# Implementation of the pharmacovigilance database in the usage of antibiotics in a tertiary care hospital: A pilot study

## TL;DR

This pilot study explores how pharmacovigilance can help monitor antibiotic use and adverse reactions in a hospital to combat antimicrobial resistance.

## Contribution

The study introduces a pilot implementation of a pharmacovigilance database in an antimicrobial stewardship program in a developing country hospital.

## Key findings

- Most antibiotics used belonged to the 'Access' group according to WHO's AWaRe classification.
- Tetracyclines and penicillins were the most commonly used antibiotics.
- Over 60% of adverse drug reaction cases were classified as 'possible' causality.

## Abstract

Antimicrobial resistance (AMR) has evolved into a severe public health issue that defies all current control strategies and needs multidisciplinary, creative solutions. Antimicrobial stewardship (AMS) activities demand a set of tools and abilities that can be used by health systems. In view of the growing AMR and the difficulty for the surveillance of it in the developing country, this study was conducted to incorporate pharmacovigilance (PV) in the AMS program.

A cross‐sectional pilot study was conducted to collect the PV database of antimicrobials induced adverse drug reactions (ADR) from the Adverse Drug Reactions Monitoring Center (AMC) of the institute for a period of 2 months from August 2022 to September 2022. The information from the database was analyzed to estimate the usage of antibiotics from the PV database from AMC and classified it under the Anatomical Therapeutic Chemical, to assess the rationality of the antimicrobial's usage based on “Access,” “Watch,” and “Reserve” (AWaRe) classification, and to assess the ADR of the antibiotics. The analysis was done by using the SPSS version 20.0 for Windows.

The results showed that the prevalence of ADRs were more in adults’ population with preponderance in female. The antibiotics usage was as per with World Health Organization standard and most of the antibiotics used were from the Access group of AWaRe classifications. Tetracyclines and penicillins were the most used antibiotic group of drugs. The number of patients included in the study was 70. Most of the causality assessment was “possible” (62.85%). In the study, almost 90% of the drug was withdrawn and 70% of the patients were in the recovering stage.

Using existing PV approaches to address usage of antibiotics and AMR issues would allow PV to progress as a field, and governments will get a stronger return on their PV investments.

Antimicrobial resistance (AMR) has evolved into a severe public health issue.Incorporating pharmacovigilance (PV) in the antimicrobial stewardship program is essential.Using existing PV approaches to address usage of antibiotics and AMR issues would allow PV to progress as a field.

Antimicrobial resistance (AMR) has evolved into a severe public health issue.

Incorporating pharmacovigilance (PV) in the antimicrobial stewardship program is essential.

Using existing PV approaches to address usage of antibiotics and AMR issues would allow PV to progress as a field.