P14 Pharmacovigilance in pediatric patients: the challenge of identifying new signal

N Kronenfeld, S Gamsu, H Flor-Hirsch, N Agajani, R Sheinberg, L Ben-Nun, M Goldman, M Berkovitch
2019 Archives of Disease in Childhood  
IntroductionThe importance of reporting adverse drug reactions (ADRs) is well known. However, the reporting rate is very low, and therefore, identifying new signal is challenging.ObjectiveTo create an interventional program in order to improve reporting rate and trying to identify new signal.Material and methodsThe interventional program was implemented at the Pediatric Division of Assaf Harofeh Medical Center and included presentations to the healthcare professionals, posters, creating new
more » ... reporting methods and alerts.ResultsReporting rate of ADRs during the year before implementation of the program was negligible. During the study period (three months), the reporting rate increased dramatically. A new signal was reported; two neonates with apnea related to IVIG administration in the neonatology department. The distribution of reports was: 50% from the general pediatric department, 26% - pediatric neurology department, 21% and 6%, from the pediatric and neonatal intensive care units, respectively. Steroids and antibiotics were responsible for various ADRs, but not for a new signal.ConclusionThere is one case report in the literature on apnea related to IVIG administration. Adverse reactions in children are a major problem and sometimes can lead to morbidity mortality. Identifying new signal in pediatric patients is not common, and very challenging.Disclosure(s)Nothing to disclose
doi:10.1136/archdischild-2019-esdppp.53 fatcat:ujclo4qfdnd5nm3or37plbpc3a