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Patient-Reported Safety Information: A Renaissance of Pharmacovigilance?

Author

Listed:
  • Linda Härmark

    (Netherlands Pharmacovigilance Centre Lareb, WHO Collaborating Center for Pharmacovigilance in Education and Patient Reporting)

  • June Raine

    (Medicines and Healthcare Products Regulatory Agency)

  • Hubert Leufkens

    (Medicines Evaluation Board)

  • I. Ralph Edwards

    (Uppsala Monitoring Centre)

  • Ugo Moretti

    (University of Verona)

  • Viola Macolic Sarinic

    (Halmed)

  • Agnes Kant

    (Netherlands Pharmacovigilance Centre Lareb, WHO Collaborating Center for Pharmacovigilance in Education and Patient Reporting)

Abstract

The role of patients as key contributors in pharmacovigilance was acknowledged in the new EU pharmacovigilance legislation. This contains several efforts to increase the involvement of the general public, including making patient adverse drug reaction (ADR) reporting systems mandatory. Three years have passed since the legislation was introduced and the key question is: does pharmacovigilance yet make optimal use of patient-reported safety information? Independent research has shown beyond doubt that patients make an important contribution to pharmacovigilance signal detection. Patient reports provide first-hand information about the suspected ADR and the circumstances under which it occurred, including medication errors, quality failures, and ‘near misses’. Patient-reported safety information leads to a better understanding of the patient’s experiences of the ADR. Patients are better at explaining the nature, personal significance and consequences of ADRs than healthcare professionals’ reports on similar associations and they give more detailed information regarding quality of life including psychological effects and effects on everyday tasks. Current methods used in pharmacovigilance need to optimise use of the information reported from patients. To make the most of information from patients, the systems we use for collecting, coding and recording patient-reported information and the methodologies applied for signal detection and assessment need to be further developed, such as a patient-specific form, development of a severity grading and evolution of the database structure and the signal detection methods applied. It is time for a renaissance of pharmacovigilance.

Suggested Citation

  • 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.
  • Handle: RePEc:spr:drugsa:v:39:y:2016:i:10:d:10.1007_s40264-016-0441-x
    DOI: 10.1007/s40264-016-0441-x
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    Citations

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    Cited by:

    1. 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.
    2. 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.
    3. 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.
    4. 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.
    5. 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.
    6. 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.

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