Spontaneous reporting of adverse drug reactions at a department of Internal Medicine

Abstract

AbstractThe aim of the present study was to characterize the pattern of adverse drug reactions (ADRs) reported in a university teaching hospital in south-east Serbia. The study was conducted based on ADRs reported during a six-month period to the ADR reporting unit of the university clinical center. Evaluation of data was done for various parameters, such as patient demographics, drug and reaction characteristics, and outcome of reactions. Assessment was also done for causality, severity and predisposing factors. During the 6-month study period, 44 ADRs were reported, with an overall incidence of 0.33%. No significant difference was seen in the overall incidence of ADRs observed in males and females. Incidence of ADRs among elderly (43.2%) and older (25%) adults was significantly higher than in other age groups. Type A reactions (66.7%) accounted for majority of the reports. The most commonly affected organ system was the renal system, (22.7%) with hyperkalemia as the only reported reaction. ACE inhibitors (48.6%) were the drug class most commonly involved, where fosinopril (25.7%) was the individual drug most frequently reported. Additional treatment was pursued for management of ADRs in majority (52.3%) of the reports. In 52.3 % of the reports, the patient had recovered from the reaction by the time of evaluation. Upon causality assessment, the majority of the reports were rated as probable (43.2%). Mild and moderate reactions accounted for 43.2% and 54.6%, respectively. In 36.3% of the reports, the reaction was considered to be preventable. The most common predisposing factors were polypharmacy and multiple disease state. The pattern of ADRs reported in our hospital is comparable to the results of studies conducted in hospital set up elsewhere. Our evaluations revealed opportunities for intervention to ensure safer drug use.