Frequency of Poison Center Exposures for Pediatric Accidental Unsupervised Ingestions of Acetaminophen after the Introduction of Flow Restrictors

Abstract

The introduction of flow restrictors was associated with a decrease in pediatric AUIs of liquid acetaminophen products. Decreases in the dose ingested and risk of hospital admission per exposure may also have resulted. Efforts to optimize flow restrictors and increase their use with medicines associated with high pediatric overdose risk should be encouraged.

Flow Restrictors and Reduction of Accidental Ingestions of Over-the-Counter Medications

“…Furthermore, pediatric exposures reported to poison centers are decreasing. The comparison with ibuprofen suggests that acetaminophen exposures decreased more than ibuprofen exposures, and other research 8 shows that unintentional acetaminophen exposures are decreasing more quickly than unintentional exposures to other medications. However, the influence of overall poison center utilization trends is unknown.…”

“…Data presented in this study show that implementation of flow restrictors as part of pediatric liquid medication packaging for OTC medications could have a substantial impact on exposures for children younger than 6 years. Although acetaminophen exposures were already showing signs of annual decline, 8 the rate of decline continued following the addition of flow restrictors and declined more rapidly than a comparator drug, ibuprofen. These data further suggest that when applied to other commonly administered OTC medications, thousands of AUIs could be prevented each year.…”

Ingestion of Over-the-Counter Liquid Medications: Emergency Department Visits by Children Aged Less Than 6 Years, 2012–2015

“…13 Based on calls to poison centers, when bottles had flow restrictors, pediatric ingestions of liquid acetaminophen were found to be significantly less likely to involve clinically significant doses. 14,15 A 2015 U.S. Food and Drug Administration (FDA) voluntary guidance recommends adoption of container features, such as flow restrictors, to reduce the incidence and magnitude of pediatric ingestions on all pediatric OTC liquid products containing acetaminophen. 16 Recommendations to use such restricted delivery systems for other medicines is currently under consideration by FDA 17 and recommended by other professional and standards organizations.…”

The Efficacy of Flow Restrictors on Children’s Liquid Acetaminophen Products

“…1 Unfortunately, accidental ingestions of liquid acetaminophen by young children are also common, contributing to over 2500 emergency department visits and 10 000 calls to poison centers annually. 2,3 Flow restrictors, adapters that have narrow bottle openings or have reclosable seals, have been shown to reduce numbers and severity of ingestions. 3 In 2015, the Food and Drug Administration recommended that flow restrictors be added for all over-the-counter pediatric oral liquid products containing acetaminophen; however, not all flow restrictors may perform equally.…”

“…2,3 Flow restrictors, adapters that have narrow bottle openings or have reclosable seals, have been shown to reduce numbers and severity of ingestions. 3 In 2015, the Food and Drug Administration recommended that flow restrictors be added for all over-the-counter pediatric oral liquid products containing acetaminophen; however, not all flow restrictors may perform equally. 4 In 2019, the American Society for Testing and Materials (ASTM) published testing standards for flow restrictors (F3375-19) that mimic child actions (shaking [deceleration], squeezing [application of force], and sucking [negative pressure]).…”