To prescribe clozapine, a clinician must be part of a clozapine system that includes a pharmacy and laboratory. There should also be methods for family and other caregivers to obtain information. There are two general approaches to clozapine systems: directly operated or consultant. The first, directly operated, approach is often used within healthcare organizations, such as hospital outpatient clinics or mental health clinics. It involves establishing a clinic that is led by a clinician, either a physician, nurse practitioner, or clinical pharmacist. The second approach, often used by solo physicians or nurse practitioners, has a consulting pharmacist coordinate the system. With either approach, both the prescribing clinician and pharmacy must first register with the national clozapine REMS program (or 1-888-586-0758).
In directly operated programs, professionals’ roles vary according to local resources and expertise. The following example is only one potential implementation. In this example, a psychiatrist develops procedures and protocols for the system, leads quality assurance, and provides clinical supervision. Patients who are considering clozapine or being prescribed clozapine attend a clozapine clinic at a specific time during the week. They attend weekly when they start clozapine, then according to the frequency of needed monitoring. A nurse leads group education, both for patients who are considering clozapine and patients who have started taking the medication. Patients are assessed by the nurse. They have their blood test drawn by a phlebotomist, or blood assessed using a point of care device. They see their prescribing clinician weekly at first and less frequently over time, and medications are prescribed. They are provided their dispensed clozapine. After the clinic, the nurse follows up on lab results, and with patients as needed. If the blood was drawn by a phlebotomist, the result is provided to the REMS program and/or pharmacy.
With the second, consulting, approach, a consulting pharmacist organization coordinates the system and oversees quality assurance. The pharmacist organization arranges for lab testing; obtains results; provides results to the REMS, prescriber and pharmacy; arranges for dispensing; coordinates prescribing from the prescriber; and manages any challenging situations, such as abnormal labs or patient travel. The pharmacist also provides consultation on prescribing and side effect management. The prescriber sees the patient as indicated in their office, on a weekly basis at first, decreasing in frequency as clinically indicated.