Background Medication incident reporting systems play a vital role in improving medication safety through the identification of medication incidents/near misses and learning from them. FMEA is an excellent tool to review a system as it systematically identifies potential problems in a system and makes them transparent on a priority basis before they occur.

Purpose To use failure modes and effects analysis (FMEA) to improve the medication incident reporting system in a hospital.

Materials and methods The prospective risk analysis tool, FMEA, was used by a multidisciplinary team to identify key failures in the original medication incident reporting system. The likelihood of the failure occurring, the severity and detectability of the failure if it occurred were agreed by the team and used to calculate the risk priority number (RPN) of each failure mechanism. Potential failures with an RPN of greater than 45 were targeted in an FMEA action plan which was produced and implemented with the aim of reducing these priority risks. This action plan included the introduction of a new medication incident report form, a new database to record and analyse incidents for trends, a new medication safety newsletter for staff and the production of a key performance indicator to feedback information to management.

Results By implementing the key measures identified in the FMEA process, an overall reduction of 75% was achieved in total risk priority number of the medication incident reporting system.

Conclusions Prospective risk analysis provides a great opportunity for system improvement. The inclusion of a multidisciplinary team at all stages in this analysis ensures a balanced approach to reviewing a system and identifying potential risks. Implementation of the FMEA action plan has lead to a significant risk reduction in the process and resulted in a robust medication incident reporting system in the hospital.