Purpose: To detect the type, rate, seriousness, and preventability of adverse drug reactions (ADRs) attributable to cardiovascular drugs in cardiovascular care unit; and to determine the relationship between patient factors and detected ADRs.
Methods: Patients admitted to cardiovascular care units in Tehran Heart Center over an eight month period who received at least one cardiovascular drug were eligible to enter the study. ADRs were recorded based on information collected by interviewing patients, reviewing patients' charts, laboratory test monitoring, and confirmation by physicians. The World Health Organization definition for ADR, its seriousness and casualty criteria, was used to evaluate the reactions. The preventability was estimated based on Schumock and Thornton questioning. The relationship between possible risk factors and ADRs occurrence were assessed by statistical analysis.
Results: During the study period, 677 patients entered the study. A total number of 189 ADRs were registered of which 22.2% were serious. The highest ADR rates were observed with Streptokinase (59.3%). The rate of preventable ADRs was 6.9%. Multivariate logistic regression analysis showed that patients with lower weight (OR = 0.95, 95%CI: 0.9-0.99) and patients with smoking history who had concurrent diseases (OR = 8.72, 95%CI: 1.53-49.52) had a higher risk of experiencing ADRs.
Conclusion: The rate of ADRs induced by cardiovascular drugs in this study was 24.2%. This study has shown that anti-arrhythmic and thrombolytic agents need more attention.
(c) 2010 John Wiley & Sons, Ltd.