Background: Adverse drug reactions (ADRs) have been evolved as a serious and major health-care problem affecting the quality of life of patients and increasing burden over the health-care system. Studying the pattern and spectrum of ADRs can help to find measures to address the problem and possibly prevent it effectively.
Aims and Objectives: The study aimed to intensively monitor ADRs in indoor patients of medicine wards and estimate the incidence rate with documentation of the spectrum of ADRs in studied patients in terms of causality, severity, and preventability.
Materials and Methods: This was prospective, observational, and single-center study, conducted at internal medicine wards of Sir Sayajirao General Hospital, Vadodara, over a duration of 8 months, after taking prior permission from the Institutional Ethics Committee. The necessary data were obtained and recorded on a pre-designed case record form and Indian Pharmacopoeia Commission-ADR reporting form after taking written informed consent and analyzed with Microsoft Excel-2016.
Results: A total 11,400 admissions recorded during the study period in all nine wards of medicine department, of which 66 patients developed 88 ADRs with the incidence of 0.5789%. They were classified into Group A (38, 57.58%), ADR developed after hospitalization and Group B (28, 42.42%), ADR is the reason for hospitalization. The most common category of causality assessment was probable according to both WHO-UMC criteria (53, 54.65%) and Naranjo scale (54, 55.68%). According to modified Hartwig-Siegel scale majority, ADRs (43, 48.32%) fall into moderate category, and according to modified Thornton and Schumock criteria, the preventable ADRs were (29, 30.85%).
Conclusion: The drug safety seems to be well considered in this setup with lower incidence rate found in our study, but there is still a need for improvement to reduce the huge portion of preventable ADRs.
Key words: Drug Safety; Intensive Adverse Drug Reaction Monitoring; Medicine Indoor Patients; Pharmacovigilance
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