Introduction: The aim of this paper is to describe personalized pediatric parenteral admixture compounding in a specialized University Hospital. Materials and methods: Pediatric formulations require small volumes, high concentrations of nutrients and electrolyte micro-additions, thus they must be carefully evaluated by pharmacists and compounded by means of an automatic filling system in a “clean room”. Different kinds of lipid emulsions are used according to the patients’ needs: composite lipids or long and medium chain triglycerides with or without fish oil-based omega-3 fatty acid addition. Admixture stability is defined by determining particle diameter, which must be in the range of 0.4-1.0 μm, like chylomicra, for a safe infusion to patients. Analyses were carried out by means of a laser diffraction technique. Results: In the last 3 years 21,500 personalized pediatric admixtures were compounded (15,480 for children and 6,020 for neonates); the total number of treated patients was 1,700, including 550 neonates. Stability studies pointed out that, in all admixtures, the physicochemical stability did not change between t=0 and t=96 hours and particle diameter was in the expected range of 0.4-1.0 μm provided calcium concentration remained below 9 mEq/L. When calcium exceeded this level, as it is often required for neonates, in the admixtures containing fish oil-based emulsion, 12% of the particles had a diameter larger than 1.0 μm and 2% exceeded 5.0 μm immediately after compounding. Conclusions: Pediatric admixture compounding in a centralized service, and stability studies allowed to prepare any required formulation, providing patients with a safe and effective product. In particular, our analyses pointed out that admixtures containing fish oil-based emulsion and calcium concentrations higher than 9 mEq/L cannot be safely infused to pediatric patients; in these cases it is advisable to infuse the fish oil-based emulsion alone through a second intravenous line.

Pediatric parenteral admixture compounding in a highly specialized university hospital

FORCHIELLI, MARIA LUISA;
2013

Abstract

Introduction: The aim of this paper is to describe personalized pediatric parenteral admixture compounding in a specialized University Hospital. Materials and methods: Pediatric formulations require small volumes, high concentrations of nutrients and electrolyte micro-additions, thus they must be carefully evaluated by pharmacists and compounded by means of an automatic filling system in a “clean room”. Different kinds of lipid emulsions are used according to the patients’ needs: composite lipids or long and medium chain triglycerides with or without fish oil-based omega-3 fatty acid addition. Admixture stability is defined by determining particle diameter, which must be in the range of 0.4-1.0 μm, like chylomicra, for a safe infusion to patients. Analyses were carried out by means of a laser diffraction technique. Results: In the last 3 years 21,500 personalized pediatric admixtures were compounded (15,480 for children and 6,020 for neonates); the total number of treated patients was 1,700, including 550 neonates. Stability studies pointed out that, in all admixtures, the physicochemical stability did not change between t=0 and t=96 hours and particle diameter was in the expected range of 0.4-1.0 μm provided calcium concentration remained below 9 mEq/L. When calcium exceeded this level, as it is often required for neonates, in the admixtures containing fish oil-based emulsion, 12% of the particles had a diameter larger than 1.0 μm and 2% exceeded 5.0 μm immediately after compounding. Conclusions: Pediatric admixture compounding in a centralized service, and stability studies allowed to prepare any required formulation, providing patients with a safe and effective product. In particular, our analyses pointed out that admixtures containing fish oil-based emulsion and calcium concentrations higher than 9 mEq/L cannot be safely infused to pediatric patients; in these cases it is advisable to infuse the fish oil-based emulsion alone through a second intravenous line.
Germana Bersani1; Alessandra Stancari1; Silvia Maselli1; Anna Maria Guarguaglini1; Lucia Loredana Bruno1; Maria Luisa Forchielli2; Cristina Puggioli1
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11585/262089
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