|
KMID : 1011320080010010068
|
|
Journal of Pharmacoepidemiology and Risk Management
2008 Volume.1 No. 1 p.68 ~ p.74
|
|
|
Analysis of Adverse Events Reported to the Korea Food & Drug Administration, 1988-2006
|
|
Seong Jong-Mi
Choi Nam-Kyong
Park Byung-Joo
Jung Sun-Young
Kim Ye-Jee
Lee Joong-Yub
Kim Hwa-Jung
Ahn Hee-Jung
Kim Seon-Ha
Shin Joon-Su
|
|
|
Abstract
|
|
|
Objective: To describe the characteristics of the reports and the reporting patterns in the Korean spontaneous adverse event (AE) reporting database from 1988 to 2006.
Methods: This study was conducted to analyze the data based on spontaneously reported AEs between December 1988 and June 2006 to Korea Food and Drug Administration. Drugs and AEs were translated to generic names and World Health Organization Adverse Reaction Terminology (WHO-ART), respectively. Patient characteristics (age, gender), reports source, number of reports and reporting rate by year according to report source were analyzed. Distribution of suspected drugs and their therapeutic classes, system-organ classes and individual AEs were also analyzed.
Results: The total number of AE reports was 4,592 during 19 years. The number of reports was very low for 10 years since 1988 but showed sharp increase after then; reports of recent half and 2 years (2004-2006.6) occupied 61.2% of all reports during the whole reporting period. In the age group 25-64 years comprised 48.7% of reports and 51.1% of reports was males. The most frequent reporting source was pharmaceutical company (56.7%) followed by hospital (29.3%). Sildenafil citrate was the most frequently reported drug (16.3%) followed by docetaxel (2.4%). According to the WHO-ART coding, the most frequently reported system-organ class was gastro-intestinal system.
Conclusion: Spontaneous AE reports have been increased recently reflecting the increasing awareness of spontaneous AE reporting system and importance of ensuring drug safety in Korea. Spontaneous AE reports by other report sources including patients and pharmacy should be encouraged as well as pharmaceutical company and hospital and the effort for collecting valuable AE reports which provide complete information is needed.
|
|
|
KEYWORD
|
|
|
Spontaneous adverse event reporting system, Adverse event, Adverse drug reaction, Reporting pattern, Signal detaction Pharmacovigilance
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|