State Fast-Tracking Pharmacy Rules Amid COVID-19
In the midst of the COVID-19 pandemic, Gov. Ron DeSantis’ administration wants to fast-track rules that expand the health-care services pharmacists are authorized to provide, a move that worries some members of a board that licenses physicians.
Ed Tellechea, general counsel of the Florida Board of Medicine, told members of a committee Wednesday that “there is pressure” to finalize rules by Aug. 1 to carry out a new law allowing certain pharmacists to test patients for influenza and streptococcus and to treat patients with chronic illnesses.
“The governor’s office would like them (the Board of Pharmacy) to get working on this right away and to get a product as soon as possible, because they want to have the pharmacists available to be able to assist in dealing with the current public-health crisis, and when it flares up again in the fall,” Tellechea said.
His remarks came after comments from Board of Medicine Vice Chairman Hector Vila, who said he thinks that the Board of Pharmacy should initially draft narrow rules that could be broadened later. He also said he would like the rules to specifically preclude pharmacists from testing and treating patients for the novel coronavirus, which causes the COVID-19 respiratory disease.
“This is a pretty big change. And I would move slowly and not try to cut any corners,” said Vila, a Tampa physician and long-serving Board of Medicine member. “Move very slowly, very deliberately, and then it’s more likely to end up a success.”
At the urging of House Speaker Jose Oliva, R-Miami Lakes, the Legislature on March 11 passed the measure (HB 389) to expand the authority of pharmacists. DeSantis signed the bill into law that same day.
Under the law, certain pharmacists will be authorized to enter “collaborative pharmacy practice agreements” with physicians that allow pharmacists to treat and manage patients.
Those pharmacists will be authorized to treat participating physicians’ patients for arthritis; asthma; chronic obstructive pulmonary diseases; Type 2 diabetes; human immunodeficiency virus or acquired immune deficiency syndrome; obesity; or “any other chronic condition adopted in rule.”
To enter into collaborative pharmacy practice agreements, pharmacists must either have doctorates in pharmacy or have practiced at least five years and have clear and unencumbered licenses. The pharmacists also must take an additional 20-hour course, the content of which will be approved by the pharmacy board.
In addition, the law authorizes pharmacists to enter into written agreements with physicians who are willing to serve as supervisors. The written agreements will lay out the protocol for pharmacists to treat non-chronic health conditions such as influenza, streptococcus and uncomplicated infections.
The law requires the Board of Pharmacy to develop a number of new rules to carry out the changes, including a formulary of drugs that pharmacists may prescribe. The rules also must include guidelines for advising patients when to seek follow-up care from physicians.
Expanding the authority of pharmacists was one of a handful of key bills for Oliva, who has made revamping the health-care system his top priority during his two-year tenure as speaker. His agenda put him at odds with physician groups such as the Florida Medical Association and the Florida Chapter of the American College of Physicians, which opposed the pharmacy bill but were powerless to slow it down.
Not only did the bill expand the services pharmacists could provide, it circumvents the Board of Medicine and the Board of Osteopathic Medicine by directing that the pharmacy board simply “consult” with them both before finalizing the rules.
That was not lost on members of the Board of Medicine’s Rules/Legislative Committee that met Wednesday in a conference call to discuss the pharmacy board’s rules, a draft of which was released this week.
“As a board we’ve been told we need to be consulted,” said Shailesh Gupta, a Coral Springs physician and vice chairman of the Rules/Legislative Committee. “But does that mean consulted and ignored (or) consulted and listened to and, if so, at what capacity?”
Chris Nuland, a lobbyist for the Florida Chapter of the American College of Physicians, is closely tracking the proposed rules. While the current iteration of the rules allows authorized pharmacists to only treat the chronic health conditions identified in law, Nuland worries that the pharmacy board is being “vague” as to what other conditions pharmacists could be authorized to test and treat, including COVID-19.
“At least initially, we would want the list of chronic health conditions limited to those explicitly set forth in the statute,” said Nuland, a Jacksonville health-care attorney who lobbies the Legislature. “I would hope and expect the Board of Pharmacy would do that if they want to get this rule enacted as soon as possible because we cannot argue about what the Legislature put in there, but there will be significant and long-term discussions about additional chronic medical conditions.”