Background The significant increase in the number of patients affected by cancer has provoked medical and pharmaceutical teams to improve the quality and safety of the chemotherapy process.

Purpose The objective was to analyse the production of chemotherapy treatments in an isolator after physician’s prescription, and pharmaceutical analysis of the prescription in our cytotoxic production centralised unit.

Material and methods The preliminary hazard analysis (PHA) method was used. To lead this analysis, a multidisciplinary group was formed. The different steps of the PHA were to:

-define the boundaries of the study, the scales of likelihood and severity, and the risk ranking table;

-realise the cartography of hazardous situations (HS) and determine the priority’s level associated with the vulnerability of exposed elements (priority 1 for very vulnerable element and priority 2 for vulnerable element); -elaborate scenarios corresponding to HS and evaluate initial risk index;-propose preventive actions and evaluate final risk index.

Data were analysed by the software Statcart.

Results The study of chemotherapy process revealed 5 phases: picking of drugs and medical devices, sterilisation, chemotherapy preparation in an isolator, packaging and dispensing. 129 HS: 43 HS of priority 1 and 86 HS of priority 2. Categories of hazards causing most HS were linked to management (29/129) and human factors (32/129). The phase ‘chemotherapy preparations in an isolator’ represented more than 55% (24/43) of priority 1 HS. From these 24 HS, 34 scenarios were developed: 44% (15/34) presented an acceptable risk (C1), 56% (19/34) presented a tolerable risk under control (C2) and none presented an inacceptable risk (C3). The 19 scenarios quoted in C2 needed preventive measures to reduce the risk. After implementation of these measures, all scenarios will present an acceptable risk.

Conclusion This PHA allowed us to highlight HS in our chemotherapy production process. Professional practice evaluations of pharmacy technicians and analytical controls of preparations are part of recommended preventive measures. A timetable for the implementation of measures is being drafted. To improve quality of the entire process, the other critical phases, such as administration, will be analysed. PHA is a method which can be used in cytotoxic production units to assess and optimise risk management.

No conflict of interest