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Characteristics, Quality and Contribution to Signal Detection of Spontaneous Reports of Adverse Drug Reactions Via the WEB-RADR Mobile Application: A Descriptive Cross-Sectional Study

Author

Listed:
  • Ingrid Oosterhuis

    (Netherlands Pharmacovigilance Centre Lareb)

  • Henric Taavola

    (Uppsala Monitoring Centre)

  • Philip M. Tregunno

    (Vigilance and Risk Management of Medicines Division, Medicines and Healthcare Products Regulatory Agency)

  • Petar Mas

    (Agency for Medicinal Products and Medical Devices)

  • Sara Gama

    (Novartis Pharma AG)

  • Victoria Newbould

    (European Medicines Agency)

  • Ola Caster

    (Uppsala Monitoring Centre)

  • Linda Härmark

    (Netherlands Pharmacovigilance Centre Lareb)

Abstract

Introduction Spontaneous reporting of suspected adverse drug reactions is key for efficient post-marketing safety surveillance. To increase usability and accessibility of reporting tools, the Web-Recognising Adverse Drug Reactions (WEB-RADR) consortium developed a smartphone application (app) based on a simplified reporting form. Objective The objective of this study was to evaluate the characteristics, quality and contribution to signals of reports submitted via the WEB-RADR app. Methods The app was launched in the UK, the Netherlands and Croatia between July 2015 and May 2016. Spontaneous reports submitted until September 2016 with a single reporter were included. For each country, app reports and reports received through conventional means in the same time period were compared to identify characteristic features. A random subset of reports was assessed for clinical quality and completeness. The contribution to signal detection was assessed by a descriptive analysis. Results Higher proportions of app reports were submitted by patients in the UK (28 vs. 18%) and Croatia (32 vs. 7%); both p

Suggested Citation

  • Ingrid Oosterhuis & Henric Taavola & Philip M. Tregunno & Petar Mas & Sara Gama & Victoria Newbould & Ola Caster & Linda Härmark, 2018. "Characteristics, Quality and Contribution to Signal Detection of Spontaneous Reports of Adverse Drug Reactions Via the WEB-RADR Mobile Application: A Descriptive Cross-Sectional Study," Drug Safety, Springer, vol. 41(10), pages 969-978, October.
    • Handle: RePEc:spr:drugsa:v:41:y:2018:i:10:d:10.1007_s40264-018-0679-6
    DOI: 10.1007/s40264-018-0679-6
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    Cited by:

    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. 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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