A REMS can require prescriber certification, pharmacy enrolment, patient registries or laboratory monitoring. Dispensing outside the REMS is both a compliance failure and, usually, unreimbursable.
Risk Evaluation and Mitigation Strategy — a required safety program for drugs with serious risks.
A REMS can require prescriber certification, pharmacy enrolment, patient registries or laboratory monitoring. Dispensing outside the REMS is both a compliance failure and, usually, unreimbursable.