Pattern of adverse drug reactions reported at a tertiary health care teaching hospital of Tripura: a retrospective study

Prithul Bhattacharjee, Lakshman Das, Ranjib Ghosh, Lalromawii ., Uttam Kumar Das


Background: ADR monitoring and reporting activity is in its infancy in India. India rates below 1% in pharmacovigilance as against the world rate of 5%. India is the fourth largest producer of pharmaceuticals in the world. So there is an immense need to improve the pharmacovigilance system to protect the Indian population. This study is aimed to identify ADRs and assess their pattern.

Methods: The reports of ADRs were recorded as per the standard guidelines fixed by pharmacovigilance programme of India (PvPI). Naranjo ADR probability scale was used to assess the causality of suspected ADRs. Severity of ADRs was identified using modified hartwig's criteria. Types of ADRs were identified using Rawlins and Thompson classification.

Results: A total 266 ADRs were reported from 190 patients. Majority of the ADRs were type A reactions. Highest incidence (78.95%) of ADRs was observed between 12-59 years of age. 56.84% of patients were male and 43.16% were female. Majority of the patients were suffering from single disease and receiving less than six medications. In the assessment of severity mild, moderate and severe ADRs were 57.89%, 35.26% and 6.84% respectively. In causality assessment 3.16% cases were unlikely, 57.37% cases were possible, 38.95% cases were probable and 0.52% cases were certain.

Conclusions: The present study shows ADRs are commonly encountered at this tertiary health care set up. Many ADRs are life threatening type B reactions, but the higher incidence of type A reactions means that these can be avoided.


Patient safety, Pharmacovigilance, Causality, Retrospective study

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