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Panic disorder — USMLE Step 3 MCQ

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HardPsychiatry (outpatient management)Panic disorderUSMLE Step 3

A stable clozapine-treated patient asks why the pharmacy no longer requests REMS authorization. What is the most accurate response?

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Correct answer: A — REMS reporting ended; continue label-directed ANC monitoring

The best answer is “REMS reporting ended; continue label-directed ANC monitoring”. FDA removed the distribution program, not the boxed neutropenia risk or recommended clinical monitoring. The clozapine REMS ended June 13, 2025; enrollment and ANC submission are no longer dispensing requirements, although clinicians should continue ANC monitoring according to prescribing information. The alternatives use a different threshold, timing, population, or intervention and therefore do not match the clinical facts presented.

Reference: FDA: Clozapine REMS Removed: https://www.fda.gov/drugs/drug-safety-communications/fda-removes-risk-evaluation-and-mitigation-strategy-rems-program-antipsychotic-drug-clozapine