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Patient Reporting in the EU: Analysis of EudraVigilance Data

Author

Listed:
  • Marin Banovac

    (European Medicines Agency (EMA))

  • Gianmario Candore

    (European Medicines Agency (EMA))

  • Jim Slattery

    (European Medicines Agency (EMA))

  • Francois Houÿez

    (European Organisation for Rare Diseases (EURORDIS))

  • David Haerry

    (European Aids Treatment Group (EATG))

  • Georgy Genov

    (European Medicines Agency (EMA))

  • Peter Arlett

    (European Medicines Agency (EMA))

Abstract

Introduction New pharmacovigilance legislation was adopted in the EU in 2010 and became operational in July 2012. The legislation placed an obligation on all national competent authorities (NCAs) and marketing authorisation holders (MAHs) to record and report cases of suspected adverse drug reactions (ADRs) received from patients. Objectives This descriptive study aims to provide insight into patient reporting for the totality of the EU by querying the EudraVigilance (EV) database for the period of 3 years before the new pharmacovigilance legislation became operational and the 3 years after as well as comparing patient reports with those from healthcare professionals (HCPs) where feasible. Methods We queried the EV database for the following characteristics of patient and HCP reports: demographics (patient sex and age), seriousness, reported ADR terms, reported indications, number of ADRs per report, time to report an ADR, and most reported substances. Wherever feasible, direct comparisons between patient reports and HCP reports were performed using relative risks. Results The EV database contained a total of 53,130 patient reports in the 3 years preceding the legislation operation period and 113,371 in the 3 years after. Member states contributing the most patient reports to the EV database were the Netherlands, the UK, Germany, France and Italy. The results for indications and substances show that patients were more likely than HCPs to report for genitourinary, hormonal and reproductive indications. Patients reported more in general disorders and administration site conditions Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), whereas HCPs reported more Preferred Terms (PTs) belonging in the Investigations SOC. However, 13 of the 20 reactions most frequently reported by patients were also among the top 20 reactions reported by HCPs. Conclusion Patient reporting complemented reporting by HCPs. Patients were motivated to report ADRs, especially those that affected their quality of life. Sharing these results with NCAs and patient associations can inform training and awareness on patient reporting.

Suggested Citation

  • 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.
    • Handle: RePEc:spr:drugsa:v:40:y:2017:i:7:d:10.1007_s40264-017-0534-1
    DOI: 10.1007/s40264-017-0534-1
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    References listed on IDEAS

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    1. 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. Wiwan Worakunphanich & Sitaporn Youngkong & Wimon Suwankesawong & Claire Anderson & Montarat Thavorncharoensap, 2022. "Comparison of Patient Adverse Drug Reaction Reporting Systems in Nine Selected Countries," IJERPH, MDPI, vol. 19(8), pages 1-12, April.
    2. Lotte A. Minnema & Thijs J. Giezen & Patrick C. Souverein & Toine C. G. Egberts & Hubert G. M. Leufkens & Helga Gardarsdottir, 2019. "Exploring the Association between Monoclonal Antibodies and Depression and Suicidal Ideation and Behavior: A VigiBase Study," Drug Safety, Springer, vol. 42(7), pages 887-895, July.
    3. 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.
    4. 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.

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