Title : Quality assurance framework for implementing therapeutic drug monitoring in preterm infants: Enhancing safety and precision in neonatal care
Abstract:
Therapeutic drug monitoring (TDM) is essential in preterm infants due to their unique pharmacokinetics and heightened susceptibility to drug toxicity and therapeutic inefficacy. This study proposes a structured quality assurance (QA) framework to enhance TDM practices in neonatal care, addressing accuracy, consistency, and regulatory compliance in managing medication for this vulnerable population.
The QA framework includes standardized protocols for blood sample collection, timing, and processing protocols—critical steps for achieving precise drug concentration measurements. Emphasis is placed on method validation, including calibration and control processes that ensure analytical accuracy across all measurement stages. Additionally, a streamlined communication protocol among clinicians, laboratory personnel, and pharmacists supports timely and accurate dose adjustments, enabling real-time response to infants' changing physiological states.
Key to this system is continuous quality improvement (CQI), which integrates routine audits, adherence tracking, and staff training. This cycle of CQI allows for early identification and correction of deviations, promoting a high standard of practice. Educational initiatives for neonatal and laboratory staff on preterm pharmacokinetics further mitigate variability and reinforce method reliability. The QA approach also lays the foundation for potentially integrating advanced tools, such as predictive modeling, which could provide more precise and individualized dosing adjustments.
Preliminary findings demonstrate that this QA-based TDM system enhances drug safety and therapeutic outcomes, with reduced incidence of adverse drug reactions and improved achievement of target drug concentrations. These results support the need for QA-driven TDM systems in neonatal care, emphasizing that rigorous, standardized practices are critical for managing drug therapy in preterm infants. Future efforts will focus on refining this QA framework and expanding it to include cutting-edge predictive analytics to individualize drug therapy for neonatal patients further.
Preliminary findings show that this QA-driven TDM system improves drug safety and outcomes in preterm infants, reducing adverse reactions and enhancing target concentration achievement.
