Drug Safety

, Volume 42, Issue 4, pp 547–557 | Cite as

The Role of European Patient Organizations in Pharmacovigilance

  • Cristiano MatosEmail author
  • Gerda Weits
  • Florence van Hunsel
Original Research Article



Patient organizations have a privileged position to be active agents for promoting pharmacovigilance and patient engagement, encouraging direct patient reporting and improving the awareness of pharmacovigilance.


The objective of this study was to understand the role of European patient organizations as stakeholders to optimize patient involvement in pharmacovigilance.


A descriptive correlational study was conducted to investigate the opinions and attitudes of patient organizations regarding general patient involvement in pharmacovigilance, and their initiatives to support drug safety through a web-based questionnaire during the months of March and April 2018.


A total of 1898 patient organizations were invited to participate in the survey, including 89 pan-European organizations. In total, 337 questionnaires (17.76%) were collected from 31 countries, including 297 complete answers (88.31%). A large number of organizations stated that they would like to increase the awareness of patients regarding specific adverse drug reactions (ADRs) related to their medicines (43.19%, n  = 130); however, 38.54% (n  = 116) declared they do not have any pharmacovigilance goals. Barriers to supporting pharmacovigilance activities include low budget to promote pharmacovigilance among members (45.45%, n  = 135), lack of resources to participate in pharmacovigilance activities (43.77%, n  = 130), or lack of support from the National Competent Authorities (33.33%, n  = 99). Organizations inform patients to report ADRs (40.40%; n  = 120), information regarding new ADRs related to their medicines (40.07%; n  = 119), or when a new drug is marketed (30.98%; n  = 92); however, more than one-third indicated that they never had any involvement in pharmacovigilance (34.68%; n  = 103).


Bringing pharmacovigilance stakeholders and patient organizations together could create a more optimal reporting culture. Patient organizations appear to have an important role in encouraging patients to talk with their doctors/pharmacists about ADRs experienced, or to help him/her report the ADRs to the pharmacovigilance systems. Lack of resources, budget, and support from NCAs are seen as the main barriers to being involved in pharmacovigilance awareness.



The authors would like to thank Kaisa Immonen and Kostas Aligiannis from the European Patient Forum, and Allan Wilsdorf from F-CRIN/EUPATI-France, for dissemination of the questionnaire among their members.

Compliance with Ethical Standards


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

Conflict of Interest

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

Supplementary material

40264_2018_748_MOESM1_ESM.pdf (502 kb)
Supplementary material 1 (PDF 501 kb)
40264_2018_748_MOESM2_ESM.pdf (327 kb)
Supplementary material 2 (PDF 327 kb)


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Copyright information

© Springer Nature Switzerland AG 2018

Authors and Affiliations

  1. 1.Department of Pharmacology, Faculty of PharmacyUniversity of SevilleSevilleSpain
  2. 2.Instituto Politécnico De CoimbraESTESC-Coimbra Health SchoolCoimbraPortugal
  3. 3.Netherlands Pharmacovigilance Centre Lareb’s-HertogenboschThe Netherlands

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