Federal RequirementsQuestion 49 of 100
Which statement best describes a Risk Evaluation and Mitigation Strategy (REMS)?
a.A DEA program that limits how much of a controlled substance a pharmacy may order each month
b.An FDA-required safety program that may mandate prescriber certification, patient enrollment, pharmacy certification, or laboratory monitoring before a drug is dispensed
c.A USP standard that sets beyond-use dates for compounded preparations
d.A manufacturer's voluntary coupon program that lowers patient copays for specialty drugs
Explanation
A REMS is imposed by the FDA when a drug's serious safety risks require controls beyond standard labeling, and its elements can include certifying prescribers and pharmacies, enrolling patients in a registry, and documenting laboratory results before dispensing. Familiar examples are iPLEDGE for isotretinoin, absolute neutrophil count monitoring for clozapine, and the restricted program for thalidomide. Ordering quotas are a DEA function, beyond-use dating is set by USP compounding standards, and copay assistance has no regulatory safety role.
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