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.

The ESPGHAN/ESPEN/ESPR-Guidelines on pediatric parenteral nutrition (PPN) recommend the administration of the semiessential amino acid (AA) cysteine to preterm neonates due to their biochemical immaturity resulting in an inability to sufficiently synthetize endogenous cysteine. The soluble precursor N-acetylcysteine (NAC) is easily converted into bioavailable cysteine. Its dimer N,N-diacetylcystine (DAC) is almost unconvertable to cysteine when given intravenously resulting in a diminished bioavailability of cysteine. This study aims to understand the triggers and oxidation process of NAC to DAC to evaluate possibilities of reducing DAC formation in standardized PPN. Therefore, different air volumes (21% O2) were injected into the AA compartment of a standardized dual-chamber PPN. O2 concentrations were measured in the AA solution and the headspaces of the primary and secondary packaging. NAC and DAC concentrations were analyzed simultaneously. The analysis showed that O2 is principally delivered from the primary headspace. NAC oxidation exclusively delivers DAC, depending on the O2 amount in the solution and the headspaces. The reaction of NAC to DAC being containable by limiting the O2 concentration, the primary headspace must be minimized during manufacturing, and oxygen absorbers must be added into the secondary packaging for a long-term storage of semipermeable containers.

Background There are variable practices in the management of the parenteral nutrition (PN) process in hospitals having a neonatal intensive care unit (NICU). In our hospital, PN is prepared partially on the neonatal ward by nurses but also at the central pharmacy by trained pharmacy technicians. A previous study showed a concentration non-conformity of 34% of on-ward PN preparations potentially resulting in under- or overfeeding of the patients. Objective The objectives were to perform preliminary risk analyses (PRA) in preparation for our hospital’s transition to universal central pharmacy PN compounding. Methods A working group including pharmacists, neonatologists, nurses, and pharmacy technicians performed two PRA. The risks of 9 management steps of the PN process were identified, evaluated, and quoted. A comparison of the number of risks and their criticality index (CI) was conducted. Results A total of 36 and 39 risks were identified for PN preparation in the NICU and the pharmacy, respectively. For the NICU, ten risks (28%) had an “acceptable” CI, 15 risks (42%) were “under control” and eleven (31%) were defined as “non-acceptable”. For the pharmacy, 14 risks (36%) had an “acceptable” CI, 19 risks (49%) were “under control” and six (15%) were defined as “non-acceptable”. Risks directly related to the preparation process, including the steps preparation hood, PN preparation and analytical quality control, represented a cumulated CI of 145 for eleven NICU-risks vs 108 for twelve pharmacy risks (−26%). The implementation of immediate improvement measures, eg, an electronic prescription form, reduces the total CI by 5.7% and 2.2% for the NICU and the pharmacy, respectively. Conclusion This PRA highlighted the safety differences between PN preparation in the NICU vs the pharmacy at our institution, and facilitated our moving forward with a process change that should improve the care of our neonatal patients. Nevertheless, long-term improvement measures have to be implemented to further reduce risks related to the PN management process.