Pattern of Adverse Drug Reactions of Antimicrobial Agents in a Tertiary Care Teaching Hospital of Tripura: A Prospective Study

ABSTRACT

Introduction: ADR monitoring and reporting activity is in itsinfancy in India. India rates below 1% in pharmacovigilanceas against the world rate of 5%. India is the fourth largestproducer of pharmaceuticals in the world. So there is animmense need to improve the pharmacovigilance system toprotect the Indian population. This study is aimed to identifyADRs of antimicrobial agents and assess their pattern.Material and methods: The reports of ADRs were recordedas per the standard guidelines fixed by pharmacovigilanceprogramme of India (PvPI). Naranjo ADR probability scalewas used to assess the causality of suspected ADRs. Severityof ADRs was identified using modified Hartwig's criteria.Types of ADRs were identified using Rawlins and Thompsonclassification.Results: A total 84 ADRs were reported from 70 patients.Out of 84 ADRs, the most were related to gastrointestinalsystem (45.23%), followed by skin and appendages disorders(36.90%). Of 70 patients 56 had one ADR, 14 suffered fromtwo ADRs, and none suffered from more than two ADRs.Based on modified Hartwig severity scale, 85.71% reactionswere mild, 12.86% were moderate and 1.43% were severe.Conclusions: The present study shows ADRs are commonlyencountered at this tertiary health care set up. Many ADRs arelife threatening type B reactions, but the higher incidence oftype A reactions means that these can be avoided.