Ohio Bill Seeks Protection for Off-Label Prescriptions

COLUMBUS, OH ( WCMH ) — A discussion about off-label drugs is back in the spotlight in Ohio after a similar effort failed last year.

House Bill 12 would generally allow a doctor to prescribe any drug, even if it is for off-label use, and require a pharmacist to dispense it. An off-label drug is when it is prescribed for a purpose that is not explicitly approved by the FDA.

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“It stems from a lot of the criticisms we’ve heard surrounding COVID response,” Ohio Rep. DJ Swearingen (R-Huron), the bill’s sponsor, said. “Doctors who felt like they had an idea of how they wanted to handle that disease and wanted to go one way with it and were kind of outcasts in some sort of sense.”

Off-label drug prescriptions have been used in more cases than just COVID-19 and Ivermectin. Executive Director of the Ohio Pharmacist Association David Burke said it is most prevalent today, for example, in diabetes drugs, like Ozempic, being used for weight loss.

“Currently, today, off-label prescribing and dispensing occurs unencumbered,” Burke said.

Swearingen said that if an off-label prescription can work in the best interests of a patient, then physicians and prescribers should “have the freedom to pursue that option.” He said there is little “medical free speech” and this bill would protect that.

“So, if a doctor gives an opinion in a medical setting that they can do that without threat of retaliation from a regulatory board or a licensing board for something along those lines,” Swearingen said.

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Burke argued that there is a different standard of free speech when it comes to medical professionals.

"Physicians aren't allowed to express their personal opinions freely about drug usage; instead, they rely on scientific evidence—just as pharmacists and nurses do—and provide patient care," Burke stated.

Burke said he worries that under this legislation, pharmacists will have little ground to push back when they think a prescription will be harmful to a patient. He said often, pharmacists have information about certain drugs before a prescriber might.

This brings us back to the era of Dr. Smith’s medicine wagon, where he possesses a potion that can heal your rheumatism," Burke stated. "This is our destination. This is whom this strengthens.

Burke mentioned that although he thinks most healthcare providers prescribe medications carefully, he has concerns regarding medical spas and the prescriptions issued from such locations.

We have people issuing prescriptions for any plausible justification they believe a patient might utilize, disregarding scientific evidence," Burke stated. "This will lead to significant damage to patients and circumvents the present system, which relies solely on personal opinions instead of scientific ones.

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Swearingen mentioned that the bill already includes a section addressing liability. It doesn’t provide complete immunity to prescribers if their medication causes harm to patients or fails to meet the acceptable standards of care. He explained that the core intent of the bill is for medical professionals to pursue "the truth."

He suggested having a conversation about their views on optimal procedures and what they think is in the patient's best interest, ensuring there's no fear of repercussions.

The legislation underwent its third review on Wednesday afternoon, with opposition statements being presented. A total of fifty-eight individuals who were against the bill provided written submissions or testified personally. In contrast, during the session for supporters of the bill, forty-two people voiced their backing.

The legislation was unable to clear the Ohio Statehouse in a last-ditch effort last year, but Swearingen expressed optimism that it might succeed this time around.

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