Ivermectin

Ivermectin.

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Getting ivermectin, a medicine for parasitic diseases now controversially being used for COVID, is proving to be a difficult task.

Dr. Clif Steinberg at Sojourns Community Health Clinic in Westminster said he and other prescribers are facing obstacles in getting ivermectin to patients.

“Most pharmacies ask what the ivermectin is for and if you say COVID, they refuse to dispense it,” he said. “In all my years of prescribing ... I have never had to tell a pharmacist why I am prescribing a medication to a patient before they will fill a prescription. It is truly unusual.”

An executive order in Vermont doesn’t name ivermectin in a list of drugs not to be dispensed for COVID-19, but it does include “any newly established outpatient prescription drug order for a drug known or popularly believed to be under investigation for COVID-19 indications.” Prescribers are instructed to report any inappropriate activity.

Many medical providers aren’t on the same page as Steinberg. Brattleboro Memorial Hospital, for instance, doesn’t recommend using ivermectin for treatment or prevention of COVID-19.

“There isn’t good evidence of effectiveness and high doses can be toxic,” said Dr. Kathleen McGraw, chief medical officer at BMH. “Overdoses are associated with hypotension and neurologic effects such as decreased consciousness, confusion, hallucinations, seizures, coma and death. Calls to poison control centers due to ivermectin ingestion have increased five-fold from pre-pandemic baseline.”

McGraw encourages people who are worried about exposure to the virus or experiencing symptoms to consult with their primary care provider for “appropriate treatments.”

A local pharmacist who asked not to be identified said lately, prescriptions for ivermectin are always coming from the naturopathic community of providers and out-of-state telehealth providers. The medication is readily available to pharmacists but the state rule prevents them from dispensing it for COVID-19.

The pharmacist said the original intent of the rule, which was to avoid people stockpiling medications and making it difficult for pharmacies to get, was good but now pharmacies are stuck in the middle of doctors and the state.

“If Vermont wants us to be able to dispense this drug, they should be more specific,” the pharmacist said, adding that if providers want to prescribe it then they should ask for clarity on the rule or buy it on their own and dispense it from their office.

Lauren Hibbert, director of the Office of Professional Regulation at the Vermont Secretary of State’s Office, said ivermectin wasn’t specifically listed in an emergency order issued at “the height of the hydroxychloroquine craze, but it does fit the description of ‘a drug known or popularly believed to be under investigation for COVID-19 indications.’”

“The April order was little more than a reminder to pharmacists to pay particular attention when doing the drug utilization review they are required to do relative to each and every prescription drug order presented for dispensing,” Hibbert said in an email, noting that on Aug. 26, the Centers for Disease Control and Prevention published a health alert to pharmacists and other clinicians warning about “the potential risks of use of ivermectin for prevention or treatment of COVID-19.”

Hibbert estimated that the Office of Professional Regulation has received about two calls about ivermectin.

“In both cases, we’ve advised that a pharmacist declining a script for ivermectin as a COVID-19 preventative is a pharmacist protecting patients by performing a drug utilization review appropriately,” Hibbert said. “Leaving aside the politics of ivermectin, any prescription is only legitimate for dispensing if it is issued by an authorized prescriber who has a bona fide provider-patient relationship to the patient. Patients walking into pharmacies with dubious ivermectin scripts almost always have obtained them online from prescribers they’ve never met. That would prevent a pharmacist from dispensing even if the drug was indicated for the use intended.”

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Steinberg said he wasn’t aware of the rule and he called it “very peculiar.” He has considered dispensing ivermectin out of his office.

“It’s just not sanctionable,” he said. “I don’t want to cross any lines that are going to jeopardize my ability to treat my patients but I will go to great lengths to get that medicine for my patients and there are legitimate ways to get it.”

Steinberg is left wondering why the medication isn’t available when there aren’t many options for a doctor treating COVID-19. He doesn’t believe it’s a matter of safety.

“I suspect it has more to do with the desire to get the vaccine more broadly accepted and ivermectin looks like an obstacle to that,” he said.

Many antibiotics have “much worse safety profiles,” Steinberg said, adding that Remdesivir, which is used for COVID, has “a pretty poor safety record. That is currently the treatment of choice for COVID, but it is [administered by] IV and generally only used late in the illness, limiting some of its potential benefits.”

“I believe ivermectin is helpful for COVID patients,” Steinberg said. “The various data I have seen are very compelling showing that places where ivermectin has been widely accessible are way ahead of places where it has not in terms of COVID mortality and morbidity. Given the incredibly good safety profile of ivermectin as a medicine when prescribed by a physician according to some established guidelines, coupled with the lack of other known, effective outpatient treatments for COVID, I think it is a very good option for some patients who are sick with COVID. It would feel like a dereliction of my duty to my patients to not offer them something so safe, and potentially life-saving.”

Patients are regularly asking Steinberg about ivermectin and other things that might be helpful for treatment or prevention of COVID. He said he’s watching for effective treatments for the virus all the time.

“I am open with all of my patients about the many things we do not fully know about COVID and treatments, and that as we learn more I will adjust my approach to treating it,” he said. “At this time, that includes ivermectin.”

On the difficulty of getting ivermectin dispensed to patients for COVID illnesses, Steinberg said, “In my 20 years of practice I have never run into anything remotely like this, even in the middle of the opioid epidemic.”

“Remember, there is virtually no downside to using pharmaceutical ivermectin prescribed appropriately by a trained doctor,” he said. “On the other hand, there is substantial upside for those in the early phases of COVID illness. I do not endorse using veterinary ivermectin for humans, due to a lack of regulatory oversight and potential problems with dosing or contaminants. I would endorse the widespread availability of ivermectin for COVID patients, particularly as part of a multi-pronged treatment plan.”

Asked about ivermectin at the governor’s news conference on Sept. 14, Vermont Health Commissioner Mark Levine said the drug has received a lot of press lately.

“But I do have to say that the medical and scientific community are pretty unified in this that it has not shown to have a role in human beings in treating COVID-19 or preventing COVID from occurring and I would urge those who are seeking to avoid vaccination to find something else that might be magical to help them, that this would not be the path to go down,” he said. “There have been numerous reports in the medical literature about significant adverse effects from people taking ivermectin, which is often dosed for horses and cows who weigh a lot more than human beings.”

At the time, Levine said he wasn’t aware of anyone who was treated for severe adverse effects of ivermectin in Vermont but he said that doesn’t mean it hadn’t happened.