Clozapine REMS Requirement, Enforcement of Vaccine Mandate Suspended, PBM legislation filed and more

November 24, 2021

New Clozapine REMS Requirement

The Clozapine REMS (Risk Evaluation and Mitigation Strategy) is a safety program required by the Food and Drug Administration (FDA) to manage the risk of severe neutropenia associated with clozapine treatment.  Members are advised that all prescribers and pharmacies must re-certify to continue to prescribe or dispense clozapine. All patients continuing on clozapine must be re-enrolled by a certified prescriber or prescriber designee.  For information on REMS enter here.

In September, President Biden issued an order that the administration was rolling out a new rule that would require all private employers with 100 or more employees to mandate vaccines or weekly testing for all personnel, a guideline that has the potential to impact nearly 80 million workers.  The Occupational Safety and Health Administration (OSHA), who is charged with appropriate rulemaking has suspended enforcement as a result of a federal court order.  Florida also just completed a special session where HB1 was approved by the legislature and signed by the Governor.  The bill counters efforts by the Federal government to require COVID-19 vaccines by creating penalties for large businesses who terminate employees who refuse vaccination.  The bill also restricts the ability for educational institutions to require COVID-19 vaccinations.

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Bills supported by the Florida Pharmacy Association to revise the regulatory framework around pharmacy benefit managers.  HB357 sponsored by Jackie Toledo (R-Tampa) and Co-Sponsored by State Reps. Mike Caruso (R-Delray Beach) and Tyler Sirois (R-Merritt Island).  SB742, sponsored by Senator Ana Maria Rodriguez is comparable to HB357 though not exact.  These bills attempt to bring forward legislative policy promoted during the previous session to address PBM practices harmful to the business of pharmacy.

Issue Background

• Pharmacy benefit managers (PBMs) were established in the 1960s to serve as middlemen between health insurers and prescription drug manufacturers, responsible for regulating prices by handling negotiations and payments within the supply chain
• PBMs themselves are unregulated, which allows them to legally engage in a variety of opportunistic, anti-competitive practices
• PBMs often practice spread pricing – charging insurers or managed care plans more than the pharmacy’s reimbursement amount and pocketing the difference
• PBMs dealing in the state’s Medicaid program – which is administered by the Agency for Health Care Administration (AHCA) – are profiting $89.6 million in taxpayer dollars annually through spread pricing alone
• Current Florida laws require fair PBM auditing standards and other things such as timely updating of MAC pricing however there is no enforcement authority given to state agencies.
• These bills attempt to correct the current imbalances that are in place

The Senate version has been referred to Banking and Insurance, Health Policy and Appropriations Committees.  The House version has been referred to Finance & Facilities Subcommittee, State Administration & Technology Appropriations Subcommittee and the Health & Human Services Committee.  Members are encouraged over the holidays to contact members of the Senate Banking and Insurance Committee and the House Finance & Facilities Subcommittee.  Ask for these bills to be placed on their respective meeting agendas as soon as possible.  Make sure that you ask for their support of these bills.

PHARMACY TECHNICIAN TRAINING WORKBOOK Recommended to use as support for your employer based technician training program

Rule 64B16-28.108 related to labeling of Medicinal Drugs by pharmacy permits have been revised by the Board of Pharmacy and will become effective November 28, 2021.  The revision is primarily for Institutional Class II, Modified Class II Type B, or Class III permits that are labeling patient specific medications.

Rule 64B16-28.6021 related to Institutional Class II and Class III Pharmacy Emergency Department Dispensing has been revised to reflect recent changes in Florida laws.  The original rule limited emergency department dispensing to 24 hours or the minimum dispensing quantity whichever is greater.  SB262 was signed into law by Governor DeSantis this year to provide for emergency department dispensing for up to 48 hours or through the end of the next business day.  With this change in law the language in rule 64B16-28.6021 became unnecessary.  The rule revision took effect November 18, 2021.