The Role of Electronic Medical Record Systems and Pharmacovigilance Databases in the Surveillance of Antimicrobial Use and Resistance in Low- and Middle-Income Countries: Protocol for a Multistudy Project

电子病历系统和药物警戒数据库在低收入和中等收入国家抗菌药物使用和耐药性监测中的作用:一项多研究项目的方案

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Abstract

BACKGROUND: Addressing antimicrobial resistance (AMR) requires proactive and innovative approaches in the digital world. The absence of comprehensive AMR data in low- and middle-income countries (LMICs) emphasizes the need for enhanced surveillance systems. OBJECTIVE: This project aims to assess the implications of using digital tools, specifically electronic medical record (EMR) systems and pharmacovigilance (PV) databases (ie, VigiBase), as additional sources for the surveillance of antibiotic use and resistance patterns in LMICs. METHODS: The project comprises 5 interconnected studies. Study 1 is a mixed methods study conducted in 3 private-sector tertiary hospitals in India. Data collection includes questionnaires and semistructured interviews with health care professionals and administrative staff. Quantitative data will be analyzed using descriptive statistics and qualitative data using reflexive thematic analysis. Study 2 is a retrospective cross-sectional study descriptively analyzing antibiotic-related individual case safety reports from LMICs submitted to VigiBase. Study 3 is a cross-sectional survey assessing health care professionals' knowledge, attitudes, practices, and perceived barriers regarding antibiotic-related adverse drug reaction reporting in India. Studies 4 and 5 are systematic reviews examining (1) digital interventions for antimicrobial surveillance and appropriate prescribing, and (2) the use of PV databases for AMR surveillance. Searches will be conducted in PubMed, MEDLINE (Ovid), Embase, CINAHL, and Web of Science. Eligibility criteria include studies evaluating digital tools or PV databases in relation to antibiotic use or resistance. Two independent reviewers will perform screening and data extraction. Findings will be synthesized narratively and categorized by intervention type and reported outcomes. RESULTS: The findings of study 1, phase 1, were published in May 2025. Phase 2 survey data collection reached 400 participants as of March 2026, and phase 3 included 36 interviews with health care professionals conducted in July and August 2024. For study 2, data were extracted from VigiBase in January 2025; analysis was completed and submitted for publication in December 2025. For study 4, article extraction was completed in December 2024, and title and abstract screening is ongoing as of December 2025. Full-text screening is scheduled to take place starting in May 2026. Data collection for study 3 is scheduled between October 2026 and May 2027. Study 5 is scheduled for 2026 and 2027. The project received funding in 2021 from the Research Council of Norway (project 325985) and the Swedish Research Council (project 2021-00889). CONCLUSIONS: Digital tools such as EMR systems and PV databases can play a crucial role in collecting more information about antibiotic use and AMR. This project emphasizes the importance of multidimensional solutions and explores the use of PV and EMRs in LMICs for effective AMR surveillance. Leveraging these digital systems offers an opportunity to enhance knowledge and strengthen efforts in the fight against AMR.

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