Risk Evaluation in Routine Pharmacovigilance Activities in SKIMS: Analysis of 3 Years Data.

Abstract

Introduction: - The study was undertaken for risk evaluation of ADRs from the wide spectra of drugs that are used in a tertiary care hospital. Methods: - Data from 1225 ADRs reported spontaneously to the center during the three year study period from 1-1-2012 to 31-12 2014 was used. Results: - The overall incidence of ADRs among inpatients that occurred during their stay in the hospital was 0.79%. The M: F ratio was 0.98 and maximum numbers of cases were seen in the 41-60 year age group. Majority of the ADRs (240, 20%) were assessed as probable on the W.H.O causality assessment scale and most of the reactions were classified as Type H (782; 64%). Severity assessment showed that majority of ADRs (832; 68%) were classified as mild. Eighteen fatal ADRs were reported, fourteen of which were attributed to pentavalent vaccine and one each to Ciprofloxacin, Levofloxacin, Cefexime and iodinated contrast. The commonest implicated drug class was antibiotics (632; 51.5%) followed by anticancer drugs (193; 15.8%), anticonvulsants (102; 8.3%). Medicine department reported the maximum number of ADRs (397; 32.5%). Rash and itching was the commonest reported ADR and Vancomycin, levofloxacin and Ceftriaxone were the most commonly implicated drugs. Conclusion: - Drug safety signals will continue to come mainly from the reporting of alert health care professionals and every effort should be made to enhance and to ease this process. Continuous sensitization, training and feedback are needed for ensuring safe and effective use of drugs.