Citation

Plöen M, Wallberg M, Olsson S. Drug Safety 2015; 38(4): 359-364.

Affiliation

Uppsala Monitoring Centre, Box 1051, 751 40, Uppsala, Sweden, monica.ploen@who-umc.org.

Copyright

(Copyright © 2015, Adis International)

DOI

10.1007/s40264-015-0276-x

PMID

25711669

Abstract

Commissioned by the Monitoring Medicines project, the Uppsala Monitoring Centre (UMC) led the design and development of a web-based ADR (adverse drug reaction) reporting tool intended for use by patients. The software design was undertaken in close collaboration with representatives of national pharmacovigilance centres (NPCs) and with patient and consumer organizations. The web-based tool was developed by these participants through several telephone conferences, a workshop and site testing. The tool is directly compatible with the UMC's Individual Case Safety Report (ICSR) data management system VigiFlow(®) and is also compliant with the ICH-E2B(R2) format. The UMC team benefited by working closely with the end-users during the development process. A major challenge was to balance the need for detailed information required by the NPCs to be able to assess reports with the amount of detail patients are able and willing to provide. Needs, ideas and suggestions from the end users were valuable and were taken into account throughout the process of designing the tool.

Language: en