See review article at https://www.ncbi.nlm.nih.gov/pubmed/16595571 - IT'S CONCLUSIONS:
After at least 6 months' treatment with clozapine, the mortality involved in stopping white blood cell monitoring is about the same as the mortality associated with other medications, such as mianserin or phenylbutazone, and with life in general (traffic or occupational accident). If the patient has been well informed and wishes to stop the monitoring, it is a medically justifiable option to do so and is preferable to stopping treatment with clozapine since this drug reduces overall mortality. See also below for additional information.
Stay well – Joe
Joe Parks, MD
Vice President, Practice Improvement & Medical Director
National Council for Behavioral Health
Direct: (202) 629-5791
From: Smith, Thomas (NYSPI) <Thomas.Smith@nyspi.columbia.edu> Sent: Saturday, March 21, 2020 2:05 PM To: Joe Parks <JoeP@TheNationalCouncil.org> Cc: Casoy, Flavio (OMH) <Flavio.Casoy@nyspi.columbia.edu> Subject: Re: Coronavirus and clozapine
Hi Joe, good news-we have clarification from FDA and Clozapine REMS that prescribers and pharmacies can use their judgment on waiving the blood draw requirement. I am sending out this guidance to NYS providers today:
TO: NYS Article 31 Mental Health Provider Agencies
NYS Article 28 Hospital Psychiatry Chiefs
OMH-Operated Psychiatric Center Executive Directors, Clinical Directors, Chief Nursing Officers, Pharmacists
FROM: Dr. Thomas Smith, Chief Medical Officer, OMH
DATE: March 21, 2020
SUBJECT: Clozapine and blood test monitoring
I have communicated with both the FDA and Clozapine REMS and can confirm that prescribers and pharmacies have discretion to order and dispense clozapine without an absolute neutrophil count reported within the specified timeframes. The following is posted on the Clozapine REMS website (https://www.clozapinerems.com/CpmgClozapineUI/home.u#):
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…
TomThomas Smith, MD
Chief Medical Officer, NYS Office of Mental Health
Special Lecturer, Columbia University Vagelos College of Physicians and Surgeons
Office of Mental Health
New York State Psychiatric Institute
1051 Riverside Drive, Unit 100, New York, NY 10032
P: (646) 774-8442 | F: (646) 774-8740 | firstname.lastname@example.org
Just posted by FDA regarding REMS.
on the last page it states . . .
"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 under sections 505-1(f)(3)(d) or (e) of the FD&C Act (21 U.S.C. 355-1 (f)(3)(d) or (e)) 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. 13 Manufacturers should document and summarize in their next REMS Assessment Report steps that were taken to accommodate patient access to these REMS drugs during this COVID-19 PHE.