Bill advances making two off-label COVID remedies available without prescription

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Lawmakers advanced a bill Thursday for dispensing hydroxychloroquine and ivermectin without a prescription after medical professionals and advocates spoke on the proposal at a House subcommittee meeting Thursday.

House File 2056 would require the state medical director to establish a standing order for the dispensing of hydroxychloroquine, a prescription drug typically used in treating malaria and managing autoimmune diseases, and ivermectin, typically used to treat parasitic infections.

Both drugs, approved for certain human uses in specific settings, became the focal point of debates following the coronavirus pandemic as some sources claimed these drugs could be used to prevent or treat symptoms COVID-19. While certain initial research showed a correlation between these drugs and positive outcomes for COVID-19 health care, further studies have not found either drug to be effective in preventing the spread or alleviating the severity of symptoms of COVID.

The proposal would require a pharmacist to dispense these two drugs to patients age 18 or older at their request, and could not require the patient to have a prescription from a medical practitioner or to schedule an appointment prior to dispensing the drug — nor could a pharmacist maintain a record of their encounter with a patient requesting  hydroxychloroquine or ivermectin.

While the bill states pharmacists dispensing these drugs under the standing order would be immune from criminal and civil liabilities for any damages caused by the dispensing or use of these drugs, medical advocates opposed the bill, saying the measure would require them to give these drugs to patients — even when they know the patient could suffer adverse side effects or have negative reactions due to interactions with other prescriptions.

Wes Pilkington, the owner of Evans Crossing Pharmacy and president of the Iowa Pharmacy Association, said the bill’s language stating, “notwithstanding any provision of law to the contrary, a pharmacist shall dispense” these drugs was particularly concerning.

“The phrase ‘shall dispense’ removes professional judgment at the very point where pharmacists are legally and ethically obligated to evaluate patient safety,” Pilkington said. “Pharmacists are not vending machines. We are licensed health care professionals whose role is to ensure medications are safe and appropriate before they reach the patient.”

These two drugs in particular carry many potential risks for consumers, Pilkington said. Patients taking ivermectin are at risk of severe skin reactions, drops in blood pressure, central nervous system depression and neurotoxicity, he said, and risks are increased when people take increased dosages of the drug.

Hydroxychloroquine “presents even more significant concerns,” Pilkington said, as the drug presents risks of overdose and can cause fatal cardiac arrhythmias, severe hypoglycemia, blood disorders, irreversible retinal damage, lung disease, acute liver failure and kidney injury, especially among elderly patients.

The drug has enough risks that patients taking the medication as prescribed regularly require routine eye exams, periodic blood counts, monitoring for heart toxicity and kidney function, as well as muscle strength and reflex testing, he said. By not allowing pharmacists to practice clinical judgment in dispensing these drugs, Pilkington said the bill raises “critical unanswered questions.”

“What prevents a patient from following high dose recommendations found online and obtaining repeated prescriptions,” he said. “What stops them from visiting multiple pharmacies or obtaining a new prescription every week or every month? What happens when an elderly patient with known cardiac or kidney disease (requests) one of these medications, and I know that medication will cause them harm? This bill states that pharmacists would carry no legal liability for patient harm, but legal immunity does not erase our moral and professional responsibility to protect patients.”

Rep. Eddie Andrews, R-Johnston, who is running for governor, said other medicines currently available for purchase without a prescription also have side effects.

“I mean, just the ones that we all know about, Tylenol, ibuprofen, they have a long laundry list of side effects, from liver (problems) to … asthma, to blood pressure to cardiovascular risk, to stomach and GI issues,” Andrews asked. “What separates this one, and why are those okay?”

Medical professionals and pharmacists at the meeting said the rate of developing adverse side effects — and the severity and risk of those side effects, like cardiac arrhythmias caused by hydroxychloroquine — are far higher than other drugs currently available over the counter.

Lindsay Maher with the group Informed Choice Iowa, said several states have passed laws allowing over-the-counter dispensing of ivermectin and claimed “research continues worldwide to uncover the various diseases that ivermectin is capable of treating. She also said as ivermectin has “established efficacy” for proven uses — largely regarding parasitic infections — that requiring doctor’s visits and prescriptions to access the drug “adds unnecessary burdens and delays treatments and could increase costs by not allowing these things to be over-the-counter.”

“It has serious side effects. That is true. A lot of things do. They are … abundantly rare, though, in standard human doses,” Maher said.

She also pointed to language in the bill requiring the manufacturer’s label be included in the product, meaning patients can evaluate the “full safety profile” of the drug themselves.

Rep. Austin Baeth, D-Des Moines, an internal medicine physician, said the bill was “mandated medical malpractice.”

“This bill is a group of politicians forcing a medical director to commit malpractice, and then forcing pharmacists to commit malpractice when a pharmacist is forced to give that drug when they know it might be harming that patient,” Baeth said. “Think of the ethical and moral situation of these pharmacists, when they know this patient might have Long QT syndrome or (there’s) a drug that they’re already taking that might interact with ivermectin or hydroxychloroquine. And yet, because this group of politicians in this Capitol is forcing them to give it to that patient, that pharmacist has to harm them against the oath that they took.”

Rep. Brett Barker, R-Nevada, said he also had “strong concerns about the bill as written.” He said he believes pharmacists have a responsibility “to ensure the safety and appropriateness of every prescription that they provide to a patient,” and that the bill’s requirement that pharmacists “shall dispense” these drugs even if it goes against their professional judgement was a problem.

He also said he believed the measure could set a “dangerous precedent,” saying the measure would conflict with other bills supported by Republicans in previous sessions on issues like medical conscience, or could create problems if pharmacists were required to dispense abortion drugs.

While Barker did not sign off on the bill at the subcommittee meeting, he signed off on the measure later Thursday with a recommendation for amendment. Andrews said he believes concerns about the current language can be addressed during the amendment process for the bill.

The measure moves to the House Health and Human Services Committee for further consideration.

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