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

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

Objectives: 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.

Methods: 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.

Results: 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).

Conclusion: 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.