A Cross-sectional Observational Study of Adverse Drug Reactions among Patients in Nephrology Department at a Tertiary Care Teaching Hospital

Abstract

Background: The World Health Organization defines adverse drug reaction (ADR) as “A response to a drug,
that is noxious and unintended, occurs at doses normally used in humans for the propylaxis, diagnosis, and
treatment of disease, for the modifications of physiological function.” Clinical pharmacists play an important
role in ADR monitoring and reporting, as the majority of serious ADR’s occur in a hospital setting and
contribute to a significant proportion of hospital admissions. Early detection of the ADR’s helps in minimizing
and preventing the ADR’s by modifying the dose or changing the offending agent. Aim: Pharmacovigilance
studies are essential in Nephrology and its main aim is to reduce the risk of drug related problems in patients.
Materials and Methods: This study was Hospital based cross-sectional observational study conducted in
Department of Nephrology, Sri Venkateswara Institute of Medical Sciences, South Indian a tertiary care
hospital, Tirupati, Andhra Pradesh. This study was approved by the Institutional Research and the Ethics
Committee of the hospital. This study used a minimum sample size of 113 participants. Results: Out of
113 patients who were treated in nephrology department, 58 (51.32%) patients developed ADRs. Of the
58 patients, 36 (62.06%) are men and 22 (37.93%) are women. Patients of 39–48 (29.31%) age group are
mostly affected. Among 58 patients, the causality assessment of 18 patients (31.03) was found to be Possible
and the remaining 40 patients (68.96) was found to be Probable. The commonly developed ADRs include
“pedal edema, hypokalemia, and maculopapular rash.” Discussion: ADRs mimic many diseases and result
in severe morbidity and mortality, making them a major clinical concern. Adverse medication events are
undoubtedly more frequent in hospitalized patients with chronic kidney disease and other comorbidities.
Conclusion: The present study has generated a useful baseline data regarding ADRs in various categories such
as age- and gender-wise distribution of ADRs. By educating the patients about the ADRs, it also contributed
to improve the patient’s health-related quality of life.