CSP REMS Programs and Risk Mitigation Strategies 3

Question 1

What is the primary consequence for a specialty pharmacy that dispenses a REMS-required medication without complying with REMS requirements?

Accepted Answer

The pharmacy may face FDA enforcement action, including warning letters, injunctions, or civil monetary penalties

Answer

The pharmacy must only notify the prescriber of the non-compliance

Answer

The pharmacy must issue a voluntary recall of the dispensed medication

Answer

The pharmacy is automatically removed from the manufacturer's preferred network

Question 2

When a new REMS element is added to an existing REMS program, how should a specialty pharmacy respond?

Accepted Answer

Update internal SOPs and staff training to reflect the new requirements before continuing to dispense

Answer

Continue dispensing under the original REMS terms until the next contract renewal

Answer

Wait for the manufacturer to update the pharmacy's certification automatically

Answer

Notify patients but continue dispensing under the prior protocol

Question 3

A specialty pharmacist is reviewing a prescription for lenalidomide (Revlimid). What REMS program governs its dispensing?

Accepted Answer

REVLIMID REMS (formerly RevAssist)

Answer

LEN-SAFE program

Answer

LENALID REMS Access

Answer

IMiDs REMS Consortium

Question 4

Under iPLEDGE, how many forms of contraception must females of childbearing potential who are not abstinent use while taking isotretinoin?

Accepted Answer

Two forms of contraception simultaneously

Answer

One form of contraception

Answer

Three forms of contraception

Answer

Contraception is recommended but not mandatory for females

Question 5

What is a key pharmacist responsibility related to REMS documentation in a specialty pharmacy setting?

Accepted Answer

Maintaining records of REMS-required patient counseling, monitoring data, and dispense confirmations for FDA audit purposes

Answer

Submitting individual prescription data to the FDA within 24 hours of each dispense

Answer

Reporting all REMS-covered prescriptions to the DEA regardless of controlled substance status

Answer

Providing written attestation to the manufacturer after each patient's first fill only

Question 6

Which term describes a REMS requirement that restricts dispensing to only specially certified pharmacies?

Accepted Answer

Restricted distribution system

Answer

Closed formulary network

Answer

Preferred pharmacy arrangement

Answer

Limited access dispensing protocol

Question 7

A patient calls the specialty pharmacy saying they cannot afford the required pregnancy test before their next REMS medication refill. What is the pharmacist's most appropriate response?

Accepted Answer

Assist the patient in finding low-cost or free testing resources and explain the prescription cannot be dispensed without a confirmed negative test

Answer

Dispense a 7-day bridge supply until the patient can obtain the test

Answer

Accept the patient's verbal confirmation that she is not pregnant and dispense the medication

Answer

Contact the prescriber to request a waiver of the pregnancy testing requirement