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The Role of European Patient Organizations in Pharmacovigilance

Author

Listed:
  • Cristiano Matos

    (University of Seville
    ESTESC-Coimbra Health School)

  • Gerda Weits

    (Netherlands Pharmacovigilance Centre Lareb)

  • Florence Hunsel

    (Netherlands Pharmacovigilance Centre Lareb)

Abstract

Introduction 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. Aim The objective of this study was to understand the role of European patient organizations as stakeholders to optimize patient involvement in pharmacovigilance. Methods 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. Results 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). Conclusion 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.

Suggested Citation

  • Cristiano Matos & Gerda Weits & Florence Hunsel, 2019. "The Role of European Patient Organizations in Pharmacovigilance," Drug Safety, Springer, vol. 42(4), pages 547-557, April.
    • Handle: RePEc:spr:drugsa:v:42:y:2019:i:4:d:10.1007_s40264-018-0748-x
    DOI: 10.1007/s40264-018-0748-x
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    References listed on IDEAS

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    1. Meredith Y. Smith & Isma Benattia, 2016. "The Patient’s Voice in Pharmacovigilance: Pragmatic Approaches to Building a Patient-Centric Drug Safety Organization," Drug Safety, Springer, vol. 39(9), pages 779-785, September.
    2. Cristiano Matos & Linda Härmark & Florence Hunsel, 2016. "Patient Reporting of Adverse Drug Reactions: An International Survey of National Competent Authorities’ Views and Needs," Drug Safety, Springer, vol. 39(11), pages 1105-1116, November.
    3. Sarah Watson & Rebecca E. Chandler & Henric Taavola & Linda Härmark & Birgitta Grundmark & Alem Zekarias & Kristina Star & Florence Hunsel, 2018. "Safety Concerns Reported by Patients Identified in a Collaborative Signal Detection Workshop using VigiBase: Results and Reflections from Lareb and Uppsala Monitoring Centre," Drug Safety, Springer, vol. 41(2), pages 203-212, February.
    4. Leàn Rolfes & Florence Hunsel & Laura Linden & Katja Taxis & Eugène Puijenbroek, 2017. "The Quality of Clinical Information in Adverse Drug Reaction Reports by Patients and Healthcare Professionals: A Retrospective Comparative Analysis," Drug Safety, Springer, vol. 40(7), pages 607-614, July.
    5. Leàn Rolfes & Florence Hunsel & Katja Taxis & Eugène Puijenbroek, 2016. "The Impact of Experiencing Adverse Drug Reactions on the Patient’s Quality of Life: A Retrospective Cross-Sectional Study in the Netherlands," Drug Safety, Springer, vol. 39(8), pages 769-776, August.
    6. Linda Härmark & June Raine & Hubert Leufkens & I. Ralph Edwards & Ugo Moretti & Viola Macolic Sarinic & Agnes Kant, 2016. "Patient-Reported Safety Information: A Renaissance of Pharmacovigilance?," Drug Safety, Springer, vol. 39(10), pages 883-890, October.
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    1. Kamila Sienkiewicz & Monika Burzyńska & Izabela Rydlewska-Liszkowska & Jacek Sienkiewicz & Ewelina Gaszyńska, 2021. "The Importance of Direct Patient Reporting of Adverse Drug Reactions in the Safety Monitoring Process," IJERPH, MDPI, vol. 19(1), pages 1-16, December.
    2. Luís Monteiro & Matilde Monteiro-Soares & Cristiano Matos & Inês Ribeiro-Vaz & Andreia Teixeira & Carlos Martins, 2022. "Inappropriate Prescriptions in Older People—Translation and Adaptation to Portuguese of the STOPP/START Screening Tool," IJERPH, MDPI, vol. 19(11), pages 1-10, June.
    3. Linda Härmark & Gerda Weits & Rietje Meijer & Federica Santoro & G. Niklas Norén & Florence van Hunsel, 2020. "Communicating Adverse Drug Reaction Insights Through Patient Organizations: Experiences from a Pilot Study in the Netherlands," Drug Safety, Springer, vol. 43(8), pages 745-749, August.

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