Characteristics of serious adverse drug reactions among spontaneously reported adverse drug reactions in a tertiary university hospital

초록

Background: Adverse drug reactions (ADRs) frequently occur in hospital setting, and serious ADRs (SAEs) may threaten the patient’s life and affect treatment outcome negatively. Early detection and urgent medical intervention is required to prevent serious outcomes from SAEs. The number of self-reported ADRs has been rapidly increased in Korea. 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 2013, and cases of SAEs were selected. Clinical information was collected from electronic medical records. Results: A total of 203 SAEs among 5,256 ADRs were identified through spontaneous reporting system. Among them, 78 (38.4%) were reported from male patients, and 125 (61.5%) were reported from patients aged 50 and over. SAEs were reported by doctors (41.4%), nurses (11.3%), and pharmacists (47.3%). ADR related-hospitalization or prolongation of existing hospitalization was the most common cause of SAEs, and other medically important event was the second cause. Antineoplastic agents (33.5%), anti-infectives (18.7%), and agents for central nervous system (16.3%) were the drug class commonly involved, and chemotherapeutic agents, cephalosporin antibiotics and NSAIDs were the 3 leading subclass. Skin and appendages disorders were frequently involved, and white cell and RES disorders were the next. Severe cutaneous adverse reaction such as Stevens-Johnson syndrome were noted in 21 cases. Conclusion: Chemotherapeutic agents, cephalosporin antibiotics and NSAIDs can elicit SAEs most frequently. Hospitalization or prolongation of existing hospitalization was the most common cause of SAEs, and might cause increased socioeconomic costs for medical care. Comprehensive prophylactic approaches will be required to prevent development of predicted SAEs, and to reduce the chance of unpredicted SAEs.