Need feedback ASAP: Email Erinn Maury, MD at emaury@gmail.com 

A new bill proposed by the Prescription Drug Affordability Board (PDAB) The "Advancing Reform In State Substitution Act" would allow pharmacists to substitute biological products with "biosimilars"—even if they are not FDA-designated as interchangeable—without your prior consent. 

While the bill aims to lower patient costs, it introduces several clinical variables that may impact your practice:

  • Non-Medical Switching: Pharmacists could switch stable patients to a different biosimilar solely based on price, potentially triggering the "nocebo effect" or treatment discontinuation, or increase the chance of formation of Anti-Drug Antibodies (ADAs).
  • Latex & Excipient Risks: Substitution is authorized based on "dosage and strength," but does not require a match for delivery-device materials (like latex needle caps) or inactive ingredients (like citrate).
  • Post-Dispense Notification: The bill only requires the pharmacy to notify you within 5 business days AFTER the drug has already been dispensed to the patient.
  • The "Safety Valve": Your "Dispense as Written" (DAW) authority remains, but you must explicitly state "Only as Directed" on every prescription to prevent a pharmacy-level switch.

Your voice matters: MedChi needs to hear from rheumatologists to ensure patient safety and protect our scope of practice. Your comments will be reviewed by MedChi's lobbyists to revise the bill, so patient care is minimally impacted if this legislation passes.


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