Seek to protect physicians from the discipline of off-label prescription

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Jan 11 – CONCORD – State Representative Betty Gay R-Salem said she was shocked when she called all of her local pharmacies and learned that none of them would fill a prescription. a doctor for ivermectin, an antiparasitic drug that has developed a strong following for its controversial off-label use as a COVID-19 treatment.

“Last May, when my husband fell ill, his doctor said he was told she couldn’t prescribe it,” Gay told the House Human Services and Elderly Affairs Committee on Tuesday. “It is not fair.”

She supported legislation (HB 1466) that would prevent any doctor from being penalized for writing or any pharmacist for filling a prescription for improper use of an FDA approved drug.

Prescribing drugs for off-label use is common. According to national health experts, up to 20% of drugs given to patients are for use other than their primary use.

For example, Cialis and Viagra, used to treat erectile dysfunction, have been approved by the FDA to relieve circulation disorders.

When the pandemic struck, the prescribing of certain drugs became very busy when then-President Donald Trump promoted the use of hydroxychloroquine as a preventive measure against COVID-19. Trump’s statement led to a national drug race.

In response, health care officials here and in other states have approved restrictions on prescribing, lest states run out of drugs to use on the sickest patients.

Following research in June 2020, the FDA revoked its authorization for emergency use of hydroxychloroquine and is no longer recommending doctors prescribe the drug for COVID-19.

Ivermectin, widely used for the treatment of parasites in animals, has been approved by the Food and Drug Administration for humans in tablet form to treat certain parasitic worms and as topical application for head lice and skin irritations.

Its use is not authorized or approved by the FDA for the prevention or treatment of COVID-19. The agency on its website warns that the drug “has not been shown to be safe or effective for these indications.”

The FDA warned, “There is a lot of misinformation around, and you may have heard that it is okay to take high doses of ivermectin. It’s not acceptable.

Nonetheless, thanks to social media and internet chat, ivermectin has become widely sought after by people in some neighborhoods for the treatment of symptoms of COVID-19.

The drug became so popular outside of mainstream medicine that many who were denied a prescription by a doctor got it from farm supply companies and self-medicated.

In December, the FDA issued a strongly worded advisory that doctors should not prescribe ivermectin to a patient with COVID-19.

Federal authorities have indicated that the drug can have toxic effects in humans when it interacts with other drugs such as blood thinners. They further warned of the possibility of overdose, with symptoms ranging from nausea and vomiting to coma or death.

In late October, AmeriHealth Caritas New Hampshire, one of three managed care organizations in the state that provides health insurance to Medicaid beneficiaries, requested and received approval to limit ivermectin prescriptions to a maximum of 10 tablets every 90 days.

The state Department of Health and Human Services has approved the quantity limit, company officials say.

“This amount covers the dose needed to treat the FDA approved indications for ivermectin,” referring to the application of the drug only to treat skin irritations and not COVID-19.

Concerns, not opposition

No one testified against the bill on Tuesday, but Rep. Jerry Knirk, D-Freedom, wondered if it might harm some patients.

“I’m still a little puzzled. We should trust the strong opinion of providers, in gathering evidence for the intervention of the treatment,” said Knirk, a retired orthopedic surgeon. “We often fight for the best treatment, but we differ and often rely on known practices to work.”

Representative Gary Merchant, D-Claremont, Chairman of the State Board of Pharmacy, said he has seen with his own eyes why physicians’ prescribing practices should not be honored on occasion.

“There is a risk, even if it is small, that we cannot ignore. How to protect the patient against ignored contraindications? said merchant.

As an example, Merchant noted that as the state’s opioid epidemic approached, many doctors were writing overly bulky prescriptions for pain relievers that ended up making their patients dependent.

Representative Erica Layon, R-Derry, a supporter of the bill, worked for years as an analyst for a medical device maker.

“We’re getting to a point where reasonable people can disagree and reasonable people can take a different path,” Layon said.

She said it was unfortunate that many healthcare guidelines and prescribing decisions regarding COVID-19 had become a source of division.

“As long as physicians get written and informed consent from their patients, this is key,” Layon said.

She said views on drug prescribing practices are set to change with more scientific research.

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