During an emergency (such as the COVID-19 pandemic, natural disaster, or other disruption of community services), can patients get clozapine prescriptions filled if they have not had the required blood draw as required by REMS?

The first step is to consider what types of flexible communication and care can be available between clinicians and patients, such as phone or telehealth visits. Required CBC/ANC lab draws can now be completed in some locations using point-of-care testing. This enables patients to have only a finger stick completed for blood collection, similar to how people with diabetes test their blood sugar levels. This testing can be completed by a clinic nurse or other trained staff quickly without patients needing to go to a laboratory. In addition, there is a small window of flexibility for the CBC/ANC testing dates in relation to the processing of clozapine prescriptions. The current table from REMS includes a row entitled, “last ANC value on file is acceptable.” This regulation allows the pharmacist to determine somewhat flexible dates of the patient’s most recent CBC/ANC that will satisfy the requirement of REMS. And, pharmacies sometimes will dispense in an emergency situation, understanding that blood testing needs to be done as soon as possible, and that REMS will become concerned. Finally, in the context of an emergency, the FDA is able to change their guidance, and disseminate these changes.

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