Novo Nordisk — manufacturer of diabetes and weight-loss drugs Ozempic and Wegovy — filed lawsuits against two pharmacies after tests concluded their products were impure, according to a recent announcement. Novo Nordisk claims both pharmacies provided compounded drugs claiming to contain semaglutide — the generic name for Wegovy and Ozempic — that were up to 33% impure. The unknown impurities “potentially pose safety risks” to consumers, including “possibly serious and life-threatening reactions” like anaphylaxis, Novo Nordisk said. Novo Nordisk is requesting both pharmacies stop selling products claiming to contain semaglutide, and wants the pharmacies to be prevented from claiming its products with BPC-157 are approved by the FDA.

Florida Gov. Ron DeSantis (R) announced the approval of rules to allow implementation of provisions from SB 1550, wide-ranging legislation passed earlier this year addressing PBMs and drug pricing. The Office of Insurance Regulation has created a web page with resources related to the new statutory requirements for PBMs, as well as information about how providers can lodge complaints.

The Florida Board of Pharmacy published a notice of intent to adopt amendments to its rule on registered pharmacy technician-to-pharmacist ratios (64B16-27.410). The amendments would allow a supervising pharmacist to determine the appropriate ratio. The current rule requires a technician-to-pharmacist ratio of 1:1 unless otherwise authorized in the rule.

The authorized ratios in the current rule are as follows: 3:1 (sterile compounding); 6:1 (if not engaged in sterile compounding); and 8:1 (in a non-dispensing pharmacy that does not engage in sterile compounding, or in a physically separate non-dispensing area of a dispensing pharmacy).

Under the proposed amended rule, these activity-specific ratios are deleted. Instead, pharmacies may employ or use a technician-to-pharmacist ratio greater than 1:1 if (a) they are in full compliance with guidelines spelled out in the rule.

Florida Gov. Ron DeSantis signed the Prescription Drug Reform Act into law, aiming to bring more accountability and transparency to pharmacy benefit managers. According to the Governor's office, this new act sets a regulatory framework for PBMs in Florida. They will now be required to pass through 100 percent of all rebates received from pharmaceutical companies for the purpose of reducing consumer costs. The act also bans affiliate-only networks, prohibits mail order mandates, and stops data sharing without consent. The governor said it will also promote fair competition in the market and help to support smaller, independent pharmacies that have struggled to compete with larger chains.

Florida lawmakers are looking to regulate pharmacy benefit managers. The issue has drawn heavy lobbying as pharmacy benefit managers play a central — and big-dollar — role in the health-care system. After the Senate passed its version of the plan this week, the House on Friday moved forward with a proposal that would increase regulations on pharmacy benefit managers. The House bill would increase the Office of Insurance Regulation's authority over PBMs; prevent spread pricing; place restrictions on PBMs with affiliated pharmacy businesses; and prevent PBMs from requiring patients to receive prescriptions by mail. The bill needs approval from the Health & Human Services Committee before it could go to the full House.

On the heels of Gov. Ron DeSantis’ (R) recent Executive Order, comprehensive PBM reform legislation has been introduced in Florida. SB 1550 was introduced by Sen. Jason Bradeur and referred to the Health Policy and Fiscal Policy Committees. HB 1509 was introduced by Rep. Linda Chaney. The bills address concerns about PBMs from both manufacturers and pharmacies, with one main difference that HB 1509 includes a passthrough drug rebate model. The bills’ pro-pharmacy provisions include granting enforcement authority to the commissioner of insurance regulation, improving transparency as it relates to PBM-owned or affiliated pharmacies, requiring pass-through pricing, ensuring network adequacy, prohibiting clawbacks, and creating appeals procedures. The bills also create an Insurance Regulatory Trust Fund, establish administrative fines, and appropriate $1.5 million to the Office of the Commissioner of Insurance Regulation for implementation.

On the heels of Gov. Ron DeSantis’ (R) recent public engagement of PBM issues, his administration announced the appointment of Michael Yaworsky as insurance commissioner. Yaworsky, who served as chief of staff to the previous insurance commissioner, David Altmaier, will serve in an interim role until his appointment is ratified by the Financial Services Commission. With two PBM bills introduced and at least one more expected, it should be a busy session ahead in the Sunshine State.

With pharmacies in some states preparing to dispense abortion pills, Florida’s Agency for Healthcare Administration sent a letter to all state healthcare providers warning them that do so in Florida is illegal. The warning follows the U.S. Food and Drug Administration’s early January decision allowing retail pharmacies to stock and dispense abortion pills in states that allow the procedure. Pharmacy chains including Walgreens and CVS both said they plan to get certified to dispense the abortion pill mifepristone in states where allowed. In Florida, abortion is legal up until 15 weeks of gestation. However, state law says only a physician can terminate a pregnancy, not a pharmacist, and it must be done in person after a 24-hour waiting period. Florida is among 18 states where pharmacies are barred from dispensing the drugs either because abortion is illegal or because patients can only get the pills directly from a physician.

Gov. Ron DeSantis, alongside state Surgeon General Dr. Joseph Ladapo, spoke at a press conference and stated his intent to work with the state Legislature during the upcoming session to pass a series of laws to “increase transparency” in the statewide pharmaceutical industry. According to the governor, the pieces of legislation will impose a range of regulations and guidelines including, but not limited to, consumer and small business protections and requirements that drug manufacturers must disclose proposed price increases before they take effect. Further, the proposal seeks to enact anti-steering measures, preventing the implementation of a pharmaceutical network that only includes PBM-affiliated pharmacies. It also requires PBMs to disclose all the organizations they are affiliated with, including any pharmacies or companies within their corporate umbrella, and any complaints or settlement agreements they've bene involved in prior to operating in Florida.

On December 28, 2022, Florida Governor Ron DeSantis announced seven new appointments to the state Board of Pharmacy. The appointments include Dr. Jonathan Hickman, Daniel Kirk, Dr. Christina Medina, Dr. Jeffrey Mesaros, Jeenu Philip, and Stephen "Ryan" West. Maja Gift, a current Board of Pharmacy member, was also reappointed. All appointments are subject to confirmation by the Florida Senate.

Florida primary winners Shane Abbott and Gallop Franklin have won State House seats in the November election. Abbott, Owner of the The Prescription Place, was appointed House District 5 seat unopposed. Franklin, pharmacist and professor at Florida A&M University College of Pharmacy, was appointed District 8 seat in a 71% to 29% victory over opponent Curt Bender. Congratulations to both pharmacists on their victories!

Florida Attorney General Ashley Moody has announced a settlement with Walmart. The settlement resolves allegations that Walmart pharmacies distributed and dispensed prescription opioid pain medication improperly, although the settlement also states that Walmart “dispensed many fewer opioids per store and in dosages that were substantially lower than the other major chain pharmacies and independent pharmacies in Florida.” As part of the settlement, Walmart has agreed to pay $215 million, approximately $188 million of which will go to remediate the impact of the opioid crisis in Florida, and also to partner with AG Moody’s office to dispense 672,000 naloxone kits—an opioid antagonist that rapidly reverses the effects of an overdose—to first responders across the state.

Two Florida pharmacists, Shane Abbott and Gallop Franklin, will advance to the November election after winning their primaries for State House seats. Abbott, Owner of The Prescription Place in DeFuniak Springs, is running for the House District 5 seat. Franklin, pharmacist and professor at Florida A&M University’s College of Pharmacy, is running for the House District 8 seat. Best of luck to both pharmacists in their respective elections.

Florida Governor Ron DeSantis announced a new executive order aimed at adding transparency to the role of pharmacy benefit managers (PBMs) in administering prescription drug programs. This order, Order 22-164, will hold PBMs more accountable by requiring state agencies to review their contracts with PBMs to ensure that their costs are justified. The order attempts to address spread pricing and clawbacks, two predatory practices of PBMs. Gov. DeSantis’s order goes into effect immediately.

As of July 1, 2022, Florida pharmacy technicians can seek certification to provide immunizations, including all immunizations approved and under emergency use authorization by the FDA. In order to get certified, techs must complete an approved immunization course and operate under the authority of a pharmacist, physician, or nurse practitioner. This decision marks an important part in expanding both pharmacists’ and pharmacy technicians’ authority.

On June 20, Florida Governor Ron DeSantis passed a new law that puts the Office of Insurance Regulation (OIR) in charge of PBMs instead of the Board of Pharmacy. This bill, HB 357, aims to address pitfalls in previous regulations and provide better oversight of PBMs through the OIR. In addition to the change in oversight, HB 357 requires PBMs to register with the state. If they don’t comply, they face a $10,000 fine. HB 357 takes effect July 1, 2022.

The new "Parents' Bill of Rights" is primarily an educational bill, however, there are also requirements listed for health care practitioners - which include pharmacists and pharmacies. The law states that health care practitioners may not provide "health care services" or prescribe medicinal drugs to a minor without obtaining parental consent. This law brings up interesting questions about how strict its interpretation will be and how it might limit the scope of a pharmacist's everyday practice when it comes to assisting potential minors.

SB 768 expands the types of vaccines that can be administered by pharmacists and pharmacy interns. It authorizes any vaccines listed in the federal CDC Adult Immunization Schedule, vaccines recommended by the CDC for international travel, and vaccines licensed for use in the United States or authorized for emergency use by the FDA. This law also authorizes certified pharmacists to administer the flu vaccine to children seven years and older.