Drug classes with REMS in effect include corticosteroids, monoclonal antibodies, tumor necrosis factor–a antagonists, and certain vaccines. A variety of opioid products will likely have a REMS associated with them, including morphine, methadone, fentanyl, and oxycodone, according to the FDA.
What’s in a REMS?
On a practical level for patients, physicians, and pharmacists, a REMS for a specific drug includes a medication guide (usually six or eight pages long) and a patient package insert, as well as more detailed safety information about the drug available via the Internet. However, a drug may also be required to have a communication plan, which includes sending letters to healthcare providers and sharing information via professional societies regarding any serious drug risks and protocols to ensure safe use.
Drugs that are deemed necessary to have a REMS before they are approved will have to make the extra research part of the approval process, says Lynn M. Fallon, president of CTI Clinical Trials and Consulting Services in Warminster, Pa. Those manufacturers will want to meet early and often with FDA officials to plan out their REMS, she says.
Penalties range from $250,000 to $1 million per violation when a manufacturer does not submit a requested REMS within 180 days, for a possible total of $10 million for all violations.
Drugs with a REMS must undergo 18-month, three-year, and seven-year assessments, says Fallon. The assessments will take place with information from databases or registries that manufacturers can use to monitor and evaluate safe use of the drug. Some drugs may require more frequent assessments; others may no longer require a REMS after three years if the safety concerns are resolved. However, if the safety concerns continue or a manufacturer is unable to demonstrate that the REMS is effective, they may need to periodically revise, add, or remove information in the REMS.
- Postmarket Drug Safety Information for Patients and Providers: www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/default.htm
- List of Drugs with Approved REMS: www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm
Implications for Patients, Physicians
REMS has the “positive or negative” effect of creating more information for patients on the drugs they are using, Fallon says. “Some patients want all of that information. Other patients want their doctors to tell them what to do.” In specialties such as oncology, for example, patients may feel that the information given to them is too detailed and complicated, and they would rather their physician weigh the risks and make a treatment selection for them.