Evaluating the Impact of Pharmacovigilance Practices at Citywide Community Pharmacy Network

Thesis Abstract

The effectiveness of pharmacovigilance (PV) practices in community pharmacy settings is a critical component of ensuring drug safety, yet there is limited empirical evidence assessing their overall impact within large-scale pharmacy networks. This study addresses the need to systematically evaluate how PV initiatives influence adverse drug reaction (ADR) reporting behaviors, pharmacist engagement, and ultimately, patient safety outcomes within the Citywide Community Pharmacy Network, which comprises 150 pharmacies across urban and suburban regions. The primary aim is to assess the extent to which PV practices enhance ADR detection, reporting frequency, and knowledge among pharmacy staff, thereby contributing to improved pharmacovigilance systems. To achieve this, specific objectives include identifying barriers and facilitators of effective PV, measuring changes in ADR reporting rates pre- and post-implementation of targeted PV interventions, and evaluating the perceptions of pharmacists regarding PV processes and their roles. Employing a mixed-methods research design, the study combines quantitative analysis of ADR reporting data with qualitative insights gathered through semi-structured interviews. The population includes all registered pharmacists and pharmacy technicians within the network, totaling approximately 900 staff members. A stratified random sampling technique identifies 220 participants for survey administration, supplemented by purposive sampling of 30 pharmacists for in-depth interviews. Data collection instruments comprise a validated questionnaire assessing PV knowledge, attitudes, and practices (KAP), alongside interview guides exploring contextual and experiential factors affecting PV activities. Furthermore, the study analyzes secondary data on ADR reports collected from the network’s pharmacovigilance database over a three-year period, utilizing descriptive statistics, paired t-tests, and multiple regression analysis to determine the impact of PV-enhancement initiatives on ADR reporting rates. Thematic analysis of qualitative data, guided by Braun and Clarke's framework, aims to elucidate nuanced perceptions and systemic barriers. The study hypothesizes that targeted PV training and standardized reporting procedures will significantly increase ADR reporting frequency and improve pharmacists' PV knowledge. It is anticipated that the findings will reveal key factors influencing PV engagement, such as workflow integration, feedback mechanisms, and perceived importance of ADR reporting, which may either facilitate or hinder effective pharmacovigilance. The research is expected to contribute novel insights into the structural and behavioral determinants of PV performance in community pharmacy networks, thereby filling a gap in the current literature which predominantly focuses on hospital settings. The findings will inform policymakers and pharmacy managers about practical strategies for optimizing PV practices, such as tailored training modules and technological supports. Additionally, the study will develop a conceptual framework linking PV activities, pharmacy staff perceptions, and patient safety outcomes, grounded in the Health Belief Model and Theory of Planned Behavior. In conclusion, the research underscores that strengthening PV practices in community pharmacy settings has the potential to significantly enhance ADR reporting and patient safety. Recommendations include implementing continuous professional development programs, integrating PV protocols into pharmacy workflows, and establishing robust feedback loops to motivate sustained pharmacist engagement. Future research avenues are suggested to explore longitudinal impacts of PV interventions and their scalability across different healthcare contexts. This study’s comprehensive evaluation provides actionable insights aimed at fostering a proactive pharmacovigilance culture within community pharmacy networks, ultimately contributing to safer medication use and improved public health outcomes.