George Sam Wang1,2, S Geoffrey Severtson2, Gabrielle E Bau2, Richard C Dart2,3, Jody L Green2,4. 1. Department of Pediatrics, University of Colorado Anschutz Medical Campus, Aurora, Colorado; george.wang@childrenscolorado.org. 2. Rocky Mountain Poison and Drug Center, Denver Health and Hospital Authority, Denver, Colorado. 3. Department of Emergency Medicine, School of Medicine, University of Colorado, Denver, Colorado; and. 4. Inflexxion, Waltham, Massachusetts.
Abstract
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.
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.
Authors: Christian Hampp; Maribeth C Lovegrove; Daniel S Budnitz; Justin Mathew; Amy Ho; Jana McAninch Journal: Drug Saf Date: 2020-02 Impact factor: 5.606