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Patient Organizations’ Barriers in Pharmacovigilance and Strategies to Stimulate Their Participation

Author

Listed:
  • Katherine Chinchilla

    (Universidad de Costa Rica
    Netherlands Pharmacovigilance Centre Lareb)

  • Cristiano Matos

    (Instituto Politécnico De Coimbra, ESTESC-Coimbra Health School)

  • Victoria Hall

    (Universidad de Costa Rica)

  • Florence Hunsel

    (Netherlands Pharmacovigilance Centre Lareb)

Abstract

Introduction European drug regulations aim for a patient-centered approach, including involving patients in the pharmacovigilance (PV) systems. However many patient organizations have little experience on how they can participate in PV activities. Aim The aim of this study was to understand patient organizations’ perceptions of PV, the barriers they face when implementing PV activities, and their interaction with other stakeholders and suggest methods for the stimulation of patient organizations as promoters of PV. Methods A sequential qualitative method study was conducted and integrated with the quantitative study performed by Matos, Weits, and van Hunsel to complete a mixed method study. Results The qualitative phase expands the understanding of the quantitative results from a previous study by broadening the knowledge on external barriers and internal barriers that patient organizations face when implementing PV activities. The strategies to stimulate patient-organization participation are the creation of more awareness campaigns, more research that creates awareness, education for patient organizations, communication of real PV examples, creation of a targeted PV system, creation of a PV communication network that provides feedback to patients, improvement of understanding of all stakeholders, and a more proactive approach from national competent authorities. Conclusion Both study phases show congruent results regarding patients’ involvement and the activities patient organizations perform to promote drug safety. Patient organizations progressively position themselves as stakeholders in PV, carrying out many activities that stimulate awareness and participation of their members in drug safety, but still face internal and external barriers that can hamper their involvement.

Suggested Citation

  • 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.
    • Handle: RePEc:spr:drugsa:v:44:y:2021:i:2:d:10.1007_s40264-020-00999-0
    DOI: 10.1007/s40264-020-00999-0
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    References listed on IDEAS

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    1. 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.
    2. 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.
    3. Aniello Santoro & Georgy Genov & Almath Spooner & June Raine & Peter Arlett, 2017. "Promoting and Protecting Public Health: How the European Union Pharmacovigilance System Works," Drug Safety, Springer, vol. 40(10), pages 855-869, October.
    4. Carrie E. Pierce & Sieta T. Vries & Stephanie Bodin-Parssinen & Linda Härmark & Phil Tregunno & David J. Lewis & Simon Maskell & Raphael Eemeren & Alicia Ptaszynska-Neophytou & Victoria Newbould & Nab, 2019. "Recommendations on the Use of Mobile Applications for the Collection and Communication of Pharmaceutical Product Safety Information: Lessons from IMI WEB-RADR," Drug Safety, Springer, vol. 42(4), pages 477-489, April.
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    Cited by:

    1. 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.

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