Korean J Intern Med.  2018 Nov;33(6):1203-1209. 10.3904/kjim.2016.001.

Adverse drug reaction monitoring during antimicrobial therapy for septicemia patients at a university hospital in New Delhi

Affiliations
  • 1Department of Pharmacy Practice and Clinical Pharmacy, Unaizah College of Pharmacy, Qassim University, Unaizah, Kingdom of Saudi Arabia, India. shamshir_pharma@yahoo.com
  • 2Department of Pharmacology, Faculty of Pharmacy, Hamdard University, New Delhi, India.
  • 3Department of Medicine, Hamdard Institute of Medical Sciences & Research and Hakeem Abdul Hameed Centenary Hospital, Hamdard University, New Delhi, India.
  • 4Department of Microbiology, Majeedia Hospital, Hamdard University, New Delhi, India.
  • 5Department of Pharmaceutical Chemistry, KIET School of Pharmacy, Delhi, India.

Abstract

BACKGROUND/AIMS
Adverse drug reaction (ADR) is an appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product. The present study was conducted in order to monitor the frequency and severity of ADR during antimicrobial therapy of septicemia.
METHODS
A prospective, observational, and noncomparative study was conducted over a period of 6 months on patients of septicemia admitted at a university hospital. Naranjo algorithm scale was used for causality assessment. Severity assessment was done by Hartwig severity scale.
RESULTS
ADRs in selected hospitalized patients of septicemia was found to be in 26.5% of the study population. During the study period, 12 ADRs were confirmed occurring in 9, out of 34 admitted patients. Pediatric patients experienced maximum ADRs, 44.4%. Females experienced a significantly higher incidence of ADRs, 66.7%. According to Naranjo's probability scale, 8.3% of ADRs were found to be definite, 58.3% as probable, and 33.3% as possible. A higher proportion of these ADRs, 66.7% were preventable in nature. Severity assessment showed that more than half of ADRs were moderate. Teicoplanin was found to be the commonest antimicrobial agent associated with ADRs, followed by gemifloxacin and ofloxacin.
CONCLUSIONS
The incidence and severity of ADRs observed in the present study was substantially high indicating the need of extra vigilant during the antimicrobial therapy of septicemia.

Keyword

Sepsis; Antimicrobial therapy; Anti-bacterial agents

MeSH Terms

Anti-Bacterial Agents
Drug-Related Side Effects and Adverse Reactions*
Female
Humans
Incidence
Ofloxacin
Prospective Studies
Sepsis*
Teicoplanin
Anti-Bacterial Agents
Ofloxacin
Teicoplanin
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