The Columbus Dispatch
Pharmacies would be required to fill prescriptions for off-label drugs under a bipartisan bill passed by the Ohio House on Wednesday.
The Food and Drug Administration approves medication to treat specific illnesses and conditions, but it’s legal and common for health care providers to prescribe them for a different ailment − a practice known as off-label use. Proponents contend House Bill 73 is needed to codify this ability and ensure doctors can exercise their medical judgment without repercussions.
But hospitals and pharmacies say the policy changes would make it harder for them to care for patients.
The legislation, approved 73-17 on Wednesday, would:
- Allow providers to prescribe off-label drugs with the patient’s consent, even if the patient hasn’t been tested for a particular illness.
- Require pharmacies to dispense off-label prescriptions, unless they refuse to religious or ethical reasons, or if the patient would have a life-threatening reaction.
- Prohibit licensing boards and the Ohio Department of Health from taking action against a prescriber or pharmacist based on their use of off-label drugs. It also bans any discipline against providers because of their medical opinions.
- Allow patients to bring an off-label drug from home or an outside pharmacy if the hospital doesn’t have it. Providers would then be required to verify the medication and give it to the patient.
- Prohibit facilities from refusing nutrition or fluids to a patient, unless it’s necessary for a medical procedure or part of someone’s end-of-life request.
- Prohibit local governments and state agencies from enforcing any federal ban on off-label drugs.
“Varied medical opinions often lead to incredible advancements in medicine and should be encouraged, not censored,” said state Rep. Jennifer Gross, R-West Chester, who’s also a nurse practitioner.
House Democrats split on whether to support the bill. Rep. Beth Liston, D-Dublin, a physician, said it would protect providers from retaliation if they choose to provide abortion medication or hormones for transgender people.
Pandemic ignites debate over off-label drugs
The use of off-label drugs got increased attention during the pandemic because of claims that a deworming drug could treat COVID-19.
Medical freedom groups touted the use of ivermectin and the anti-malaria drug hydroxychloroquine as tools to combat COVID symptoms. But multiple studies found they weren’t effective at treating COVID-19, and the World Health Organization, FDA and other groups discouraged patients from taking them for that purpose.
The Wisconsin Supreme Court recently ruled that hospitals shouldn’t be forced to prescribe ivermectin for COVID-19.
In testimony before a House committee, several people said they lost loved ones after hospitals denied the patients different treatment options for COVID-19. That includes a Wooster couple for whom the legislation is named. One proponent of the bill said a pharmacy wouldn’t fill the amount of ivermectin prescribed for her husband’s COVID.
David Burke, executive director of the Ohio Pharmacists Association, said the purported benefits of ivermectin and hydroxychloroquine exhausted the supply of those drugs and increased the cost due to scarcity. That could happen with other medications if this becomes law, Burke said, potentially harming patients who need them for their approved use.
The Ohio Hospital Association and Ohio Council of Retail Merchants also oppose the bill, saying it could expose patients to drugs that are unsafe or not accepted by the medical community.
“Patient care in hospitals is complex and providers need to be able to practice their profession to the fullest extent of their training,” the association said in written testimony. “Sub. H.B. 73 impairs providers’ ability to do that in a hospital and is both unsafe for patients and will cause hospitals, pharmacists, and other providers to choose whether to violate Sub. H.B. 73 or other laws governing their practice.”