September 11, 2013
Buprenorphine Film Strips Less Likely to Be Unintentionally Ingested by Children

Denver—Dispensing buprenorphine as a film strip is much less likely to result in unintentional ingestion by children, according to a new study.

The study, led by researchers from the Rocky Mountain Poison and Drug Center and the University of Colorado School of Medicine, found that children were 3.5 to 8.8 times more likely to accidentally ingest tablets as have unintentional exposure to film strips. In fact, 95% of cases involved tablets, which typically are dispensed in 30-day supply bottles with child-resistant caps as opposed to film strips, which are dispensed in single-dose, child-resistant foil packs.

“Unintentional exposure to buprenorphine can cause central nervous system depression, respiratory depression, and death in young children. Exposure rates to film formulations are significantly less than to tablet formulations. Package and storage deficiencies contribute to unintentional exposures in young children,” according to the study authors.

Their report, published online by the Journal of Pediatrics, was based on review of 2,380 unintentional exposures to buprenorphine-containing products by children 28 days to less than 6 years old. Four deaths and 587 admissions to intensive care units were recorded among the cases, which were collected from the Researched Abuse, Diversion, and Addiction-Related Surveillance System Poison Center Program in Denver and Reckitt Benckiser Pharmaceuticals’ pharmacovigilance system from October 2009 to March 2012.

Researchers found that exposures to buprenorphine-naloxone combination film were significantly less frequent than exposures to buprenorphine tablets (rate ratio 3.5 [95% CI, 2.7-4.5]) and buprenorphine-naloxone combination tablets (rate ratio 8.8 [7.2-10.6]).

The most common adverse effects reported for 536 cases reviewed by an expert panel were lethargy, respiratory depression, miosis, and vomiting, with the greatest severity not differing significantly by formulation.

In 57% of cases, the study also identified root causes for exposure to buprenorphine or the buprenorphine-naloxone combination form, used to treat adults who are addicted to opioids:

• In 415 cases, the medication was stored in sight;
• In 110 cases, the child accessed the medication from a bag or purse; and
• In 75 cases, the medication was not stored in the original packaging.

Most exposures were in the child’s own home, although 5% of exposures occurred while the child was being watched by an outside caregiver.

"This study underscores the value of providing medications that are particularly dangerous when taken by children, in single dose, child resistant packaging,” said lead author Eric Lavonas, MD, associate director or the Rocky Mountain Poison and Drug Center.

U.S. Pharmacist Social Connect