Development and evaluation of a test program for Y-site compatibility testing of total parenteral nutrition and intravenous drugs

Vigdis Staven,Ingrid Grønlie,Siri Wang,Ingunn Tho

doi:10.1186/s12937-016-0149-x

Abstract

BackgroundThere is no standardized procedure or consensus to which tests should be performed to judge compatibility/incompatibility of intravenous drugs. The purpose of this study was to establish and evaluate a test program of methods suitable for detection of physical incompatibility in Y-site administration of total parenteral nutrition (TPN) and drugs.MethodsEight frequently used methods (dynamic light scattering, laser diffraction, light obscuration, turbidimetry, zeta potential, light microscopy, pH-measurements and visual examination using Tyndall beams), were scrutinized to elucidate strengths and weaknesses for compatibility testing. The responses of the methods were tested with samples containing precipitation of calcium phosphate and with heat destabilized TPN emulsions. A selection of drugs (acyclovir, ampicillin, ondansetron and paracetamol) was mixed with 3-in-1 TPN admixtures (Olimel® N5E, Kabiven® and SmofKabiven®) to assess compatibility (i.e. potential precipitates and emulsion stability). The obtained compatibility data was interpreted according to theory and compared to existing compatibility literature to further check the validity of the methods.ResultsLight obscuration together with turbidimetry, visual inspection and pH-measurements were able to capture signs of precipitations. For the analysis of emulsion stability, light obscuration and estimation of percent droplets above 5 μm (PFAT5) seemed to be the most sensitive method; however laser diffraction and monitoring changes in pH might be a useful support. Samples should always be compared to unmixed controls to reveal changes induced by the mixing. General acceptance criteria are difficult to define, although some limits are suggested based on current experience. The experimental compatibility data was supported by scattered reports in literature, further confirming the suitability of the test program. However, conflicting data are common, which complicates the comparison to existing literature.ConclusionsTesting of these complex blends should be based on a combination of several methods and accompanied by theoretical considerations.

Highlights

There is no standardized procedure or consensus to which tests should be performed to judge compatibility/incompatibility of intravenous drugs
If a patient receives a continuous infusion of total parenteral nutrition (TPN), the infusion should be stopped and the line flushed before administration of other drugs in the same line [2, 3]
The focus of this paper is on physical incompatibility that is precipitation of particles or growth of droplets leading to destabilization of the lipid emulsion [3, 11,12,13,14]

Summary

Introduction

There is no standardized procedure or consensus to which tests should be performed to judge compatibility/incompatibility of intravenous drugs. Frequent stops may lead to under-nutrition, and the repeated flushing may be problematic with regard to the patient’s fluid balance [4] In this situation it might be beneficial to coadminister drugs and TPN through a Y-site connector. The focus of this paper is on physical incompatibility that is precipitation of particles or growth of droplets leading to destabilization of the lipid emulsion [3, 11,12,13,14]. Both precipitates and large oil droplets can potentially be dangerous upon infusion. There are reports of emboli-like effects as a complication of intravenous fat emulsion administration [21, 22] it is believed that the body can handle soft and flexible particles like oil droplets better than harder particles [23]

Objectives

Methods

Results