Article Text
Abstract
Background and Importance The Pharmacy Department prepares and distributes fluid therapy (2 bags-system) for the treatment of diabetic ketoacidosis (DKA) in the paediatric emergency unit.
The implementation of this procedure has improved patient safety, since standardised preparations are used only the rhythm being modified according to the patient‘s needs.
The two bags system consists in sets of two bags of maintenance electrolytes in 1 litre of 10% dextrose or isotonic saline. Unfortunately, their expiration date was only 7 days due to the lack of data on stability.
In order to improve the convenience and reduce wastage, we designed and carried out a physical-chemical stability study of these solutions.
Aim and Objectives The objective of this study was to evaluate the physical and chemical stability of these solutions prepared in the Pharmacy Department to manage paediatric DKA.
Material and Methods
The two bags system contains:
Solution 1: Potassium (k) 38meq/l, phosphate (P) 59 mg/dl, magnesium (Mg) 5mg/dl and Sodium (Na)143meq/l in isotonic saline.
Solution 2: The same electrolytes concentration in dextrose 10%.
We prepared 8 units of each solution, half of them were stored at room temperature (23ªC), and half of them in the refrigerator (4°C).
We analysed the electrolytes concentration and made visual inspection for physical changes on the following days: 0 (d0), 14 (d14), 28 (d28), 49 (d49) and 92 (d92).
Material and MethodsThe chemical analysis was performed by the Laboratory Department through the following techniques: sodium and potassium by indirect potentiometry with selective electrode, phosphate by phosphomolybdate reaction; magnesium and glucose by enzymatic technique.
The physical analysis was determined in pharmacy through visual inspection searching for changes in colour and matter particles against a white and a black background.
The results were expressed in mean+/-SD. It was accepted a deviation <5%.
Results The electrolytes concentration remained stable during the study period. The visual inspection showed physical stability. Table 1 summarises the results.
Conclusion and Relevance The results show the stability of solutions in the period of study. Nevertheless, the beyond-use-date will be re-evaluated when a validated sterility test is performed.
Conflict of Interest No conflict of interest.