Spontaneous reporting of adverse drug reactions through electronic submission from regional society healthcare professionals in Korea

Jae Hyun Lee, Kyung Hee Park, Hyun Joo Moon, Yong Won Lee, Jung Won Park, Chein Soo Hong

Research output: Contribution to journalArticlepeer-review

12 Citations (Scopus)

Abstract

Purpose: 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. Materials and 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%). Conclusion: 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.

Original languageEnglish
Pages (from-to)1022-1027
Number of pages6
JournalYonsei medical journal
Volume53
Issue number5
DOIs
Publication statusPublished - 2012 Jul

All Science Journal Classification (ASJC) codes

  • Medicine(all)

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