President Issues Executive Order on Rx Pricing, BOP Writing Rules on Collaborative Practice and more

July 26, 2020

President Trump Issues Executive Orders on Prescription Drug Pricing

On Friday, President Donald Trump issued an executive order to pave the way for prescription drug importation from Canada and foreign countries to lower prices. The order directs the Secretary for the Department of Health and Human Services to take certain actions to allow for safe use of drugs from Canada and other foreign countries. Legislation was adopted during last year’s legislative session here in Florida to allow for this practice.

The President also issued an order to reign in prescription drug middlemen practices of kickbacks through rebate programs. According to the Executive Order, the Secretary of the Department of Health and Human Services is charged with completing rulemaking to exclude the safe harbor provision under the anti-kickback statutes in the Social Security Act. This would cause things like rebates to be passed on to consumers at the point of sale.

COVID-19 Vaccine Trials Showing Favorable Results

Researchers at Oxford University are showing that a single dose of vaccine under investigation prompted effective immune and T cell responses. This is good news in scientists’ efforts to find a solution to the coronavirus.

Board of Pharmacy Committee to Review Collaborative Practice and Test and Treat Rules

The Florida Board of Pharmacy Rules will be meeting on July 29, 2020 at 9:00 am to discuss revisions to new draft rules. These new proposed rules are designed to implement the provisions adopted by the 2020 Florida legislature allowing pharmacists to test and treat patients for non-chronic conditions as well as to manage patients with chronic diseases. These rules include definition to required certification programs and also a formulary that a pharmacist could prescribe from.

The FPA has submitted a comment letter to the Board essentially asking that the rule be crafted broadly to allow flexibility in the provision of pharmacist services.

PHARMACY CALL TO ACTION!!!
HB 59 RULEMAKING

HB 59 that passed during the regular session of the Legislature would allow remote dispensing machines in places that are NOT pharmacies. The independent pharmacy community along with the Florida Pharmacy Association opposed this legislation but was unable to stop it from passing. The bill was signed by the Governor and went into effect July 1st. The Board of Pharmacy has rulemaking authority to address “security requirements” and “use” of the automated pharmacy systems.

WE NEED YOU TO WRITE A LETTER TO THE BOARD OF PHARMACY ASKING THEM FOR PROMPT RULEMAKING TO ENSURE PATIENT SAFETY AND ACCESS TO THEIR PRESCRIPTION DRUGS. Independent Pharmacists, Pharmacy Technicians, employees and your patients need to contact the Board of Pharmacy to express their concerns. The Florida Pharmacy Association has filed a comment letter on the concerns with HB59 to the Board that is available through this hyperlink.

When contacting the Board of Pharmacy, please use the points below:

1. The Bill allows for these systems to be placed at any indoor environment area that “increases patient access to prescriptions”. The Bill authorizes the Board to adopt rules addressing “security requirements” for the system. This will ensure that the pharmacy systems are located in safe and secure environments while furthering the Bill’s intent to increase patient access to prescriptions in underserved locations.

2. The Bill does not provide any guidance as to how many systems a pharmacy or pharmacist may supervise at any given time or where the supervising pharmacy or pharmacist must be located. The Bill authorizes the Board to adopt rules relating to the “use” of automated pharmacy systems. This will regulate the supervision and control of automated pharmacy systems.

CONTACT INFORMATION FOR THE BOARD OF PHARMACY:

FLORIDA BOARD OF PHARMACY
JESSICA SAPP, EXECUTIVE DIRECTOR
4052 BALD CYPRESS WAY, C-04
TALLAHASSEE, FLORIDA 32399

DEA Publishes Frequently Asked Questions on COVID-19 Issues

With the current pandemic we are in, the Drug Enforcement Administration has published a number of frequently asked questions of interest to health care providers and distributors.