Lawmaker: Allow ‘off-label’ prescriptions for COVID
PHOENIX – The way Kelly Townsend sees it, if a doctor is willing to write you a prescription for ivermectin or any other drug, a pharmacist has no right to refuse to fill it – even if it's for a condition for which the manufacturer had not obtained federal approval for the drug.
The proposal by the Republican senator from Mesa is designed to ensure that patients get access to "off-label” medications their doctors have prescribed. Pharmacists that send customers away could be subject to discipline by the board that regulates them.
But what's in SB 1016 is not absolute.
First, it would apply only when there is a proclaimed state of emergency.
And it would have to be for a drug that is "potentially life saving,” though Townsend's legislation does not define what that would include.
Her proposal comes more than a year after Gov. Doug Ducey forbade pharmacists from dispensing hydroxychloroquine or chlorquine unless they have a prescription which specifically says the patient actually has COVID-19.
That followed a spike in demand for the drug in early 2020 – before there was a vaccine – after President Trump mentioning the drugs in a White House briefing despite the lack of medical evidence that it actually would prevent anyone from contracting the virus. Ducey, who had declared an emergency a month earlier, acted because that, in turn, resulted in shortages for patients who use the drugs not only for malaria but autoimmune diseases like lupus and rheumatoid arthritis.
But Townsend said her legislation is aimed at the more recent problem: the refusal of some pharmacists to fill prescriptions for ivermectin, a drug normally used to treat parasites, particularly in animals.
There have been some studies touting the anti-viral properties of the drug. And the Food and Drug Administration says that ivermectin, in tablet form – versus the topical paste – can be usedto treat parasitic worms in humans.
Only thing is, the FDA says it has not authorized or approved ivermectin for use in preventing or treating COVID-19 in humans. And the agency has specifically cautioned against self-medication, especially using the version for livestock.
But prescribing it, by itself, is not illegal. Doctors in the United States have wide latitude to prescribe drugs "off-label,” meaning for conditions beyond those for which the FDA has approved their use.
The problem, Townsend told Capitol Media Services, is that some pharmacies are refusing to fill these off-label but otherwise legitimate prescriptions. And that, she said, is not acceptable.
"If a doctor feels this would save your life from the pandemic, from some whatever it is, and you say, 'I agree with you, doctor, I want to try it,' ... who the hell is is the pharmacist to say 'no'?” Townsend said.
Townsend conceded that forcing pharmacists to fill prescriptions despite their own personal misgivings actually runs contrary to prior legislative precedent which actually lets pharmacists turn away some customers.
An existing state law prohibits the government from denying, suspending or revoking anyone's professional or occupational license for "declining to provide or participate in providing any service that violates the person's sincerely held religious beliefs.” The sole exception to that involves peace officers.
And a separate and more specific statute says that pharmacists, hospitals and health professionals are "not required to facilitate or participate in the provision of an abortion, abortion medication, emergency contraception or any medication or device intended to inhibit or prevent implantation of a fertilized ovum” if they object "on moral or religious grounds.” In fact, that law does not require pharmacists who refuse to fill a prescription to refer the customer to someone else who will.
"We don't want to interrupt that,” said Townsend, saying she wants to preserve the ability of pharmacists to refuse to sell drugs that can cause an abortion, like RU-486, or drugs like Plan B which may preclude a fertilized egg from implanting in a woman's uterus.
She said that's why she crafted the measure to be narrow, with the two conditions.
It would apply only during a pandemic where there is a declared emergency. And it only involves potentially life-saving drugs.
"It's not life-ending,” said Townsend of the drugs that can cause abortion.
Still, she conceded, what constitutes a "potentially life saving” drug – the language in SB 1016 – may be subject to debate, what with no evidence from the FDA or even the Centers for Disease Prevention and Control that applies to ivermectin. And that, in turn, could leave it up to pharmacists to decide whether to fill prescriptions for that or any other drug.
Townsend said that may require some tweaks to her bill to put in a definition, perhaps a requirement for a doctor, in writing a prescription, to state that he or she considers the medication to be "potentially life saving.”
"I don't want to put that decision or definition in the hands of the CDC or any other political arm of any medical anything,” she said. "It should be the doctor and the patient.”
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