PAHO develops a protocol on notifications of suspected adverse reactions to medicines and products used to treat or prevent COVID-19

Health worker with facemask

Washington DC, February 5, 2020 (PAHO) - The Pan American Health Organization (PAHO) together with experts from the pharmacovigilance programs of seven countries in the Americas (Chile, Costa Rica, Colombia, Cuba, El Salvador, Mexico and Peru) is developing a protocol to determine the reports of suspected adverse reactions to medicines and products used without robust evidence to treat or prevent COVID-19 in these countries.

The initiative will consolidate and classify the notifications of suspected adverse reactions received by the pharmacovigilance programs of the participating countries between 1 March 2020 and 31 August 2020. In many cases, antimicrobials have been incorporated as treatment of people infected with COVID-19. 

The protocol will analyze the severity and frequency of the events reported and will establish the differences between the medicines used in the usual indications and in the clinical context of COVID-19. The results of the analysis will be compared with those documented in clinical trials and those reported in specific pharmacovigilance studies in COVID-19.

The medicines and products selected as part of the protocol were selected based on recommendations from the national health or regulatory authorities; management guides from scientific societies and other sources in the participating countries; from the Document “Ongoing Living Update of Potential COVID-19 Therapeutics: Summary of Rapid Systematic Reviews. Rapid Review” regularly published by PAHO (PAHO, 2020); and from recommendations issued by two reference health agencies: the U.S. Food and Drug Administration (FDA), and the European Medicines Agency (EMA).

Findings from this initiative will support informed decision-making particularly regarding the magnitude of safety concerns in the use of proposed treatments for COVID-19.

Given the current COVID-19 pandemic, pharmacovigilance activities in the Americas have gained relevance for the success of health initiatives. This initiative includes monitoring the safety of all therapeutic interventions endorsed by health systems to face the pandemic, monitoring unwanted outcomes in patients with a confirmed or suspected diagnosis of COVID-19 treated in each country. The study will be completed in the next months.