Risk Evaluation and Mitigation Strategies

Risk Evaluation and Mitigation Strategies

(REMS)

Vasiliki Beleri MS4

What is REMS?

The Risk Evaluation and Mitigation Strategies (REMS) program is a vital part of the Monitoring stage of the medication use process.

The purpose of REMS is to have a system focused on preventing, monitoring, and managing specific serious risks of certain medications by education and reinforcement of actions to reduce frequency and/or severity of the event. Although the FDA determines which medications require a REMS, it is the responsibility of the medication's manufacturer to develop and implement the program.

https://www.opioidanalgesicrems.com/home.html

What is REMS?

Each REMS includes a specific risk mitigation goal and may require healthcare providers, pharmacists, and patients to follow certain procedures to ensure safe medication use. This can include education, certification, or documentation of safe use conditions, such as lab tests. REMS may also require drug manufacturers to develop educational materials, such as Medication Guides, to help ensure the safe use of a drug and prevent serious adverse events. The requirements of each REMS vary based on the medication, its risks, and its intended use setting. In many cases, multiple safeguards are combined to achieve the REMS goal, ensuring patient safety while maintaining access to necessary medications.

https://www.uspharmacist.com/article/the-impact-of-rems-on-pain-management

REMS Participants

https://www.fda.gov/drugs/risk-evaluation-and-mitigation-strategies-rems/roles-different-participants-rems

REMS in Reality:

A Closer Look at Clozapine

Pharmacies must be certified in the Clozapine REMS to receive and dispense clozapine.

To receive treatment, a patient must be enrolled in the Clozapine REMS program by a certified doctor.

Healthcare Providers must be certified in the Clozapine REMS to prescribe clozapine for outpatient use.

In Summary

REMS is an important part of ensuring the safety of certain high-risk medications. By implementing REMS, the FDA can work with manufacturers to keep these drugs on the market and to minimize patient harm.

We examined the roles of key players in the REMS process. The intersection of physician prescribing, responsible dispensing, and patient education provide checks and balances to keep patient safety at the forefront.

Through the clozapine case study, we examined how a physician could interact with REMS. The burden of REMS can be significant but is appropriate when the benefits of a medication need to outweigh the risks.

Sources

• https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems
• https://www.fda.gov/drugs/risk-evaluation-and-mitigation-strategies-rems/whats-rems
• https://www.fda.gov/drugs/risk-evaluation-and-mitigation-strategies-rems/roles-different-participants-rems
• https://www.fda.gov/drugs/risk-evaluation-and-mitigation-strategies-rems/frequently-asked-questions-faqs-about-rems
• https://www.newclozapinerems.com/home#

Patients

Patients play a crucial role in REMS by following specific requirements to ensure the safe use of their medication. Depending on the REMS, patients may receive counseling on serious risks, be required to sign acknowledgment forms, undergo lab testing, or enroll in a registry for monitoring. Certain REMS medications may only be available through specific pharmacies, and patients may need to plan ahead for refills and required tests.Additionally, patients may be asked to provide feedback through surveys to help assess the REMS’ effectiveness. Overall, REMS help ensure patients have access to medications with serious risks while maintaining necessary safety measures.

Prescribers

Health care providers play a crucial role in ensuring the safe use of medications requiring REMS. The specific requirements for providers vary but may include receiving communications, enrolling in programs, completing training, documenting patient counseling, monitoring, and ensuring compliance with safe use conditions. Some REMS also require patient enrollment to track medication use, laboratory results, and potential adverse events. Providers may also need to follow restrictions on prescription refills and dispensing limits to ensure patient safety. Detailed requirements are available through REMS@FDA, product labeling, or REMS-specific websites.

FDA

The FDA can require a Risk Evaluation and Mitigation Strategy (REMS) for prescription drugs, biologics, and certain generic medications if it determines that additional safety measures are needed to ensure the benefits outweigh the risks. REMS do not apply to over-the-counter medications. Without a REMS, some medications would not be approved or would be withdrawn from the market due to serious known or potential risks. The FDA assesses the need for a REMS by evaluating whether a medication has specific risks that outweigh its benefits and whether additional safety measures beyond standard labeling are necessary.

Pharmacy

Pharmacists play a vital role in REMS by ensuring medications with serious risks are dispensed safely. Their responsibilities vary by REMS and pharmacy setting but may include completing training, verifying safe use conditions, counseling patients, and providing educational materials. Some REMS require pharmacies to be certified, which involves an authorized representative completing training and overseeing compliance. Pharmacists may also need to verify that patients and healthcare providers are enrolled in REMS programs before dispensing medication. Certain REMS medications have restrictions on dispensing, such as limits on refills or supply quantities.

Monitoring Guidelines

During the first six months of treatment:

• Weekly ANC monitoring is required for all patients

During the second six months of treatment:

• Monitoring frequency can be reduced to every two weeks if the ANC remains in the normal range.

After one year of treatment:

• If the patient’s ANC continues to remain in the normal range, ANC monitoring may be reduced to monthly (every 4 weeks) thereafter.