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Are consumers ready to take part in the Pharmacovigilance System?—a Portuguese preliminary study concerning ADR reporting

  • Pharmacoepidemiology and Prescription
  • Published:
European Journal of Clinical Pharmacology Aims and scope Submit manuscript

Abstract

Background

New pharmacovigilance legislation allows consumers to report adverse drug reactions (ADRs) directly to competent authorities in all European Union countries. Consumer reporting is available in Portugal since July 2012. In 2013, the National Pharmacovigilance System (SNF) had received 3461 spontaneous ADR reports, of which only 1.4 % (n = 50) were from consumers. Consumer reporting could be one opportunity to reduce underreporting.

Aim

The aim of this study was to describe the attitudes and knowledge of the general public regarding spontaneous reporting and the reasons and opinions that can influence consumers’ ADR underreporting.

Methods

A descriptive-correlational study was performed looking for consumers’ attitudes and knowledge regarding spontaneous reporting. A 6-month survey was conducted from June to November 2013 in general adult consumers from a community pharmacy in Coimbra, Portugal, who used prescribed medicines or over-the-counter (OTC) drugs. Attitudes and opinions were surveyed by personal interview in a closed-answer questionnaire using a Likert scale. Questionnaires from healthcare professionals or incomplete ones were not considered. Data were analyzed using descriptive statistics, chi-square (χ 2) tests, and Spearman’s correlation coefficients.

Results

One thousand eighty-four questionnaires were collected (response rate of 81.1 %) and 948 completed were selected for analysis. Of the respondents, 44.1 % never heard about SNF. Younger people and those with a higher education were significantly more likely to be aware of SNF. Only one consumer had previously reported directly an ADR. Reporting ADRs indirectly through a healthcare professional (HCP) was preferred by 62.4 %. The main reasons for consumers reporting spontaneous ADR would be the severity of reactions (81.1 % agreed or strongly agreed) and worries about their situation (73.4 % agreed or strongly agreed). Only weak and moderate correlations were found between studied statements..

Conclusions

Consumers are more likely to do spontaneous report about severe reactions or if they are worried about the symptoms. Tailored and proactive information on ADR reporting and educational interventions on consumers could increase the number of reports from consumers in Portugal.

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Acknowledgments

No sources of funding were used to assist in the preparation of this manuscript.

Conflict of interest

The authors declare that they have no competing interests.

Author Contributions

All authors conceived and designed the study protocol.

Matos C. conducted the study, has collected and analyzed the data, and was the primary author of the manuscript.

Van Hunsel F. and Joaquim J. were the supervisors of the study and assisted with the manuscript preparation.

All authors contributed to the study design discussions and revision of the manuscript and gave the approval of final versions.

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Authors and Affiliations

  1. Instituto Politécnico de Coimbra, Coimbra Health School—ESTESC, Farmácia, Coimbra, Portugal

    Cristiano Matos & João Joaquim

  2. Netherlands Pharmacovigilance Centre Lareb, ‘s-Hertogenbosch, the Netherlands

    Florence van Hunsel

Authors
  1. Cristiano Matos
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  2. Florence van Hunsel
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  3. João Joaquim
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Correspondence to Cristiano Matos.

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Matos, C., van Hunsel, F. & Joaquim, J. Are consumers ready to take part in the Pharmacovigilance System?—a Portuguese preliminary study concerning ADR reporting. Eur J Clin Pharmacol 71, 883–890 (2015). https://doi.org/10.1007/s00228-015-1867-2

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  • DOI: https://doi.org/10.1007/s00228-015-1867-2

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