Analysis of voluntary reported adverse drug reactions in a tertiary care hospital
Keywords:Adverse drug reactions, Completeness of ADR form, Pharmacovigilance, Spontaneous reporting
Background: Adverse drug reactions are the major cause for increased hospital stay and it increases the economic burden of the patients. Reporting of ADR helps in signal generation and to ensure safe use of a drug. Present study was conducted to analyse the ADR reporting pattern and completeness of the ADR forms.
Methods: This was a retrospective study conducted for 6 months in a tertiary care hospital. A total of 330 ADR forms were analysed and completeness of ADR forms were assessed.
Results: A total of 330 ADRs were reported. 46% ADRs were reported in 2018, 23% in 2019, 11% in 2020, 8.9% in 2021 and 10.7% in 2022. 177 (53%) were males and 153 (47%) were females. Most occurred reaction was Hyponatremia 22 (6%), followed by Hypokalaemia 18 (5%). Neuropsychiatry cases were 62 (18.78%), Urinary system cases were 45 (13.63%). 122 (88%) patients were taking concomitant drugs whereas only 17 (12%) patients were not taking. Above 80% completeness were seen in 155 (46.96%) forms. Above 70% completeness in 292 (88.68%) forms.
Conclusions: ADRs occurrence was high in male compared to female. Most of the ADRs affected Neuropsychiatry followed by Urinary system. Antimicrobials are responsible for majorly reported ADRs followed by cephalosporins (17.6%) and Penicillin (11.76%). Overall completeness of reported ADR form was 80%, 67.87% of forms were not adequately filled with mandatory fields.
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