Background Following the introduction of a new iodine-containing contrast medium (IC) (iomeprol) to our hospital formulary, an unexpected increase in adverse drug reactions (ADRs) to the IC was observed. Consequently, a root cause analysis (RCA) was made to identify the causes of adverse events, and to suggest improvements to prevent recurrences.

Purpose To determine the corrective measures resulting from an RCA to investigate the unexpected increase in ADRs associated with the introduction of a new IC (iomeprol) in the hospital, and to evaluate the effectiveness of measures implemented.

Material and methods The study was made in a 460-bed specialty hospital. The RCA multidisciplinary team was composed of medical and nursing directors and supervisors of radiology and pharmacy units. Steps followed in RCA involve: 1-problem description and data collection, 2-organisational system analysis, 3-human factor analysis, 4-team and material management analysis, 5-patient-related factors analysis, 6-RCA team proposal. The monthly number of ADRs notified before and after RCA was used to assess the effectiveness of corrective measures. Notifications of IC ADRs were extracted from the records of yellow card reports, as well as patient data, drug data and ADR data.

Results Proposals generated by RCA were: 1-to retrain radiology technicians and doctors on the use of IC pumps for administration, 2-to inspect pump calibration, 3-to verify the premedication needed. In the period 2009–2012 average notification of IC ADRs was 0.87/month. Since iomeprol was introduced in 2013/03 until RCA was performed (2013/05/08) 9 notifications were recorded (6/month); type and severity were similar to the previous period. Retraining and pump calibration inspection were finalised in June. The average IC ADR notification rate in the period July–December 2013 was 1.67/month. In the period January–October 2014, the notification rate was 0.89/month, similar to that before introduction of the new IC.

Conclusion 1. Technical training, machine calibration and patient evaluation were identified by RCA as aspects to improve. 2. After corrective measures had been taken, IC RCA notification has returned to the usual value.

References and/or acknowledgements No conflict of interest.