Abstract
Introduction
Recent legislative amendments in Romania mandate that qualified pharmacy personnel undertake the centralized compounding of cytotoxic infusions and the handling of cytotoxic drugs. Nevertheless, numerous hospitals continue to depend on inadequately trained nursing staff to perform these critical tasks, thereby heightening the risk of contamination and procedural errors. It is imperative that compounding occurs within a designated room equipped with a laminar airflow hood and that appropriate protective equipment is utilized, adhering to stringent work procedures to mitigate associated risks. This study assesses the outcomes resulting from the implementation of these work procedures and the efficacy of closed transfer systems. Additionally, it compares surface contamination levels of cytotoxic drugs and bacterial presence prior to and following the establishment of these procedures.
Methods
Before this study, written work procedures were absent, and the application of closed transfer systems was limited. Comprehensive compounding and administration procedures were thus developed. After a two-year period of implementing these interventions, surface contamination levels were re-evaluated. Surface samples for cytotoxic drug contamination were collected on July 15, 2022, and on May 14, 2024. The presence of four cytotoxic drugs were evaluated initially and seven in the second period from six tested areas. In September 2023, microbial surface contamination inside the hood was assessed using the surface wipe method, then analysed with a commercially available bioluminescence kit and the sterility of the final compounded infusion was checked using the incubation method, using BacT/ALERT® PF Plus culture bottles.
Results
Wipe samples taken in 2022 indicate contamination with two to three drugs on all tested surfaces. Out of 24 samples collected, 10 tested negative. Contamination levels were detected for 5-fluorouracil, gemcitabine and paclitaxel on different surfaces. However, wipe samples taken in 2024 show contamination levels only for cyclophosphamide and 5-fluorouracil on two surfaces. Out of 42 samples tested, 40 were negative. Three surfaces exhibited no bacterial contamination, while one surface recorded a low level. All three compounded infusion samples for microbial contamination yielded negative results, indicating the absence of bacteria or fungi in the final infusions.
Conclusions
The findings indicate that centralized compounding performed by trained pharmacy personnel, in compliance with established work procedures, significantly reduced surface contamination levels and ensured the sterility of the compounded infusions. Similar studies must be conducted across other hospitals to enhance the understanding of contamination dynamics in the compounding of cytotoxic infusions.
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