2015 The Clinical Characteristics of Adverse Drug Reactions Reported in a Regional University Hospital for 6 Years and the Suggestions for the Reporting System

Thursday, 15 October 2015
Hall D1 Foyer (Floor 3) (Coex Convention Center)

Jaechun Lee, MD, PhD , Internal Medicine, Jeju National University School of Medicine, Jeju, South Korea

Su Hee Kim, MD , Internal Medicine, Jeju National University Hospital, Jeju, South Korea

Eunkyoung Lee, MBA , Regional Pharmacovigilance Center, Jeju National University Hospital, Jeju, South Korea

Background: Adverse drug reaction (ADR) increases in-hospital stay, cost of care, and even mortality. Prevention of ADRs leads to marked socioeconomic benefits. We performed this study to investigate the incidence, actual reporting status and clinical features of ADRs, for improving ADR reporting system and preventing recurrent ADRs.

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.