IDEAS home Printed from https://ideas.repec.org/a/spr/drugsa/v42y2019i4d10.1007_s40264-019-00813-6.html
   My bibliography  Save this article

Recommendations on the Use of Mobile Applications for the Collection and Communication of Pharmaceutical Product Safety Information: Lessons from IMI WEB-RADR

Author

Listed:
  • Carrie E. Pierce

    (Booz Allen Hamilton (formerly Epidemico, Inc.))

  • Sieta T. Vries

    (University of Groningen, University Medical Center Groningen)

  • Stephanie Bodin-Parssinen

    (UCB Pharmaceuticals)

  • Linda Härmark

    (Netherlands Pharmacovigilance Centre Lareb)

  • Phil Tregunno

    (Vigilance, Intelligence and Research Group, Medicines and Healthcare Products Regulatory Agency (MHRA))

  • David J. Lewis

    (Chief Medical Office and Patient Safety, Global Drug Development, Novartis
    University of Hertfordshire)

  • Simon Maskell

    (University of Liverpool)

  • Raphael Eemeren

    (Amgen Europe BV)

  • Alicia Ptaszynska-Neophytou

    (Vigilance, Intelligence and Research Group, Medicines and Healthcare Products Regulatory Agency (MHRA))

  • Victoria Newbould

    (Pharmacovigilance Department, Inspections and Human Medicines Pharmacovigilance Division, European Medicines Agency (EMA))

  • Nabarun Dasgupta

    (University of North Carolina at Chapel Hill)

  • Antoni F. Z. Wisniewski

    (AstraZeneca, Global Regulatory Affairs, Patient Safety and Quality Assurance)

  • Sara Gama

    (Chief Medical Office and Patient Safety, Global Drug Development, Novartis)

  • Peter G. M. Mol

    (University of Groningen, University Medical Center Groningen
    Dutch Medicines Evaluation Board (CBG-MEB))

Abstract

Over a period of 3 years, the European Union’s Innovative Medicines Initiative WEB-RADR (Recognising Adverse Drug Reactions; https://web-radr.eu/ ) project explored the value of two digital tools for pharmacovigilance (PV): mobile applications (apps) for reporting the adverse effects of drugs and social media data for its contribution to safety signalling. The ultimate intent of WEB-RADR was to provide policy, technical and ethical recommendations on how to develop and implement such digital tools to enhance patient safety. Recommendations relating to the use of mobile apps for PV are summarised in this paper. There is a presumption amongst at least some patients and healthcare professionals that information ought to be accessed and reported from any setting, including mobile apps. WEB-RADR has focused on the use of such technology for reporting suspected adverse drug reactions and for broadcasting safety information to its users, i.e. two-way risk communication. Three apps were developed and publicly launched within Europe as part of the WEB-RADR project and subsequently assessed by a range of stakeholders to determine their value as effective tools for improving patient safety; a fourth generic app was later piloted in two African countries. The recommendations from the development and evaluation of the European apps are presented here with supporting considerations, rationales and caveats as well as suggested areas for further research.

Suggested Citation

  • 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.
    • Handle: RePEc:spr:drugsa:v:42:y:2019:i:4:d:10.1007_s40264-019-00813-6
    DOI: 10.1007/s40264-019-00813-6
    as

    Download full text from publisher

    File URL: http://link.springer.com/10.1007/s40264-019-00813-6
    File Function: Abstract
    Download Restriction: Access to the full text of the articles in this series is restricted.
    File URL: https://libkey.io/10.1007/s40264-019-00813-6?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    As the access to this document is restricted, you may want to search for a different version of it.

    References listed on IDEAS

    as
    1. 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.
    2. 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.
    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. Joanne Barnes & Jane L. Sheridan & Christine Yang Dong & Linda Härmark & Sunita Vohra & Mira Harrison-Woolrych, 2020. "Evaluation of a Web-Based, ‘Purchase Event’ Intensive Monitoring Method for Pharmacovigilance of Natural Health Products: Lessons and Insights from Development Work in New Zealand," Drug Safety, Springer, vol. 43(10), pages 981-998, October.
    2. Babafunso Aderemi Adenuga & Timothy William Rennie, 2019. "A Profile of Adverse Drug Reactions of Atazanavir- and Lopinavir-Based Antiretroviral Regimens in Namibia," Drug Safety, Springer, vol. 42(7), pages 915-917, July.
    3. Christine Mary Hallinan & Yvonne Ann Bonomo, 2022. "The Rise and Rise of Medicinal Cannabis, What Now? Medicinal Cannabis Prescribing in Australia 2017–2022," IJERPH, MDPI, vol. 19(16), pages 1-7, August.
    4. 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.

    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. Joanne Barnes & Jane L. Sheridan & Christine Yang Dong & Linda Härmark & Sunita Vohra & Mira Harrison-Woolrych, 2020. "Evaluation of a Web-Based, ‘Purchase Event’ Intensive Monitoring Method for Pharmacovigilance of Natural Health Products: Lessons and Insights from Development Work in New Zealand," Drug Safety, Springer, vol. 43(10), pages 981-998, October.
    2. 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.

    More about this item

    Statistics

    Access and download statistics

    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:spr:drugsa:v:42:y:2019:i:4:d:10.1007_s40264-019-00813-6. 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: Sonal Shukla or Springer Nature Abstracting and Indexing (email available below). General contact details of provider: http://www.springer.com/economics/journal/40264 .

    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.