Unit-Dose Packaging of Buprenorphine-Naloxone Effective on Unintentional Pediatric Exposure

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Since 2010, many manufacturers of buprenorphine combination products have switched to child-resistant unit-dose packaging.
Since 2010, many manufacturers of buprenorphine combination products have switched to child-resistant unit-dose packaging.

Unit-dose packaging of buprenorphine-naloxone was associated with a reduced number of unintentional exposures of young children presenting to poison centers, according to a study published in Pediatrics.

Buprenorphine was found to account for the greatest percentage (47%) of opioid-related pediatric hospital admissions. Since 2010, many manufacturers of buprenorphine combination products have switched to child-resistant unit-dose packaging, with >80% of products currently available in this form.

This transition has resulted in a two-thirds reduction in pediatric emergency department visits resulting from ingestion of buprenorphine-naloxone.

To further explore the benefits of unit-dose packaging, researchers conducted an observational surveillance study that compiled data on all reported cases of unintentional opioid exposure involving children age <6. The study examined 3 periods preceding, during, and post transition to unit- dose packaging (2008-2010; 2011-2012; and 2013-2016, respectively). A total of 6217 unintentional pediatric exposures to combination buprenorphine-naloxone products occurred between 2008 and 2016.

There were 20.57, 8.77, and 4.36 exposures per 100,000 dispensed prescriptions during the periods preceding, concurring, and following transition to pre-unit dose packaging, respectively, corresponding to a 78.8% decrease in unintentional pediatric exposure to the drug associated with the change in packaging.

Study limitations include the possibility that poison centers may have underestimated the rate of buprenorphine exposures and that other factors that may have contributed to the observed benefits were not examined.

“Packaging and engineering controls such as unit-dose packaging, in addition to safe storage and education, should be a mainstay in the approach to the prevention of unintentional buprenorphine pediatric exposures as well as exposures to other prescription opioids,” concluded the study authors.

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Reference

Wang GS, Severtson SG, Bau GE, Dart RC, Green JL. Unit-dose packaging and unintentional buprenorphine-naloxone exposures [published online March 9, 2018]. Pediatrics. doi:10.1542/peds.2017-4232

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