Performing a preliminary hazard analysis applied to administration of injectable drugs to infants.

Rationale, Aims and Objectives: Errors in hospitals during the preparation and administration of intravenous drugs to infants and children have been reported to a rate of 13% to 84%. This study aimed to investigate the potential for hazardous events that may lead to an accident for preparation and administration of drug injection in a pediatric department and to describe a reduction plan of risks. Methods: The preliminary hazard analysis (PHA) method was implemented by a multidisciplinary working group over a period of 5 months (April-August 2014) in infants aged from 28 days to 2 years. The group identified required hazard controls and follow-up actions to reduce the error risk. To analyze the results, the STATCART APR software was used. Results: During the analysis, 34 hazardous situations were identified, among 17 were quoted very critical and drawn 69 risk scenarios. After follow-up actions, the scenarios with unacceptable risk declined from 17.4% to 0%, and these with acceptable under control from 46.4% to 43.5%. Conclusion: The PHA can be used as an aid in the prioritization of corrective actions and the implementation of control measures to reduce risk. The PHA is a complement of the a posteriori risk management already exists.