Clozapine REMS: What You Need to Know in 2023
Clozapine is an antipsychotic medication that is used to treat schizophrenia in adults who have not responded well to other treatments. It can also help reduce the risk of suicidal behavior in people with schizophrenia or similar disorders. However, clozapine can also cause a serious and potentially life-threatening side effect called severe neutropenia, which is a condition where your white blood cells (which fight infections) become very low, making you more prone to serious and fatal infections.
To ensure the safe use of clozapine and prevent interruption of treatment for patients, the Food and Drug Administration (FDA) requires a safety program called the Clozapine Risk Evaluation and Mitigation Strategy (REMS). The Clozapine REMS is a shared system for all approved clozapine products that ensure appropriate patient monitoring for and management of clozapine-induced severe neutropenia. The Clozapine REMS also provides a centralized system for prescribers and pharmacists in managing patient risk, regardless of which clozapine product is being used.
In this blog post, we will explain what the Clozapine REMS is, how it works, and what you need to know in 2023.
What is the Clozapine REMS?
The Clozapine REMS is a drug safety program that the FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. The Clozapine REMS consists of the following elements:
- A medication guide that informs patients about the benefits and risks of clozapine
- A communication plan that educates healthcare professionals about the safe use of clozapine
- Elements to assure safe use (ETASU) that require:
- Prescribers are to be certified in the Clozapine REMS program by completing an online training and knowledge assessment
- Patients are to be enrolled in the Clozapine REMS program by their certified prescriber
- Pharmacies to be certified in the Clozapine REMS program by designating an authorized representative who completes an online training and knowledge assessment
- Prescribers are to obtain a baseline blood absolute neutrophil count (ANC) before initiating treatment with clozapine and regular ANC monitoring during treatment
- Prescribers are to submit a new Patient Status Form monthly for all outpatients to document monitoring
- Pharmacies to verify patient enrollment, prescriber certification, and ANC results before dispensing clozapine
- Pharmacies to obtain authorization from the Clozapine REMS program either through the contact center or online via the REMS website before dispensing clozapine
How does the Clozapine REMS work?
The Clozapine REMS works by ensuring that only patients who meet certain criteria can receive clozapine and that they are monitored regularly for signs of severe neutropenia. The Clozapine REMS also provides a centralized database that tracks patient enrollment, prescriber certification, pharmacy certification, ANC results, and dispensing information.
The following steps describe how the Clozapine REMS works:
- A certified prescriber enrolls a patient in the Clozapine REMS program by submitting a Patient Enrollment Form with the patient’s demographic information, informed consent, baseline ANC result, and treatment indication.
- The prescriber initiates treatment with clozapine according to the Prescribing Information and submits a new Patient Status Form monthly for all outpatients to document monitoring.
- The prescriber obtains regular ANC monitoring for the patient according to the Prescribing Information and adjusts the dose or discontinues treatment as needed based on the ANC result.
- A certified pharmacy receives a prescription for clozapine from a certified prescriber for an enrolled patient.
- The pharmacy verifies patient enrollment, prescriber certification, and ANC results by accessing the Clozapine REMS website or contacting the Clozapine Contact Center.
- The pharmacy obtains authorization from the Clozapine REMS program either through the contact center or online via the REMS website before dispensing clozapine.
- The pharmacy dispenses clozapine with a medication guide and counsels the patient on how to take it safely.
What do you need to know in 2023?
In 2023, some changes will take effect in the Clozapine REMS program that you need to be aware of. These changes include:
- Pharmacies will no longer be able to use telecommunication verification (also known as the switch system) to verify safe use conditions for clozapine. The authorization to dispense clozapine can be obtained either through the contact center or online via the REMS website.
- Prescribers will need to submit a new Patient Status Form monthly for all outpatients to document monitoring. Patient monitoring must still continue per the Prescribing Information.
- The Clozapine REMS program will provide additional educational materials and resources for healthcare professionals and patients on the safe use of clozapine.
These changes do not impact the safe use of clozapine or the benefits of the medication. They are intended to simplify the verification process for pharmacies, enhance patient monitoring for prescribers, and improve communication and education for all stakeholders.
Conclusion
Clozapine is an effective medication for treating schizophrenia in adults who have not responded well to other treatments. It can also help reduce the risk of suicidal behavior in people with schizophrenia or similar disorders. However, clozapine can also cause a serious and potentially life-threatening side effect called severe neutropenia, which is a condition where your white blood cells (which fight infections) become very low, making you more prone to serious and fatal infections.
To ensure the safe use of clozapine and prevent interruption of treatment for patients, the FDA requires a safety program called the Clozapine Risk Evaluation and Mitigation Strategy (REMS). The Clozapine REMS is a shared system for all approved clozapine products that ensure appropriate patient monitoring for and management of clozapine-induced severe neutropenia. The Clozapine REMS also provides a centralized system for prescribers and pharmacists in managing patient risk, regardless of which clozapine product is being used.
In 2023, some changes will take effect in the Clozapine REMS program that you need to be aware of. These changes include removing the use of telecommunication verification for pharmacies, requiring a new Patient Status Form monthly for prescribers, and providing additional educational materials and resources for healthcare professionals and patients.
If you are a prescriber, a pharmacist, or a patient who uses clozapine, you should familiarize yourself with the Clozapine REMS program and its requirements. You should also follow your doctor’s instructions carefully and report any problems or concerns as soon as possible. By doing so, you can benefit from clozapine while minimizing its risks.
References
(1) Clozapine REMS.
(2) Frequently Asked Questions | Clozapine REMS Modification.
(3) Information on Clozapine | FDA.
FAQs
Q: What is the Clozapine REMS Program?
A: The Clozapine REMS (Risk Evaluation and Mitigation Strategy) Program is a safety program implemented to minimize the risk of severe neutropenia (a decrease in a certain type of white blood cells) and to monitor and manage other potentially serious side effects associated with clozapine use.
Q: Who is required to participate in the Clozapine Risk Evaluation and Mitigation Strategy Program?
A: Prescribers, pharmacists, and patients are all required to participate in the Clozapine REMS Program when prescribing, dispensing, or taking clozapine.
Q: What are the goals of the Clozapine Risk Evaluation and Mitigation Strategy Program?
A: The goals of the Clozapine REMS Program are to ensure the safe use of clozapine by monitoring white blood cell counts, managing neutropenia risks, and educating patients and healthcare providers about the potential risks and benefits of clozapine treatment.
Q: What is the purpose of monitoring white blood cell counts in the Clozapine Risk Evaluation and Mitigation Strategy Program?
A: Regular monitoring of white blood cell counts is important to detect the development of severe neutropenia, which is a potential side effect of clozapine that can be life-threatening.
Q: How often are white blood cell counts monitored in the Clozapine REMS Program?
A: During the first six months of clozapine treatment, white blood cell counts must be monitored weekly. Afterward, monitoring can be reduced to every two weeks for the next six months and then monthly thereafter.
Q: Can a patient continue taking clozapine if they develop severe neutropenia?
A: In most cases, clozapine must be discontinued if severe neutropenia occurs. However, the decision to discontinue or continue treatment is based on the individual patient’s circumstances and the healthcare provider’s assessment.
Q: What are some other safety measures of the Clozapine REMS Program?
A: The Clozapine REMS Program includes patient and prescriber education, mandatory enrollment and training for healthcare providers, and a centralized database for tracking and monitoring clozapine use.
Q: How can patients enroll in the Clozapine REMS Program?
A: Patients can be enrolled in the Clozapine REMS Program by their prescribers or the healthcare facility where they receive their clozapine prescriptions.
Q: What should patients do if they experience side effects while on clozapine?
A: Patients should promptly report any side effects or adverse reactions to their healthcare provider while on clozapine. It is important to communicate openly with the healthcare team for appropriate management.
Q: Is participation in the Clozapine REMS Program lifelong?
A: The Clozapine REMS Program requires ongoing participation as long as the patient continues to take clozapine. Regular monitoring and adherence to program requirements are essential for patient safety.