Sécurisation du circuit de fabrication des médicaments anticancéreux: de l'analyse globale des risques au plan d'action d'amélioration

The protocols of anticancer drugs are becoming more defined, allowing improvement of the benefit/risk ratio of these health products, which are known to be highly toxic; their handling combines multiple dangers for patients, professionals and environment. The objective of this work was to review and update the assessment of the vulnerabilities for the anticancer drugs manufacturing process and to design a relevant risk management plan in order to improve these processes. Materials and method. The Global Risk Analysis (GRA) method was implemented by a multidisciplinary group involving teams from clinical pharmacy department and quality department. After mapping the system and its dangers, the hazardous situations were identified. Scenarii for high-risk hazardous situations were described and rated (severity, likelihood and criticality) aiming to develop a risk reduction action plan and manage residual risks. Results. This work revealed 119 hazardous situations. Only 57 with a prioritisation index equal to IP1 were analysed, leading to 276 scenarii, including 14 of unacceptable criticality (C3) without any major risk. This analysis highlighted the impact of hazards related to the information system and occupational risks. The phase identified as most at risk was the preparation stage. This analysis led to the implementation of a risk reduction action plan consisting of twenty-five action templates and two safety parameters for managing residual risks. Discussion/Conclusion. Carrying out an GRA highlighted the vulnerabilities of our organisation and assessed them. Three main areas for improvement were identified: infrastructure, information system and human resources management. The results of the GRA highlight a system which is under control with an acceptable risk. However, this process is constantly evolving and will therefore be re-evaluated regularly and improved as often as necessary.