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User-Driven Development of a Web-Based Tool for Patient Reporting of Drug-Related Harm

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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.

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Acknowledgments

We thank the two pilot national pharmacovigilance centres in Croatia and Turkey, and are indebted to the input from Svilen Konov, European AIDS treatment group.

Funding and conflict of interest

The Monitoring Medicines project was funded through the 7th Framework Programme (FP7) of the European Commission (grant 223566).

Monica Plöen, Magnus Wallberg and Sten Olsson have no conflicts of interest that are directly relevant to the content of this study.

Theme issue

This article is part of a theme issue co-edited by Elliot G. Brown, Shanthi Pal, and Sten Olsson. No external funding was used to support the publication of this theme issue.

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Authors and Affiliations

  1. Uppsala Monitoring Centre, Box 1051, 751 40, Uppsala, Sweden

    Monica Plöen, Magnus Wallberg & Sten Olsson

Authors
  1. Monica Plöen
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  2. Magnus Wallberg
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  3. Sten Olsson
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Corresponding author

Correspondence to Monica Plöen.

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Plöen, M., Wallberg, M. & Olsson, S. User-Driven Development of a Web-Based Tool for Patient Reporting of Drug-Related Harm. Drug Saf 38, 359–364 (2015). https://doi.org/10.1007/s40264-015-0276-x

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  • DOI: https://doi.org/10.1007/s40264-015-0276-x

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