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.

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 w

SUBMITTER: Oosterhuis I 

PROVIDER: S-EPMC6153975 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature