Patients centred pharmacovigilance

Scurti, Veronica (2012). Patients centred pharmacovigilance. PhD thesis The Open University.

DOI: https://doi.org/10.21954/ou.ro.0000d4e9

Abstract

In recent years, periodically high peaks of attention and publications have documented severe adverse reactions to new molecules, which have raised many questions about the efficacy- efficiency of traditional methodological tools of phannacovigilance, as well as about the role of regulatory systems. Drugs cannot be considered as an independent variable: the evaluation of all of their effects must take into account the real context in which they are used, and in which they are expected have a role, not only in terms of efficacy, but also of tolerability and safety. Specific emphasis is given to recent and promising developments, which are focused on the participation of patient populations as key actors in producing knowledge that can also technically integrate what has been produced so far, and can allow the evolution of surveillance from a role of control to one of the promotion of rights. The replacement of phannacovigilance in an epidemiological context is the main aim of this project. This is applied across the development of various projects realised in different scenarios (e.g. hospital, community) using different methodologies (e.g. administrative database linkage, prospective studies, qualitative projects), and through the direct involvement of all of the actors involved in the process of care (e.g. clinicians, general practitioners, patients). In particular, despite the many recommendations, patient participation can be considered as an exception in the health care setting: for this reason the project was developed with the intention to give voice to patients. Promotion of the use of a more narrative style between health professionals and citizen-patients in phannacovigilance should be considered the most important outcome of a renewed phannacovigilance.