Abstract

STUDY OF ADVERSE DRUG REACTIONS IN PATIENTS RECEIVING ANTI-MICROBIAL AGENTS IN MEDICAL INTENSIVE CARE UNIT OF A TERTIARY CARE TEACHING HOSPITAL

Mansij Biswasa*, Nirmala N. Regeb, Nitin D. Karnikc, Rajnish M. Dhediya

ABSTRACT

Objectives: To find out the incidence, type, presentation, duration and outcome of ADRs in patients receiving AMAs in MICU and analyse their causality, severity, predictability and preventability. Methods: This was a single centre, prospective, observational, longitudinal study in MICU of a tertiary care teaching hospital. Following Ethics Committee approval and informed consent, adult patients receiving AMAs were enrolled and followed up daily till they were in MICU. Demographic, disease, treatment and details of ADRs, were recorded and analyzed using various standard scales/scoring systems. Descriptive statistics used to present the numerical data. Association between variables were analyzed by Chi Square, Fisher’s exact and Kendall’s test using standard software, P value <0.05 considered significant. Results: Of 600 patients (35.1±14.8 years; M:F=1:1.1), 72 patients developed ADRs due to prescribed AMAs. Skin and appendages were the most involved organ system followed by vascular and gastro-intestinal system (WHO-ART coding). ADRs were mainly ‘probable’ (58% WHO-UMC and 67% Naranjo) and ‘possible’ (38% WHO-UMC and 29% Naranjo). Seventy four per cent ADRs were ‘Mild’ (modified Hartwig-Siegel), 71% ‘not preventable’ (Schumock-Thornton), 12% ‘serious’ and 74% ‘predictable’. Most of the ADRs (80%) resolved after withdrawal of suspected drug and 45% resolved within 48 hours. Co-morbid conditions found in 1/3rd of the patients with ADRs. Linezolid caused maximum ADRs (19%), followed by anti-tubercular drugs (17%) and cephalosporin (14%). Conclusions: Documented 12% incidence of ADRs

Keywords: (?1/3rd preventable) due to prescribed AMAs in our MICU. Careful selection, due precautions and intense monitoring are warranted to strengthen rational AMA policy, minimize toxicity and improve patient care.