A RETROSPECTIVE OBSERVATIONAL STUDY OF ADVERSE DRUG REACTION PROFILE IN A TERTIARY CARE HOSPITAL
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Keywords
Adverse Drug Reactions, Manuscript writing, Retrospective Analysis, ADR monitoring center
Abstract
Adverse drug reactions (ADR) are unintended, harmful effects at therapeutic doses, causing 0.2%-24% of hospital admissions and 3.7% fatalities, especially in the elderly (9%). ADRs increase hospital stays, treatment costs, and mortality risks. Pharmacovigilance in India, monitors ADRs through 250 centers, yet reporting remains low (<1% vs. 5% globally). It remains the responsibility of healthcare professionals to report the adverse drug reactions.
AIMS AND OBJECTIVES - 1. To assess the adverse drug reactions (ADRs) reported during a one year period (2024) based on severity, causality and its preventability. 2.To analyse which drugs have caused maximum ADR and the types of ADRs reported.
METHODS - A retrospective observational study was conducted after analysing all adverse drug reactions(ADR) forms received from hospital (one year). Drugs were classified according to the class. Causality assessment done using Naranjo scale and severity assessed using Hartwig scale. Reactions were analysed presented in bar, graphs and pie charts
RESULTS - A total of 440 ADRs were reported. Out of these Anti-TB drugs (22.5%) had the highest ADRs, followed by iron preparations (16.82%) and anti-microbials (14.55%). The occurrence of ADRs was almost equal among male(48.41%) and females(51.59), the maximum were in 31 to 40 age group. ADR reporting increased from 4-7% per month to 9-11% after an awareness session during Pharmacovigilance (PV) Week. The most common ADR caused by antitubercular therapy were hepatitis, numbness, chills and rigors, antimicrobials was rashes, tachycardia. Most of the reactions observed in the patients were mild(86.6%) and only 5.45% were severe.
CONCLUSION - This study highlights the positive impact of educational initiatives on ADR reporting and the need for continuous awareness programs to improve pharmacovigilance practices.
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Dr. K. MADHUMITHA
Post graduate, Department of Pharmacology, Affliated to Rajiv Gandhi University of Health Sciences, Belagavi Institute of Medical Sciences, Belagavi, Karnataka, Ph.No. 9710085519
Dr. JAGADISHCHANDRA S RATNAKAR
2Assisstant Professor, Department of Pharmacology, Belagavi Institute of Medical Sciences,
Belagavi, Karnataka
Dr. PANKAJKUMAR MASARE
Associate Professor, Department of Pharmacology, Belagavi Institute of Medical Sciences,
Belagavi, Karnataka
Mr. HARSHA M NAIKWAD
Pharmacovigilance Associate, Department of Pharmacology, Belagavi Institute of Medical Sciences, Belagavi, Karnataka
Dr. PRASANNA S
Admin - AMC Co-ordinator, Kauvery Hospitals, Chennai, Tamil Nadu