How Does it Work?

How do REMS Work?

All medicines carry some risk. This is why prescription drug information sheets include warnings and possible side effects.  This information is approved by the Food and Drug Administration (FDA) and is updated as new information becomes available.  Most prescription drugs are safe enough that this information is all that is needed to use the drug safely.

However, some drugs have risks that require added measures to assure safe use. For these medicines, the FDA requires the manufacturer to take safety measures beyond the prescribing information and develop a Risk Evaluation and Mitigation Strategy (REMS).  The REMS is a set of specific safeguards to combat the drug’s known risks.

When are REMS needed?

Most prescription medicines do not need a REMS. FDA has the power to require a REMS when FDA deems it necessary to protect patients from serious risks. This decision can take place:

When deciding if a REMS is necessary, FDA considers the benefits and risks of the drug and how it will be used, including:

  • The number of patients likely to take the medicine
  • The seriousness of the disease the drug treats
  • The expected benefits of the drug
  • How long a patient uses the drug (duration)
  • The seriousness of the side effects that can result from taking the medicine
  • Whether there are other treatment options available for the disease

What are the components of REMS?

Arming Patients with the Information to Prevent Serious Adverse Events

FDA may require the manufacturer to produce a Medication Guide, which is given to patients when they receive their prescription drug from the pharmacy.  The Medication Guide contains the most important information explained in plain language and gives directions on how to take the drug safely.

Educating Health Professionals on the Safe and Appropriate Use of REMS Drugs

FDA may require manufacturers to implement a Communication Plan so health professionals (pharmacists, physicians, nurses, etc.) will have detailed information on how to prescribe a REMS drug correctly and counsel patients on how to take the medicine appropriately.  Under a Communications Plan, the sponsor develops and FDA approves materials for patients and health care providers regarding the specific risks of the drug and how to use it safely.

Reducing a Serious Risk of Harm through Special Safeguards

In rare situations involving medicines with particularly serious risks, FDA may require stringent precautions called “Elements to Assure Safe Use” (ETASU) when a medication guide and/ or a communications plan is not sufficient to manage the risks.

Depending on the types of patients taking the medicine, the way the medication is used, the disease treated, and the potential risks of the drug, ETASU may include:

  • Special training for prescribers of the drug
  • Certifying the pharmacies and other health care settings that dispense the drug
  • Patient education and informed consent
  • Limiting use of the drug to hospitals or other health care settings
  • Requiring pregnancy testing or other laboratory test results before dispensing the drug to patients
  • Enrolling patients in a registry and monitoring their progress

For medicines with serious risks like birth defects, organ damage, and even death, ETASU can provide the extra level of protection needed to ensure these drugs are available and can be taken safely by patients who need them.