REMS Certification Comprehensive Nursing Paper Example

REMS Certification Comprehensive Nursing Paper Example

Clozapine REMS Program

The Clozapine REMS (Risk Evaluation and Mitigation Strategy) is a safety program needed by Food and Drug Administration (FDA) to control or manage severe neutropenia risks related to clozapine treatment. It ensures appropriate patient monitoring to manage clozapine-induced severe neutropenia. It offers a centralized system for providers and pharmacists to manage patient risk, regardless of which clozapine product they are using (Borrelli et al., 2020). The program’s primary motivation is to ensure the benefits of certain medications outweigh the risks. It offers education for prescribers and pharmacists regarding severe neutropenia risks and proper monitoring requirements. Patients under clozapine need routine weekly-to-monthly monitoring. Patient information required includes results for regular blood tests, especially white blood cell count and minimum absolute neutrophil count. Generally, they should provide patient information on results of ongoing monitoring, potential drug interactions, and adverse reactions. (REMS Certification Comprehensive Nursing Paper Example)

It is common for pharmacists to prescribe or dispense clozapine without the REMS dispense authorization or certification. Wholesalers do not have to confirm the REMS enrolment of prescribers, health care settings, or pharmacists before shipping clozapine. However, pharmacists that dispense clozapine should have the Clozapine REMS certificate. Out-patient pharmacists need Pre-Dispense Authorization (PDA) before dispensing clozapine (FDA, 2021). They also need to submit ANCs to the Clozapine REMS program and complete an eligibility check. Prescribers prescribing clozapine for inpatient purposes do not require the REMS certification if dispensing to patients enrolled in the program. They must enroll the patient in the Clozapine REMS program before giving them their first dose if the patient is initiated on clozapine in an inpatient setting (FDA, 2021). Pharmacists should use clinical judgment to decide whether the benefits of dispensing clozapine outweigh the risks, particularly when the patient has an ANC showing moderate or severe neutropenia while in the inpatient setting.(REMS Certification Comprehensive Nursing Paper Example)

References

Borrelli, E. P., Lee, E. Y., & Caffrey, A. R. (2020). Clozapine and hematologic adverse reactions: Impact of the Risk Evaluation and Mitigation Strategy program. The mental health clinician, 10(3), 70–75. https://doi.org/10.9740/mhc.2020.05.070 (REMS Certification Comprehensive Nursing Paper Example)

FDA. (2021, December 2). The FDA is temporarily exercising enforcement discretion regarding specific Clozapine REMS program requirements to ensure continuity of care for patients taking clozapine. https://www.fda.gov/drugs/drug-safety-and-availability/fda-temporarily-exercising-enforcement-discretion-respect-certain-clozapine-rems-program (REMS Certification Comprehensive Nursing Paper Example)

National Center for Biotechnology Information (nih.gov)