Strengthening Spontaneous Adverse Drug Reaction Reporting in Vietnamese Provincial Hospitals: A Multicenter Clinical Pharmacy–Led Multifaceted Intervention
Suol Thanh Pham, Thang Nguyen, Ngoc Van Pham, Hao Yen TranABSTRACT
Background
Under‐reporting of adverse drug reactions (ADRs) limits medication‐safety learning in provincial hospitals, where dedicated pharmacovigilance infrastructure and personnel are often constrained. The objective of this study was to evaluate a clinical pharmacy–led multifaceted intervention to improve healthcare professionals' knowledge, attitudes, and reporting practices and to strengthen hospital pharmacovigilance performance.
Methods
We conducted a multicenter pre–post evaluation in three provincial hospitals in Ca Mau province, Vietnam (January 1, 2022–June 30, 2025). Repeated cross‐sectional surveys were administered before and after a 6‐month intervention (July–December 2023) ( n = 372 each round). All spontaneous ADR reports submitted to the national pharmacovigilance center and archived at hospital pharmacies were retrospectively reviewed. Report completeness was assessed using VigiGrade (well documented ≥ 0.8), and organizational capacity was assessed using the Indicator‐based Pharmacovigilance Assessment Tool (IPAT).
Results
Adequate knowledge increased from 2.7% (10/372) preintervention to 29.8% (111/372) postintervention. Adequate attitudes increased from 57.5% to 64.2%, and adequate self‐reported practices from 47.8% to 55.6%. Among professionals who had encountered suspected ADRs, ever‐reporting increased from 46/308 (14.9%) to 75/334 (22.5%) ( p = 0.015). Spontaneous ADR reports increased from 26 preintervention to 144 postintervention while maintaining high completeness (VigiGrade ≥ 0.8: 96.2% vs. 97.9%; p = 0.419). IPAT performance improved across domains, with the largest gains in monitoring and reporting activities.
Conclusions
A pragmatic, pharmacy‐coordinated multifaceted intervention was associated with increased ADR reporting participation and volume without compromising documentation completeness and with strengthened organizational pharmacovigilance performance. This model appears feasible for resource‐limited provincial hospitals, but the outcomes should be interpreted as improvements in reporting processes rather than direct evidence of reduced patient harm.