Characteristics of serious adverse drug reactions: experience in a single university hospital

초록

Background: Serious ADRs (SAEs) may threaten the patient’s life and negatively affect treatment outcome. Early detection and appropriated medical intervention is required to prevent serious outcomes from SAEs. The number of self-reported adverse drug reactions (ADRs) has been rapidly increased in Korea. This study was conducted to investigate the clinical characteristics of SAEs among spontaneously reported ADRs in a single university hospital. Methods: ADRs reported to Inha University Hospital Pharmacovigilance Center were collected from Jan 2012 to Dec 2015, and cases of SAEs were selected. Clinical information was collected from electronic medical records. Results: A total of 495 SAEs (4.9%) among 10,064 ADRs were identified through spontaneous reporting system. Among them, 294 (59.4%) were developed in female patients, and 298 (60.2%) were reported from patients aged 50 and over. SAEs were reported by doctors (41.4%), nurses (24.4%), and pharmacists (34.1%). 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 (31.7%), anti-infectives (19.2%), and agents for central nervous system (14.5%) were the drug class commonly involved, and cephalosporin antibiotics and NSAIDs were the leading subclass. Thirty-two cases of severe cutaneous adverse reaction such as Stevens-Johnson syndrome and toxic epidermal necrolysis were detected during study period. Conclusion: Cephalosporin antibiotics and NSAIDs can frequently elicit SAEs. Hospitalization or prolongation of existing hospitalization was the most common cause of SAEs, and might cause increased socioeconomic costs for medical care. Active systemic approach will be required to prevent development of predicted SAEs, and to reduce the chance of unpredicted SAEs.