Seeking to protect doctors from discipline from off-label prescribing [The New Hampshire Union Leader, Manchester]

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

"Last May when my husband got sick, his doctor said she had been told she couldn't prescribe that," Gay told the House Human Services and Elderly Affairs Committee on Tuesday. "That's just not right."

She has gotten behind legislation (HB 1466) that would prevent any doctor from being disciplined for writing or any pharmacist for filling a prescription for off-label use of an FDA-approved drug.

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

For example, Cialis and Viagra, used to treat erectile dysfunction, were approved by the FDA to assist with circulation ailments.

When the pandemic hit, the prescribing of some drugs became highly charged when then-President Donald Trump promoted the use of hydroxychloroquine as a preventive against COVID-19. Trump's statement led to a national run on the drug.

In response, health care officials here and in other states approved restrictions on prescribing, for fear the states would run out of the medication to be used on the sickest patients.

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

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

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

The FDA has warned, "There's a lot of misinformation around, and you may have heard that it's okay to take large doses of ivermectin. It is not okay."

Nevertheless, thanks to social media and internet chatter, ivermectin became widely sought by people in certain quarters for treatment of COVID-19 symptoms.

The drug became so popular outside the medical mainstream that many who were denied a prescription by a physician were obtaining it from farming supply companies and self-medicating.

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

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

AmeriHealth Caritas New Hampshire, one of the state's three managed care organizations that provides health insurance to those on Medicaid, in late October asked for and received approval to limit the prescriptions of ivermectin that it would allow to no more than 10 pills every 90 days.

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

"This quantity 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, questioned whether it could do harm to some patients.

"I am still a little bit baffled. We should rely on the sound opinion of the providers, gathering evidence for the intervention of treatment," said Knirk, a retired orthopedic surgeon. "We often have fights over the best treatment, but we differ and then often defer to the practices known to work."

Rep. Gary Merchant, D-Claremont, chairman of the state Board of Pharmacy, said he has seen firsthand why doctors' prescribing practices on occasion should not be honored.

"There is a risk out there, although it is small, that we cannot ignore. How do we protect the patient against contraindications that are ignored?" Merchant said.

As an example, Merchant noted that in the run-up to the state's opioid epidemic, many physicians were writing too-large prescriptions for pain killers that ended up getting their patients addicted.

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

"We get to a point where reasonable people can disagree and reasonable people can take a different path," Layon said.

She said it was unfortunate many health care guidance and prescribing decisions about COVID-19 have become divisive.

"So long as physicians obtain written and informed consent from their patients, that's the key," Layon said.

She said views about drug-prescribing practices are bound to change with more scientific research.

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