Sometimes the instructions on drug labels are not enough to ensure that patients and prescribers use a medicine safely. In these cases, the Food and Drug Administration (FDA) has the power to require a REMS.
All medicines come with a certain level of risk. This is why all prescription drugs include information reviewed and approved by the FDA about how the medication works in the body, its uses and when it should not be used, possible side effects, the recommended dosage, and other facts about the appropriate use of the drug.
What exactly are REMS and how do they impact patients?
Authorized by Congress, REMS are safety restrictions that the FDA requires of drug manufacturers to ensure that the benefits of a needed medicine outweigh the drug’s risks.
REMS programs exist because certain medicines can cause serious side effects, life-threatening infections, allergic reactions, liver damage or birth defects. Before patients take one of these drugs, they and their prescriber should be aware of the risks, and may need to take certain steps that lessen these risks.
REMS make patient safety paramount by ensuring that medicines with serious risks are appropriately prescribed, appropriately dispensed by pharmacists, and taken correctly by patients. Similar to a flight checklist that a pilot completes before each journey, a REMS is a set of safety tools and procedures for prescribers, patients, and pharmacists.
FDA’S DEFINITION OF REMS
“REMS are required risk management plans that use risk minimization strategies beyond the professional labeling to ensure that the benefits of prescription drugs outweigh their risks”
Each REMS program has specific safety measures unique to the risks associated with a particular drug or class of drugs. As a result, no two REMS programs are exactly alike.
What is included in a REMS?
Depending on the specific medicine and the severity of the safety risks, FDA can require the manufacturer to take a number of specific actions – from providing educational patient information to implementing safeguards designed to control how the medicine is prescribed, dispensed, and taken by patients.
Specific REMS measures FDA may require of the manufacturer are:
- Distributing with each prescription a Medication Guidethat contains FDA-approved information specifically for patients. The medication guide explains the risks of the REMS drug and how to take it safely
- Designing and implementing a detailed Communication Planthat informs prescribers and other health professionals about the drug’s risks and how to counsel patients to use it safely
- Strict safety measures called “Elements to Assure Safe Use”required when FDA determines that controls, such as requiring pharmacies and prescribing physicians to be certified, are needed to use the medicine safely
Who is responsible for developing a REMS program?
Although FDA makes the decision to require a REMS, it is the responsibility of the drug manufacturer to develop and implement the REMS. FDA requires that a proposed REMS program contain:
- The goals of the REMS program
- The detailed components that will be developed to ensure the drug is prescribed, dispensed and used safely and appropriately
The steps the manufacturer will take to evaluate whether the REMS is meetings its goals at various points in time