Background The manipulation of products with health risks is a source of concern for hospital pharmacy (HP) staff, even if good distribution practices require labelling of containers to identify them and secure their handling. This is particularly the case with cytotoxic products. Our HP, which ensures the supply and distribution of health products to 37 hospitals, is highly impacted by this risk even if cytotoxics are stored in specific areas and are subject to specific procedures in accordance with good HP practices. Therefore, we wanted to assess all the risks related to the handling of cytotoxics in our HP.
Purpose The objective is to establish a mapping of the risks associated with the cytotoxic circuit within our HP. The steps identified as most risky will be subject to action plans and corrective measures to secure the health products circuit.
Material and methods The scope of the study includes the reception and the storage of cytotoxics, preparation order, delivery to hospitals and disposal circuits. The Failure Mode, Effects and Criticality Analysis has been used to map risks. Failure modes with a criticality index (CI) greater than the average CI will be subject to a corrective action proposal.
Results The analysis reveals 51 failures with an average CI of 16 (min=2; max=48). Among these failures, 23 have a major criticality (CI higher than the average CI) and are mainly due to the lack of an identification label of the cytotoxic at different steps (n=13). The main steps at risk are the reception of unidentified packages arriving from suppliers or returning from hospitals, and the transport to hospitals. Breaks that can occur any time lead to a significant risk of contamination.
Conclusion The action plan to be set up requires working with suppliers, carriers and our logistics sectors, in such a way that everyone is aware of the risks incurred by each actor. The main focus of improvement concerns the identification of cytotoxics and staff training, especially in cases of product breakage. Finally, the disposal circuit is to be improved. A continuous evaluation process must allow the follow-up of the corrective actions.
References and/or acknowledgements https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2013:343:0001:0014:EN:PDF
No conflict of interest.
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