(P-206) Pediatric Fentanyl Overdose Within an Electronic Health Record Database

Background: Fentanyl is a potent synthetic opioid analgesic that presents a high risk of life-threatening respiratory depression in patients who are not opioid tolerant. In 2011, the Food and Drug Administration approved a Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) products indicated for breakthrough pain in adult cancer patients who are opioid tolerant. The goal of the REMS is to mitigate the risks associated with the use of TIRF products, in part by preventing accidental exposure in children.

Objectives: The aim of this study was to identify and describe pediatric patients who experienced fentanyl overdose or poisoning, including those associated with TIRF products.

Methods: This observational study consisted of patients aged 6 years and younger who were selected for having a potential fentanyl overdose or poisoning event within Optum’s Electronic Health Record (EHR) database from 01 November 2015 through 30 September 2019. Patients with potential events were identified via search criteria that consisted of diagnosis codes corresponding to fentanyl overdose (e.g. T40.4X1* - poisoning by other synthetic narcotics, accidental [unintentional]), and/or a combination of terms indicating a potential fentanyl overdose derived from natural language processing (NLP) of the free-text clinical notes (e.g. “fentanyl”, “overdose”, “poisoning”, “naloxone”, “fentanyl screen”). Baseline characteristics, including medication use and comorbidities, were identified in the month preceding the event that qualified the patient for the study. Two clinician adjudicators reviewed the deidentified notes to confirm the occurrence of fentanyl overdose, and if confirmed whether a TIRF product was involved.

Results: From a source population of 2,527,160 children, 39 were identified as having a potential fentanyl overdose, with a mean age of 1.4 years. In total, 30.8% (N = 12) of the potential cases were confirmed as fentanyl overdoses, 64.1% (N = 25) as not a fentanyl overdose, and 5.1% (N = 2) could not be confirmed or ruled out. All confirmed fentanyl overdoses were identified via both a diagnostic code and an NLP combination. None of the confirmed overdoses had a mortality outcome, and none involved a TIRF product.

Conclusions: Within a large EHR database, this study identified few pediatric fentanyl overdoses, and none involved TIRF products. These results suggest that pediatric exposure to TIRF medicines and consequent fentanyl poisoning are rare and are being adequately managed within the TIRF REMS.