The Pattern of Adverse Drug Reaction Reporting at a Regional Pharmacovigilance Center in North India: A Retrospective...

Background Adverse drug reactions (ADRs) are one of the common causes of morbidity and mortality and contribute significantly to the healthcare burden. However, they are largely preventable. Pharmacovigilance can help alert healthcare providers about possible ADRs. It can also help protect the patients from the probable side effects of medications in the future. Methodology This retrospective study included ADRs reported in ESIC Medical College & Hospital, Faridabad, an ADR monitoring center under the National Co-ordination Centre-Pharmacovigilance Programme of India and the Indian Pharmacopoeia Commission, Ghaziabad. The assessment was performed to analyze the pattern of ADRs reported from January 2022 to December 2022. Reports were scrutinized based on patient demographics, drug characteristics, type of ADRs, outcomes, causality, severity, and seriousness. The data were collected and entered into the standard ADR reporting form. Each reported adverse event was assessed individually. Causality was determined using the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) causality assessment scale. Results A total of 282 reported/notified suspected ADRs from different departments were analyzed and reported over 12 months. Almost 78% (n = 156) of ADRs were seen in the adult age group (21-60 years). Antibiotics were the most frequently implicated drug class, presenting 36% (n = 72) of ADRs. Causality assessment, vital for linking ADRs to drugs, was performed using the WHO-UMC scale. Overall, 91% (n = 182) of ADRs were classified as "probable" and 8% (n = 16) as "possible," with no cases categorized as "certain" or "unlikely." Conclusions The study provides important insights into serious ADRs reported in 2022 at a tertiary care center in India. Adults were predominantly affected, with antibiotics, especially cephalosporins, being common culprits. Most ADRs were recognized and labeled, confirming known drug-event relationships, though a few potentially novel or rare ADRs were noted.