Analysis of IV Drugs in the Hospital Workflow by Raman Spectroscopy: The Case of Piperacillin and Tazobactam.

Ioanna Chrisikou,Malvina Orkoula,Christos Kontoyannis

doi:10.3390/molecules26195879

Ioanna Chrisikou, Malvina Orkoula + Show 1 more

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https://doi.org/10.3390/molecules26195879

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Abstract

Medical errors associated with IV preparation and administration procedures in a hospital workflow can even cost human lives due to the direct effect they have on patients. A large number of such incidents, which have been reported in bibliography up to date, indicate the urgent need for their prevention. This study aims at proposing an analytical methodology for identifying and quantifying IV drugs before their administration, which has the potential to be fully harmonized with clinical practices. More specifically, it reports on the analysis of a piperacillin (PIP) and tazobactam (TAZ) IV formulation, using Raman spectroscopy. The simultaneous analysis of the two APIs in the same formulation was performed in three stages: before reconstitution in the form of powder without removing the substance out of the commercial glass bottle (non-invasively), directly after reconstitution in the same way, and just before administration, either the liquid drug is placed in the infusion set (on-line analysis) or a minimal amount of it is transferred from the IV bag to a Raman optic cell (at-line analysis). Except for the successful identification of the APIs in all cases, their quantification was also achieved through calibration curves with correlation coefficients ranging from 0.953 to 0.999 for PIP and from 0.965 to 0.997 for TAZ. In any case, the whole procedure does not need more than 10 min to be completed. The current methodology, based on Raman spectroscopy, outweighs other spectroscopic (UV/Vis, FT-IR/ATR) or chromatographic (HPLC, UHPLC) protocols, already applied, which are invasive, costly, time-consuming, not environmentally friendly, and require specialized staff and more complex sample preparation procedures, thus exposing the staff to hazardous materials, especially in cases of cytotoxic drugs. Such an approach has the potential to bridge the gap between experimental setup and clinical implementation through exploitation of already developed handheld devices, along with the presence of digital spectral libraries.

Highlights

Introduction iationsIn a hospital workflow routine, the intravenous administration of drugs to patients is a usual phenomenon
The errors that are associated with the preparation and administration of intravenous drugs constitute one of the most usual categories of medical errors, which can lead to morbidity and to mortality due to the direct effect they have on patients
This paper reports on the employment of Raman spectroscopy for the development of a new methodology, aiming at the identification and quantification of a piperacillin (PIP)

Summary

Introduction

In a hospital workflow routine, the intravenous administration of drugs to patients is a usual phenomenon. Some of the most important advantages of intravenous drug administration include the immediate and fast therapeutic result, which is of utmost importance in case of emergency and the treatment of patients who are unable to receive oral administration [1]. The errors that are associated with the preparation and administration of intravenous drugs constitute one of the most usual categories of medical errors, which can lead to morbidity and to mortality due to the direct effect they have on patients. A large number of studies have been conducted regarding the detection of intravenous medication errors. The majority of them have focused on the preparation and administration procedure and the frequency the errors occurred [2,3,4,5,6,7,8,9,10,11,12,13].

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