Pharmacovigilance in Ophthalmic Drug Use: Monitoring Adverse Effects at Selected Hospitals in Ogun State

Pharmacovigilance in ophthalmology is an important patient safety function that involves systematic monitoring of adverse drug reactions associated with topical and systemic medications used in ophthalmic practice. This study evaluates pharmacovigilance activities related to ophthalmic drug use at selected hospitals in Ogun State, South West Nigeria. A mixed-methods study will be conducted at five hospitals, including one federal medical centre, two state general hospitals, and two private specialist clinics in Sagamu and Abeokuta. Quantitative data will be obtained from pharmacy drug dispensing records and adverse drug reaction (ADR) reporting forms submitted to the National Pharmacovigilance Centre. Qualitative data from interviews with ophthalmologists, pharmacists, and pharmacy technicians will explore awareness of ADR reporting systems, barriers to reporting, and actual reporting practices. Descriptive statistics will characterise the types and frequencies of reported ophthalmic ADRs. Pharmacovigilance is universally documented as underperformed in Nigerian healthcare institutions, with ophthalmic drug reactions including topical steroid-induced glaucoma, antibiotic hypersensitivity, and prostaglandin analogue side effects rarely captured in formal reporting systems. This study provides Ogun State-specific evidence and will be shared with the National Agency for Food and Drug Administration and Control (NAFDAC) and the Ogun State Hospital Management Board. Recommendations will address pharmacovigilance training for ophthalmologists, simplified ADR reporting tools, and incentives for clinical reporting. Robust pharmacovigilance is essential to protecting patients from preventable ophthalmic drug harms in Nigerian health facilities. Keywords: pharmacovigilance, adverse drug reactions, ophthalmic drugs, Ogun State, patient safety