Abstract

To assess Pediatric pharmacovigilance in tertiary care hospital. Material and Methods: Fifty-six children with Adverse drug reactions (ADRs) of both genders were selected. Causality assessment of ADRs was done by WHO-UMC system of causality assessment scale. The severity of the ADRs was assessed by modified Hartwig and Siegel scale. Preventability of the ADRs was assessed by modified Schumock and Thornton scale. Results: Out of 56 children, 30 (53.5%) were males and 26 (46.5%) were females. Age group 0-6 years had 10, 7-12 years had 24 and 13-17 years had 22 cases. The difference was significant (P< 0.05). In ADR, class of drugs involved was, anti-emetics in 1, anti-psychotics in 2, NSAIDS in 7, steroids in 10 and anti-microbials in 36 cases. Organ involved was musculoskeletal in 12, oral cavity in 18 and dermatological in 26. WHO causality scale found to be certain in 16, probable in 30 and possible in 10. Modified Hartwig and Siegel scale was mild in 34 and moderate in 22. Modified Schumock and Thornton scale was preventable in 56 cases. The difference was significant (P< 0.05). Conclusion: The role of pediatric pharmacovigilance in monitoring the safety of drugs among children is of paramount importance for the detection of newer and rarer ADRs. In maximum cases, adverse drug reactions were seen in children with anti-microbials.

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