Impact of Handling Errors for Chemical Cross-contamination Risk for the Preparation of Parenteral Cytotoxic Drugs

Abstract

The aim of the study was to evaluate the risk of chemical cross-contamination between preparations of cytotoxic drugs performed in hospital pharmacy. Simulation of handling process errors was performed with two selected tracers, thiamine and retinol to mimic hydrophilic and lipophilic cytotoxic drugs. Four types of handling errors were simulated: errors associated with the re-use of a disposable transfer device: syringe, spike and needle and errors associated with surface contamination such as the use of a contaminated pad. The results show rates of contamination above the limit of quantification with the re-use of a syringe, a needle or a spike. For example, with the thiamine solution at 50 mg/ml final concentration, the re-use of a spike led to a contamination of approximately 100 µl equivalent to 5 mg. By contrast, the use of a surface contaminated pad failed to detect a cross-contamination. Cross-contamination related to a contamination of surface by a cytotoxic drug represents a low risk. However, the re-use of a single medical device due to handling human error led to quantifiable risk of cross-contamination. Furthermore, this type of error is very difficult to detect and may be frequent enough to have potential impact on patient.