Cytotoxic waste disposal: handling environmental contamination using the FMECA method

Background and objectives
In December 2023, in collaboration with the occupational health department, a study evaluating professional exposure to systemic anti-cancer drugs (SACDs) was conducted at the hospital pharmacy. The study revealed environmental contamination with SACDs, both inside and outside the Cytotoxic drug Reconstitution Unit (CRU). Among the hypotheses formulated, the possibility of contamination during the disposal of waste outside the CRU was investigated. The objective of this study was to reduce the risk of environmental contamination by SACDs using the FMECA (Failure Mode, Effects, and Criticality Analysis) method.

Materials and Methods
This study was conducted in 5 steps: (1) reviewing the CRU’s waste disposal procedures; (2) observing current practices; (3) conducting the Five Whys checklist (Who, What, When, Where, Why) to assess current practices; (4) collectively reviewing the checklist with a Multidisciplinary Discussion Group (MDG) consisting of the concerned staff members; (5) conducting a FMECA method to identify high-risk practices, prioritize them (calculating criticality: the product of severity, frequency, and controllability, as determined in the MDG), and establish corrective action plans with the MDG.

Results
An assessment of practices regarding the CRU’s waste disposal was conducted. Practices creating potential risks of environmental contamination by SACDs were identified. Results showed: 18 failure modes, 23 root causes (including 17 with criticality above 12, i.e., high). The implementation of 6 corrective actions reduced the criticality of 19 of the identified causes (82%). These actions addressed 100% (n = 17) of the causes with a criticality rating ≥ 12. New practices for waste disposal from the CRU were implemented, and existing procedures were revised. Posters now remind staff of the handling rules to follow, and new equipment (adapted cart…) has been made available to the staff.

Discussion – Conclusion
Following the identification of a potential risk exposure to SACDs for hospital pharmacy workers, an analysis of the CRU’s waste disposal process was conducted as part of the continuous quality improvement initiative. This analysis, carried out in collaboration with a multidisciplinary team, led to changes in practices and increased awareness on this issue. Now that the new measures are implemented, it will be necessary to reassess staff exposure risks (using the FMECA method) and the environmental contamination through new sampling campaigns.

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