WV Senate Health committee advances bill allowing over-the-counter sale of ivermectin
Lawmakers on the West Virginia Senate Health Committee advanced a bill Tuesday that, if made law, will allow pharmacists in the state to sell ivermectin for human use over the counter and without a prescription.
Senate Bill 614 hinges upon the federal Food and Drug Administration approving the drug — which is commonly prescribed for animals to treat some parasites — for human use in wider circumstances than currently allowed.
Different formulations of ivermectin that are made specifically for humans are, occasionally, prescribed to treat people with topical conditions or infections that stem from parasitic worms, according to the FDA. While some medical providers have prescribed the drug for off-label uses — meaning uses different than what clinical trials have shown it is safe and effective to treat and what it's been approved for by the FDA — the federal government does not recommend that they do so.
Interest in and pushes for the wider use of ivermectin became common during and after the COVID-19 pandemic, when people alleged that the drug could help treat infections from the virus. To date, no clinical trials or peer-reviewed evidence have been accepted by the FDA to support such claims.
The drug became a common talking point for COVID-19 conspiracists and, due to this misinformation, health leaders urged the public not to use the drug for off-label purposes, citing concerns over other medications that could be contraindicated and different formulations of it that could be safe for animal consumption but not for humans.
In the Senate Health committee on Tuesday, Sen. Tom Takubo, R-Kanawha, said there could be some risk in taking the drug. Takubo, who is a doctor by trade, continued by saying this could be especially true if people are unaware of how it interacts with other medications and in situations where a patient isn't being monitored by a health care provider.
'So there are some concerns,' Takubo said. 'Ivermectin, for the most part, is a pretty well-tolerated medication when taken in appropriate doses.'
Takubo said potential side effects of the drug include changes to the heart's rhythm which could, in serious circumstances, lead to fatal arrhythmia. The drug has also been shown, Takubo said, to potentially increase liver toxicity in patients, especially if taken at the wrong dosages.
During COVID-19 — specifically, Takubo said, 'early on, when we really had nothing' to treat the infections — Takubo worked in an intensive care unit where ivermectin was being used on patients admitted with severe coronavirus infections. In those circumstances, however, patients were being closely monitored by physicians. They would receive daily electrocardiograms so providers could survey heart functions and doctors would regularly test liver enzymes to ensure the drug wasn't leading to unintended risks.
'So if you're taking any medications that also affect heart rhythm or affect liver function, etc, it can potentiate that and cause that,' Takubo said. '… My concern is, if a patient doesn't get the proper education there could be some adverse consequences of that.'
SB 614, as it is currently written, says that pharmacists 'shall provide the patient with the FDA-approved patient information sheet on Ivermectin at the time of sale.'
Over-the-counter medications, however, don't necessarily require that a pharmacist be involved when they are purchased. The bill also states that pharmacists will not be held liable for any adverse interactions that come from someone purchasing ivermectin from them.
In committee, a conceptual amendment from Sen. Tom Willis, R-Berkeley, would have made it so the ivermectin would only be available 'behind the counter,' but still without a prescription. That way, he said, the pharmacist could 'have conversation with the patient' and look for 'possible conflicts' that could arise from other prescribed medications.
Sen. Patricia Rucker, R-Jefferson, said that while it's clear no one wants anyone to be taking a medication that is contraindicated against their other medications, a risk of such will always exist with over-the-counter medications. Look at Tylenol, she said.
Willis said that he didn't believe Tylenol and ivermectin are comparable in this circumstance.
'I'm a freemarket-guy, and I'm a big-boy-pants-guy in general, and I want as few restrictions on decisions as possible, but it's a question of where this lands on the risk continuum,' Willis said. 'So as I would understand it — and again, I'm not an expert — but Tylenol would be lower on the risk continuum than ivermectin when you're talking about confluence with other drugs.'
After further discussion, however, Willis pulled his amendment since the bill — as it currently stands — would only be relevant if the FDA took steps to approve the drug and change its labeled use in the first place.
The bill passed the committee via voice vote and will now advance to the Senate Judiciary Committee for consideration before it goes before the whole Senate.
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