{
  "schema": "upg.factor.v1",
  "id": "ptce/safety/rems",
  "exam": [
    "PTCE"
  ],
  "confidence": 0.98,
  "updated_at": "2026-09-07",
  "token_cost_hint": 220,
  "integrity": "practice_only",
  "domain": "Patient Safety & Quality Assurance",
  "title": "REMS \u2014 Risk Evaluation and Mitigation Strategies",
  "claim": "A REMS is an FDA drug safety program required for certain medicines with serious safety concerns to help ensure benefits outweigh risks. REMS reinforce specific safe-use actions (education, monitoring, restricted distribution) beyond ordinary labeling \u2014 only a minority of drugs have one.",
  "plain": "REMS = extra FDA-required safety steps for a few high-risk drugs. Not every med has one. Follow the program\u2019s certification / monitoring rules when it applies.",
  "citations": [
    {
      "authority": "FDA \u2014 Risk Evaluation and Mitigation Strategies (REMS)",
      "url": "https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems",
      "pin": "FDA REMS overview",
      "retrieved_at": "2026-09-07",
      "quote": "A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks."
    }
  ],
  "html": "/factors/ptce/safety/rems",
  "json": "/factors/ptce/safety/rems.json"
}