There is an increased lack of short- and long-term real-life effectiveness and safety
data on new oral antivirals authorised and commercialised to treat COVID-19. To date,
only two clinical trials have been published with data on the efficacy and safety of the
use of the Paxlovid® and Lagevrio®. Since there is a public health, political, social and
economic pressure to prevent severity, hospitalisation and death from COVID-19,
monitoring the effectiveness and safety of commercialised oral antiviral therapies
against COVID-19 has become emergent pharmacovigilance and public health task6.

A real-life cohort event monitoring system allows for the monitoring of newly introduced
oral antivirals, in addition to existing spontaneous reporting systems and healthcare
database studies (i.e., secondary data), as it is complementary to these systems in
several ways. First, it is better suited to capture the more frequent AE, including those
that are not medically attended. It generates more comprehensive safety data, e.g. on
disease course and the impact of the AE. Moreover, there is insufficient data on these
new medicines in real clinical practice, particularly from large-scale studies on the
long-term efficacy or safety.

This work, with scientific and academic interest but, essentially, clinical and
regulatory importance, constitutes a duty of the regional pharmacovigilance units. As
such, it is also an obligation of the Pharmacy and Therapeutics Commissions, based on the
legislation in force, to "collaborate in studies to monitor the safety and effectiveness
of medicines promoted in the context of the National Pharmacovigilance System".