Risk mapping within a cytotoxic preparation unit

28 September 2021

HAINAUT Marc-Antoine1, FILLATRE Adrien1, ABDAOUI Ahmed1, SAINT-GERMAIN Pierre1, HOUBERT Audrey1 1 Centre hospitalier de Saint-Quentin, 1 Avenue Michel de l’Hospital BP 608, 02321 Saint-Quentin – France

The preparation of injectable cytotoxic is a high-risk sector. Following the arrival of a new pharmacist and in the context of the renewal of our hospital pharmacy’s authorization, analysis of our strengths and vulnerabilities appears as essential. A risk map has been realized to ensure security.

The aim is to evaluate our injectable cytotoxic circuit and implement action plans.

The evaluation is based on the tool ChimioPrep® elaborated by the Paris Regional Health Agency; in the form of a questionnaire divided into 3 tabs, it studies the different aspects of our circuit : "Process" (from prescription to administration), "Steering and Management" (hygiene, quality, equipment, etc.) and "Cooperation - Subcontracting". Multidisciplinary meetings with the actors involved (pharmacists, prescribers, preparers, quality managers, nurses) and their different opinions helped to fill out the questionnaire in order to calculate a risk control score.

The control score for the "Process" tab is 79%: delivery represents the lowest score (60%). Prescription, pharmaceutical validation and preparation have respectively scores of 78%, 74% and 71%. Finally, storage, bag control/release and administration have scores of 89%, 91% and 82%. The score for the "Leadership and Management" tab is 87% with scores of 100% for communication, 90% for the controlled atmosphere area (premises and equipment), 83% for hygiene and 80% for the information system and personnel (training and evaluation). The control score for the "Cooperation - Subcontracting" tab is 91% with a score of 25% for risk management and 100% for organization, information system, documentation system and production.

The risk map shows that most of the stages of our cytotoxic process are under control. Nevertheless, some points require improvement and priority action plans have already been set up like an annual theoretical reassessment of the preparers, a training on how to behave in the event of exposure to cytotoxics and the modification of the delivery with the separation of the refrigerated and ambient cytotoxic. In order to improve pharmaceutical validation, support documents for each molecule with the key control points have been established. Other action plans will be defined in order to respond to the results of the risk mapping, which remains time-consuming.

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