(1338) Proposed Removal of Probiotics From UKHC Formulary Secondary to FDA and CDC Warnings

Introduction: The use of probiotics in hospital settings, especially in neonatal intensive care units (NICUs), has been a subject of much debate. Probiotics are commonly administered to prevent necrotizing enterocolitis (NEC) and reduce all-cause mortality in preterm infants. Studies have shown that probiotics can significantly reduce the risk of NEC, decrease mortality in preterm neonates, decrease the length of hospital stays, and decrease time to full feeds. However, there are growing concerns regarding probiotic safety and efficacy, including bacteremia and death, particularly in vulnerable populations such as preterm infants. Recent alerts from the FDA and CDC, coupled with varying clinical evidence and expert recommendations, have raised significant questions about the routine use of probiotics in acute care settings. In light of these alerts, this project aimed to assess the utilization and appropriateness of probiotic use at the University of Kentucky HealthCare (UKHC), particularly in the NICU.

Methods: Dispense data from UKHC formulary probiotics were obtained from May 15, 2023, to May 13, 2024, using Epic Slicer Dicer. Probiotics evaluated include: ACIDOPHILUS PROBIOTIC BLEND PO CAPS, FLORANEX PO PACK, CULTURELLE BABY IMMUNE+DIGEST PO LIQD, and CULTURELLE KIDS PO CHEW / CULTURELLE PROBIOTICS KIDS 5 B CELL PO PACK. Data were then further divided to showcase total number of orders per probiotic, dispense location, and mode of order entry (continued from home medication reconciliation, new order, etc.).

Results: The utilization of probiotics in the NICU drastically decreased at UKHC after CDC and FDA warnings were released. With this data and growing concern regarding the routine use of probiotics in preterm infants, this data was presented to the Pharmacy and Therapeutics (P&T) Committee at UKHC with the recommendation of removal from formulary. The decision to remove from formulary is currently pending.

Conclusions: This study demonstrates a marked decrease in the use of probiotics in the NICU at UKHC following CDC and FDA warnings, highlighting the impact of regulatory alerts on clinical decisions. These findings were presented to the P&T Committee with a recommendation to remove probiotics from the formulary to optimize neonatal patient safety.