Ohio bill offers protection for off-label prescriptions
COLUMBUS, Ohio (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 don't have free speech for personal opinion on how drugs are to be used, they use scientific background just like pharmacists do or nurses do, and they administer care to a patient,' Burke said.
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 returns us to the days of Dr. Smith's medicine wagon, where he has a liquid that will cure your rheumatism,' Burke said. 'That's where we're going. That's who this empowers.'
Burke said while he believes most prescribers do act with care, he worries about places like medical spas and the prescriptions that come from those establishments.
'We've got folks writing prescriptions for any valid reason to which they think a patient could use without scientific background,' Burke said. 'That's going to cause a lot of harm to patients and bypasses the current system that just allows an individual opinion rather than a scientific opinion.'
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Swearingen said the bill already has a liability portion, and does not leave the prescriber completely immune should the drug cause harm to the patient and not meet the standard of care. He said that at the heart of the bill is wanting 'medical providers to seek the truth.'
'Also have a dialogue about what they believe to be best practices and what they believe to be in the patient's best interest without threat of retaliation,' he said.
The bill had its third hearing on Wednesday afternoon, which featured opponent testimony. Fifty-eight people against the bill either submitted written testimony or appeared in person. During the bill's proponent testimony hearing, 42 people supported it.
The bill failed to pass the Ohio Statehouse last year, in a last-minute move, but Swearingen said he is hopeful it will get through this time.
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