IDEAS home Printed from https://ideas.repec.org/a/gam/jijerp/v18y2021i4p1507-d493917.html
   My bibliography  Save this article

Adverse Drug Reaction Reporting by Patients in 12 European Countries

Author

Listed:
  • Agne Valinciute-Jankauskiene

    (Department of Drug Technology and Social Pharmacy, Lithuanian University of Health Sciences, Sukileliu Ave. 13, LT-50166 Kaunas, Lithuania)

  • Loreta Kubiliene

    (Department of Drug Technology and Social Pharmacy, Lithuanian University of Health Sciences, Sukileliu Ave. 13, LT-50166 Kaunas, Lithuania)

Abstract

Patients who report suspected adverse drug reactions (ADRs) help minimize drug safety risks and bolster the pharmacovigilance system. The aim of this study was to examine the contribution of patients to pharmacovigilance and compare the tools used to promote patient reporting in European countries that implemented this reporting type in 2012–2013. A web-based questionnaire was sent to the national competent authorities (NCAs) of the European countries. The received answers were systematized and compared using statistical analysis. The performed statistical analysis demonstrated that changes in the number of received ADR reports increased significantly in each country during the analyzed period. These changes were significantly different in Ireland and Finland from those in the other reviewed countries. The common source of information on direct patient reporting was the country’s NCA website. Other sources used were social media pages, leaflets, and posters. This is the first study on patient reporting schemes implemented after the significant reform of the European regulatory system for pharmacovigilance. However, some countries did not actively promote their patient reporting schemes. Our findings indicate that countries with minimal experience in pharmacovigilance systems that include direct patient reporting should organize comprehensive campaigns on ADR reporting.

Suggested Citation

  • Agne Valinciute-Jankauskiene & Loreta Kubiliene, 2021. "Adverse Drug Reaction Reporting by Patients in 12 European Countries," IJERPH, MDPI, vol. 18(4), pages 1-8, February.
  • Handle: RePEc:gam:jijerp:v:18:y:2021:i:4:p:1507-:d:493917
    as

    Download full text from publisher

    File URL: https://www.mdpi.com/1660-4601/18/4/1507/pdf
    Download Restriction: no

    File URL: https://www.mdpi.com/1660-4601/18/4/1507/
    Download Restriction: no
    ---><---

    References listed on IDEAS

    as
    1. Geneviève Durrieu & Julien Jacquot & Mathilde Mège & Emmanuelle Bondon-Guitton & Vanessa Rousseau & François Montastruc & Jean-Louis Montastruc, 2016. "Completeness of Spontaneous Adverse Drug Reaction Reports Sent by General Practitioners to a Regional Pharmacovigilance Centre: A Descriptive Study," Drug Safety, Springer, vol. 39(12), pages 1189-1195, December.
    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. 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.

    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. Mário Rui Salvador & Cristina Monteiro & Luísa Pereira & Ana Paula Duarte, 2022. "Quality of Spontaneous Reports of Adverse Drug Reactions Sent to a Regional Pharmacovigilance Unit," IJERPH, MDPI, vol. 19(7), pages 1-8, March.

    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:gam:jijerp:v:18:y:2021:i:4:p:1507-:d:493917. 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: MDPI Indexing Manager (email available below). General contact details of provider: https://www.mdpi.com .

    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.