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Community pharmacists’ attitudes towards adverse drug reaction reporting and their knowledge of the new pharmacovigilance legislation in the southern region of Portugal: a mixed methods study

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Abstract

Objective

The study aimed to investigate the habits of spontaneous reporting of adverse drug reactions (ADRs) by community pharmacists employed in pharmacies across the southern region of Portugal, as well as their knowledge of the new pharmacovigilance legislation.

Methodology

Two studies were conducted. An initial quantitative cross-sectional study used a questionnaire to survey a sample of pharmacies under the responsibility of the Portuguese South Pharmacovigilance Centre about their reporting of ADRs. This was followed by a qualitative study that interviewed a focus group of experts directly involved in the National Pharmacovigilance System, in order to explain the initial survey results.

Results

One-quarter of 154 respondents were familiar with the new ADR definition and were aware that, since July 2012, patients in Portugal can report ADRs directly to the appropriate authority. Of the pharmacists interviewed, 38.3 % had previously reported an ADR. The main barrier to spontaneous reporting was uncertainty concerning the causal relationship between the ADR and the drug. Educational measures were considered the main facilitating factor. According to the focus group, reasons for underreporting were primarily related to pharmacists’ attitudes.

Conclusions

A higher reinforcement of this subject during education and training in pharmaceutical sciences, a greater awareness and use of the INFARMED website and its pharmacovigilance portal, and the reading of information specifically produced by the regulatory authority (e.g. the pharmacovigilance bulletin), are recommended, together with close collaboration between the regulatory authority, the Pharmaceutical Society, pharmacy associations and the pharmaceutical industry to promote and disseminate information about this topic among community pharmacists in Portugal.

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Acknowledgments

No funding has been received for the conduct of this study and preparation of this manuscript. Maria Duarte, Paula Ferreira, Maria Soares, Afonso Cavaco and Ana Paula Martins declare that they have no conflicts of interest relevant to the content of this manuscript.

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Authors and Affiliations

  1. Faculty of Pharmacy, University of Lisbon, Lisbon, Portugal

    Maria Duarte, Afonso Cavaco & Ana Paula Martins

  2. South Pharmacovigilance Centre, Lisbon, Portugal

    Paula Ferreira & Maria Soares

Authors
  1. Maria Duarte
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  2. Paula Ferreira
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  3. Maria Soares
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  4. Afonso Cavaco
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  5. Ana Paula Martins
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Correspondence to Ana Paula Martins.

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Duarte, M., Ferreira, P., Soares, M. et al. Community pharmacists’ attitudes towards adverse drug reaction reporting and their knowledge of the new pharmacovigilance legislation in the southern region of Portugal: a mixed methods study. Drugs Ther Perspect 31, 316–322 (2015). https://doi.org/10.1007/s40267-015-0227-8

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  • DOI: https://doi.org/10.1007/s40267-015-0227-8

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