An a priori analysis of the risks on the injectable chemotherapy process: the FMECA method

The injectable chemotherapy process includes critical steps that require to acknowledge and control risks to prevent undesirable events. The permanent increase of activity, diversity (elderly patients, children, diseases), changes in production protocols, has led us to conduct an analysis of risks according to the FMECA method (Failure modes, effects and criticality analysis) to set up preventive measures.

The risks and their causes have been identified from the pharmaceutical validation of the prescription to its dispensation. The criticality index (CI) was calculated for each risk in terms of gravity (G), frequency (F) and detectability (D) according to the equation CI = F * G * D. A five-level scale of severity is used in our institution for undesirable events. Two scales of detectability were used for the production process and for the support processes (facilities, equipment, staff...).

Risk analysis has highlighted 77 risks: 0 of high criticality, 8 of medium criticality and 69 of low criticality. For the production process the medium criticality steps are: validation of prescriptions, handling in isolators, dual control and validation of preparations (visual inspection). For support processes, identified risks are related to the staff (workforce, training) and the supplying (out of stock...).

This work has identified areas for improvement: training of staff, additional human resources, pooling of costly product stocks with other institutions... A new FMECA analysis is intended to verify the impact of these actions and expand the risk analysis to prescription, transport, and administration steps.