REMS
The FDA requires Risk Evaluation and Mitigation Strategies (REMS) for certain available specialty drugs which entail stringent monitoring requirements. REMS often include risk management plans and strict guidelines for use and monitoring of these drugs. CoramRx utilizes its comprehensive policies, experienced clinical and pharmacy staff, and patient monitoring capabilities to ensure that REMS requirements are fully supported.
CoramRx is ideally positioned to assist manufacturers with their FDA requirements using the following strategy:
- Safe Access:
Controlled or limited distribution — specially pharmacy and/or specialty infusion provider -
Assure Safe Use:
Documentation of patient monitoring — nurse training technology to collect lab results and patient health measures -
Assessments and Monitoring:
Health management, patient registry, therapy compliance and adherence, integrated systems with pharmacy dispensing data -
Enhance Communications:
Pharmacist education/counseling — 24/7 clinical support nurse training, education, and clinical services
By continually working with the physician, patient, payor and manufacturer, CoramRx provides the framework to support the increased monitoring, compliant distribution and patient monitoring models required by REMS. As an additional add-on, we also provide our Primary Case Management Model to all patients. This model allows us to:
- Formulize unique patient care assessments including confirmation of drug and dose
- Proactively monitor possible drug interactions and side effects
- Create a plan for frequency of clinical and educational interactions for the patient
- Offer toll-free access to product information, multi-media learning tools, and educational material
FDA-Approved REMS
The FDA provides a list of approved REMS from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks.
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