Background Parenteral nutrition (PN) is crucial for hospitalised premature infants. The quality of these preparations has a direct impact on patient safety. In our hospital, individualised bags are prepared partially in the central pharmacy and partially in the neonatal unit.
Purpose The objective of this study was to evaluate the physicochemical and microbiological quality of the bags prepared on the ward.
Material and methods Samples were retrieved from all PN bags after their administration over a period of 11 weeks. Formulations included 0–4 electrolytes and variable concentrations of glucose.
Depending on the sample volume, up to 3 controls were performed.
Assay of electrolytes (K+, Na+, Ca2+, Mg2+) by capillary electrophoresis and of glucose by UV (enzymatic method of hexokinase).1
Test for bacterial endotoxin by kinetic colouration of LAL (limulus amoebocyte lysate).
Sterility according to Ph Eur (2.6.01).
The results obtained were evaluated on the basis of the specifications established by the pharmacy.
The analysis of amino acids was not included.
Results 78 bags were analysed. The results are shown in table 1.
Concentrations were below the lower limit of 90% or over the upper limit of 110% accepted by the pharmacy in 6 bags (0.8%) for K+, 4 (0.6%) for Na+, 11 (1.4%) for Ca2+ and 11 (1.4%) for glucose. 23 perfusions (29.5%) did not conform to their medical prescription.
There was no perfusion among the 78 PN tested that contained endotoxins (limit 2.25 EU/mL).
All 56 PN tested were sterile.
Conclusion These results show that the PN bags compounded by nurses in the neonatal unit were frequently not accurate for electrolyte or glucose concentrations but were sterile and non-pyrogenic. This situation could be improved by preparation at the pharmacy with physicochemical analysis before administration.
References and/or Acknowledgements
Nussbaumer, Set al. Determination of potassium, sodium, calcium and magnesium in total parenteral nutrition formulations by capillary electrophoresis with contactless conductivity detection. J Pharm Biomed Anal 2010;53:130-6
References and/or AcknowledgementsNo conflict of interest.
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