Quality and safety of parenteral nutrition for newborn and preterm infants as an on-ward preparation

Abstract

BackgroundFor newborn and preterm infants, standardised and individual parenteral nutrition (PN) is used. PN preparation is at risk for contamination and dosing errors. The quality of PN is crucial for infants and has a direct impact on their health status and safety.PurposeThe aim of this study is to evaluate the physicochemical and microbial quality of PN for newborn and preterm infants prepared on a neonatal ward.MethodsSampling of various individual PN prepared by nurses on a neonatal ward was performed. Formulations included maximal four electrolytes, variable dextrose and amino acid concentrations. Depending on the sample volume, up to three quality analyses were performed: (1) test for bacterial endotoxins by kinetic-chromogenic method, (2) sterility according to the European and US Pharmacopoeia, and (3) quantification of electrolytes by capillary electrophoresis and of dextrose by ultraviolet detection after enzymatic reaction of hexokinase. The concentrations obtained were evaluated based on the US and Swiss Pharmacopoeia specifications for compounded preparations and compared to the widened pharmacy specifications.ResultsThe composition of 86% of the 110 analysed PN prepared by nurses on the neonatal ward corresponded to their medical prescription. 14% were out of the acceptable widened pharmacy ranges. We found no microbial contamination in the samples. All PN were free from endotoxins.ConclusionComponent concentrations of PN prepared on wards by nurses differed frequently and significantly from their medical prescription, and the deviation can be critical depending on the component and its mode of action. The sample size is too small to evaluate the microbial contamination.

Parenteral Nutrition Process Management for Newborn and Preterm Infants – A Preliminary Risk Analysis

“… 4 We also showed in a previous article that 34% of PN prepared manually by nurses on the ward did not conform to their medical prescription (Pharmacopoeia concentration limits for compounded preparations: 90–110%) and concentration of ingredients ranged from 58% to 164% based on their target value (=100%). 8 …”

“…4 We also showed in a previous article that 34% of PN prepared manually by nurses on the ward did not conform to their medical prescription (Pharmacopoeia concentration limits for compounded preparations: 90-110%) and concentration of ingredients ranged from 58% to 164% based on their target value (=100%). 8 Following our assessments, measures to standardize the PN preparation process were proposed to face these risks as recommended by the American Society for Parenteral and Enteral Nutrition ASPEN. 29 As immediate action until the complete take-over of compounding at the pharmacy, standardized PN preparation protocols for the NICU must be reviewed and applied.…”

“…What is known, is that 34% of PN prepared on the ward is likely to not conform to the medical prescription in a range from 90% to 110%. 8 …”

Exposure of preterm neonates receiving total parenteral nutrition to phthalates and its impact on neurodevelopment at the age of 2 months

“…Total parenteral nutrition (TPN) has been an integral part of the clinical management of low birth weight premature neonates, as feeding via the enteral route is not attainable 7 , 8 . Studies have reported the risks to premature neonates from TPN solutions contaminated with chemicals and/or microbes 9 , 10 . Preterm neonates in a neonatal intensive care unit (NICU) setting are highly vulnerable to harmful chemicals, which can impact their growth and neurodevelopment in the long term 11 , and the authors suggest improving the NICU environment.…”

The Use of Standardized Solutions Instead of Individualized Prescriptions for Parenteral Nutrition on the Neonatal Intensive Care Unit in UZ Brussel: A Feasibility Study

“…12 There is also a reduction in infection risk and prescription errors which simplifies handling of PN. [17][18][19] Besides these benefits, MPN has a substantial drawback: industrially, MPN solutions cannot be adapted quickly to new scientific evidence, as all changes require timeconsuming regulatory application, approval and costly changes of large-scale production facilities. 20 In contrast, PCSM are also ready-to-use but can easily be adapted to changing guidelines.…”