Abstract

Buprenorphine Products and Formulations and Rate of Unintentional Pediatric Exposures

George Wang, MD1, Gabrielle Bau, MS2, Becki Bucher Bartelson3, Geoff Severtson4, Jody Green3 and Richard Dart, MD, PhD4
(1)University of Colorado Anschutz Medical Campus, Aurora, CO, (2)Rocky Mountain Poison and Drug Center, Denver Heath, Denver, CO, USA, Denver, CO, (3)Rocky Mountain Poison and Drug Center, Denver Heath, Denver, CO, USA, (4)Rocky Mountain Poison and Drug Safety, Denver Heath, Denver, CO, USA, Denver, CO

APHA 2016 Annual Meeting & Expo (Oct. 29 - Nov. 2, 2016)

Background: The prescription opioid epidemic has impacted millions in the United States, including young children where accidental exposures to small doses can result in death. Unit dose packaging (UDP) is a method intended to prevent unintentional pediatric exposures. Our objective was to evaluate the impact of unit dose packaging on unintentional general buprenorphine pediatric exposures. Methods: The Researched Abuse, Diversion, and Addiction Related Surveillance (RADARS) System collects data from multiple programs to assess prescription drug abuse, misuse and diversion. We examine unintentional general buprenorphine exposures involving children under 6 years reported to participating poison centers between July 2014 and September 2015. Using Poisson regression, we compared average rates of the following drug groups: buprenorphine products with UDP, combination buprenorphine/naloxone tablets without UDP, and single entity buprenorphine tablets (without UDP). Buprenorphine products with UDP include Suboxone Oral Film, Zubzolv tablet, and Bunavil oral film. Results: Per 10,000 prescriptions dispensed, the average rate of unintentional general pediatric exposures to buprenorphine products with UDP was 0.26 (95% CI: 0.24 - 0.29). This was significantly less (p<0.0001) than the average rate of combination buprenorphine/naloxone tablets without UDP (1.11, 95% CI 0.96 - 1.29) and the average rate of single entity buprenorphine tablets (0.84, 0.69 – 1.03). Similar results were found per dosing units dispensed and per unique recipients of drug dispensed (URDD). Conclusion: The average unintentional general pediatric exposure drug utilization rates of buprenorphine products with UDP were significantly lower than combination buprenorphine/naloxone tablets without UDP, and single entity buprenorphine tablets per prescription dispensed, dosing units dispensed and URDD. Unit dose packaging should be considered a significant injury prevention intervention and may decrease morbidity and mortality from pediatric buprenorphine exposures.

Epidemiology Public health or related research