Abstract
Background: Effects of drugs that are undesirable and beyond their therapeutic effect are labeled as adverse drug reactions (ADRs). These often lead to increase hospital stay, repeated hospitalization, adversely affecting the quality of life, and perhaps, one of the causes of mortality making it a chief challenge in modern health-care system. This observational study analyzed and summarized details linked to ADRs identification, reporting, severity, treatment, and preventive measures for health professionals.

Aims and Objectives: The objectives of the study are to assess and evaluate demographic profile, drug prescribed with its dosage, clinical findings, seriousness, outcome, causality, and organ system affected by concerned ADRs.

Materials and Methods: An observational prospective study analyzing submitted ADRs mentioned in individual case safety reports (ICSR), mentioning demographics profile, suspected drug, involved bodily organ system, causality and reaction severity in different age groups of indoor and outdoor patients reported from 2020 January to 2022 December at ADR monitoring center, Department of Pharmacology, IMS-BHU. Performa used for ADRs reporting is ICSR, which later on transferred to the Indian database (VigiFlow) for data collection and analysis.

Results: Total 1096 ADRs were identified and reported in 36-month duration, with male (629/1096) to female (466/1096) ratio of 1.35:1. On age group analysis, 74.8% (820/1096) adults (18–59 years) followed by 23.4% (256/1096) elderly (>59 years) and only 1.8% (20/1096) children and adolescents (<17 years) cases were found. Endocrine system was the most common organ system affected with 27.9% case (306/1096), succeeded by 25.4% (278/1096). ADRs were linked to the gastrointestinal system and 15.69% (172/1096) cases were related to dermatological problems. Drugs belonging to antimicrobial drug group were the most involved comprising of 668/1096(60.94%) cases which includes mainly antibiotics, anti-viral and antifungal drugs. On further analyzing and classifying, it was found that majority of ADRs were due to anti-viral drugs, followed by antibiotics with 31.02% (340/1096) cases and 27.09% (297/1096) cases, respectively. Antiallergic and antifungal drug groups were found be least involved with only 1.6% (17/1096) cases each. On assessment of causality, majority of ADRs were possible in 60.40% (662/1096) cases and probable in 39.14% (429/1096) cases.

Conclusion: Occurrence of ADRs is very common and perhaps a serious concern regarding well-being and safety of public as may lead to non-serious to serious health problems. This observational study identified the need of increased awareness of ADR monitoring, reporting and benefits, to fulfill the space created by underreporting, especially in geriatrics and pediatric age group patients. A detail evaluation and removal of the obstacles faced by these age groups during process of reporting ADRs is important so that all the patients may easily approach for spontaneous reporting of side effects after start usage of any medicinal product, if any. In addition, surveillance studies emphasizing on reporting are essential for early recognition, detection, and avoidance of ADRs leading to appropriate with safe usage of drugs.

Key words: Pharmacovigilance; Adverse Drug Reactions; Monitoring; Antimicrobial; Antiviral