Nurses' spontaneous reporting of adverse drug reactions: expert review of routine reports

Authors

  • Diogo Mendes PharmD,

    Research Assistant, Corresponding author
    1. Central Portugal Regional Pharmacovigilance Unit, Health Technology Assessment Centre, AIBILI, Coimbra, Portugal
    • Correspondence

      Diogo Mendes

      Unidade de Farmacovigilância do Centro

      AIBILI

      Azinhaga de Santa Comba - Celas

      3000-548 Coimbra

      Portugal

      E-mail: diogomendes26@gmail.com

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  • Carlos Alves PharmD,

    Research Assistant, PhD Student, Collaborator, Associate Professor
    1. Central Portugal Regional Pharmacovigilance Unit, Health Technology Assessment Centre, AIBILI, Coimbra, Portugal
    2. School of Pharmacy, University of Coimbra and at CICS-UBI – Health Science Research Centre, University of Beira Interior, Health Technology Assessment Centre, AIBILI, Coimbra, Portugal
    3. School of Pharmacy, University of Coimbra, Central Portugal Regional Pharmacovigilance Unit, Health Technology Assessment Centre, AIBILI, Coimbra, Portugal
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  • Francisco Batel Marques PharmD, PhD

    Research Assistant, Associate Professor
    1. Central Portugal Regional Pharmacovigilance Unit, Health Technology Assessment Centre, AIBILI, Coimbra, Portugal
    2. School of Pharmacy, University of Coimbra and at CICS-UBI – Health Science Research Centre, University of Beira Interior, Health Technology Assessment Centre, AIBILI, Coimbra, Portugal
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  • All the authors contributed equally for this paper.

Abstract

Aim

The aims of this study were to analyse spontaneously reported adverse drug reactions according to their previous description, seriousness, causality and the reporting professional.

Background

Previous findings showed that fewer nurses than physicians and pharmacists report adverse drug reactions. This is not attributed to any lack of ability in identifying adverse drug reactions.

Method

Adverse drug reactions received by the Central Portugal Regional Pharmacovigilance Unit, between 2001 and 2011, were studied. Certain and probable adverse drug reactions were included to test differences between professional groups for serious and non-serious adverse drug reactions.

Results

The Central Portugal Regional Pharmacovigilance Unit received 1014 adverse drug reactions. Fifty-four nurses reported 66 adverse drug reactions, whereas 232 physicians and 145 pharmacists reported 589 and 357 adverse drug reactions, respectively. Considering the number of practising professionals, it was estimated that 0.55% of nurses, 3.96% of physicians and 7.08% of pharmacists have reported an adverse drug reaction. Of the 633 adverse drug reactions assessed as certain or probable, 46 (21 serious), 387 (192 serious) and 198 (77 serious) were reported from nurses, physicians and pharmacists, respectively. There were no differences in the reporting of serious adverse drug reactions among nurses, physicians and pharmacists.

Conclusions

Nurses are able to identify serious adverse drug reactions although they report less than other professionals.

Implications for Nursing Management

Nurses need to increase their involvement in spontaneous reporting schemes by taking responsibility for routinely reporting suspected adverse drug reactions.

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