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Drug Safety

, Volume 42, Issue 10, pp 1115–1124 | Cite as

Pharmacovigilance as Scientific Discovery: An Argument for Trans-Disciplinarity

  • Elena RoccaEmail author
  • Samantha Copeland
  • I. Ralph Edwards
Current Opinion

Abstract

Pharmacovigilance currently faces several unsolved challenges. Of particular importance are issues concerning how to ascertain, collect, confirm, and communicate the best evidence to assist the clinical choice for individual patients. Here, we propose that these practical challenges partially stem from deeper fundamental issues concerning the epistemology of pharmacovigilance. After reviewing some of the persistent challenges, recent measures, and suggestions in the current pharmacovigilance literature, we support the argument that the detection of potential adverse drug reactions ought to be seen as a serendipitous scientific discovery. We further take up recent innovations from the multidisciplinary field of serendipity research about the importance of networks, diversity of expertise, and plurality of methodological perspectives for cultivating serendipitous discovery. Following this discussion, we explore how pharmacovigilance could be systematized in a way that optimizes serendipitous discoveries of untargeted drug effects, emerging from the clinical application. Specifically, we argue for the promotion of a trans-disciplinary responsive network of scientists and stakeholders. Trans-disciplinarity includes extending the involvement of stakeholders beyond the regulatory community, integrating diverse methods and sources of evidence, and enhancing the ability of diverse groups to raise signals of harms that ought to be followed up by the network. Consequently, promoting a trans-disciplinary approach to pharmacovigilance is a long-term effort that requires structural changes in medical education, research, and enterprise. We suggest a number of such changes, discuss to what extent they are already in process, and indicate the advantages from both epistemological and ethical perspectives.

Notes

Acknowledgements

We thank four anonymous reviewers for constructive feedback on a previous draft of this paper.

Compliance with Ethical Standards

Conflict of interest

Elena Rocca, Samantha Copeland, and I. Ralph Edwards have no conflicts of interest that are directly relevant to the content of this article.

Funding

This research was funded by the Norwegian Research Council (Grant no. 240073).

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Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.Centre for Applied Philosophy of Science, School of Economics and BusinessNorwegian University of Life SciencesÅsNorway
  2. 2.Ethics and Philosophy of Technology Section, Department of Values, Technology and InnovationTechnical University of DelftDelftThe Netherlands
  3. 3.Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug MonitoringUppsalaSweden

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