7 REMS and Restricted Drug Programs Free Online FlashCards

What is a REMS?

A Risk Evaluation and Mitigation Strategy is an FDA-required safety program for a particular drug when additional measures are needed to ensure its benefits outweigh its risks.

Does every REMS restrict drug distribution?

No. Some REMS require only communication or patient materials; others impose conditions on prescribing, distribution, or dispensing.

How is a REMS distinct from a DEA controlled-substance schedule?

A REMS is distinct from a drug’s DEA controlled-substance schedule. A medication may be subject to one, both, or neither.

What are Elements to Assure Safe Use (ETASU)?

Elements to Assure Safe Use are REMS measures that may require steps such as prescriber or pharmacy certification, patient enrollment, testing, monitoring, or registry participation.

What tasks might a REMS assign to prescribers?

Depending on the program, prescribers may need to enroll or certify, train, assess and counsel the patient, order tests or monitoring, and enroll the patient.

Why should a pharmacy check each program’s certification requirements?

Certification is program-specific. Check the current FDA REMS document and official program materials rather than assuming requirements are the same across programs.

What should staff do first when checking a drug’s REMS requirements?

Confirm the drug and formulation, then consult the current REMS requirements. Familiarity with a medication or prior dispensing does not establish that no REMS steps apply.

What should staff confirm about REMS authorization before dispensing?

Follow the program’s specified method and confirm the authorization applies to this patient and prescription. If a required condition cannot be verified, pause dispensing and resolve the gap.

What responsibilities might a REMS assign to a pharmacy?

A pharmacy may need certification and staff training, and may have to verify program conditions, obtain dispensing authorization, and provide required counseling or materials.

What might a REMS require of patients?

Patients may need to enroll or acknowledge program materials, follow treatment and monitoring instructions, and complete required tests or follow-up.

What might a REMS administrator do?

The manufacturer or REMS administrator may operate program tools, including enrollment systems or authorization services, and communicate program requirements.

What eligibility checks should precede REMS dispensing?

Verify that the dispensing pharmacy or setting is certified and that required staff training is complete and current.