What is the Clozapine REMS program?

What is the Clozapine REMS program?

The U.S. Food and Drug Administration (FDA) developed Risk Evaluation and Mitigation Strategy (REMS) programs that are intended to reinforce safe medication use and monitoring behaviors of medication with serious safety concerns (U.S. Food and Drug Administration, 2021). Clozapine is an antipsychotic medication associated with severe neutropenia, which requires regular monitoring to ensure safe management (Clozapine REMS, 2021).

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What patient information do you have to enter each week, two weeks, or monthly?

The baseline Absolute Neutrophil Count (ANC) is obtained. The ANC is then required to be obtained and reported weekly from initiation to six months, and if it stays in the normal range, it will be reported every two weeks from 6-12 months and then monthly after 12 months (Clozapine REMS, 2021). If the ANC value is out of the normal range, a recommended monitoring protocol is provided in the prescriber’s guide (Clozapine REMS, 2021).

Can you prescribe Clozapine without this certification?

Prescribers who prescribe Clozapine in the outpatient setting or initiate Clozapine in the inpatient setting must be certified (Clozapine REMS, 2021). If the patient is receiving inpatient medical care or other services for surgery, acute medical conditions, or injuries, the provider is not required to be certified (Clozapine REMS 2021).

References:

Clozapine REMS. (2021). Clozapine and the risk of neutropenia. https://cpmgstorageproduction.blob.core.windows.net/cpmg-public/cpmg-hpguide-clozapine-prescriber-guide%20v0_05%20clean.pdf?skoid=153f69fb-5a75-4401-8fda-28b1bd974fd0&sktid=59fc620e-de8c-4745-abcc-18182d1bf20e&skt=2022-03-17T16%3A32%3A05Z&ske=2022-03-23T16%3A37%3A05Z&sks=b&skv=2020-04-08&sv=2020-04-08&st=2021-08-10T13%3A51%3A35Z&se=2031-08-10T23%3A59%3A59Z&sr=b&sp=rc&sig=YIJQWbnSWXvgLVIN3oAWyBd1lQgMKY4YeAQfWL0kGVE%3D

U.S. Food and Drug Administration. (2021). Frequently asked questions, Clozapine REMS modification. Drugs. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/frequently-asked-questions-clozapine-rems-modification

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Student Response 2 

What is the Clozapine REMS program?

Clozapine (marketed under the brand names Clozaril, Fazaclo ODT, Versacloz, and generics) is an antipsychotic medication used to treat schizophrenia in patients whose symptoms do not respond to traditional antipsychotic medications (Center for Drug Evaluation and Research, 2021). Clozapine REMS was approved in September 2015 and is a \”shared-system\” program, which means it encompasses all clozapine medications licensed by the Food and Drug Administration (FDA) (FDA, 2021). The Clozapine REMS Program enables optimal patient monitoring and management of clozapine-induced severe neutropenia by offering a centralized method for prescribers and pharmacists to manage patient risk regardless of the clozapine product used. Prior to the Clozapine REMS Program\’s certification, individual clozapine manufacturers maintained their own patient registries.

Clozapine is also used to treat patients who have repeated suicidal conduct in the context of schizophrenia or schizoaffective disorder.  Clozapine, in particular, has been shown to reduce the number of neutrophils, a type of white blood cell that helps the body fight infection.

When neutrophils are considerably depleted, severe neutropenia occurs and the body becomes more susceptible to infection. As a result, patients on clozapine should have their absolute neutrophil count (ANC) checked on a frequent basis. This obligation for monitoring forms the cornerstone of the Clozapine Risk Evaluation and Mitigation Strategy (REMS) (Center for Drug Evaluation and Research, 2021).

What patient information do you have to enter each week, or two weeks, or monthly?

Weekly blood tests are required for the first 6 months when taking clozapine An ANC is required every 2 weeks for the next 6 months if an acceptable ANC is maintained during the first 6 months of continuous therapy (NAMI, 2020; see also Center for Drug Evaluation and Research, 2021).

Can you prescribe Clozapine without this certification?

Unfortunately, one is unable to prescribe any clozapine without this certification, prescribers must be certified in the modified Clozapine REMS to prescribe or dispense clozapine.  Pharmacies must be certified in the modified Clozapine REMS to prescribe or dispense clozapine and all patients on clozapine must be enrolled in the modified Clozapine REMS (Center for Drug Evaluation and Research, 2021)

References

Center for Drug Evaluation and Research. (2021). Information on clozapine. U.S. Food and Drug Administration.

FDA. (2021). Information on clozapine. U.S. Food and Drug Administration Center for Drug Evaluation and Research

NAMI. (2020). Clozapine (clozaril and FazaClo). NAMI National Alliance on Mental Illness Clozapine (Clozaril and FazaClo).

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