Medication Error Definitions:
- Mild: enhanced monitoring, no harm
- Moderate: active treatment required, enhanced monitoring, but no lasting harm
- Severe: patient harm that requires enhanced treatment and increased patient stay
FDA’s Adverse Event Reporting System (FAERS):
- FAERS is a database that contains adverse event reports, medication error reports and product quality complaints resulting in adverse events that were submitted to FDA. The database is designed to support the FDA’s post-marketing safety surveillance program for drug and therapeutic biologic products.
- Healthcare professionals, consumers, and manufacturers submit reports to FAERS.
- FDA receives voluntary reports directly from healthcare professionals (such as physicians, pharmacists, nurses and others) and consumers (such as patients, family members, lawyers and others).
- Healthcare professionals and consumers may also report to the products’ manufacturers. If a manufacturer receives a report from a healthcare professional or consumer, it is required to send the report to FDA as specified by regulations.
- Reports are submitted via MedWatch (an FDA website).
- Facilities, distributors, importers, applicants, and manufacturers submit a different, mandatory report then consumers and healthcare professionals.