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KMID : 0869620130300020108
Journal of Korean Society of Hospital Pharmacists
2013 Volume.30 No. 2 p.108 ~ p.118
Assessment of Pediatric Adverse Drug Reaction Reports
Chung Ji-Hyun

Kim Jung-Tae
Rhew Ki-Yon
Abstract
Objectives : This study was conducted in order to analyze the pattern and severity of pediatric
adverse drug reactions (hereafter, ADRs), suspicious medication and the reports for preventing and predicting further ADRs in order to apply for the construction of the Korean pediatric ADR database.
Methods : A total of 1,011 reports, including pediatric ADRs, reported to the KFDA between
January and June 2010 were analyzed. The reports, which had a higher category than ¡®possible¡¯ in the Naranjo scale, were included.
Results : Oseltamivir phosphate (364 reports, 11.0%), methylphenidate (272 reports, 8.2%) and
acetaminophen (109 reports, 3.3%) were the most suspicious drugs found in pediatric ADRs. The most common ADRs in pediatrics were vomiting (451 reports, 16.2%), nausea (319 reports, 11.5%) and diarrhea (183 reports, 6.5%). Most of the ADR reports were conducted with health care professionals, including doctors, pharmacists, and nurses.
Conclusion: Drug monitoring for pediatric patients should be intensively conducted with health professionals and public health care programs for the education of ADR reports should
also be offered.
KEYWORD
Adverse drug reaction, Pediatric ADRs, ADR reporting system, Health care program, Public health education
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