Considering robotic production of injectable anti-cancer drugs? Think ahead!

4 October 2023

T. Martin, E. Grassi, A. Mitha, H. Aboudagga, C. Bertrand, P. Coliat, COPIL APOTECA FRANCE
Institut de Cancérologie Strasbourg Europe, Strasbourg, Centre Eugène Marquis, Rennes, Gustave Roussy, Villejuif, Communauté Apoteca France

Automated compounding of injectable anti-cancer drugs has become increasingly popular in hospital pharmacies worldwide in recent years. This new production method has changed conventional practices and therefore needs to be anticipated in order to adequately prepare the teams and initiate the activity.
The aim of this study was to propose a tool for anticipating and securing the implementation of robotic production of injectable anti-cancer drugs.

Each member centre of the Apoteca France Community (CAF) was asked to complete an Ishikawa diagram using the 5M method. The data were compiled into a single document that was discussed and validated during team meetings and CAF project reviews. For each risk identified, a person responsible and a deliverable were defined. A timeframe was attached to each risk, identifying the various milestones preceding the start of robotic production. Finally, all data were integrated into an action plan presented in the form of a tracking sheet.

The Ishikawa diagram resulted in a total of 70 risks identified across the 5Ms, such as defining robot selection criteria, establishing workflows, software interfacing, and so on. Each risk was assigned a responsible person (e.g. production pharmacist, infrastructure manager, or management) and a deliverable (e.g. defined, adapted and qualified work environment, validated documentation system, approved logistics circuit).
The timeframe was modelled using a Gantt chart with deadlines at >1 year, 1 year, 6 months, 1 month, 1 day, associated with each risk.
The risk mapping coupled with the action plan was presented as a spreadsheet with filters (by actor, by deadline, ...) to facilitate monitoring and sharing among project stakeholders.

The transition to robotic production compels hospital pharmacies to re-engineer their processes and requires project management with risk assessment. This first iteration of this practical and adaptable tool aims to facilitate project management and will be refined through the feedback from future users.

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