Abstract Introduction Systemic anti-cancer therapy (SACT) compounding is a high-risk process. Traditional mixed method systems for workflow management in aseptic compounding units (ACUs) are inherently prone to risk. Workflow management systems (WFMSs) are recognised internationally to improve safety, reduce costs, and increase ACU capacity.[1] Planning of the implementation of a WFMS has not been characterised before. In our ACU, Clinichemo® will be replaced with BD-CATO®. BD-CATO® is a WFMS and is the vendor for the National Cancer Information System (NCIS), implemented by the National Cancer Control Programme (NCCP).[2] Aim The aim of this study was to demonstrate how the implementation of a new WFMS can be safely planned, managed, and assessed. This aim was achieved using the following objectives: 1. Describe and risk assess the current workflows for SACT compounding. 2. Investigate agreed and published standards for SACT compounding. 3. Define the change management process. 4. Describe and evaluate the benefits, challenges and risks associated with the introduction of a new SACT compounding system. 5. Interview adopters of NCIS/BD-CATO® to assess their experience of the barriers encountered, how challenges were overcome, risks identified, mitigated, and eliminated through the change management process and ongoing. Methods The current workflow and future workflow for SACT compounding were characterised and current process risk assessed. Semi-structured interviews were carried out to evaluate pharmacist and pharmacy technicians’ attitudes and opinions towards the implementation of BD-CATO® in their organisations and the system itself. Participants were recruited by means of purposive and snowball sampling from ACUs across the country that had implemented/were in the process of implementing BD-CATO®/NCIS. Themes identified in interviews were compared to those found in the literature and guidelines. Interviews, a review of guidelines, published standards and the literature were used to guide and risk assess future process development. The change management plan was also defined. Results Nine participants (8 pharmacists and 1 pharmacy technician) were interviewed in June-August 2023. The interviews were conducted across 7 ACUs in Ireland. Thematic analysis of interview data yielded four key themes: 1. Participants discussed the importance of planning activities, such as communication with key stakeholders, discussions around phased implementation, and development of training material. 2. Having a designated individual tasked with change implementation improved outcomes of the implementation project. 3. Participants also discussed benefits and risks associated with BD-CATO®. 4. Participants discussed their reasons for perceived complexity of the system. A combination of interview data, review of guidelines, published standards and the literature were used to devise future process workflow and the change management plan. The future process workflow was also risk assessed using bowtie analysis. Conclusion The introduction of WFMSs has been interpreted both in the literature and within the Irish healthcare setting to increase efficiencies, reduce error rates, and improve the accuracy of SACT compounding. A formal change management strategy devised with resourcing, training, and obtaining stakeholder engagement is key to successful implementation.
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