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Patient Access to Certain REMS Drugs During COVID-19 National Emergency

  • 1.  Patient Access to Certain REMS Drugs During COVID-19 National Emergency

    National Council Staff
    Posted 03-17-2020 18:38

    Dear National Council Members - See below concerning patient access to certain REMS drugs during COVID-19 National Emergency (in response to a member inquiry of FDA). Thanks to National Council Medical Director and Vice President for Practice Improvement Joe Parks, MD for sharing.  

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    FDA Reply:
    FDA has received several inquiries from external stakeholders raising concerns about patient access to certain REMS drugs during COVID-19 National Emergency.

    As you are aware the goal of the Clozapine REMS is to mitigate the risk of severe neutropenia associated with the use of clozapine.  Prescribers are to perform on an ongoing basis, monitoring of absolute neutrophil counts (ANC) for patients according to the monitoring frequency on file and as described in the prescribing information.  FDA recognizes that during the COVID-19 national emergency, monitoring ANC may be difficult for patients with increased risks that may necessitate avoiding public places and patients suspected of having COVID-19 that may be self-isolating and/or subject to quarantine. FDA has been in communication with the manufacturers of the Clozapine REMS and are working with them to avoid interruptions in treatment for patients that need clozapine.  We have communicated to the manufacturers that we do not intend to object to manufacturers supporting healthcare providers as they care for their patients and using their best clinical judgement for monitoring patients and dispensing clozapine REMS through the end of April 2020 at which time the Agency will re-assess.  Please contact the Clozapine REMS call center for additional information regarding the Clozapine REMS program.

     

     



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