Background: Continuous pharmacovigilance (PV) monitoring helps identify trends in antibiotic resistance and misuse. PV databases provide valuable data on ADRs and medicine misuse, supporting policy development and antimicrobial stewardship efforts in the fight against AMR.
Objectives: To assess the role of pharmacovigilance databases in monitoring antibiotic resistance trends and unindicated use in LMICs
Methods:
Design: This study employs a retrospective observational design using adverse drug reaction (ADR) reports from VigiBase, the global pharmacovigilance database managed by the WHO and Uppsala Monitoring Center (UMC). Setting: The study includes ADR of antibiotics reports from low- and middle-income countries (LMICs) submitted to VigiBase. All submitted ADR reports until January 2024. Only reports that meet specific inclusion criteria based on Medical Dictionary for Regulatory Activities (MedDRA) preferred terms are included. Main Outcome Measures: The primary outcome is the detection of antibiotic resistance patterns and unindicated antibiotic use through pharmacovigilance data. Secondary outcomes include the frequency and distribution of reported ADRs, stratified by antibiotic class and region, to assess trends in antibiotic misuse and resistance in LMICs. Statistical Analysis: Descriptive statistics are used to summarize the distribution of ADR reports by antibiotic classification, MedDRA preferred terms, and geographical regions. Proportions, frequencies, and trends over time are analyzed to identify patterns of antibiotic resistance and inappropriate use. When applicable, inferential statistical methods, such as chi-square tests or logistic regression, are used to examine associations between antibiotic classifications and reported ADR outcomes. All statistical analyses are conducted using R.
Results: We identified 59 MedDRA preferred terms related to antibiotic resistance, ineffectiveness, off-label use, and medication errors. The examined terms under the System Organ Classes (SOC) of Infections and infestations, General disorders and administration site conditions, Investigations, and Injury, poisoning, and procedural complications. These terms were then grouped into four key categories: Resistance, Ineffectiveness, Off-Label Use, and Error of Use. Based on this classification, we extracted adverse drug reaction (ADR) reports associated with systemic-use antibiotics from LMICs. The analysis of these reports is currently in progress.
Conclusions: This study utilizes pharmacovigilance data to identify antibiotic resistance, ineffectiveness, off-label use, and medication errors in LMICs. The ongoing analysis will provide valuable insights to support antibiotic surveillance and stewardship efforts.
