Chemical contaminations in the centralized reconstitution units of cytotoxic drugs using isolators : benchmarking study in the Auvergne region

Background

The chemical risk is significant in the centralized reconstitution units of cytotoxic drugs. A collaborative inquiry has been made among centralized units in order to benchmark their practices and identify areas of improvement. The purpose of this study is to minimize surface contaminations and hence limit cytotoxic chemotherapy’s exposures to healthcare personnel.

Methods

As a first step, an analysis of the measurable levels of contamination was carried out. Dosing cytotoxic drugs residue were previously performed by 7 preparation areas.
Next, we have evaluated practices by a 35-item questionnaire throughout the whole circuit.

Results

None of the centralized units is free of chemical contamination. The assays allowed determine 3 contaminated common surfaces to the 7 units (gloves, isolator’s work surface and surface of infusion bags). 5-Flurorouracil (5-FU) is the only molecule measured on all samples in every hospital pharmacy in the regional district.

The questionnaire then revealed 3 common risk steps for the 7 units:

• Storage of residues: opened vials keep out at room temperature are stored in 6 units inside the isolator
• DPTE® transfer system: among 5 units that use this kind of containers, 3 don’t clean them and 4 transport vials without individual packaging
• cleaning: the operating method and the frequency differ according to the units (for example, the worktops are cleaned according to 5 different procedures)

Conclusion-discussion

Considering the diversity of practices the units have decided to use 5-FU as a single tracer molecule, to harmonize sampling sites for chemical measurements and to carry out all chemical dosages at the beginning and end of activity. In this way, the least risky practices to induce contamination can be highlighted and areas of improvement can be proposed in each unit.