Background on Clozapine
As you may recall, clozapine was one of the first atypical antipsychotic medications. It provided an alternative to phenothiazines, one that had much lower incidence of extrapyramidal side effects, and it was another option for patients who hadn’t responded to the traditional medications. Unfortunately, it soon was realized that clozapine had its own significant side effect, that of neutropenia. This led to periodic monitoring of white blood cell counts which has for years been mandatory. In order for a pharmacy to be permitted to dispense clozapine – now available as Clozaril(R) , FazaCloz(R) and Versacloz(R), a patient has had to be registered in one of the several clozapine registries and have proof of a recent ANC (absolute neutrophil count, requiring a CBC with differential cell count). The protocol is that if the ANC is acceptable, only enough medication is allowed to be dispensed to get the patient to their next scheduled ANC. This could be only enough for a week, two weeks or a month. Until the registry gets proof of the ANC, the drug may not be dispensed.
What has changed?
All patients on clozapine are therefore in some registry and this was the system until October. Together with the FDA, the makers of clozapine consolidated the registries into one. Patients and doctors in the registries are supposed to be automatically “migrated” from their previous registries into the new Clozapine REMS (Risk Evaluation and Management Strategy) registry.
Up to this point, pharmacies had been given significant latitude in order to help the physician with the prescribing and monitoring of clozapine. As of Nov. 2, 2015 (today) in addition to prescribing or ordering the medication, physicians are required to register the patient and enter the labs into the registry. Once registered, physicians may allow another party, such as a pharmacist or office employee, to be a designee.
Physicians who currently are registered as prescribers of Clozapine should have received notification by mail, e-mail or fax from both the registries and from your pharmacy provider. Nevertheless, this information is provided in case you missed it.
What this means for you
Since it is now Nov. 2, you must do the following ASAP today:
Physicians who have patients on Clozapine (even prescribers who have been using a previous registry), must become certified through the new Clozapine REMS registry. Fortunately, this process is quick and painless. There is a minimal information input followed by a brief education program concerning neutropenia and clozapine management. There are a few post-test questions. This takes about 20 minutes, at most. You can get to this at: www.clozapinerems.com
if you are interested in naming a designee to retrieve and enter information into the registry for you, there is a process to do this on the website. The potential designee must also register, once that is processed, you may select them for a patient as a designee.
Because this applies to all attending physicians, please communicate this information to your medical staff. Talk to your DNS and Consultant pharmacy to see if there are patients in your Living Center who are receiving clozapine. Feel free to give your fellow providers in the LivingCenter a copy of this issue of First Monday.
GLC and Our Pharmacies Can Help
We are working with our pharmacy partners and staff to make sure that you will be advised as a prescriber of the status of patients with regard to the timing of ANCs. Please feel free to contact your pharmacy provider or consultant pharmacist for assistance in getting registered.
What you need to know about Clozapine REMS, may be found at: https://www.clozapinerems.com/CpmgClozapineUI/rems/pdf/resources/Clozapine_REMS_Guide_Patients_Caregivers.pdf
Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers: