One year experience of spontaneouly reported adverse drug reactions in a tertiary university hospital

초록

Background: Adverse drug reactions (ADRs) frequently occur in hospital setting and affect negatively patient outcomes. The number of self-reported ADRs has been rapidly increased in Korea. This study was conducted to investigate the clinical characteristics of ADRs in a single university hospital, and to evaluate the features of ADRs to anti-asthma or anti-allergic drugs in patients with allergic diseases. Methods: ADRs reported to hospital Pharmacovigilance Center were collected from Jan 2012 to Dec 2012. Assessment was performed for causality and severity. Clinical information was also collected from electronic medical records. Results: The total number of ADRs through spontaneous reporting system was 2,673. Among them, 1,693(63.3%) were reported from female, and 35.4% were reported from patient aged 60 and over. ADRs were reported by doctors (36.5%), nurses (39.7%), and hospital pharmacists (23.8%). Central nervous system (CNS) agents and anti-infective agents (AIA) were the drug class most commonly involved, and NSAIDs and cephalosporin antibiotics were the most frequently offending subclass. The most frequently reported system-organ class was GI system disorders (33.9%), and skin and appendages disorders (22.1%) were the next. Serious adverse events (SAE) were developed in 109 cases (4.1%), severe cutaneous adverse reaction (SCAR) such as DRESS syndrome and Stevens-Johnson syndrome were noted in 17 cases. About 6.9% of total ADRs were severe in severity. Compared to ADRs reported from doctor or pharmacists, severity of ADR reported from nurses was more mild form (p<0.01). 85 ADRs (3.2%) were developed against anti-asthmatic or anti-allergic drugs. Most of them were mild (71.8%) and moderate (24.7%) in severity. Anti-histamines (29 of 85) were the most commonly involved drugs in these classes. ADRs to inhaled steroids with/without LABA (9) and LTRA (4) were also reported. Conclusion: Nurses report relatively mild ADRs, however, doctors and pharmacists may h