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

Ingrid Oosterhuis, Henric Taavola (), Philip M. Tregunno, Petar Mas, Sara Gama, Victoria Newbould, Ola Caster and Linda Härmark
Additional contact information
Ingrid Oosterhuis: Netherlands Pharmacovigilance Centre Lareb
Henric Taavola: Uppsala Monitoring Centre
Philip M. Tregunno: Vigilance and Risk Management of Medicines Division, Medicines and Healthcare Products Regulatory Agency
Petar Mas: Agency for Medicinal Products and Medical Devices
Sara Gama: Novartis Pharma AG
Victoria Newbould: European Medicines Agency
Ola Caster: Uppsala Monitoring Centre
Linda Härmark: Netherlands Pharmacovigilance Centre Lareb

Drug Safety, 2018, vol. 41, issue 10, No 7, 969-978

Abstract: Abstract Introduction Spontaneous reporting of suspected adverse drug reactions is key for efficient post-marketing safety surveillance. To increase usability and accessibility of reporting tools, the Web-Recognising Adverse Drug Reactions (WEB-RADR) consortium developed a smartphone application (app) based on a simplified reporting form. Objective The objective of this study was to evaluate the characteristics, quality and contribution to signals of reports submitted via the WEB-RADR app. Methods The app was launched in the UK, the Netherlands and Croatia between July 2015 and May 2016. Spontaneous reports submitted until September 2016 with a single reporter were included. For each country, app reports and reports received through conventional means in the same time period were compared to identify characteristic features. A random subset of reports was assessed for clinical quality and completeness. The contribution to signal detection was assessed by a descriptive analysis. Results Higher proportions of app reports were submitted by patients in the UK (28 vs. 18%) and Croatia (32 vs. 7%); both p

Date: 2018
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DOI: 10.1007/s40264-018-0679-6

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