Effectiveness of Closed System Drug Transfer Devices in Reducing Leakage during Antineoplastic Drugs Compounding.

Maria Teresa Piccardo,Alberto Izzotti,Alessandra Forlani

doi:10.3390/ijerph18157957

Abstract

This study, conducted in a centralized cytotoxic drug preparation unit, analyzes the effectiveness of two closed system drug transfer devices (CSTDs) in reducing leakage during antineoplastic drug compounding. Wipe/pad samplings inside and outside the preparation area were taken during surveillance programs from 2016 to 2021. All samples were analyzed for gemcitabine (GEM) contamination. In 2016, the presence of GEM in some samples and the contamination of the operators’ gloves in the absence of apparent drug spilling suggested unsealed preparation systems. In subsequent monitoring, GEM was also evaluated in the vial access device and in the access port system to the intravenous therapy bag of TexiumTM/SmartSiteTM and Equashield® II devices after the reconstitution and preparation steps of the drug. The next checks highlighted GEM dispersion after compounding using TexiumTM/SmartSiteTM, with positive samples ranging from 9 to 23%. In contrast, gemcitabine was not present at detectable levels in the Equashield® II system in all of the evaluated samples. The Equashield® II closed system seems effectively able to eliminate spills and leakage during gemcitabine compounding. Since drugs with different viscosities can have different effects on CSTDs, Equashield® II needs to be considered with other antineoplastic drugs during a structured surveillance program.

Highlights

The primary purpose of this study was to evaluate the effectiveness of two closed system transfer devices (TexiumTM /SmartSiteTM and Equashield® II) in reducing leakage during antineoplastic drug compounding, which was achieved by surface wipe sampling
Environmental monitoring has played an important role in protecting workers from exposure to antineoplastic drugs because it has allowed the identification of the weak points in the working procedures
closed system drug transfer devices (CSTDs) are important supplemental engineering controls for containing the exposure of healthcare professionals involved in the handling of hazardous drugs

Summary

Introduction

Antineoplastic drugs, known as cytotoxic or cytostatic drugs, are medications designed to destroy cells that grow rapidly and uncontrollably, preventing them from replicating or growing. They are non-selective and do not differentiate between malignant and normal cells; it is likely that they can damage healthy tissues, resulting in adverse health effects [1]. Essential for cancer treatment, they play an important role in hematology. They are used to treat rheumatologic diseases, multiple sclerosis, psoriasis, and lupus erythematosus [2]. These drugs are widely used, and the number of preparations and administrations has increased significantly over the years, highlighting the risk associated with occupational exposure [3,4]

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