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

• Published in: Drug safety 2018-10, Vol.41 (10), p.969-978
• Main Authors: Oosterhuis, Ingrid, Taavola, Henric, Tregunno, Philip M., Mas, Petar, Gama, Sara, Newbould, Victoria, Caster, Ola, Härmark, Linda
• Format: Article
• Language: English
• Subjects: Drug Safety and Pharmacovigilance; Medicine; Medicine & Public Health; Original; Original Research Article; Pharmacology/Toxicology
• ISSN: 0114-5916; 1179-1942
• DOI: 10.1007/s40264-018-0679-6

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