The FDA is changing dispensing requirements for the schizophrenia drug clozapine (Clozaril) to address safety concerns about severe neutropenia.

The first change involves new prescribing information that clarifies how health care professionals should manage clozapine treatment and monitor patients for neutropenia.

Now, neutropenia will be monitored only by the absolute neutrophil count (ANC), rather than in conjunction with the white blood cell count. Moreover, patients will be able to continue taking clozapine with a lower ANC, and those with benign ethnic neutropenia who previously were not eligible for clozapine will now be able to receive it.

Second, the FDA approved a shared risk evaluation and mitigation strategy (REMS) for clozapine that replaces the 6 individual clozapine registries. This change is “expected to reduce the burden and possible confusion related to having separate registries for individual clozapine medicines,” the FDA stated.

In order to prescribe and dispense clozapine, prescribers and pharmacies must be certified in this Clozapine REMS Program starting October 12, 2015.

To become certified, a pharmacy must designate an authorized representative to:

·         Review Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers.
·         Pass the Knowledge Assessment for Healthcare Providers.
·         Complete and submit the appropriate Clozapine REMS Pharmacy Enrollment Form.
·         Implement the necessary staff training and processes to comply with the Clozapine REMS Program requirements.

Pharmacies with multiple locations must certify on behalf of each pharmacy location, and add each pharmacy location as that pharmacy completes the necessary training.

Unless they are prescriber designees, pharmacists will no longer be able to enroll patients in the Clozapine REMS Program or view a list of patients taking clozapine.

Starting December 14, 2015, outpatient pharmacies will be required to obtain a pre-dispense authorization (PDA) from the Clozapine REMS Program before clozapine can be dispensed.

A PDA is an electronic code that indicates the Clozapine REMS Program has verified that the prescriber and pharmacy are certified and the patient is enrolled, and that the patient’s ANC is acceptable or the certified prescriber has authorized the patient to continue taking clozapine.

A PDA can be obtained by enabling the pharmacy management system to support electronic communication with the Clozapine REMS Program, signing into the REMS program’s website, or calling the program at 844-267-8678.

Inpatient pharmacies do not need to obtain a PDA before dispensing clozapine.

Patients currently treated with clozapine will be automatically transferred to the REMS program.

Clozapine is an antipsychotic drug used to treat schizophrenia in patients whose symptoms are not controlled with standard treatment. It is also be used to treat recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder.

The most common side effects of clozapine include constipation, drooling, sleep problems, and weight gain. Some patients may also experience drowsiness or dizziness.

The FDA encourages health care providers and patients to report any related adverse effects to its MedWatch program.