A study on incidence of adverse drug reactions with commonly prescribed drugs and causality assessment in Silchar Medical College and Hospital
Keywords:Adverse drug reaction, Causality assessment, Severity, Spontaneous reporting
Background: Present study was carried out to assess the incidence of adverse drug reactions (ADRs) and assessment of causality, severity with reported suspected ADRs.
Methods: A prospective observational study was conducted over a period of one year in inpatients and out patients hospitalization due to ADRs, at Silchar Medical College & Hospital, Silchar, Assam. WHO–UMC Probability scale was used for causality assessment. Reported ADRs were classified according to Wills and Brown classification and assessed for severity using scale developed by Hartwig et al. All data were calculated by ‘Descriptive statistics’ analysis as percentage of patient population who encountered ADRs.
Results: A total of 192 suspected ADRs were reported and Overall incidence of ADRs during the study period was found to be 0.41% of which 0.22% of ADRs had lead to hospital admissions and 0.19% of ADRs occurred during the hospital stay. Most common drug class associated with ADRs were Antimicrobials [101(52.6%)], which was found to have mostly affected the Skin system followed by NSAIDs [24(13.54%)], Haematinics [21(10.93%)]. Severity of the ADRs were found to be moderate [79(41.14%)], followed by [71 (36.97%)] ADRs which were severe and [42(21.87%)] which were mild.
Conclusions: Present study revealed that, more awareness about the importance of Pharmacovigilance have to be provided among the health care professionals by way of ADR bulletins, seminars and workshops. Also, more studies need to be conducted in Indian population to know the exact prevalence of ADRs in Indian hospitals.
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