Florida’s 2015 Legislative Session ushered in two new laws affecting pharmacies: One addressing pharmacist immunizations (HB 279) and the second clarifies that veterinarians are authorized to dispense compounded drugs and regulates “maximum allowable cost” pricing (HB 1049). In addition, the FDA has delayed enforcement of certain provisions of the federal Drug Quality and Security Act (DQSA) that went into effect on July 1, 2015.
HB 279 amends s. 465.189, Florida Statutes (FS), and now authorizes registered interns, under the supervision of certified pharmacists, to administer a number of vaccines. The new legislation also expands the types of vaccines that pharmacists and registered interns may administer. Prior to this legislation, pharmacists were only able to administer influenza, pneumococcal, meningococcal, and shingles vaccines. The list has been expanded to include “[i]mmunizations or vaccines listed in the Adult Immunization Schedule as of February 1, 2015, by the United States Center for Disease Control and Prevention,” “[i]mmunizations or vaccines recommended by the United States Centers for Disease Control and Prevention for international travel as of July 1, 2015″ and “[i]mmunizations or vaccines approved by the board in response to a state emergency declared by the Governor…” Registered interns are authorized to administer vaccines as long as there is a supervision ratio of one certified pharmacist to one registered intern. Additionally, registered interns must complete at least 20 hours of coursework approved by the Board of Pharmacy as part of the certification program allowing for interns to administer vaccines.
HB 1049 amends Section 465.0276, FS, and clarifies that veterinarians (Vets) licensed under Chapter 474, FS, are authorized dispensing practitioners. Vets may now also administer a compounded drug to a patient, as defined in Section 474.202, FS, or dispense a compounded drug to the patient’s owner or caretaker. The statute states that it does not affect the regulation of the practice of pharmacy.
HB 1049 also addresses issues associated with “maximum allowable cost” or MAC pricing and requires that contracts between pharmacies and pharmacy benefits managers contain specific language. The legislation broadly defines “maximum allowable cost” to mean “the per-unit amount that a pharmacy benefits manager reimburses a pharmacist for a prescription drug, excluding dispensing fees, prior to the application of copayments, coinsurance, and other cost-sharing charges, if any.” “Pharmacy benefits managers” are defined as persons or entities doing business in this state which contract to administer or manage prescription drug benefits on behalf of a health insurance plan, as defined in Section 627.6482, FS, to Florida residents. The legislation creates Section 465.1862, Florida Statutes, to require pharmacy benefits managers to update maximum allowable cost pricing information at least every seven calendar days. HB 1049 also requires pharmacy benefits managers to “maintain a process that will, in a timely manner, eliminate drugs from maximum allowable cost lists or modify drug prices to remain consistent with changes in pricing data used in formulating maximum allowable cost prices and product availability.” Presumably this is to combat the problem of MAC pricing (pharmacy reimbursement) not keeping pace with pharmaceutical price increases (pharmacy costs).
Lastly, Section 582(d) of the DQSA places new requirements on drug dispensers that went into effect July 1, 2015. Starting July 1, a “dispenser” “shall not accept ownership of a product, unless the previous owner prior to or at the time of the transaction provides transaction history, transaction information, and a transaction statement.” This section also requires dispensers to provide the subsequent owner with a transaction history, transaction information, and a transaction statement for the product, prior to or at the time of each transaction in which the dispenser transfers ownership of a product. However, this information requirement does not apply to transfers of ownership that include dispensing to a patient or returns. Dispensers are required to capture transaction information (including lot level information, if provided), transaction history, and transaction statements, as necessary to investigate a suspect product. Dispensers are required to maintain this information, history, and statements for at least six years after the transaction. However, on June 30, 2015, the Food and Drug Administration, responding to requests by pharmacy trade associations, announced that it was exercising enforcement discretion to not enforce compliance with the new track and trace requirements until November 1, 2015. This allows the dispensers and their trading partners additional time to put systems in place to address the above requirements electronically.