Assessment of Adverse Drug Reactions and Pharmacological Awareness in Hospital Patients: A Prospective Observational Study

Abstract

Background: Adverse drug responses (ADRs), which are unintentional and harmful side effects of drugs taken at therapeutic doses, are a significant contributor to patient morbidity, prolonged hospital admissions, and increased medical costs. Despite well-established initiatives like the Pharmacovigilance Programme of India (PvPI), patient awareness of ADR reporting is still poor. Pharmacovigilance is essential for detecting, assessing, and preventing adverse drug reactions (ADRs).
Objectives: To identify and document ADRs among hospitalized patients and assess their awareness of pharmacovigilance and ADR reporting.
Methods: A one-month prospective observational study involved one hundred adult inpatients in the general medicine department of Malla Reddy Hospital in Hyderabad. Patients were enlisted by sequential sampling after obtaining informed consent. Data on demographics, the incidence of adverse drug reactions (ADRs), suspected drugs, their severity, and their outcomes were collected using a standardized form. Pharmacovigilance awareness was assessed using a seven-item questionnaire. The data were evaluated using descriptive statistics and then shown as frequencies and percentages.
Results: 55% of the 100 participants were women and 45% were males. The largest age group (32%) was those between the ages of 31 and 45. Adverse drug reactions (ADRs) occurred in 50% of patients, with rash (16%), nausea (20%), and dizziness (22%) being the most common. Of the reported adverse drug reactions, 22% were severe, 34% were moderate, and 44% were mild. All participants accepted that pharmaceuticals may have bad effects, but just 52% were aware of adverse drug reactions (ADRs), 50% knew they could be reported, and 17% had previously reported a side effect. Reporting adverse drug reactions (ADRs) improves patient safety, according to the majority of participants (79%), and 86% expressed a need for further information.
Conclusion: Although ADRs were common, reporting protocols and awareness remained inadequate. Hospital-based pharmacovigilance programs and targeted patient education are necessary to improve medication safety and ADR reporting.