Retrospective review of vancomycin monitoring via trough only versus two-point estimated area under the curve in pediatric and adult patients with cystic fibrosis.

OBJECTIVES: The primary objective of this study was to compare the occurrence of acute kidney injury (AKI) in patients with cystic fibrosis (CF) receiving intravenous (IV) vancomycin monitored through single serum trough concentrations and two-point estimated area under the curve (AUC). Time to next exacerbation and return to baseline lung function were also assessed. METHODS: A retrospective review was conducted in patients of all ages with CF admitted to the University of Kentucky who received IV vancomycin between October 2015 and January 2021. Patients were excluded if they received less than 5 days of IV vancomycin therapy. RESULTS: A total of 113 adults and 42 pediatric encounters met the inclusion criteria. There was no statistically significant difference in occurrence of AKI, however, all grade 2-3 AKIs were in the serum through the monitoring group. Adult patients monitored with AUC also had a higher return to baseline lung function over trough monitoring (86% vs. 57%) (p = 0.002). There was not a statistically significant difference in time to the next exacerbation in either group. CONCLUSIONS: Adult patients with CF experienced less severe AKIs when monitored with AUC versus trough. The results of this study indicate that AUC monitoring may enhance the efficacy of IV vancomycin in adult patients with CF.

FDA Approaches in Monitoring Drug Quality, Forces Impacting the Drug Quality, and Recent Alternative Strategies to Assess Quality in the US Drug Supply.

Since the US Food and Drug Administration (FDA) began monitoring the quality of pharmaceutical manufacturing by enforcing current good manufacturing practices roughly 60 years ago, forces related to the global economy have changed, rendering the task of monitoring quality more difficult. Alternative strategies by groups like Valisure, LLC, and the University of Kentucky Drug Quality Study to monitor the quality of the currently circulated US drug supply through end-product testing and screening have resulted in several concerning findings. Given the successful approaches of identifying quality defects in pharmaceuticals by non-regulatory bodies, and considering the changing landscape and pressures on manufacturing, the FDA, large buying groups, and the US Department of Defense should consider these alternative strategies as a means to augment current regulatory activities.