Analysis of burden and outcomes of anticoagulant induced adverse drug effects at a tertiary care centre

Abstract

Background: Anticoagulants are among the most commonly used drugs in hospitalized patients known to cause adverse drug reactions (ADRs). They have commonly been used as standard therapy in venous thromboembolism, stroke prevention, etc. Objectives: The authors aimed to assess the incidence of ADRs, clinical profile, severity and causality among the admitted patients taking anticoagulants in a tertiary care hospital. Materials and Methods: This was a hospital-based, prospective, observational, non-interventional cohort study undertaken in the General Medicine Wards of King Edward Memorial Hospital, Mumbai from June 2017 to December 2018. Every patient’s data was recorded using a structured ADR reporting form. The baseline parameters, medical history and underlying diseases, clinical data, characteristics of ADRs, and details of medication responsible for ADRs, as well as details of the drugs used for treatment of ADRs were recorded. The data was analyzed using descriptive statistics with the Statistical Packages for the Social Sciences (SPSS) version 26.0 software. Results: Out of the 164 patients admitted due to ADRs within the study period, 32 (19.5%) had developed ADRs due to anticoagulant treatment. Most anticoagulant-related ADRs involved the vascular system (n = 32). The severity of ADR was found to be mild in one patient (3.1%), moderate in 22 patients (68.8%), and severe in nine patients (28.1%). Twenty (62.5%) patients completely recovered, nine (28.1%) patients were still recovering (at the time of the analysis of the data), and three (9.4%) patients had a fatal outcome. Presence of systemic comorbidities and polypharmacy were found to be significant risk factors associated with anticoagulant-associated ADRs. Conclusion: Anticoagulants commonly cause ADRs in the study population. Patient education at the time of prescription can prevent many ADRs due to medication error or poor compliance. In addition, installing a better surveillance system in hospitals could alleviate the prevalence of ADRs.