Methods: A retrospective study was performed in a regional university hospital located in Jeju, Korea. ADR cases were recruited by review of medical records from 2009 to 2013. An ADR event was defined as either of ADR-related diagnosis in a patient or ADRs reported through in-hospital ADR reporting system. The incidence, culprit drug, clinical manifestation, source of reporting, severity, treatment, and recurrence rate were assessed.
Results: In 1112 patients, 1375 ADR events were enrolled, estimated as 0.06% of total patient-visit during the study period. Diagnostic contrast agent (46.4%) was most common as culprit drugs, followed by antibiotics (22%), non-steroidal anti-inflammatory drugs (9.9%), and opioids (4.5%). Cutaneous involvement (67.5%) such as rash and hives was the most frequently observed manifestation. In two thirds of ADR cases, additional medical attentions were noted. In severity, 180 (13.1%) were categorized in severe ADRs. Nineteen (1.4%) experienced re-exposure to the culprit drugs, resulting recurrent ADR and 4 (0.3%) died of ADRs. Physicians were the most frequent ADR reporter using in-hospital ADR reporting system.
Conclusions: Large proportions of ADR events might be omitted in medical records or in reporting system. ADRs due to re-exposure to the culprit drugs were not rare. To prevent avoidable ADRs, an effective reporting and alerting system is necessary.