title: Spontaneous reporting of adverse drug reactions through electronic submission from regional society healthcare professionals in Korea.
abstract: OBJECTIVE
  Pharmacovigilance Research Network built a spontaneous reporting system and collected adverse drug reactions (ADRs) by electronic submission (e-sub) in Korea. We analyzed ADRs spontaneously reported through e-sub from regional health professionals.
  
  
  METHODS
  Nine hundred and thirty three ADR cases were collected and analyzed from January to December in 2008. "A matter" was defined as one symptom matched to one culprit drug included in an ADR case. We collected and analyzed e-sub ADR cases and matters to determine common culprits and organ specified ADR matters.
  
  
  RESULTS
  There were 3,049 matters in 933 ADR cases for 1 year, and 3.3 matters per case were reported. In organ specific ADR classification, skin reactions which took the first place in 866 matters (28%) included urticaria and rash. The next cases were neurologic symptom (624 matters, 21%) and gastrointestinal symptom (581 matters, 19%). Doctor (53%) and pharmacist (31%) were the most important participants in e-sub spontaneous reporting system, and 3% of ADR cases were reported by patients or their guardians. WHO-Uppsala Monitoring Center causality assessment results showed certain 10.6%, probable 37.7%, possible 41.7% and below unlikely 10.0%. Culprit drugs were antibiotics (23.4%), neurologic agents (14.7%) and non-steroidal anti-inflammatory drugs (9.4%).
  
  
  CONCLUSIONS
  In our study, antibiotic was most common culprit drug, and skin manifestation was most common symptom in e-sub ADRs collected from regional healthcare practitioners in Korea.
authors.affiliation: Department of Internal Medicine, Yonsei University College of Medicine, Seoul 120-752, Korea.
authors.forename: Jae-Hyun
authors.initials: JH
authors.lastname: Lee
authors.forename: Kyung Hee
authors.initials: KH
authors.lastname: Park
authors.forename: Hyun Joo
authors.initials: HJ
authors.lastname: Moon
authors.forename: Yong Won
authors.initials: YW
authors.lastname: Lee
authors.forename: Jung-Won
authors.initials: JW
authors.lastname: Park
authors.forename: Chein-Soo
authors.initials: CS
authors.lastname: Hong
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D001330:Electronic Data Processing; D006282:Health Personnel; D006801:Humans; D020407:Internet; D007723:Korea