Unit-Dose Packs Help Prevent Unintended Buprenorphine-Naloxone Exposure in Kids

By Will Boggs MD

NEW YORK (Reuters Health) - The shift to unit-dose packaging of buprenorphine-naloxone products was associated with a substantial drop in reports to poison centers of unintentional pediatric exposures, according to a new study.

"Unit-dose packaging should be considered in high-risk medications, specifically where low-dose exposures can lead to dangerous outcomes in children," Dr. George Sam Wang from University of Colorado Anschutz Medical Campus, in Aurora, told Reuters Health by email.

Beginning in 2010, the buprenorphine-naloxone combination film was distributed using UDP, and currently over 80% of dispensed combination buprenorphine prescription products are packaged via UDP.

Dr. Wang's team used data from the Researched Abuse, Diversion, and Addiction-Related Surveillance (RADARS) System Poison Center Program to evaluate the impact of UDP on unintentional pediatric buprenorphine-naloxone exposures reported to poison centers.

From 2008 through 2016, there were 6,217 exposures to combination buprenorphine-naloxone products in children under 6 (median age, 2.0 years), including major effects in 114 children and three reported deaths.

In the pre-UDP era (2008 through 2010), there were 20.57 pediatric unintentional exposures per 100,000 prescriptions dispensed. During the transition to UDP, there were 8.77 exposures per 100,000 prescriptions dispensed.

In the post-UDP period - when more than 80% of combination buprenorphine-naloxone prescriptions dispensed were four products in UDP - there were only 4.36 pediatric unintentional exposures per 100,000 prescriptions dispensed, a 78.8% reduction from the pre-UDP period (P<0.001).

Unintentional pediatric exposure rates for combination sublingual film, which had UDP since its introduction, remained consistent at about 2.5 cases per 100,000 prescriptions, the lowest of any formulation studied, the researchers report in Pediatrics, online May 3.

In contrast to the decreasing rates of pediatric unintentional exposures, prescriptions for buprenorphine-naloxone sublingual film and combination products with UDP increased over the study period.

"In addition to using products with UDP, counseling about safe storage practices and potential dangers of these medications in the setting of children is still important in prevention," Dr. Wang said.

SOURCE: https://bit.ly/2IgcnGu

Pediatrics 2018.

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