Table 1 REMS Program Overview
Goal | Stakeholders | REMS Intervention | Process Assessment | Outcome Assessment |
|---|---|---|---|---|
▪ Drug safety risk assessment and mitigation | ▪ FDA: regulatory requirements and guidance ▪ Pharmaceutical manufacturers: implementation and assessment requirements ▪ Health care settings/providers: adoption and risk mitigation delivery ▪ Patient/caregiver: program recipient | Intervention strategies, as specified by FDA REMS authority: ▪ Medication Guide (patient communication) ▪ Communication Plan (health care provider communication) ▪ Elements to Assure Safe Use • Certification or specialized training, prescriber • Certification or specialized training, pharmacy or other dispensing setting • Dispensing/drug administration requirement, limited settings • Dispensing/drug administration requirement, evidence of safe-use conditions being met • Patient, monitoring requirement • Patient, registry enrollment | REMS participation assessment category, as defined by FDA draft Guidance to Industry: ▪ Program Outreach and Communication ▪ Program Implementation and Operations | REMS outcome assessment category, as defined by FDA draft Guidance to Industry: ▪ Knowledge ▪ Safe Use Behavior ▪ Health Outcomes and/or Surrogate Health Outcomes Other impact considerations: ▪ Burden on the health care delivery system ▪ Barriers to patient access |