Clozapine, REMS and COVID-19

FDA issued the statement on March 22, 2020 regarding the patient access to REMS (Risk Evaluation and Mitigation Strategy) medications like clozapine during COVID-19 public health emergency. Here is the summary of these recommendations:

(1) Weigh Benefits and Risks with Medical Judgment

  • Healthcare providers prescribing and/or dispensing these drugs should consider whether there are compelling reasons not to complete this test (CBC with differentials) during this public health emergency and use their best medical judgment in weighing the benefits and risks of continuing treatment in the absence of laboratory testing.

(2) Communicate with Patients:

  • Healthcare providers should also communicate with their patients regarding these judgments including their benefits and risks.

(3) FDA not intending to take action:

  • The FDA does not intend to take action against sponsors and others for the duration of the public health emergency for failing to adhere to REMS requirements of laboratory testing with clozapine.

(4) Clozapine REMS Certification Required:

OUTPATIENT SETTING:

  • Only prescribers certified in the Clozapine REMS Program will be able to prescribe clozapine to patients for outpatient use.

INPATIENT SETTING:

  • Prescribing clozapine for patients receiving inpatient care does not require prescriber certification in the Clozapine REMS Program IF the patient is already enrolled in the program.
  • If the patient is to be initiated on clozapine while admitted to an inpatient setting, a certified prescriber must enroll the patient in the Clozapine REMS Program prior to receiving the first dose of clozapine.

REFERENCES:

  1. Policy for Certain REMS Requirements During the COVID19 Public Health Emergency. March 2020 (PDF)
  2. Clozapine REMS (webpage)

PSYCHIATRY EDUCATION FORUM’S 1ST CME CONFERENCE

Our 1st online conference have total 9 lectures and one of the lecture series is focused on the detailed management of clozapine adverse events:

THIS LECTURE IS DIVIDED INTO FOLLOWING FIVE SECTIONS (TOTAL DURATION: 90 MIN):

(1) CLOZAPINE HEMATOLOGIC ADVERSE EVENTS:

  • Types and definition of adverse events.
  • Neutropenia, Eosinophilia, Thrombocytopenia and Thrombocytosis.
  • Relation to dose and duration.
  • Management recommendations.
  • When to consider Clozapine Re-challenge.

(2) CLOZAPINE CARDIAC ADVERSE EVENTS:

  • Types and definition of adverse events.
  • Clinical Symptoms.
  • Relation to dose and duration.
  • Detailed Evaluation.
  • Monitoring Protocol.
  • Management recommendations.
  • When to consider Clozapine Discontinuation and Re-challenge.

(3) CLOZAPINE NEUROLOGIC ADVERSE EVENTS:

  • Types of adverse events.
  • Risk factors.
  • Relation to dose and duration.
  • Role of EEG.
  • Management recommendations.
  • When to consider Clozapine Discontinuation and Re-challenge.

(4) CLOZAPINE GASTRO-INTESTINAL ADVERSE EVENTS:

  • Types of adverse events.
  • Underlying Mechanism.
  • Clinical symptoms.
  • Risk factors.
  • Preventive measures.
  • Management recommendations.
  • When to consider Clozapine Discontinuation and Re-challenge.

(5) CLOZAPINE INDUCED HYPERSALIVATION:

  • Underlying Mechanism.
  • Discuss seven management options.

CONFERENCE TABLE OF CONTENT:

Psychiatry Education Forum’s first CME online conference is dedicated to the essential and must-know clinical facts in psychiatry.

This conference will offer a maximum of 10 AMA PRA Category 1 Credits™ for topics clinically relevant to your daily clinical practice.

  • Online conference: finish this conference at your own pace, and at any time with no need to spend money on travel-related expenses.
  • Peer-Reviewed: each presentation is reviewed by independent peer-reviewers.
  • No Disclosures: No pharmaceutical or non-pharmaceutical sponsors. All lectures are based on clinical data from literature with no influence from sponsors.
  • Conference Booklet: PDF version of reading material for each lecture will also be provided.

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