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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
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    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.
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    2. 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.
    3. 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.
    4. 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.

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