- 3-year project (2014-2016)
- Project financed by ANSM (French Agency for the Safety of Health Products).
- Consortium of 7 partners from public sector
Studies have shown that patient statements to regulatory agencies on medication may be of similar quality to that of health professionals, and it seems that patients are more likely to spontaneously report adverse drug reactions that health professionals. In recent years, online social network have become very popular in the era of Web 2.0, allowing users to communicate, interact and share worldwide. The hypothesis of Vigi4MED project (Vigilance in web forums for Medication) is that feedback from patients on adverse reactions may be drug-related reported in social networks and are an additional source to improve our knowledge in pharmacovigilance. The few studies described in the literature show that can be found retrospectively adverse effects of drugs but do not allow to conclude on the interest of social networks within the pharmacovigilance process. Vigi4MED The project aims to fill this gap. This project is part of the measures to strengthen the surveillance of health products and is particularly aimed at the detection of weak signals.
The goal of this project is the use of patient messages from social networks as a source of information on the safety and use of medicines. Messages will be assessed from the perspective of their potential interest (unexpected and serious nature of the reaction) and quality (information sufficient to permit satisfactory accountability on the Internet reported cases). One should check the likelihood of adverse effects taking into account the patients' language which may differ in some aspects of medical language, and the same side effect is not described on several different sites.
The evaluation process developed will be made (1) retrospectively to drugs withdrawn from the market, by checking whether the patients had written comments before the decision to withdraw and possible media coverage of this withdrawal, and (2) prospectively in order to identify new drugs likely to have serious and unexpected adverse reactions not observed in clinical trials because of their rarity.