Methods: ADRs reported to hospital Pharmacovigilance Center were collected from Jan 2012 to Dec 2014, and cases of SAEs were selected. Clinical information was collected from electronic medical records.
Results: A total of 283 (3.7%) SAEs among 7,629 ADRs were identified through spontaneous reporting system. A gradually decreased tendency in the frequency and incidence of SAE was noted from 2012 to 2014. SAEs were reported by doctors (40.6%), nurses (11.0%), and pharmacists (48.4%). ADR related-hospitalization or prolongation of existing hospitalization (53.2%) was the most common cause of SAEs, and other medically important event was the second cause. SAEs were developed from the injections (54.4%), PO medications (44.9%), and the patch type agents (0.7%). Antineoplastic agents (40.9%), anti-infectives (16.8%), and anti-tuberculosis drugs (6.9%) were the drug class commonly involved. White cell and RES disorders (21.6%) were frequently involved system organ classes, and skin and appendages disorders (16.4%) were the next. Leukopenia and neutropenia were the most frequently noted SAEs.
Conclusion: Antineoplastic agents, anti-infectives, and anti-tuberculosis drugs can elicit SAEs most frequently. A decreased tendency for the development of SAEs was noted, and this might be result at least partly from the pharmacovigilance activity and ADR monitoring. Comprehensive prophylactic approaches will be required to prevent development of predicted SAEs, and to reduce the chance of unpredicted SAEs.