Adverse drug events in children during hospitalization and after discharge in a Norwegian University Hospital

Abstract

ADEs, mainly gastrointestinal, CNS and skin reactions related to drugs affecting the nervous system, anti-infectives and antiasthmatics, were seen in 28% of the patients. The reporting of events by parents was a useful supplement to the screening of patient records.

Adverse drug reactions in childhood: a review of prospective studies and safety alerts

“…The severity of events was reported in five studies12 18 20 21 23: in two no severe ADRs were reported,20 23 while in the other three the percentage of severe ADRs ranged between 2% and 30%. Six studies reported the criteria for causality assessment,12 18 19 20 21 23 five of which used the WHO criteria 12 18 19 20 21.…”

“…One additional study was identified after the manual search 12. Three studies performed in the United States were subsequently excluded because their data involved ADEs and not ADRs and one because adults were also involved 13 14 15 16…”

“…12 17 18 19 20 21 22 23 Prospective paediatric drug surveillance studies were performed in six different countries, with two each in Germany and France. A majority of the reports concerned ADR incidence in hospitalised children (6/8), four dealt with ADRs in children leading to hospital admission, and two reported the incidence of ADRs in outpatient children.…”

“…A majority of the reports concerned ADR incidence in hospitalised children (6/8), four dealt with ADRs in children leading to hospital admission, and two reported the incidence of ADRs in outpatient children. Two papers reported data regarding ADRs in hospitalised patients and leading to admission12 21 and one reported data from all three settings 17. The incidence of ADRs ranged from 1.5% to 19.9% among the studies involving hospitalised children.…”

“…Six studies reported the criteria for causality assessment,12 18 19 20 21 23 five of which used the WHO criteria 12 18 19 20 21. In these studies the ADRs with a cause assessed as definite/probable ranged between 56% and 91%.…”