The rapid spread of COVID-19 has posed an unprecedented challenge to healthcare providers and the public health community. The COVID-19 pandemic has an immense societal impact and has called for an all-out public health response. There is an urgent need for rapid data collection and dissemination of medical information associated with COVID-19 to the medical and public health community, including treatments to combat the disease.
Treatment for COVID-19 has included both the new use of established medications and the emergence of novel therapeutics. The advancing knowledge of COVID-19 mechanisms has led to a rapid pace of evolving treatment methods with very little prior scientific evidence or proven dosing regimens. The risk of increased adverse drug events (ADEs) is evident, and there is a need for enhanced monitoring.
The Toxicology Investigators Consortium (ToxIC) is a multicenter medical toxicology surveillance and research network. With sites across the United States, in every federal region, ToxIC is well-positioned to support enhanced surveillance in diverse populations. Safety surveillance of adverse events specific for drugs and substances associated with the treatment of patients with COVID-19 is consistent with FDA’s mission of ensuring drug safety throughout the drug lifecycle. The FDA ACMT COVID-19 ToxIC (FACT) Pharmacovigilance Project Sub-registry will provide a mechanism for enhanced collection of safety data related to drug therapies used in patients treated for COVID-19.