Background Medication errors (MEs) are frequent in hospitals, and newborns are particularly exposed. Identification and understanding the causes and risk factors associated with MEs will help to improve the effectiveness of medication.

Purpose First, we aimed to compare the rate of MEs highlighted through voluntary incident report and direct observation. Second, we aimed to identify risk factors that contributed to the occurrence of MEs, in order to implement interventions to reduce their occurrence and improve effectiveness of medication.

Material and methods This study was carried out in the 12-bed neonatal intensive care unit (NICU) of our University Hospital. All MEs occurring during drug prescription, preparation or administration in the NICU and voluntarily reported by carers in our incident reporting system from June to September 2010 and from August to November 2012 were analysed and compared with MEs detected prospectively through direct observation by a clinical pharmacist. Direct observation and voluntary incident reporting were compared in terms of the number of MEs identified, error type, severity and other variables related to MEs. Poisson regressions were performed to identify risk factors for MEs. Different outcomes were considered: number of prescription errors, number of preparation errors, number of administration errors and total number of MEs. For each outcome, the following explanatory variables were included in the analysis: year, birthweight, gestational age, severity of the disease, mode of ventilation and number of drugs prescribed per patient.

Results A total of 164 patients were included in the study. Ultimately, 383 MEs were identified by the clinical pharmacist, and two MEs were declared by carers. Prescription errors accounted for 38.4%, preparation errors for 16.2% and administration errors for 45.4%. Incorrect rate of administration (21.9%), incorrect timing of administration (18.3%), dose omission (10.4%) and improper dose (8.1%) were the most frequent errors observed. The two variables significantly related to the occurrence of MEs were gestational age <32.0 wk (p=0.04) and number of drugs prescribed (p<0.01).

Conclusion Cares underreported the true rate of MEs in our NICU. The risk of MEs is increased in newborns<32.0 weeks and increases with the number of drugs prescribed to each patient.

References and/or acknowledgements No conflict of interest.