Drug preparation with CytoCare : monitoring product contamination, environmental contamination and exposure of pharmacy technicians

Aim

CytoCare is an automated device for compounding injectable drugs such as cytostatics. The aim of the study was to measure environmental contamination with and exposure to cytostatic drugs of pharmacy technicians handling CytoCare. Three different conditions were monitored :

1. normal working conditions reflecting the daily working routines
2. normal working conditions with a small spill (droplets) inside CytoCare
3. normal working conditions with simulation of a big spill (massive leak) inside CytoCare

Methods

Cyclophosphamide was selected for drug monitoring because of the high toxicity of the drug and the low detection limit of the analytical method. In addition, many studies have been published with cyclophosphamide which can be used for comparison.

Environmental contamination was measured by taking wipe samples from potential contaminated surfaces inside and outside CytoCare. Stationary and personal air-samples were collected to measure the presence of cyclophosphamide in environmental air. Wipe samples were also taken from vials containing cyclophosphamide, bags, prepared bags and ports of bags. To measure exposure to and uptake of the drug, urine samples of the pharmacy technicians handling CytoCare were collected and analysed for cyclophosphamide. Gloves used for preparation and cleaning and the hands of the pharmacy technicians were also monitored for contamination with cyclophosphamide.

Results

The results show low levels of contamination with cyclophosphamide after normal practise. However, contamination increases inevitably after the small and the big spill.

Also other studies have shown environmental contamination with cyclophosphamide in hospital pharmacies. These studies all concern manual preparation. The results with CytoCare show low levels of contamination with cyclophosphamide after normal practise compared to the reference data.

Conclusion

The results indicate that preparation with CytoCare can be performed with low levels of contamination compared to manual preparation.