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Clozapine REMS Now Allowing Clozapine Refills Without Blood Draw - action requested

  • 1.  Clozapine REMS Now Allowing Clozapine Refills Without Blood Draw - action requested

    National Council Staff
    Posted 03-21-2020 18:50
    Dear Association Executives -

    Summary - The Clozapine Risk Evaluation and Mitigation Strategy (REMS) is an FDA-mandated program implemented by the manufacturers of clozapine which includes a patient registry and requirements for prescribers, pharmacists, patients, and distributors. Until today, it has required patients to have their blood drawn and tested each time by their pharmacist before they receive Clozapine. As a result of the COVID-19 pandemic and recent medical evidence, the Clozapine REMS program will now allow pharmacists to use their discretion and not require blood draws to before providing Clozapine. 

    Requested Action - Please share this information with the pharmacy association in your state ASAP and ask them to share it with their pharmacist members. 

    Background - As you may know, Clozapine is the most effective antipsychotic and used for treating people who of not done well on any of the other antipsychotic medications. It has a rare side effect called neutropenia where your body stops making white cells which makes it highly susceptible to infection. As a result of this there is been a requirement that people get periodic neutrophil counts as often as every week and nevertheless often than every month and that the lab result has to be presented to the pharmacy before they will give you your medication refill. People who did well on clozapine and stop taking it usually rapidly become quite psychotic often sicker than they were before and almost always require hospitalization. In the current coronavirus environment there is clearly a substantially increased risk of infection if you have to get your blood drawn and your medication filled every week. Blood draw stations and pharmacies are full of sick people so we don't want our patients going there during the epidemic unless absolutely necessary. Also, often the patients requiring this kind of medication need assistance with transportation from CMHC staff. Allowing longer clozapine refills without the frequent blood draws is a huge advantage and relief. And the requirement for this monitoring was much more stringent than was necessary given how extremely rare the side effect is.


    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

    JoeP@theNationalCouncil.org

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    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:

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    MEMORANDUM
     

    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…

    Tom

    Thomas 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 | thomas.smith@nyspi.columbia.edu

    www.omh.ny.gov

     









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    Joe Parks, MD
    Vice President, Practice Improvement & Medical Director
    National Council for Behavioral Health
    Direct: (202) 629-5791
    JoeP@theNationalCouncil.org

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  • 2.  RE: Clozapine REMS Now Allowing Clozapine Refills Without Blood Draw - action requested

    National Council Staff
    Posted 03-22-2020 14:54
    Dear Association Executives - See more on this from the FDA below.

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    Just posted by FDA regarding REMS.

    https://www.fda.gov/media/136317/download

    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.

     

    Joe Parks, MD

    Vice President, Practice Improvement & Medical Director

    National Council for Behavioral Health

    Direct: (202) 629-5791

    JoeP@theNationalCouncil.org

     

     



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    Neal Comstock
    Director of Membership
    National Council
    NealC@TheNationalCouncil.org
    202 748-8793
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