Enhancing Patient Safety: Patterns of Adverse Drug Reaction Reporting in a Tertiary Care Hospital in Eastern India: A Record-based Retrospective Study.
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Abstract
Background: Adverse drug reactions (ADRs) are a significant cause of increased morbidity and mortality, prolonged hospitalisation, and financial burden on patients. Regular ADR monitoring helps formulate strategies for the safe and effective use of medicines in healthcare settings. This study was conducted to assess the trends in ADR reporting along with their various aspects.
Methods: This record-based observational study was conducted at the ADR Monitoring Centre of our healthcare facility. ADRs reported from April to September 2023 were analysed. The WHO-UMC scale, Modified Hartwig Severity Assessment Scale and Modified Schumock and Thornton Scale were used to assess the causality, severity, and preventability of ADRs, respectively. Descriptive statistics were used for the analyses.
Results: A total of 146 adverse drug reactions (ADRs) were reported during the study period. Of these, 68.49% of the ADRs were reported from the Department of Psychiatry. Female patients accounted for 53.42% of reported ADRs. Neurological system involvement was observed in 32.9% of the ADRs. Escitalopram was the most frequently implicated drug. Causality assessment revealed that 63.01% of ADRs were possible. Meanwhile, 83% of the ADRs were mild in severity, and a total of five ADRs were found to be serious in this study, none of which were fatal. Furthermore, 39.73% of the ADRs were classified as probably preventable.
Discussion: The predominance of neuropsychiatric ADRs observed in this study may reflect both prescribing patterns and improved recognition of CNS-related adverse effects in psychiatric practice. These findings also highlight the importance of strengthening ADR reporting practices across all departments.
Conclusion: The ADR reporting pattern observed in this newly established tertiary healthcare facility in eastern India may help increase physicians' awareness of the importance of timely ADR reporting and support their clinical decision-making process.
期刊介绍：
Current Drug Safety publishes frontier articles on all the latest advances on drug safety. The journal aims to publish the highest quality research articles, reviews and case reports in the field. Topics covered include: adverse effects of individual drugs and drug classes, management of adverse effects, pharmacovigilance and pharmacoepidemiology of new and existing drugs, post-marketing surveillance. The journal is essential reading for all researchers and clinicians involved in drug safety.
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