Clinical profile of adverse drug reactions in patients admitted to internal medicine wards of a tertiary care hospital

Introduction: Adverse drug reactions (ADRs) are unwanted, often harmful reaction resulting from a pharmacological intervention that warrants treatment, prevention, and future precautions. ADRs are highly prevalent with 10%-20% of patients suffering from one when admitted. The aim of this study was to identify cases and provide data on the incidence, severity, causality, and preventability of ADRs in a clinical setting in various age groups. The study also aimed to identify ADR risk factors which can be used to create ADR risk prediction models for application in everyday clinical practice to proactively detect patients at risk of developing these reactions. Materials and Methods: This was an inpatient, prospective, observational cohort study in the internal medicine ward of a major tertiary care hospital. Once the institutional ethics approval was obtained, patients fulfilling the inclusion criteria were enrolled with informed consent. Their data were recorded in an ADR data form. These data were then analyzed using standardized scales to identify causality, severity, preventability, and avoidability along with specific risk factors and comparing them across age groups and drug classes. Results: One hundred and sixty-four patients were eligible and enrolled. Seventy percent of those suffering from ADRs were in the 30-60 years age group. Oral hypoglycemics and antituberculosis drugs were most commonly implicated, whereas metabolic and hepatic systems were the most frequent organ systems involved. Polypharmacy and hypertension were the most common risk factors identified. The cause of 96.3% of ADRs was probable, and 51.2% of the ADRs were categorized as severe. Nearly a fourth of the severe ADRs were categorized as life-threatening. A majority of the ADRs were treated by terminating the suspected drug, and 54% of patients recovered completely. 6.1% of the ADRs were definitely avoidable while 42.1% were unavoidable. Conclusion: This study clearly demonstrates the massive burden of ADRs, both on the patients and the hospitals. There is a dire need for a standardized, easily accessible means of mandatory reporting of ADRs, and that data need to be utilized to treat, decrease morbidity, and prevent ADRs by proactively anticipating them to ultimately improve patient care. The following core competencies are addressed in this article: Patient care, Medical knowledge, Interpersonal and communication skills, Practice-based learning and improvement, and Systems-based practice