Adverse drug reactions in hospitalized cardiac patients: characteristics and risk factors.

Background/aim: Adverse drug reactions (ADRs) appear more frequently than actually reported and registered. The main goal of our work was to analyze risk factors, incidence and characteristics of ADRs in hospitalized cardiac patients.

Methods: This prospective study included 200 patients, hospitalized at Cardiology Center of the Clinical Centre of Montenegro. ADRs were collected using specially designed questionnaire, based on the list of symptoms and signs that could point out to potential ADRs. Data from medical charts of patients, lab tests and other available parameters were observed and combined with the data from questionnaire. Severity of ADRs were assessed as serious or nonserious according to the World Health Organization criteria. Causality was assessed using the Naranjo probability scale.

Results: A total of 34% of all the patients experienced at least one ADR. The most common ADRs occurred as nervous system disorders, less frequent were cardiovascular disorders, while the immune system disorders were the rarest. Sixteen percent of all ADRs were characterized as serious, most often caused by carvedilol and amiodarone. The majority of patients (97.3%) recovered without consequences. The multivariate analysis showed independent significant associations between ADRs and age, gender, comorbidities and polypragmasia.

Conclusion: ADRs represent a significant issue in hospitalized cardiac patients population. The most significant predictors for ADRs in observed population were age, comorbidity, number of medications used during hospitalization and patients' gender. Preventive measures such as pharmacotherapy rationalization and continual education of health care professionals could reduce the frequency of ADRs appearance in patients with detected risk factors.