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Arch Pediatr. 2009 Feb;16(2):106-11. doi: 10.1016/j.arcped.2008.11.013. Epub 2008 Dec 30.

[Active drug monitoring of adverse drug reactions in pediatric emergency department].

[Article in French]

Author information

1
Service de pharmacologie clinique, hôpital L.-Pradel, Inserm CIC201, EPICIM, CNRS UMR 5558, université de Lyon, CHU de Lyon, 69000 Lyon, France.

Abstract

OBJECTIVES:

The aim of this study was to systematically evaluate adverse drug reactions (ADRs) in children consulting at the pediatric emergency unit during a 6-month period.

METHOD:

The regional pharmacovigilance center (CRPV) and the department of clinical pharmacology prospectively and systematically recorded all potential ADRs among patients younger than 18 years of age in the pediatric emergency unit reported at the daily staff meetings. All cases were then screened and validated by the CRPV. For validated cases, preventability, seriousness, and off-label use were evaluated.

RESULTS:

During the study period, from 1 March to 1 September 2005, 90 children presented potential adverse drug events. ADRs were confirmed in 43 patients, 19 females and 24 males. Thirty-four patients (79%) were under the age of 5. According to the European definition, 14 patients (33%) had serious ADRs. One anaphylactic shock after amoxicillin injection; antimalarial prophylaxis misuse leading to convulsive status epilepticus, convulsion, and coma after hepatitis B and MMR vaccines were deemed life-threatening. Three ADRs were considered avoidable. Antibiotics and vaccines were the most common possible cause of ADRs (76%). Skin reactions (n=27), fever (n=8), and gastric disorders (n=5) were the most common clinical manifestations.

CONCLUSIONS:

Because ADRs were reported by clinicians on a voluntary basis, serious ADRs were probably reported more systematically. Compared to a similar period without active monitoring, active drug monitoring of ADRs doubled the number of confirmed cases 43 vs 17, p<0.001. Close collaboration between the pharmacovigilance center, pharmacologists, and clinicians is necessary and seems feasible for improving the monitoring of ADRs in children.

PMID:
19117738
DOI:
10.1016/j.arcped.2008.11.013
[Indexed for MEDLINE]
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