Analyse des risques, par la méthode AMDEC, du circuit de contrôle des médicaments dangereux

Risk management is one aspect of improving the quality and safety of medication care.

To map the process of monitoring hazardous drugs, assess the risks of the monitoring cycle and identify corrective actions to be implemented to ensure the safety of the cycle within a drug monitoring laboratory.

An analytical study was conducted over a period of 6 months in Tunisia's national drug monitoring laboratory. The risk analysis was carried out using the failure modes and effects analysis (FMEA) method.

A total of 53 failure modes and 3 critical levels were detected using the Ishikawa diagram and the 5M method (equipment environment, methods, materials, workforce). Thirty-three of the failure modes were of major criticality, 14 of moderate criticality and 6 of minor criticality. Overall, hazardous drug monitoring was found to be a high criticality (C_avg: 31.9) process, which required the implementation of an effective action plan in order to reduce the level of criticality to minor (C_avg: 10.4).

The hazardous drug monitoring process was complex and was associated with a high level of risk. After analyzing possible causes and pre-existing obstacles, an action plan was developed. Monitoring the elements of the action plan remains essential to controlling this process. A specialized department may be considered in the event of an increase in activity, for example with the surge of innovative therapies that require more restrictions during handling.