Practice and Determinants of Spontaneous Adverse Drug Reaction Reporting Among Healthcare Professionals: A Multicenter Cross-Sectional Study in Vietnam

Abstract

Background:

Spontaneous adverse drug reaction (ADR) reporting is a cornerstone of pharmacovigilance but remains underutilized globally and in Vietnam. Evidence on healthcare professionals’ knowledge of ADR reporting procedures and related determinants is essential to inform system-level improvements.

Objectives:

To assess ADR-reporting procedure knowledge (practice-related knowledge) among healthcare professionals (HCPs) and to identify associated factors, perceived barriers, and support needs in public hospitals.

Methods:

A multicenter cross-sectional survey was conducted among 372 HCPs (nurses/midwives, 67.6%; physicians, 22.7%; pharmacists, 9.6%) across 3 public hospitals. A structured instrument assessed 5 scored procedural items: ADR detection, appropriate receiving unit, reporting timelines, access to reporting forms, and minimum required fields. Attainment of ADR-reporting procedure knowledge was defined as ≥4 of 5 correct items (≥80%). Chi-square tests and logistic regression analyses examined associations with age, sex, tenure, profession, and prior pharmacovigilance training.

Results:

Overall, 47.8% of respondents achieved the predefined attainment threshold (hospital range 32.5%-59.9%). Correct response rates were high for identifying the appropriate receiving unit (83.3%), reporting timelines (83.1%), and access to forms (79.6%), but lower for ADR detection (46.5%) and identification of minimum required fields (54.6%). Although 82.8% of HCPs reported having encountered suspected ADRs, only 14.9% had ever submitted an ADR report. In multivariable analysis, profession remained the only independent predictor of attainment (pharmacists vs nurses/midwives: OR 2.50, 95% CI 1.10-5.69; physicians vs nurses/midwives: OR 1.92, 95% CI 1.11-3.33). Commonly reported barriers included difficulty identifying suspected drugs (80.1%), grading severity (54.3%), and form complexity (30.1%). The most frequently requested supports were peer assistance (95.4%), feedback after submission (93.3%), and targeted training (89.2%).

Conclusions:

ADR-reporting procedure knowledge among HCPs was suboptimal, with profession-related disparities and specific gaps in ADR detection and documentation of minimum required fields. These findings underscore the need for system-level approaches that support clinical recognition, role-tailored collaboration, and feedback-enabled reporting processes to strengthen hospital pharmacovigilance.