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



Pierce, Carrie E, de Vries, Sieta T, Bodin-Parssinen, Stephanie, Harmark, Linda, Tregunno, Phil, Lewis, David J, Maskell, Simon ORCID: 0000-0003-1917-2913, Van Eemeren, Raphael, Ptaszynska-Neophytou, Alicia, Newbould, Victoria
et al (show 4 more authors) (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, 42 (4). pp. 477-489.

Access the full-text of this item by clicking on the Open Access link.

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.

Item Type: Article
Uncontrolled Keywords: Humans, Pharmaceutical Preparations, Data Collection, Adverse Drug Reaction Reporting Systems, Communication, European Union, Health Personnel, Africa, Europe, Pharmacovigilance, Social Media, Drug-Related Side Effects and Adverse Reactions, Mobile Applications
Depositing User: Symplectic Admin
Date Deposited: 03 Apr 2019 14:49
Last Modified: 19 Jan 2023 00:55
DOI: 10.1007/s40264-019-00813-6
Open Access URL: https://doi.org/10.1007/s40264-019-00813-6
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3035699