World Journal of Pharmaceutical
and Medical Research

( An ISO 9001:2015 Certified International Journal )

An International Peer Reviewed Journal for Pharmaceutical and Medical Research and Technology
An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)
ISSN (O) : 2455-3301
ISSN (P) : 3051-2557
IMPACT FACTOR: 6.842

ICV : 78.6

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SJIF Impact Factor: 6.842

Abstract

STUDY OF DRUG SAFETY ALERTS DESCRIBED BY PHARMACOVIGILANCE PROGRAMME OF INDIA IN A TERTIARY CARE HOSPITAL

Janhavi Kadam*, Vaishnavi Khatate, Adnan Patwekar and Dr. Nupuri Joshi

ABSTRACT

A prospective observational study was carried out in the tertiary care hospital setting. A total of 301 patients were studied over a period of 8 months for occurrence of ADRs as per the drug safety alerts issued by PvPI. The objectives are to assess the occurrence of ADRs mentioned in drug safety alerts issued by PvPI and to classify them and assess their causality and severity. Data were collected from the medical records of tertiary care hospitals from September 2023 to April 2024.The ADRs were assessed using WHO causality scale and Hartwig and Siegel scale for causality and severity respectively. A total of 301 patients were included in the study, with 189 (62.8%) males and 112 (37.2%) females.

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