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Drug Saf. 2019 Apr;42(4):477-489. doi: 10.1007/s40264-019-00813-6.

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

Author information

1
Booz Allen Hamilton (formerly Epidemico, Inc.), Boston, MA, USA.
2
Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
3
UCB Pharmaceuticals, Allée de la Recherche, 60, 1070, Brussels, Belgium.
4
Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, 's-Hertogenbosch, The Netherlands.
5
Vigilance, Intelligence and Research Group, Medicines and Healthcare Products Regulatory Agency (MHRA), 151 Buckingham Palace Road, Belgravia, London, SW1W 9SZ, UK.
6
Chief Medical Office and Patient Safety, Global Drug Development, Novartis, Basel, Switzerland.
7
Department of Pharmacy, Pharmacology and Postgraduate Medicine, University of Hertfordshire, Hatfield, Hertfordshire, AL10 9AB, UK.
8
Department of Electrical Engineering and Electronics, University of Liverpool, Liverpool, L69 7ZX, UK.
9
Amgen Europe BV, Minervum 7061, 4817 ZK, Breda, The Netherlands.
10
Pharmacovigilance Department, Inspections and Human Medicines Pharmacovigilance Division, European Medicines Agency (EMA), London, E14 5EU, UK.
11
University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA.
12
AstraZeneca, Global Regulatory Affairs, Patient Safety and Quality Assurance, Granta Park, Cambridge, CB21 6GH, UK.
13
Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. p.g.m.mol@umcg.nl.
14
Dutch Medicines Evaluation Board (CBG-MEB), Utrecht, The Netherlands. p.g.m.mol@umcg.nl.

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.

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