Which FDA reporting system collects adverse event reports, medication error reports, and product quality complaints?

Which FDA reporting system collects adverse event reports, medication error reports, and product quality complaints?

• A. FAERS
• B. MedWatch
• C. MedSun
• D. Sentinel

Answer: (A)

FAERS, the FDA Adverse Event Reporting System, is the centralized database that collects safety reports about drugs and biologics, including adverse events, medication error reports, and product quality complaints. Reports can come from healthcare professionals, manufacturers, and consumers, and FAERS data support FDA in detecting new safety signals and guiding actions like labeling changes or safety warnings. MedWatch is the FDA program for safety information and voluntary reports in general, MedSun focuses on medical devices, and Sentinel is an active surveillance system using electronic health data to monitor safety. The combination of adverse events, medication errors, and product quality complaints specifically aligns with FAERS.

FAERS, the FDA Adverse Event Reporting System, is the centralized database that collects safety reports about drugs and biologics, including adverse events, medication error reports, and product quality complaints. Reports can come from healthcare professionals, manufacturers, and consumers, and FAERS data support FDA in detecting new safety signals and guiding actions like labeling changes or safety warnings.

MedWatch is the FDA program for safety information and voluntary reports in general, MedSun focuses on medical devices, and Sentinel is an active surveillance system using electronic health data to monitor safety. The combination of adverse events, medication errors, and product quality complaints specifically aligns with FAERS.