Vancomycin is the antibiotic of choice to treat serious infectious diseases caused by Methicillin-resistant Staphylococcus aureus (MRSA), one of the multidrug-resistant pathogens identified as a serious threat by the Centers for Disease Control and Prevention (CDC) in the 2019 Antibiotic Resistance Threats report. It is often administered through intravenous infusions for systemic infections and is one of the most prescribed antibiotics in the pediatric and neonatal intensive care units in US hospitals. However, its treatment is frequently reported to be subtherapeutic due to its narrow therapeutic window and high interindividual pharmacokinetics variability. 

 

Therapeutic drug monitoring (TDM) is therefore recommended to optimize individual treatment effect. Vancomycin serum concentrations are required to calculate drug exposure in the patient during TDM for an accurate dose recommendation. Erroneously timed serum concentrations may lead to miscalculations of doses and potential risk of patient harm. Solutions such as interventions in the electronic healthcare systems (EHR) to remind clinicians about correct blood sample timing have implemented to improve clinical practice. Precision dosing software is also increasingly called to improve timely patient pharmacokinetics estimation.

 

However, system-level factors in vancomycin treatment processes persist in complex clinical environments and may introduce preanalytical errors in serum concentrations used for TDM decisions. For example, incomplete information flow among stakeholders, wrongly timed doses and wrong documentation were reported to lead to dose omission, delay, or improper doses. A detailed understanding of workflows and information flows among relevant stakeholders, the manner in which infusion tasks are executed and documented in the EHR and EHR related safety concerns regarding vancomycin treatment has not yet studied in-depth.  

 

To fill these gaps, the research is composed of three main parts: (1) a case study was conducted in a single-site hospital to map physical and information flows in vancomycin TDM, focusing on dose recommendation decision-making process and identification of gaps in the EHR that may impact the accuracy of TDM, (2) data consistency of timestamps documented in the EHR based on nurses workflow and those automatically recorded in smart infusion pump system regarding the same vancomycin infusion activity was investigated, and (3) a computer simulation was conducted to evaluate the impact of different sources and degrees of time discrepancy during vancomycin infusion process on the therapeutic values observed in the TDM.