4014 Characteristics of Serious Adverse Drug Reactions in a Tertiary University Hospital

Saturday, 17 October 2015
Hall D1 Foyer (Floor 3) (Coex Convention Center)

Cheol-Woo Kim, MD , Department of Internal Medicine, Inha University Hospital, Incheon, South Korea

Jae Hwa Cho, MD , Inha University Hospital, Incheon, South Korea

Ji Young Kang , Inha University Hospital, Incheon, South Korea

Mi Ra Eom , Inha University Hospital, Incheon, South Korea

Hye Gyeung Lee , Inha University Hospital, Incheon, South Korea

Background: Adverse drug reactions (ADRs) frequently occur in hospital setting, and serious ADRs (SAEs) may threaten the patient’s life and lead poor clinical outcome. Early detection and urgent medical intervention is required to prevent development of SAEs. This study was conducted to investigate the clinical characteristics of SAEs in a single university hospital.

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.