IDEAS home Printed from https://ideas.repec.org/a/gam/jijerp/v19y2021i1p413-d715148.html
   My bibliography  Save this article

The Importance of Direct Patient Reporting of Adverse Drug Reactions in the Safety Monitoring Process

Author

Listed:
  • Kamila Sienkiewicz

    (Department of Management and Logistics in Healthcare, Medical University of Lodz, Lindleya Street 6, 90-131 Lodz, Poland)

  • Monika Burzyńska

    (Department of Epidemiology and Biostatistics, Medical University of Lodz, Żeligowskiego Street 7/9, 90-752 Lodz, Poland)

  • Izabela Rydlewska-Liszkowska

    (Department of Management and Logistics in Healthcare, Medical University of Lodz, Lindleya Street 6, 90-131 Lodz, Poland)

  • Jacek Sienkiewicz

    (Department of Management and Logistics in Healthcare, Medical University of Lodz, Lindleya Street 6, 90-131 Lodz, Poland)

  • Ewelina Gaszyńska

    (Department of Nutrition and Epidemiology, Medical University of Lodz, Żeligowskiego Street 7/9, 90-752 Lodz, Poland)

Abstract

All medicinal products authorized in the European Union are subjects of constant drug-safety monitoring processes. It is organized in a pharmacovigilance system that is designed to protect human health and life by the detection, analysis and prevention of adverse drug reactions (ADRs) and other drug-related problems. The main role of the aforementioned system is to collect and analyze adverse drug reaction reports. Legislation introduced several years ago allowed patients, their legal representatives and caregivers to report adverse drug reactions, which caused them to be an additional source of safety data. This paper presents the analysis of EudraVigilance data related to adverse drug reactions provided by patients, their representatives, as well as those obtained from healthcare professionals related to medicines which belong to M01A anti-inflammatory and antirheumatic products, a non-steroid group. The objective of the study was to identify the changes in the number and structure of adverse reaction reporting after the introduction of pharmacovigilance (PV) obligations in EU. A review of scientific literature was also conducted to assess the differences in adverse reactions reported by patients or their representatives and by healthcare professionals. We also identified other factors which, according to literature review, influenced the number of adverse reaction reports provided by patients. Analysis of data collected from the EudraVigilance showed that from 2011 to 2013 the number of reports made by patients and their caregivers increased by approx. 24 percentage points, and then, from 2014, it constituted around 30% of the total of reported reactions every year, so patient reporting is an important part of pharmacovigilance system and a source of drugs’ safety information throughout their use in healthcare practice. Additionally, there was no interrelationship between the seriousness of reported adverse reactions and the overall number of patient reports when compared to reports form healthcare professionals.

Suggested Citation

  • 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.
    • Handle: RePEc:gam:jijerp:v:19:y:2021:i:1:p:413-:d:715148
    as

    Download full text from publisher

    File URL: https://www.mdpi.com/1660-4601/19/1/413/pdf
    Download Restriction: no
    File URL: https://www.mdpi.com/1660-4601/19/1/413/
    Download Restriction: no
    ---><---

    References listed on IDEAS

    as
    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. Patricia McGettigan & Carla Alonso Olmo & Kelly Plueschke & Mireia Castillon & Daniel Nogueras Zondag & Priya Bahri & Xavier Kurz & Peter G. M. Mol, 2019. "Patient Registries: An Underused Resource for Medicines Evaluation," Drug Safety, Springer, vol. 42(11), pages 1343-1351, November.
    4. Rodrigo Postigo & Sabine Brosch & Jim Slattery & Anja Haren & Jean-Michel Dogné & Xavier Kurz & Gianmario Candore & Francois Domergue & Peter Arlett, 2018. "EudraVigilance Medicines Safety Database: Publicly Accessible Data for Research and Public Health Protection," Drug Safety, Springer, vol. 41(7), pages 665-675, July.
    5. 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.
    6. 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.
    7. 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.
    Full references (including those not matched with items on IDEAS)

    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. 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.
    3. 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.
    4. 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.
    5. 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.
    6. Rita Francisco & Sandra Brasil & Carlota Pascoal & Andrew C. Edmondson & Jaak Jaeken & Paula A. Videira & Cláudia de Freitas & Vanessa dos Reis Ferreira & Dorinda Marques-da-Silva, 2022. "A Community-Led Approach as a Guide to Overcome Challenges for Therapy Research in Congenital Disorders of Glycosylation," IJERPH, MDPI, vol. 19(11), pages 1-19, June.
    7. 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.
    8. 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.
    9. Emanuel Raschi & Matteo Bianchin & Milo Gatti & Alessandro Squizzato & Fabrizio De Ponti, 2019. "Comparative Effectiveness and Safety of Direct Oral Anticoagulants: Overview of Systematic Reviews," Drug Safety, Springer, vol. 42(12), pages 1409-1422, December.
    10. Ravi Jandhyala, 2019. "Comment on: “Patient Registries: An Underused Resource for Medicines Evaluation: Operational Proposals for Increasing the Use of Patient Registries in Regulatory Assessments”," Drug Safety, Springer, vol. 42(12), pages 1515-1516, December.
    11. 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.
    12. 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.
    13. Patricia McGettigan & Carla Alonso Olmo & Kelly Plueschke & Mireia Castillon & Daniel Zondag & Priya Bahri & Xavier Kurz & Peter G. M. Mol, 2019. "Authors’ Reply to Ravi Jandhyala’s Comment on “Patient Registries: An Underused Resource for Medicines Evaluation: Operational Proposals for Increasing the Use of Patient Registries in Regulatory Asse," Drug Safety, Springer, vol. 42(12), pages 1517-1518, December.
    14. Kacper Wróbel & Beata Zastawna & Anna Justyna Milewska & Michał Marczak & Remigiusz Kozłowski, 2023. "Comparison between the American and the European Systems of Monitoring Adverse Effects of Dietary Supplements and Their Usefulness on the Polish Market," IJERPH, MDPI, vol. 20(2), pages 1-19, January.
    15. 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.

    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:19:y:2021:i:1:p:413-:d:715148. 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.