IDEAS home Printed from https://ideas.repec.org/a/spr/drugsa/v42y2019i4d10.1007_s40264-018-0748-x.html
   My bibliography  Save this article

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
    as

    Download full text from publisher

    File URL: http://link.springer.com/10.1007/s40264-018-0748-x
    File Function: Abstract
    Download Restriction: Access to the full text of the articles in this series is restricted.

    File URL: https://libkey.io/10.1007/s40264-018-0748-x?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    As the access to this document is restricted, you may want to search for a different version of it.

    References listed on IDEAS

    as
    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. 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.
    3. 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.
    4. 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.
    5. 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.
    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.
    Full references (including those not matched with items on IDEAS)

    Citations

    Citations are extracted by the CitEc Project, subscribe to its RSS feed for this item.
    as


    Cited by:

    1. 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.
    2. 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.
    3. 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.

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. Gilles Defer & Sophie Fedrizzi & Damien Chevanne & François Montastruc & Anais R. Briant & Jean-Jacques Parienti & Laure Peyro-Saint-Paul, 2021. "Adverse Drug Reaction Reporting Using a Mobile Device Application by Persons with Multiple Sclerosis: A Cluster Randomized Controlled Trial," Drug Safety, Springer, vol. 44(2), pages 223-233, February.
    2. Sieta T. de Vries & Judy Harrison & Patrick Revelle & Alicia Ptaszynska-Neophytou & Anna Radecka & Gowthamei Ragunathan & Phil Tregunno & Petra Denig & Peter G. M. Mol, 2019. "Use of a Patient-Friendly Terms List in the Adverse Drug Reaction Report Form: A Database Study," Drug Safety, Springer, vol. 42(7), pages 881-886, July.
    3. George Tsey Sabblah & Delese Mimi Darko & Hudu Mogtari & Linda Härmark & Eugène Puijenbroek, 2017. "Patients’ Perspectives on Adverse Drug Reaction Reporting in a Developing Country: A Case Study from Ghana," Drug Safety, Springer, vol. 40(10), pages 911-921, October.
    4. Inácio, Pedro & Gomes, João José & Airaksinen, Marja & Cavaco, Afonso, 2018. "Exploring sociodemographic and economic factors that promote adverse drug reactions reporting by patients," Health Policy, Elsevier, vol. 122(3), pages 263-268.
    5. Francesco De Pretis & Barbara Osimani, 2019. "New Insights in Computational Methods for Pharmacovigilance: E-Synthesis , a Bayesian Framework for Causal Assessment," IJERPH, MDPI, vol. 16(12), pages 1-19, June.
    6. 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.
    7. Cedric Bousquet & Bissan Audeh & Florelle Bellet & Agnès Lillo-Le Louët, 2018. "Comment on “Assessment of the Utility of Social Media for Broad-Ranging Statistical Signal Detection in Pharmacovigilance: Results from the WEB-RADR Project”," Drug Safety, Springer, vol. 41(12), pages 1371-1373, December.
    8. A. Cecilia Jimenez-Moreno & Eline Overbeeke & Cathy Anne Pinto & Ian Smith & Jenny Sharpe & James Ormrod & Chiara Whichello & Esther W. Bekker-Grob & Kristin Bullok & Bennett Levitan & Isabelle Huys &, 2021. "Patient Preferences in Rare Diseases: A Qualitative Study in Neuromuscular Disorders to Inform a Quantitative Preference Study," The Patient: Patient-Centered Outcomes Research, Springer;International Academy of Health Preference Research, vol. 14(5), pages 601-612, September.
    9. 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.
    10. Corine Ekhart & Florence Hunsel & Eugène Puijenbroek & Rebecca Chandler & Eva-Lisa Meldau & Henric Taavola & G. Niklas Norén, 2022. "Post-Marketing Safety Profile of Vortioxetine Using a Cluster Analysis and a Disproportionality Analysis of Global Adverse Event Reports," Drug Safety, Springer, vol. 45(2), pages 145-153, February.
    11. 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.
    12. 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.
    13. 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.
    14. Katherine Chinchilla & Cristiano Matos & Victoria Hall & Florence Hunsel, 2021. "Patient Organizations’ Barriers in Pharmacovigilance and Strategies to Stimulate Their Participation," Drug Safety, Springer, vol. 44(2), pages 181-191, February.
    15. Rike van Eekeren & Leàn Rolfes & Andries S. Koster & Lara Magro & Gurumurthy Parthasarathi & Hussain Al Ramimmy & Tim Schutte & Daisuke Tanaka & Eugène van Puijenbroek & Linda Härmark, 2018. "What Future Healthcare Professionals Need to Know About Pharmacovigilance: Introduction of the WHO PV Core Curriculum for University Teaching with Focus on Clinical Aspects," Drug Safety, Springer, vol. 41(11), pages 1003-1011, November.
    16. Solomon Shiferaw Nadew & Kidanemariam G/Michael Beyene & Solomon Worku Beza, 2020. "Adverse drug reaction reporting practice and associated factors among medical doctors in government hospitals in Addis Ababa, Ethiopia," PLOS ONE, Public Library of Science, vol. 15(1), pages 1-19, January.
    17. Marin Banovac & Gianmario Candore & Jim Slattery & Francois Houÿez & David Haerry & Georgy Genov & Peter Arlett, 2017. "Patient Reporting in the EU: Analysis of EudraVigilance Data," Drug Safety, Springer, vol. 40(7), pages 629-645, July.
    18. Leàn Rolfes & Michelle Haaksman & Florence van Hunsel & Eugène van Puijenbroek, 2020. "Insight into the Severity of Adverse Drug Reactions as Experienced by Patients," Drug Safety, Springer, vol. 43(3), pages 291-293, March.
    19. Willy Fonseca & Cristina Monteiro & Luís Taborda-Barata, 2021. "Inhaled Drug Therapy-Associated Adverse Reactions in Obstructive Respiratory Diseases: A Review of a Decade of Reporting to the Portuguese Pharmacovigilance System," IJERPH, MDPI, vol. 18(23), pages 1-13, November.

    More about this item

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:spr:drugsa:v:42:y:2019:i:4:d:10.1007_s40264-018-0748-x. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Sonal Shukla or Springer Nature Abstracting and Indexing (email available below). General contact details of provider: http://www.springer.com/economics/journal/40264 .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.