Guiding axes for drug safety management of pharmacovigilance centres during the COVID-19 era

The COVID-19 pandemic presents several challenges to the organisation and workflow of pharmacovigilance centres as a result of the massive increase in reports, the need for quick detection, processing and reporting of safety issues and the management of these within the context of lack of complete information on the disease. Pharmacovigilance centres permanently monitor the safety profile of medicines, ensuring risk management to evaluate the benefit-risk relationship. However, traditional pharmacovigilance approaches of spontaneous reporting, are not suitable in the context of a pandemic; the scientific community and regulators need information on a near real-time point. The aim of this commentary is to suggest six interrelated multidimensional guiding axes for drug safety management by pharmacovigilance centres during the COVID-19 pandemic. This working plan can increase knowledge on COVID-19 and associated therapeutic approaches, support decisions by the regulatory authorities, oppose fake news and promote more efficient public health protection.

Automated summary

During the COVID-19 pandemic, pharmacovigilance centres face challenges due to increased reports, the need for quick safety issue detection and the lack of complete disease information. This commentary suggests six interrelated guiding axes to improve drug safety management, increase knowledge on COVID-19, support regulatory decisions, combat fake news, and enhance public health protection.