Pharmacovigilance and patient safety in community pharmacy: theoretical foundations and an auditable conceptual model for processes, documentation, training, and organizational learning

Abstract

Community pharmacies serve as the last checkpoint before medicines are used by patients, shifting a substantial share of safety risk to routine dispensing and counselling activities. Pharmacovigilance, beyond adverse reaction reporting, encompasses detection, assessment, understanding, and prevention of medicine-related problems, including medication errors, misuse, and quality defects. Evidence on community pharmacy dispensing errors shows real occurrence and wide variation across studies depending on detection methods, highlighting the need for structured, comparable prevention and learning strategies. International Good Pharmacy Practice standards state that patient welfare is the pharmacist’s first concern and require systems that enable reporting and feedback on adverse events and other medicine-related problems. This paper proposes an audit-ready conceptual model grounded in international standards and medication safety self-assessment frameworks to organize processes, minimal sufficient documentation, workforce training, and continuous improvement cycles in community pharmacies. The model is presented as a governance architecture with verifiable routines aimed at operational reliability and reduced variability at critical points of care.