Lawmakers push legislation to protect doctors who prescribe ivermectin for COVID-19. Can they do that? – USA TODAY

Dozens of state lawmakers push bills that would make it easier for doctors to prescribe ivermectin for COVID-19, even though the anti-parasitic has not been proved effective at preventing or treating the disease.
As of Thursday, at least 26 states have proposed or passed legislation that would increase patient access to the drug, according to a database created by the Federation of State Medical Boards.
Dr. Ezekiel Emanuel, chair of the department of medical ethics and health policy at the University of Pennsylvania’s Perelman School of Medicine, said the bills “drive (him) nuts.” 
“It’s just a serious intrusion into medical practice by people who aren’t doctors and don’t know medical practice,” Emanuel told USA TODAY. “It’s inevitable someone’s going to be harmed, and this is harmful to the country.”
Most of the bills attempt to protect doctors who prescribe ivermectin for COVID-19 against disciplinary action from state medical boards and hospitals. The Federation of State Medical Boards said in a statement sent to USA TODAY it opposes any legislation intended to limit a state board’s ability to protect patients.
“It sets a dangerous precedent and puts the public at risk,” the federation said. “State legislatures are encouraged to work with their state medical boards to uphold existing statutory authority to respond to complaints about the quality of care provided and take disciplinary action against physicians when necessary to protect the public.”
Other proposed bills seek to make ivermectin available over the counter or by standing order, prohibit pharmacists from refusing to refill ivermectin prescriptions or prohibit medical professionals from providing information that would discourage patients from taking ivermectin for COVID-19.
Health, legal and political experts said states are well within their power to pass many of these bills into law; however, some pieces of legislation may be harder to pass than others.
State medical boards serve as independent groups of regulatory experts who keep patients safe by upholding medical standards, but legal experts said states have ultimate legislative authority on who can practice medicine and how.  
“Health and safety is within the states’ power unless the federal government uses authority … to step in,” said Jennifer Bard, professor of law at the University of Cincinnati College of Law and professor of medicine at the university’s College of Medicine. “States are doing what they can do within their authority to remove whatever concerns physicians might have prescribing these drugs.”
The FSMB database shows at least 18 states, mostly Republican-controlled, introduced or passed bills that would prohibit state medical boards and hospitals from taking any action against physicians, chief medical officers or pharmacists who prescribe or fill orders for ivermectin off-label.
North Dakota senators passed a bill, initially dubbed the “ivermectin bill,” that would prohibit boards of medicine, nursing and pharmacy from disciplining a licensed professional for prescribing and dispensing ivermectin for COVID-19.
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The state’s Board of Medicine submitted testimony opposing the bill, defending its duty to “protect the health, safety, and welfare of the public.”
“We hold physicians to a higher standard because of their position of power and their perceived medical knowledge and expertise,” said Dr. Robert Sticca, chairman of the North Dakota Board of Medicine. “The Board of Medicine needs to be able to do a thorough review of a case and complaint to determine whether a physician’s actions have fallen below a standard of care that could result in harm to patients and members of the public.”
Lawmakers amended the bill to allow disciplinary action if the prescription of ivermectin involved an unlicensed practice, inappropriate documentation or substandard care. 
States may have the authority to overturn a medical board’s decision, Bard said, depending on its legislative process and how the bill is written. 
“The state is in charge of licensing, and they delegate that to a peer-review medical board,” she said. “So they absolutely can limit what a medical board can do.”
At least three states introduced bills that attempt to make ivermectin available to patients over the counter without a prescription, according to the FSMB database.
Experts said such a move is beyond states’ power. The Food and Drug Administration is the only agency with the power to approve drugs and their use. If a drug is approved to be prescribed by a doctor, it can’t appear on pharmacy shelves next to medications such as ibuprofen.
“There’s an internal process for the FDA to change the label,” Bard said. “The FDA could make something over-the-counter, but only they can do that.”
Once the FDA approves a drug, doctors can use their medical judgment to prescribe it for other conditions, what’s called prescribing “off-label,” she said.
The medication still requires a prescription and can’t be sold over the counter.
Lawmakers who sponsored bills attempting to make ivermectin available over the counter in Alaska and Oklahoma did not respond to USA TODAY.
A spokesperson for state Rep. Susan Lynn, the sponsor of a similar bill in Tennessee, declined to comment on the legislation. The lawmaker sponsored another bill that would keep ivermectin behind the counter. 
Emanuel called the bills “totally ridiculous.”
Lawmakers are “clearly not concerned about the safety of patients. What they’re clearly concerned about is simply ideology,” he said. “And that’s not the grounds on which we should be dispensing medications.”
Although states can’t make ivermectin available without a prescription, there is a workaround.
Several states introduced bills that would allow physicians to prescribe ivermectin by “standing order.” This would allow a health care provider to write a prescription that covers a large group of people, not a particular person.
Under a standing order, pharmacists would be able to dispense the drug to anyone who requested it, Bard said, even if they’re not a patient of the health care provider who prescribed it.
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“Anybody would have to come to the pharmacy and ask for the drug, but they wouldn’t have to have any preexisting prescription,” she said.
States have the authority to make this happen unilaterally, she said, and have done so. 
Common medications available in some pharmacies by standing order include naloxone, a medication designed to rapidly reverse an opioid overdose, and emergency contraception, commonly referred to as the “morning after pill.” 
Many health experts support removing barriers for naloxone and emergency contraception but oppose increased access to ivermectin for COVID-19.
Though the drug is effective at killing painful and crippling parasites, it has not been proved to work against the coronavirus. 
States are also looking to reduce the power of pharmacists to curb ivermectin use for COVID-19.
According to the FSMB database, at least nine states proposed bills that would prohibit pharmacists from refusing to fill prescriptions or providing information that might discourage a patient from using ivermectin to treat or prevent COVID-19.
States may have more trouble making the measures law, said Caroline Mala Corbin, a professor at the University of Miami School of Law.
“This is the government censoring private speech,” she said. “The default assumption of free speech law is that the government’s attempt to censor an opinion it doesn’t like is presumptively unconstitutional.” 
But the government has manipulated speech in medical settings before, under “informed consent,” Corbin said.
In abortion regulation, the Supreme Court has upheld special informed consent laws that require abortion providers to give detailed information to the patient about the procedure – including on its risk, psychological consequences, gestational age of the fetus and abortion alternatives – before performing it.
The Supreme Court argued informed consent laws were a regulation of the medical profession, Corbin said, not a regulation of speech.
If the ivermectin bills are conceivably a part of informed consent, then the state can dictate the doctors’ speech in ways they cannot do in the case of ordinary citizens,” she said. 
Though this may be the case, Corbin said states may have a “harder sell” censoring pharmacists than compelling doctors’ speech in the abortion context.
“We live in a country where we believe in free speech, and this idea of limiting speech of experts by amplifying speech of quacks is very, very dangerous,” Emanuel said. “It’s very dangerous to the health and well-being of the country.”
Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT. 
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

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