Pharmacovigilance System in the USA

A multifaceted approach was developed by the Food and Drug Act (FDA) in the USA pharmacovigilance (PV) system, making it robust and well-established with technological advancements. The combined effort of all stakeholders to report and keep track of adverse events assist in effective post-marketing surveillance (PMS) at the national and international level. The PMS program further enables the identification of causal links between medications and adverse events. In this chapter, we have outlined the regulations and database maintenance approaches in the PV system of the USA and how this database helps promote safe drug use in public health benefits. Different databases like FAERS (FDA Adverse Event Report System), VAERS (The Vaccine Adverse Event Reporting System), and MAUDE (Manufacturer and User Facility Device Experience for Medical Devices) form the post-marketing system. The crucial role of the aggregate reporting process in the USA-PV system has been addressed which ensures the safety of pharmaceuticals and abides by the standards set by the FDA to maintain the legality of drug marketing. Data mining is an essential tool in aggregate reporting. Identifying safety risk factors, advantages, challenges, and future directions for advancement in the system’s database management is discussed. A wider range of scientific spectrum and new data science technologies might be integrated to establish big data laboratories. Creating novel strategies for using electronic health records, and developing an innovative scientific community is coming up to figure out how to take advantage of the system’s core capabilities beyond medication safety.