Pharmacists Play Key Role in Risk Evaluation and Mitigation Strategies

A presentation at the ASHP 54th Midyear Clinical Meeting and Exhibition in Las Vegas, Nevada, touched on how pharmacists can help manage risk evaluation and mitigation strategies (REMS).

A presentation at the ASHP (American Society of Health-System Pharmacists) 54th Midyear Clinical Meeting & Exhibition in Las Vegas, touched on how pharmacists can help manage risk evaluation and mitigation strategies (REMS).

In the presentation titled “New Drug Approvals With REMS: the Pharmacist’s Role in Supporting Safe Use,” 2 FDA analysts, Selena Ready, PharmD, and Somya Dunn, MD, discussed the role of REMS in new drug approvals and post-marketing safety, the safety concerns that required a REMS for certain new drug approvals, and resources for practitioners to use products safely.

Ready, commander in the US Public Health Service and a risk management analyst at the FDA, first went over the basics of REMS, saying that the agency’s label is the official description of the drug product.

“If we determine that labeling can’t mitigate a safety issue, we require a REMS,” she said. “The communication plan is not intended for patients but health care providers.”

REMS programs can be designed for a specific drug or a drug class, Ready said, adding that they are unique. “If you’ve seen 1 REMS, you’ve seen 1 REMS, she said.

A REMS must include a timetable for submission of assessments and can have several features, including elements to assure safe use (ETASU). These may include that prescribers have special certifications or specific experience or training, that pharmacists or other dispensers be specially certified, and that the drug can be dispensed only in certain health care settings.

Ready and Dunn discussed 3 new drug approvals with REMS.

The first, brexanolone (Zulresso), is the first FDA-approved treatment for postpartum depression. The safety concern for Zulresso that resulted in a REMS is the risk of excessive sedation or sudden loss of consciousness during infusion. The REMS goals for Zulresso include that it must be administered only to patients in a medically supervised setting that provides monitoring while the drug is administered, ensuring that health care settings and pharmacies that dispense it are certified, ensuring that patients are informed of the risk of excessive sedation and loss of consciousness, and need for monitoring while it is administered. Pharmacies must verify that the health care setting is certified prior to dispensing and not distribute, transfer, loan, or sell Zulresso.

The role of the pharmacist includes serving as the authorized representative for REMS enrollment, training staff members about REMS requirements and setting up policies and procedures to ensure safe use, and ensuring that the health care setting submits a post-infusion form documenting the outcome of the infusion, as well as a separate adverse event form, if excessive sedation or loss of consciousness occur.

The second drug approval is buprenorphine extended-release injection (Sublocade), which is intended to treat moderate to severe opioid use disorder. The safety concern for Sublocade that resulted in a REMS is the risk of death or serious harm that could result if the drug is self-administered intravenously. The REMS goal is to ensure that health care settings and pharmacies are certified and only dispense Sublocade directly to a health care provider for administration by a health care provider. Health care settings and pharmacies must complete, sign, and submit an enrollment form to the REMS program, train all relevant staff members about REMS requirements, verify that Sublocade is dispensed directly to a health care provider, and notify health care providers that Sublocade must not be dispensed directly to patients.

The role of the pharmacist includes serving as the authorized representative for REMS enrollment, training staff members about REMS requirements and setting up policies and procedures to ensure safe use.

The third drug approval, esketamine nasal spray (Spravato), is used in conjunction with an oral antidepressant to treat treatment-resistant depression in adults. The risks for Spravato that led to REMS that were observed in clinical trials were dissociation, increased blood pressure, and sedation. Safety concerns reported post-marketing were abuse and misuse, liver function and long-term cognitive impairment, and interstitial or ulcerative cystitis. The REMS goals included ensuring that Spravato is only dispensed and administered to patients in a medically supervised health care setting that monitors these patients. Health care setting requirements include completing, signing, and submitting the health care setting enrollment form to the REMS program, as well as having a prescriber during administration and for monitoring. Patient requirements include enrolling in the patient registry by completing the enrollment form with a health care provider and receiving counseling about the risks. Pharmacy requirements include completing, signing, and submitting the pharmacy enrollment form to the REMS program.

The role of the pharmacist includes serving as the authorized representative for REMS enrollment, training staff members about REMS requirements and setting up policies and procedures to ensure safe use, and ensuring that the health care setting submits a patient-monitoring form documenting the outcome of the dose, as well as a separate adverse event form, if excessive sedation or loss of consciousness occur.

REFERENCE

Ready S, Dunn S. New drug approvals with REMS: the pharmacist’s role in supporting safe use. Presented at: American Society of Health-System Pharmacists 54th Midyear Clinical Meeting and Exhibition; Las Vegas, Nevada: December 9, 2019.