Effect of US Food and Drug Administration–Approved Pediatric Labeling on Dispensing of Extended-Release Oxycodone in the Outpatient Retail Setting

Effect of US Food and Drug Administration– Approved Pediatric Labeling on Dispensing of Extended-Release Oxycodone in the Outpatient Retail Setting For years, extended-release (ER) oxycodone has been prescribed to children for management of pain.1,2 In August 2015, based on studies conducted under the Best Pharmaceuticals for Children Act that are designed to better inform pediatric prescribing, the US Food and Drug Administration approved the use of OxyContin (Purdue Pharma) for management of pain requiring treatment with an ER/long-acting opioid in children 11 years and older who are already tolerating a daily opioid dose equivalent to at least 20 mg of oxycodone, as described in the labeling.3 The new labeling was not intended to expand pediatric use of ER opioids, but rather to help clinicians use OxyContin safely in pediatric patients. Following the label change, some voiced concerns regarding the potential for increased prescribing and misuse of OxyContin in children.4,5 To understand the effect of the pediatric labeling for OxyContin on dispensing of all oxycodone ER products (OxyContin and authorized generics) in the pediatric population, we examined national data on dispensed prescriptions for oxycodone ER in outpatient retail pharmacies before and after the label change.