A prospective study of adverse drug reactions in a dermatologydepartment

Abstract

The objective of this study was to evaluate the clinical pattern and risk factors for adverse drug reactions (ADRs) in patients hospitalized in a specialized dermatology department. A prospective study was conducted in the Clinic of Dermatology and Venereology in Stara Zagora for a 5-year period. ADRs were classified by type, severity and causality. Case-causality was scored according to Naranjo et al. (1981). A total of 1041 admissions were analyzed. ADRs occurred in 147 patients. Cutaneous reactions represented the most common ADRs followed by endocrine/metabolic, cardiovascular and gastrointestinal disorders. The prevalent clinical patterns of cutaneous ADRs were exanthematous and urticarial. ADRs were almost evenly distributed as type A and type B reactions. Drug classes most frequently responsible for ADRs were glucocorticosteroids (GLCs) and antiinfective agents. The factors significantly associated with ADRs were the use of GLCs (OR 11.11; 95% CI 6.69-18.43), antiinfective agents (OR 1.48; 95% CI 1.04-2.11) and older age. Patients hospitalized in a dermatology department may develop ADRs with multiorgan clinical presentation. The most important risk factors for ADRs in this sample of patients were the use of GLCs, antiinfective agents and older age. The study establishes a specific ADR risk profile of patients with dermatological disorders in a hospital setting.