Risk Evaluation Mitigation Strategy (REMS) Program Requirements for Bispecific Antibodies

Opinion
Video

Anthony Perissinotti, PharmD, BCOP, provides an overview of the REMS program requirements for bispecific antibodies and describes the processes, procedures, and training programs implemented at his institution.

This is a video synopsis/summary of a Practice Pearls involving Ryan Haumschild, PharmD, MS, MBA; Matthew Pianko, MD; and Anthony Perissinotti, PharmD, BCOP.

The specialists discuss operational considerations for the U.S. Food and Drug Administration (FDA) required risk evaluation and mitigation strategies (REMS) programs associated with bispecific antibodies for relapsed/refractory multiple myeloma. At Perissinotti’s center, a pharmacy manager handles REMS program enrollment/documentation for the health system while physicians like Pianko must also complete their specific REMS requirements. Haumschild notes a best practice is having a pharmacist lead coordinate all providers’ REMS enrollment since coverage is needed if the primary prescriber is unavailable.

The REMS requires provider training on cytokine release syndrome/neurotoxicity risks and an enrollment form. Pharmacists must verify prescriber enrollment before every dispense and document it. Patients receive wallet cards about signs/symptoms requiring prompt attention. While rigorous, the REMS facilitates safe prescribing/dispensing of these novel immunotherapies, especially as community providers adopt them. Ongoing reattestation promotes continued competency.

Video synopsis is AI-generated and reviewed by Pharmacy Times® editorial staff.

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