What program is used for voluntary reporting of adverse drug reactions?

The program used for voluntary reporting of adverse drug reactions is the FDA Form 3500, commonly known as MedWatch. MedWatch serves as the Food and Drug Administration's (FDA) reporting system for practitioners and consumers to voluntarily report any adverse events, side effects, product quality problems, or therapeutic failures associated with medications or medical devices.

This program is crucial because it allows healthcare professionals and the public to provide the FDA with real-world data on the safety and efficacy of products, contributing to ongoing monitoring and assessment. The information collected through MedWatch is essential for the FDA to evaluate any potential risks related to drugs, leading to necessary actions such as labeling changes, product recalls, or additional safety studies.

The other options, while related to adverse event reporting, do not serve the same voluntary purpose in the context outlined in the question. For instance, the Adverse Event Report System typically refers to structured internal systems used by healthcare organizations rather than a voluntary reporting mechanism accessible to all. Similarly, Drug Event Notification and Pharmacovigilance Portal may not be specifically recognized nor widely utilized as a mechanism for individual voluntary reports to the FDA like MedWatch does.