Strengthening Spontaneous Adverse Drug Reaction Reporting in Vietnamese Provincial Hospitals: A Multicenter Clinical Pharmacy-Led Multifaceted Intervention.

چکیده اصلی

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.

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