Reviewing Adverse Drug Reaction Reporting Infrastructure and Practices at Referral Hospitals in Niger State, North Central Nigeria

Robust adverse drug reaction reporting infrastructure is a prerequisite for effective pharmacovigilance and timely signal detection within Nigeria's national drug safety monitoring system. Referral hospitals, which manage complex patient populations, are particularly important sites for adverse drug reaction identification and reporting. This study reviewed the adverse drug reaction reporting infrastructure and current practices at referral hospitals in Niger State, North Central Nigeria. A multi-site descriptive study was conducted across six referral hospitals using a combination of facility infrastructure audits, review of adverse drug reaction records, and interviews with 35 pharmacists, physicians, and nurses. Infrastructure adequacy was assessed against National Agency for Food and Drug Administration and Control pharmacovigilance standards. Findings showed that adverse drug reaction report forms were physically available in only three hospitals, and only one hospital had a functional pharmacovigilance focal point. Over the preceding 24 months, a combined total of only 14 adverse drug reaction reports had been submitted to the National Pharmacovigilance Centre from all six sites. Most healthcare workers were unfamiliar with the online reporting portal. Knowledge of adverse drug reaction causality assessment was poor across all professional cadres. Systemic underreporting was attributed to inadequate training, lack of incentives, and poor awareness of reporting obligations. The study recommends urgent investment in pharmacovigilance training, appointment of dedicated adverse drug reaction reporting officers, and integration of pharmacovigilance into hospital accreditation criteria. Keywords: adverse drug reaction reporting, pharmacovigilance, referral hospitals, Niger State, drug safety