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Background <p>Pharmacovigilance and suspected adverse drug reaction (ADR) reporting are key components of patient safety and post-marketing drug surveillance. Spontaneous reporting systems concern suspected reactions, because causality is not established at the time of reporting. Despite their importance, suspected ADRs remain widely underreported, commonly due to limited knowledge, insufficient procedural competence, and inadequate training of healthcare professionals. Undergraduate education is therefore important for future pharmacovigilance capacity, yet comparative evidence across health sciences disciplines remains limited.</p> Methods <p>A nationwide, cross-sectional survey was conducted among health sciences students enrolled in long-cycle or first- or second-cycle programmes in Poland between October 2024 and October 2025. An anonymous online questionnaire, distributed via academic and student networks, assessed pharmacovigilance knowledge, attitudes toward suspected ADR reporting, perceived barriers, and educational needs. Associations between categorical variables were analysed using Pearson’s chi-square or likelihood ratio tests, with effect sizes expressed as Cramér’s V. Multiple comparisons were adjusted using the Benjamini–Hochberg false discovery rate procedure.</p> Results <p>A total of 648 complete questionnaires were analysed. Significant disparities in pharmacovigilance knowledge and regulatory competence were observed across fields of study. Pharmacy students demonstrated higher awareness, more accurate conceptual understanding, and greater ability to correctly identify the competent authority for suspected ADR reporting compared with medical, nursing/midwifery, and other health sciences students (all q &lt; 0.001, large effect sizes). While attitudes toward reporting were generally positive, they were not consistently supported by adequate procedural knowledge, particularly outside pharmacy curricula. Pharmacovigilance competence showed a non-linear relationship with year of study, with lower levels observed among sixth-year students in selected disciplines. Key barriers, including lack of remuneration and reluctance to assume additional workload, were already apparent at the undergraduate stage. Support for expanding pharmacovigilance education was high across all disciplines.</p> Conclusions <p>The findings indicate important gaps in pharmacovigilance preparedness among health sciences students, especially in procedural and regulatory aspects of suspected ADR reporting. Undergraduate curricula should include more consistent, longitudinal, and practically focused pharmacovigilance training.</p>

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Are health sciences students prepared for pharmacovigilance? A nationwide study of knowledge and suspected adverse drug reaction reporting

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月29日

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  • Dorota Kopciuch,
  • Julia Wach,
  • Krzysztof Kus

摘要

Background

Pharmacovigilance and suspected adverse drug reaction (ADR) reporting are key components of patient safety and post-marketing drug surveillance. Spontaneous reporting systems concern suspected reactions, because causality is not established at the time of reporting. Despite their importance, suspected ADRs remain widely underreported, commonly due to limited knowledge, insufficient procedural competence, and inadequate training of healthcare professionals. Undergraduate education is therefore important for future pharmacovigilance capacity, yet comparative evidence across health sciences disciplines remains limited.

Methods

A nationwide, cross-sectional survey was conducted among health sciences students enrolled in long-cycle or first- or second-cycle programmes in Poland between October 2024 and October 2025. An anonymous online questionnaire, distributed via academic and student networks, assessed pharmacovigilance knowledge, attitudes toward suspected ADR reporting, perceived barriers, and educational needs. Associations between categorical variables were analysed using Pearson’s chi-square or likelihood ratio tests, with effect sizes expressed as Cramér’s V. Multiple comparisons were adjusted using the Benjamini–Hochberg false discovery rate procedure.

Results

A total of 648 complete questionnaires were analysed. Significant disparities in pharmacovigilance knowledge and regulatory competence were observed across fields of study. Pharmacy students demonstrated higher awareness, more accurate conceptual understanding, and greater ability to correctly identify the competent authority for suspected ADR reporting compared with medical, nursing/midwifery, and other health sciences students (all q < 0.001, large effect sizes). While attitudes toward reporting were generally positive, they were not consistently supported by adequate procedural knowledge, particularly outside pharmacy curricula. Pharmacovigilance competence showed a non-linear relationship with year of study, with lower levels observed among sixth-year students in selected disciplines. Key barriers, including lack of remuneration and reluctance to assume additional workload, were already apparent at the undergraduate stage. Support for expanding pharmacovigilance education was high across all disciplines.

Conclusions

The findings indicate important gaps in pharmacovigilance preparedness among health sciences students, especially in procedural and regulatory aspects of suspected ADR reporting. Undergraduate curricula should include more consistent, longitudinal, and practically focused pharmacovigilance training.