FEDERAL REQUIREMENTS — REMS, Recalls & Reporting

REMS

Risk Evaluation and Mitigation Strategies.

Purpose of REMS

Risk-management program involving the FDA and drug manufacturers for medications requiring additional safety measures.

Example of medication requiring REMS

Thalidomide.

Who may issue a drug recall?

FDA.

Recalled medication storage

Isolate recalled medications from active stock.

MedWatch

Safety reporting program.

FAERS

FDA Adverse Event Reporting System.

VAERS

Vaccine Adverse Event Reporting System.

MERP

Medication Error Reporting Program.

Purpose of safety reporting programs

Report, alert, or track errors/adverse events to help prevent future occurrences.