Update from the FDA regarding COVID-19, Clozapine REMS, and blood monitoring

Per communication with FDA and Clozapine REMS, prescribers and pharmacies have discretion to order and dispense clozapine without an absolute neutrophil count reported within the specified time frames. [This information is current as released on 1/23/2020; obtained on 3/22/2020.]

The following is posted on the Clozapine REMS website (click to view full guidance):

***Important Program Update (as of 01/23/2020)***

ANC Current Lab Requirements Absolute Neutrophil Count not current (i.e., within 7, 15, or 31 days of the lab draw date) based on the patient’s monitoring frequency (MF) will not prevent a patient from receiving clozapine from the pharmacy. Although ‘ANC not current’ will not prevent a patient from receiving clozapine from the pharmacy, pharmacies are encouraged to submit the ANC to the Clozapine REMS Program when the pharmacist is made aware of a more current ANC than the most recent lab value reported in the PDA response.

FDA sent additional guidance entitled “Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency: Guidance for Industry and Health Care Professionals.” (click to view full guidance)

[This information is current as released on 3/22/2020]

Excerpts from this document:

For clozapine, the FDA requires certain elements to assure safe use (ETASU) as part of the REMS, which includes laboratory monitoring. FDA recognizes that during the COVID-19 PHE, completion of REMS-required laboratory testing or imaging studies may be difficult because patients may need to avoid public places and patients suspected of having COVID-19 may be self-isolating and/or subject to quarantine. Under these circumstances, undergoing laboratory testing or imaging studies in order to obtain a drug subject to a REMS can put patients and others at risk for transmission of the coronavirus. For drugs subject to these REMS with laboratory testing or imaging requirements, health care providers prescribing and/or dispensing these drugs should consider whether there are compelling reasons not to complete these tests or studies during the PHE, and use their best medical judgment in weighing the benefits and risks of continuing treatment in the absence of laboratory testing and imaging studies. Health care providers should also communicate with their patients regarding these judgments, including the risks associated with it. Although all REMS requirements remain in effect, FDA does not intend to take enforcement action against sponsors or others for accommodations made regarding laboratory testing or imaging study requirements imposed … during the PHE declared by the Secretary of HHS on January 31, 2020, provided that such accommodations were made based on the judgment of a health care professional. Manufacturers should document and summarize in their REMS Assessment Report steps that were taken to accommodate patient access to these REMS drugs during this COVID-19 PHE.

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