FDA Is Making It Easier To Meet Required Extra Safety Measures for Certain FDA-Approved Drugs

By: Theresa Toigo, MBA, RPh

For some FDA-approved drugs specific safety steps must be taken before the patient can receive the medication.

Terry ToigoThese measures, which may involve the patient, health care providers and manufacturers, are part of an FDA-required program called a risk evaluation and mitigation strategy (REMS). They are specifically designed to help ensure that the benefits of a prescription drug outweigh its risks. As an example, if a drug has a known risk for causing birth defects, a REMS program might require that a patient be asked her pregnancy status before beginning that drug, information that the health care provider documents in her health record.

Each REMS program is unique and targets a specific risk or risks associated with a particular drug or drug class. Depending on the risk or risks involved, a REMS program could include a range of requirements such as providing a patient or healthcare professional with an information sheet, enrolling a patient in a registry prior to taking the drug, requiring special training for a prescriber, or requiring that a patient’s lab values be reviewed before he or she can be given the drug.

REMS requirements have raised concerns about clinical and administrative burdens placed on already busy healthcare professionals who express concerns that these requirements could delay a patient’s course of treatment. FDA is listening — and acting — on those concerns, specifically:

  • We revised our draft recommendations on the format and content of REMS documents. The revised REMS document template includes a section for each participant so they can more easily focus on their own specific program responsibilities;
  • We revamped the REMS@FDA website to prominently display this reorganized REMS document in an easily searchable way;
  • We integrated REMS into a Structured Product Labeling (SPL) format to facilitate making REMS information available within existing healthcare systems and workflows. SPL can be used to capture and present REMS information in a format that is easily shared with stakeholders and readily incorporated into health information technology.
  • We published a report highlighting some best practices for healthcare professionals when counseling patients about drugs that require a REMS. This will serve to ensure a collaborative and balanced conversation with the patient about both potential benefits and risks of the drug, reinforcing the patient’s role in mitigating these risks and helping them make more informed decisions.
  • Stakeholders also told us that use of continuing education credit (CE credit) for training under a REMS might make training more appealing to healthcare providers, so we conducted a feasibility assessment and issued a report discussing the findings, including potential scenarios for incorporation of CE into REMS programs.

These changes to REMS come as a result of our recently completed REMS Integration Initiative, a long-term project with the goal of standardizing these programs and better integrating them into the healthcare system. The project included meeting with a wide range of outside entities, including think-tanks and standards development organizations. We also held 3 public meetings, 5 workshops, and 15 listening sessions, and launched a pilot with 9 companies whose products require REMS programs. We wanted to include all stakeholder points of view with regard to how REMS programs can best be implemented.

The end of our REMS Integration Initiative does not mean an end to our efforts to improve REMS. FDA will continue our work to make REMS more responsive to stakeholder needs. The REMS Platform Standards Initiative is one example of a new project to continue improving REMS. As part of this initiative, this month FDA introduced a draft guidance on the REMS format and content (e.g., REMS template).

FDA will continue to make every effort to ease the burden of REMS requirements.  Our goal is to maintain patient access while still ensuring safe use of a drug.

Theresa Toigo, MBA, RPh, serves as associate director for Drug Safety Operations in the FDA’s Center for Drug Evaluation and Research

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