Clozaril (clozapine) is classified as Schedule F in Australia, and Schedule III in Canada.
In the United States, clozapine products like Clozaril are not classified as controlled substances and are not scheduled under the Controlled Substances Act (CSA). Prescriptions for Clozaril do not require special schedules or licenses.
However, due to significant risks associated with clozapine such as agranulocytosis, prescribers, pharmacists, patients, and treatment facilities must be certified under the Clozapine REMS program, which has the following requirements:
- Prescribers must have privileges to prescribe clozapine, certify patient enrollment in the REMS program and commit to comply with the REMS protocol including frequency of monitoring. Only psychiatrists should prescribe Clozaril, or other physicians working closely with a psychiatrist.
- Pharmacists must be certified to dispense clozapine, counsel patients on the medication guide, and monitor for situations requiring an alert to be placed. Pharmacies must maintain a log linking patients with the respective prescriber.
- Patients and caregivers must understand risks and comply with blood monitoring through an initial ANC (absolute neutrophil count) prior to starting treatment, weekly ANC monitoring for 6 months, biweekly for the next 6 months, and monthly there after. The patient must be willing and able to have their blood drawn as needed.
- Treatment facilities must ensure that procedures are in place to comply with the REMS requirements if they are involved in prescribing, monitoring or dispensing Clozaril.
- Distributors must only supply Clozaril to pharmacies and healthcare facilities that are certified in the Clozapine REMS program.
- Manufacturers must ensure compliance with all REMS requirements and training of stakeholders. Novartis, as the drug manufacturer for Clozaril in the US, operates the Clozapine REMS program.
- A database identifies patients and records date and result of each ANC to track compliance with safety monitoring. Prescribers and pharmacies must report patient deaths or hospitalizations promptly to the REMS program.
So in summary, while clozapine itself is not a scheduled or controlled substance, regulatory safeguards are in place to ensure it is only used appropriately under tight safety controls due to risks. The Clozapine REMS aims to restrict access to certified and monitored use of Clozaril based on demonstrated knowledge of protocols to maximize benefits relative to risks for each patient.