Unit-Dose Packaging and Unintentional Buprenorphine-Naloxone Exposures

Pediatrics. 2018 Jun;141(6):e20174232. doi: 10.1542/peds.2017-4232. Epub 2018 May 3.


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.

Publication types

  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Buprenorphine, Naloxone Drug Combination / poisoning*
  • Child, Preschool
  • Drug Overdose / epidemiology
  • Drug Overdose / prevention & control*
  • Drug Packaging*
  • Female
  • Humans
  • Infant
  • Male
  • Narcotic Antagonists / poisoning*
  • Opioid-Related Disorders / drug therapy
  • United States / epidemiology


  • Buprenorphine, Naloxone Drug Combination
  • Narcotic Antagonists