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A Comparison of Active Surveillance Programs Including a Spontaneous Reporting Model for Phamacovigilance of Adverse Drug Events in a Hospital

Authors
 Il Seon Yun  ;  Myung Jin Koo  ;  Eun Hye Park  ;  Sung-Eun Kim  ;  Jae-Hyun Lee  ;  Jung-Won Park  ;  Chein-Soo Hong 
Citation
 KOREAN JOURNAL OF INTERNAL MEDICINE, Vol.27(4) : 443-450, 2012 
Journal Title
 KOREAN JOURNAL OF INTERNAL MEDICINE 
ISSN
 1226-3303 
Issue Date
2012
MeSH
Adverse Drug Reaction Reporting Systems* ; Drug-Related Side Effects and Adverse Reactions ; Female ; Hospitals, Teaching ; Humans ; Male ; Middle Aged ; Pharmacovigilance* ; Republic of Korea ; Retrospective Studies
Keywords
Active surveillance ; Drug toxicity ; Spontaneous reporting
Abstract
Background/Aims: Spontaneous reporting systems have several weak points, such as low reporting rates and insufficient clinical information. Active surveillance programs, such as ward rounds and a clinical data repository (CDR), may supplement the weak points of such systems. We developed active surveillance programs and compared them with existing spontaneous reporting. Methods: We collected adverse drug event (ADE) cases, which comprised 1,055 cases of spontaneous reporting, 309 reported by ward rounds, and 229 found using a CDR. The clinical features and causative drugs were evaluated. Results: Active surveillance programs detected additional serious ADEs compared to those of spontaneous reporting programs. The ADEs identified by CDR (22.9%) were more likely to be classified as "serious" than those reported spontaneously (5.2%) or identified during ward rounds (10.3%). Causative drugs also differed. Opioids, antibiotics, and contrast media were the most common drugs causing ADEs in the spontaneous reporting system, whereas the active surveillance programs identified antibiotics as the most common causative drug. Clinical features also differed. ADEs with gastrointestinal manifestations were reported most frequently by spontaneous reporting programs. ADEs reported from active surveillance more reliably identified events associated with changes in laboratory values, such as hepatobiliary toxicity, hematologic manifestations, and nephrologic manifestations, compared with spontaneous reporting programs. Conclusions: Our findings suggest that active surveillance programs can supplement spontaneous reporting systems in hospitals. ADEs related to laboratory abnormalities were monitored more closely by active surveillance programs and may be useful for identification of serious ADEs.
Files in This Item:
T201205599.pdf Download
DOI
23269886
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Park, Jung Won(박중원) ORCID logo https://orcid.org/0000-0003-0249-8749
Yun, Il Seon(윤일선)
Lee, Jae Hyun(이재현) ORCID logo https://orcid.org/0000-0002-0760-0071
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/91276
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