About ‘Pharmacovigilance as Scientific Discovery’ for January 2021

Pharmacovigilance as Scientific Discovery: An Argument for Trans-Disciplinarity


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.

Questions for Twitter

  • You say that pharmacovigilance (like serendipity) requires ‘a prepared mind’. But some might think of a prepared mind as a biased mind, where we find what we expect. But you mean something else, right?
  • Health science and clinical decision-making tend to oppose the idea of the prepared mind: instead we should be neutral, objective, data-informed, and not rely too much on clinical experience, expertise or theory. Or?
  • You say that serendipity is perhaps more relevant for discovering side-effects than targeted effects of medicines. Could one say that in general for all science? That serendipity is how one deals with cases of failure, exceptions and deviance from the norm?
  • You talk about the importance of trans-disciplinarity in discovering side-effects of treatments. What role can you and I play in this process, not being scientists or medical experts?

Citation & Links:

Rocca, E., Copeland, S. & Ralph Edwards, I. Pharmacovigilance as Scientific Discovery: An Argument for Trans-Disciplinarity. Drug Safety 42, 1115–1124 (2019). https://doi.org/10.1007/s40264-019-00826-1

Is there a paper about serendipity that you would like to discuss in the journal club? Contact us at the Society email (see our contact page, here) to let us know.

Need a copy of the paper but don’t have access? Email the Society at our email address and we can send you one, with the author’s permission. Our contact page is here!