Your Patient Has an Adverse Reaction to a Drug: How to Report to FDA's MedWatch

This article is the first in a series of activities in collaboration with the Food and Drug Administration (FDA) and Medscape Education on how to report safety issues to the FDA and how these reports are used to ensure safe use of drugs and medical products.

Healthcare professionals must remain knowledgeable and vigilant about the latest drug and device safety issues and other adverse events that may affect patient health outcomes. Physicians, physician assistants, advanced practice nurses, nurses, pharmacists, and other providers often are the first to identify and witness the negative effects of drug-drug interactions, drug use errors, malfunctions and flaws in medical devices, or other adverse events.

Documenting these types of problems is critical to the safety of patients and clinical practice. The healthcare professional must disseminate these findings to help inform the medical and public health communities and the general public of these potential serious adverse events or issues associated with a medication or medical product.

The US Food and Drug Administration (FDA) established MedWatch, the FDA Safety Information and Adverse Event Reporting Program, to assist healthcare providers and the general public in notifying the agency of adverse events or medical product errors.

To learn more about the MedWatch program and the types of safety information to report through the system,Medscape Education recently interviewed Anna M. Fine, PharmD, MS, director of the Health Professional Liaison Program, Office of Special Health Issues. Dr. Fine oversees the MedWatch educational outreach program. Read More