May 6, 2020

REMS Changes Due to the COVID-19 Pandemic

By Wendy H. Vogel, MSN, FNP, AOCNP®

Risk Evaluation and Mitigation Strategies (REMS) are required by the U.S. Food & Drug Administration (FDA) for select drugs that require certain elements or procedures to assure safe use. This process is to ensure that the benefits of a drug or biologic agent outweigh its risks (FDA, 2020a). Some elements may fall to the sponsor (manufacturer) of the drug product, some to the prescriber, some to the pharmacist, or some may even fall to the patient (Vogel & Haas, 2011).

As of April 17, 2020, there are 58 drugs or biologics on this list. The elements of the REMS could include a medication guide, a patient package insert, a communication plan for health-care providers, certain packaging, and safe disposal methods. An Elements to Assure Safe Use (ETASU) implementation system may also be required. An ETASU often involves laboratory or imaging tests. Currently, there are 50 that require an ETASU.

Table 1 lists the element that may be included in an ETASU. The ETASU may require an implementation system to monitor, evaluate, and improve the process of performing these elements. Many of these are utilized in oncology and hematology and are familiar to oncology advanced practitioners (APs).

New REMS Guidance

On March 22, 2020, in response to the COVID-19 pandemic, the FDA published guidelines for health-care prescribing or dispensing drugs with an ETASU (FDA, 2020b). As with other FDA guidance documents, this guideline does not establish legally enforceable responsibilities and should be viewed as recommendations, unless “specific regulatory or statutory requirements are cited” (FDA, 2020b).

These guidelines were developed due the number of queries to the FDA regarding the impact of these requirements on patient access to drugs or biologics with certain REMS during a time when patients are instructed to self-isolate or are subject to quarantine (FDA, 2020b). The FDA recognized that during the COVID-19 pandemic, laboratory or imaging studies could be detrimental to the patient or to society due to the risk of transmission of the coronavirus. For drugs with laboratory or imaging requirements, health-care providers prescribing or dispensing these drugs must consider whether there are “compelling reasons” not to complete these tests or studies during this public health emergency. The provider should use their best medical judgement regarding continuation of treatment if these laboratory tests and imaging studies cannot be obtained. It is important to note that any accommodations made to the ETASU must be made by a health-care professional.

All REMS requirements will remain in effect. However, the FDA does not intend to take enforcement action against the drug sponsor or others due to any accommodations made regarding laboratory or imaging tests (FDA, 2020b). They will require sponsors to document accommodations and to summarize these in their next REMS Assessment Report.

Drug Sponsor Actions

Certain drug sponsors have taken further action to support patients during the COVID-19 pandemic. In March 2020, Bristol Myers Squibb (BMS), the makers of Revlimid (lenalidomide), Thalomid (thalidomide), and Pomalyst (pomalidomide) modified prescription quantity limits for these agents (Celgene, 2020a, 2020b, 2020c). These quantity increases only apply to adult males, male children, or adult females not of reproductive potential (female children and adult females of reproductive potential will still be limited to a maximum supply of 28 days).

Prescribers may now prescribe a maximum of a 56-day supply for appropriate patients (previously maximum supply was for 28 days). The accurate quantity should be noted on the prescription. Patients will still be required to complete the educational patient survey every 28 days. Pharmacies may dispense up to a 56-day supply for patients who have been authorized by their health-care provider.

BMS also noted that patients who require routine pregnancy tests under their drug REMS could use home (over-the-counter) pregnancy tests as long as the test has a sensitivity of at least 50 mlU/mL and the prescriber agrees. Prescribers are to use their best discretion on how to verify these results. It is important to note that pregnancy testing is still required during this time and at the same frequency (every 28 days). All of the changes noted above are effective until May 15, 2020, but could be subject to change. Any questions regarding this should be directed to REMS customer care at 1-888-423-5436.

The Oncology Advanced Practitioner Role

The oncology AP must be knowledgeable and vigilant about the REMS of any drug or biologic agent prescribed. Furthermore, APs are well poised to educate other members of the health-care team and patients regarding current changes. During the COVID-19 pandemic, accommodations of REMS may be acceptable. Thorough evaluation and documentation of each patient’s risk and their clinical situation is required. The oncology AP should make their best medical judgement concerning continuation of certain treatments if REMS-required clinical testing cannot be obtained.

References

Celgene. (2020a). Pomalyst REMS. Retrieved from http://www.pomalystrems.com/

Celgene. (2020b). Thalomid REMS. Retrieved from http://www.thalomidrems.com/

Celgene. (2020c). Revlimid REMS. Retrieved from http://www.revlimidrems.com/

U.S. Food & Drug Administration. (2020a). Approved Risk Evaluation and Mitigation Strategies (REMS). Retrieved from https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm

U.S. Food & Drug Administration. (2020b). Policy for Certain REMS Requirement During the COVID-19 Public Health Emergency: Guidance for Industry and Health Care professionals. Retrieved from https://www.fda.gov/media/136317/download

Vogel, W. & Haas, M. (2011). REMS: Application for the Advanced Practitioner in Oncology. Journal of the Advanced Practitioner in Oncology, 2 (1), 51–57. https://doi.org/10.6004/jadpro.2011.2.1.7

Read more from the  APSHO Advance: Special COVID-19 Series