Unit-Dose Packaging and Unintentional Buprenorphine-Naloxone Exposures.

BACKGROUND AND OBJECTIVES: Buprenorphine accounts for the most opioid-related pediatric hospital admissions when compared with other opioid analgesics. Since 2010, several manufacturers began distributing their buprenorphine products with unit-dose packaging (UDP). Our main objective in this study is to evaluate the impact of UDP on unintentional pediatric buprenorphine-naloxone poison center exposures. METHODS: This is an observational surveillance study in which the Researched Abuse, Diversion, and Addiction-Related Surveillance System Poison Center Program is used. The main outcome was cases of unintentional ingestions involving children <6 years old and buprenorphine-naloxone (combination) products. The study was split into 3 periods: pre-UDP (first quarter 2008 through fourth quarter 2010), transition to UDP (first quarter 2011 through fourth quarter 2012), and post-UDP (first quarter 2013 through fourth quarter 2016). RESULTS: Overall, there were 6217 exposures to combination products. In the pre-UDP period, there were 20.57 pediatric unintentional exposures per 100 000 prescriptions dispensed; in the transition to UDP period, there were 8.77 pediatric unintentional exposures per 100 000 prescriptions dispensed; and in the post-UDP period, there were 4.36 pediatric unintentional exposures per 100 000 prescriptions dispensed. This represents a 78.8% (95% confidence interval: 76.1%-81.3%; P < .001) relative decrease from the pre-UDP period. CONCLUSIONS: The shift from non-UDP to UDP in over 80% of buprenorphine-naloxone products was associated with a significant decrease in unintentional pediatric exposures reported to poison centers. Packaging controls should be a mainstay in the approach to the prevention of unintentional buprenorphine pediatric exposures as well as exposures to other prescription opioids.

Assessment of Tapentadol API Abuse Liability With the Researched Abuse, Diversion and Addiction-Related Surveillance System.

Tapentadol, a Schedule II opioid with a combination of µ-opioid activity and norepinephrine reuptake inhibition, is used for the management of moderate to severe acute and chronic pain. Its dual mechanism of action is thought to reduce opioid-related side effects that can complicate pain management. Since approval, tapentadol has been tracked across multiple outcomes suggesting abuse liability, and a pattern of relatively low, although not absent, abuse liability has been found. This retrospective cohort study further details the abuse liability of tapentadol as an active pharmaceutical ingredient (API) when immediate-release as well as extended-release formulations were on the market together (fourth quarter of 2011 to second quarter of 2016). Tapentadol (API) was compared with tramadol, hydrocodone, morphine, oxycodone, hydromorphone, and oxymorphone across Poison Center, Drug Diversion, and Treatment Center Programs Combined data streams from the Researched Abuse, Diversion and Addiction-Related Surveillance system. Findings suggest the public health burden related to tapentadol to date is low, but present. Event rates of abuse per population-level denominators were significantly lower than all other opioids examined. However, when adjusted for drug availability, event rates of abuse were lower than most Schedule II opioids studied, but were not the lowest. Disentangling these 2 sets of findings further by examining various opioid formulations, such as extended-release and the role of abuse-deterrent formulations, is warranted. PERSPECTIVE: This article presents the results from an examination of tapentadol API across the Researched Abuse, Diversion and Addiction-Related Surveillance System: a broad and carefully designed postmarketing mosaic. Data to date from Poison Center, Drug Diversion, and Treatment Centers combined suggest a low, but present public health burden related to tapentadol.

Abuse and diversion of buprenorphine sublingual tablets and film.

Buprenorphine abuse is common worldwide. Rates of abuse and diversion of three sublingual buprenorphine formulations (single ingredient tablets; naloxone combination tablets and film) were compared. Data were obtained from the Researched Abuse, Diversion, and Addiction-Related Surveillance (RADARS) System Poison Center, Drug Diversion, Opioid Treatment (OTP), Survey of Key Informants' Patients (SKIP), and College Survey Programs through December 2012. To control for drug availability, event ratios (rates) were calculated quarterly, based on the number of patients filling prescriptions for each formulation ("unique recipients of a dispensed drug," URDD) and averaged and compared using negative binomial regression. Abuse rates in the OTP, SKIP, and College Survey Programs were greatest for single ingredient tablets, and abuse rates in the Poison Center Program and illicit diversion rates were greatest for the combination tablets. Combination film rates were significantly less than rates for either tablet formulation in all programs. No geographic pattern could be discerned.

Risk-taking propensity as a predictor of induction onto naltrexone treatment for opioid dependence.

OBJECTIVE: Heroin addiction is a chronic relapsing disorder that has devastating social, medical, and economic consequences. Naltrexone is an antagonist that blocks opioid effects and could be an effective medication for the treatment of opioid dependence. However, its clinical utility has been limited partly because of poor adherence and acceptability. Given the importance of compliance to naltrexone treatment for opioid dependence, the goal of the current study was to examine predictors involved in successful induction onto naltrexone treatment. METHOD: Parametric and nonparametric statistical tests were performed on data from a sample of 64 individuals entering treatment who met DSM-IV criteria for opioid dependence. The relationship between naltrexone induction (ie, inducted vs not inducted onto naltrexone) and risk-taking propensity, as indexed by riskiness on the Balloon Analogue Risk Task (BART), was examined. Participants were recruited from local detoxification programs, inpatient drug treatment, and other Baltimore programs that provided services to opioid-dependent adults (eg, Baltimore Needle Exchange Program) during the period from August 2007 to September 2008. RESULTS: Positive association was shown between risk-taking propensity and odds of naltrexone induction. Specifically, each 5-point increase in the total BART score was associated with a 25% decrease in odds of naltrexone induction (OR = 0.76; 95% CI, 0.58-0.99; P = .041). This association remained statistically significant, even after adjusting for potential confounds, including injection drug use and cocaine positive urine results (P = .05). After adjusting for the covariates, each 5-point increase in BART score was associated with 28% decrease in the odds of achieving the maintenance dose (adjusted OR = 0.73; 95% CI, 0.54-0.99; P = .046). CONCLUSIONS: Risk-taking propensity was predictive of induction onto naltrexone treatment, above and beyond injection drug use and cocaine-positive urine samples.

Prevalence and correlates of Hepatitis C among injection drug users: The significance of duration of use, incarceration and race/ethnicity.

The study examined associations between Hepatitis C (HCV) seropositivity and a lifetime history of jail or correctional facility incarceration among injection drug users. The sample consisted of 351 injection drug users recruited in inner-city neighborhoods of Baltimore. Multiple logistic regressions were fit to assess associations between HCV seropositivity and a lifetime history of incarceration for the total sample and stratified by race. Analyses demonstrated HCV nearly two times greater for whites than African Americans. In addition, HCV was 2.6 times greater in participants incarcerated in correctional facilities and HCV was 7.4 times greater in participants reporting more than 5 years of injection drug use compared to participants reporting less than 1 year of injection drug use. The study findings suggest that incorporating systematic HCV screening, prevention, and treatment programs within correctional systems represents a vital yet underutilized strategy to reduce HCV transmission in society as a whole.