From Recognition to Reporting: One-year Trends in Adverse Drug Reactions at a Newly Designated Adverse Drug Reaction...

To analyze spontaneously reported adverse drug reactions (ADRs) during the first year after the adverse drug reaction monitoring center (AMC) recognition.

A retrospective observational study was conducted from April 2023 to March 2024 at a tertiary care hospital in Pune, Maharashtra, India. All reported ADRs were included and analyzed by gender, age, department, drug class, and severity (modified Hartwig and Siegel scale). Causality was assessed using Naranjo's algorithm and World Health Organization-Uppsala Monitoring Center (WHO-UMC) assessment criteria. Data were expressed as frequencies and percentages.

A total of 255 ADRs were reported. Most ADRs occurred in elderly patients aged 61-80 years (56%). Anticancer drugs were the most common culprits (45.67%), followed by antimicrobials (21.63%). Causality assessments of suspected ADRs were probable (47%), possible (51%), and certain (2%). Most ADRs were mild (78.43%) and nonserious, and patients recovered with drug withdrawal and supportive care (39%), while 47% were recovering when the ADR was reported.

Adverse drug reactions (ADRs) were mild and preventable, with anticancer drugs being the leading cause. Elderly patients were most affected. Underreporting remains a challenge despite AMC recognition, underscoring the need for continued sensitization and feedback mechanisms to promote a culture of ADR reporting.