U.S. poison centers received more than 11,000 calls from 2007 to 2016 related to unintended pediatric exposures to buprenorphine-naloxone products, many leading to serious harm, new research shows.
“Parents and child caregivers who use buprenorphine need to store it safely: up, away, and out of sight—in a locked cabinet is best,” Dr. Gary Smith, director of the Center for Injury Research and Policy, Nationwide Children’s Hospital in Columbus, Ohio, told Reuters Health by email.
Since 2002, when the U.S. Food and Drug Administration approved buprenorphine, either alone or in combination with naloxone, for treatment of opioid dependence, the number of prescriptions have skyrocketed, up from about 100,000 in 2005 to more than 800,000 in 2010. Unintentional exposure among children has become increasingly common.
From 2007 to 2016, U.S. poison control centers received reports of 11,275 children and adolescents aged 19 or younger who were exposed to buprenorphine.
Most exposures involved children younger than age six (86 percent) and were unintentional (89 percent), Dr. Smith and colleagues reported in Pediatrics. Because not all pediatric buprenorphine exposures are called into poison centers, the true number of cases is likely underestimated, they note.
About 45 percent of children exposed to buprenorphine were admitted to a health care facility and more than one-fifth had a serious medical outcome. The type of formulation (film or tablet) did not affect the odds of a serious outcome among young children. “Therefore, regardless of formulation, buprenorphine is dangerous to young children and primary prevention of access is key,” the investigators write in their paper.
Adolescents aged 13 to 19 made up 11 percent of buprenorphine exposures; 77 percent of these were intentional including 12 percent that were suspected suicide attempts.
Overall exposures increased from 2007 to 2010, followed by a transient decrease from 2010 to 2013, before increasing again in 2016.
“The decline in the buprenorphine exposure rate in this study coincided with the August 2010 FDA approval of a buprenorphine film that was sold only in unit-dose child-resistant packaging,” Dr. Smith noted. “Unit-dose packaging of buprenorphine film makes it less accessible to young children. Drug manufacturers should use unit-dose packaging for all buprenorphine products to help prevent unintentional access and exposure by young children.”
This is already happening, and research published last month in Pediatrics suggests that unit-dose packaging has led to a drop in unintentional pediatric exposures.
“Physicians should inform patients and their families about the dangers of buprenorphine exposure and that safe storage and disposal of all opioids, including buprenorphine, is crucial,” said Dr. Smith.