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Patient Reporting of Adverse Drug Reactions: An International Survey of National Competent Authorities’ Views and Needs

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Abstract

Introduction

Patient reporting of adverse drug reactions (ADRs) to spontaneous reporting systems can make a valuable contribution to pharmacovigilance. However, the implementation and promotion of patient reporting systems (PRSs) differ worldwide.

Objective

The objective of the study was to describe attitudes toward PRSs, and progress toward implementing such systems among national competent authorities participating in the World Health Organization Programme for International Drug Monitoring.

Methods

A web-based questionnaire was constructed based on qualitative interviews, and distributed through SurveyMonkey® to all countries listed on the World Health Organization Programme for International Drug Monitoring (n = 178) during November and December of 2015. Data were analyzed using descriptive statistics and Chi-square tests.

Results

A total of 143 valid questionnaires were received from 141 countries (79.2 %). A spontaneous reporting system for both healthcare professionals and patients was present in 58 countries (41.1 %). An official PRS to report ADRs directly was implemented in 44 countries (31.2 %) and in a pilot stage in five countries (3.5 %). Patients were not allowed to report in 34 countries (24.1 %). The reasons for not having an official PRS were mainly a lack of resources/budget (56.5 %) or a lack of information/education for patients (56.5 %). When analyzing the attitudes among the respondents toward a PRS, most acknowledge that the general public contributes to the detection or strength of drug safety signals (82.2 % agree or strongly agree) and with information that is not present in healthcare professional reports (80.7 % agree or strongly agree). For respondents, giving feedback to patients could be an incentive for patients to report more (80.8 % agree or strongly agree). To be able to further PRSs, guidelines on promoting a PRS efficiently to the general public (87.4 % agree or strongly agree), training courses/conferences (86.7 % agree or strongly agree), or a public list of Lareb’s scientific publications (86.7 % agree or strongly agree) were the support measures most well accepted by the respondents.

Conclusions

Most countries accept ADR reports from patients by an official reporting system designed for patients or through the existing system for healthcare professionals. The main reasons for not having a PRS is financial restraints and a lack of information/education of patients. Attitudes toward a PRS are positive, but some countries fear that they will not be able to handle an increase in reports.

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Acknowledgments

The authors thank Anna Hegerius, PharmD at the Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, Sweden for her feedback on the questionnaire.

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Authors and Affiliations

  1. Department of Pharmacology, Faculty of Pharmacy, University of Seville, C/Profesor García-González 2, 41012, Seville, Spain

    Cristiano Matos

  2. Netherlands Pharmacovigilance Centre Lareb, World Health Organization Collaborating Centre for Pharmacovigilance in Education and Patient Reporting, Goudsbloemvallei 7, 5237 MH, ’s-Hertogenbosch, The Netherlands

    Linda Härmark & Florence van Hunsel

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  1. Cristiano Matos
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  2. Linda Härmark
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  3. Florence van Hunsel
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Correspondence to Cristiano Matos.

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

Conflicts of interest

Cristiano Matos, Linda Härmark, and Florence van Hunsel have no conflicts of interest that are directly relevant to the content of this study.

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Matos, C., Härmark, L. & van Hunsel, F. Patient Reporting of Adverse Drug Reactions: An International Survey of National Competent Authorities’ Views and Needs. Drug Saf 39, 1105–1116 (2016). https://doi.org/10.1007/s40264-016-0453-6

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