as high as 40%. No reduction or smaller reductions were found in countrywide studies; less is known about the impact of statewide ordinances. We previously demonstrated identical 27% reductions in acute myocardial infarction hospitalizations in 2 Colorado communities after enactment of strict smoking ordinances. Subsequently, on July 1, 2006, a statewide ordinance went into effect. We sought to determine the impact of this legislation on acute myocardial infarction hospitalization rates. METHODS Hospital admissions for a primary acute myocardial infarction diagnosis were examined from 2000 to 2008. Poisson regression models were fit to the monthly events from January 1, 2000, to March 31, 2008. The final model included a quadratic trend over time, harmonic terms, and a post-ordinance effect. The model was adjusted temporally for population changes, using population estimates as an offset variable. RESULTS A total of 58,399 unique acute myocardial infarctions were recorded during the study period. No significant reduction in acute myocardial infarction rates was observed post-ordinance (relative risk, 1.059; 95% confidence interval, 0.993-1.131). However, a steep decline in acute myocardial infarction rates was noted from 2000 to 2005 just before enactment. There were 11 strict, local smoking ordinances in effect within Colorado before enactment of the statewide ordinance. After excluding these communities, the findings were similar (relative risk, 1.038; 95% confidence interval, 0.971-1.11). CONCLUSIONS Although local smoking ordinances in Colorado previously suggested a reduction in acute myocardial infarction hospitalizations, no significant impact of smoke-free legislation was demonstrated at the state level, even after accounting for preexisting ordinances.

Changes in misuse and abuse of prescription opioids following implementation of Extended‐Release and Long‐Acting Opioid Analgesic Risk Evaluation and Mitigation Strategy

An unintended consequence of extended‐release (ER) and long‐acting (LA) prescription opioids is that these formulations can be more attractive to abusers than immediate‐release (IR) formulations. The US Food and Drug Administration recognized these risks and approved the ER/LA Opioid Analgesic Risk Evaluation and Mitigation Strategy (ER/LA REMS), which has a goal of reducing opioid misuse and abuse and their associated consequences. The primary objective of this analysis is to determine whether ER/LA REMS implementation was associated with decreased reports of misuse and abuse.