A team of researchers from CINTESIS – Center for Health Technology and Services Research and the Faculty of Medicine of the University of Porto (FMUP) is developing a project to actively monitor the safety of the therapy used in the context of COVID-19 in hospitals in the district of Porto.
The project “Intensive Drug Monitoring COVID-19” takes place within the scope of the activity developed by the Porto Pharmacovigilance Unit (UFPorto), headed by Jorge Polónia, a CINTESIS researcher and professor at FMUP.
One of the objectives of this multicentric study is to develop a database of adverse drug reactions (ADRs) in patients with COVID-19. Another objective is to characterize the pharmacotherapeutic profile before infection by SARS-CoV-2 in patients with COVID-19, in order “to assess the favorable, unfavorable or neutral effect of this profile in the course of the infection, in terms of susceptibility, severity, and outcome ”.
According to an article published in Acta Médica Portuguesa (“The Role of Pharmacovigilance in the Context of Pandemic by COVID-19”), this project will collect data on ADR retrospectively and prospectively, the latter of which will allow the “signs of risk real-time” detection.
In this regard, the team will track clinical records and actively monitor the medication administered to patients with COVID-19 identified in the various health institutions, even after hospital discharge.
“The active monitoring methodologies may contribute to gaining a more accurate idea of the reality of the ADRs associated with COVID-19 in clinical practice, namely with regard to the drugs used in the treatment”, say the authors of the study.
To date, they say, only the remdesivir and dexamethasone drugs have been approved for the treatment of COVID-19 by regulatory authorities, with very strict indications and, in the case of remdesivir, with contradictory results, which justifies close monitoring.
One of the major obstacles to monitoring ADR in infected patients will be the evolution to a critical state. Another factor that can hinder better knowledge of ADRs is the age of the patients.
In the European Union, adverse reactions to medicines represent 6.5% of hospitalizations and 197 thousand deaths per year.
In addition to Jorge Polónia, the researchers Renato Ferreira da Silva, Inês Ribeiro Vaz, Ana Marta Silva and Joana Marques (CINTESIS / FMUP), and Manuela Morato from the Faculty of Pharmacy of the University of Porto, also participate in the study. The project also counts on the collaboration of UFPorto’s pharmacovigilance delegates in the respective health institutions where they work.