|Risk Evaluation and Mitigation Strategies: What do REMS Mean for You?|
The Food and Drug Administration (FDA), the government department in charge of regulating drugs and medications, has begun a new program in which the makers of certain cancer drugs, biologic agents, and supportive care therapies are required to complete analyses called Risk Evaluation and Mitigation Strategies (REMS). These programs are intended to assess the risks of side effects and other toxicities that are associated with particular drugs and biologic agents. These kinds of analyses were traditionally the responsibility of private sponsors and companies, but now the FDA can mandate (require) them.
REMS are issued by the FDA for drugs and biologic agents that the agency thinks need a plan to ensure that the benefits outweigh the risks for patients. This applies mainly to new drugs that companies are applying to the FDA to approve, but the FDA can also require REMS for already approved medicines. In these cases (both new and older drugs), companies are asked to create systematic plans that can be used both to educate patients and healthcare providers about the risks of particular medications and to simultaneously try to reduce those risks by adjusting dosages and how the drugs are given.
The specific strategy used will vary, but REMS may include a medication guide, a patient package insert, a communication plan, elements to assure safe use, and an implementation system. All REMS programs must contain a timetable for assessment.
REMS programs are important for patients to understand, because they could change the way you receive prescriptions and get them filled for some oncologic drugs. Due to tightening regulations, some medications may only be available at certain locations through certified doctors or health care providers. REMS may also require that you participate in educational programs, that you provide documents such as lab results to ensure that the medication is safe for you to use, that you enroll in a patient registry, and/or that you participate in monitoring during treatment.
NCCN is working to help patients who may be affected by REMS by providing an online page where drug manufacturers can place direct links to their specific REMS programs. These will contain educational information for clinicians to prescribe or dispense and for patients who need to receive the medicines. These links can help you if you are wondering what REMS will mean to you.
For a comprehensive list of FDA approved REMS, please visit: FDA Approved REMS.