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

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, Nabarun Dasgupta, Antoni F. Z. Wisniewski, Sara Gama and Peter G. M. Mol ()
Additional contact information
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
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

Drug Safety, 2019, vol. 42, issue 4, No 1, 477-489

Abstract: 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.

Date: 2019
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DOI: 10.1007/s40264-019-00813-6

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