Landmark Legislation Safeguarding the Use of Off-Label Drugs Passes the Ohio State House With Bipartisan Support
Does anyone have the current weather in hell? I’m thinking it may have finally frozen over and am happy to report that the Ohio House of Representatives has passed HB73 on a BIPARTISAN basis!!! This bill passed by a huge margin even seeing some democrats support it. Could it be that we have finally found something that is so based on common sense that even Governor DeWine and I could find common ground? I guess we will see but let’s talk about HB73.
Throughout the COVID nightmare, patients were denied access to treatments that their doctors wanted for them by bureaucrats at hospital that were focused on the bottom line rather than the interests of the patients. Doctors would prescribe Ivermectin or HCQ but the hospital would not allow the patient to have it. While this may well have constituted a tort in many states, that was not something a sick person being denied proper treatment had time to litigate. The result was the denial of effective treatment for COVID and the needless death of many thousands of people.
I have been working with OAMF and Rep. Jennifer Gross on the language of this bill and believe it is good. The bill is 8 pages long (you can see it here) and is an easy read. OAMF has provided these bullet points which do a good job summarizing. This legislation:
- Protects against licensing boards and Ohio state and local health departments pursuing a disciplinary action against a prescriber, hospital or skilled nursing facility, for prescribing an off-label drug, or a pharmacist who dispenses it, unless there is gross negligence.
- Says patients are not required to be tested or screened for or exposed to a particular disease, illness, or infection in order to get the off-label prescription from their prescriber filled for home or prophylactic use.
- Requires a pharmacist, hospital, or inpatient facility to dispense the prescribed off-label drug, unless there is a religious/ethical objection or a life-threatening contraindication.
- This legislation does NOT in any way prevent conversations regarding drug concerns between pharmacists and prescribers
- In cases where a pharmacist, hospital, or inpatient facility has to fill a prescription that they are not religiously opposed to, and there is no life-threatening reason not to give it, but they have a good faith scientific objection to filling the drug prescribed by the doctor…. then the pharmacist, hospital or inpatient facility is immune from any harm that may come from the use of the drug, so long as the objection is documented in the patient’s record and also submitted by the pharmacist to the Board of Pharmacy or by the hospital or inpatient facility to the Ohio Department of Health. This provides documentation for lawyers to reference to see if immunity is in place for a particular off label drug when a patient or entity is considering a suit.
- In cases where the hospital or inpatient facility doesn’t have the drug in stock, they have to attempt to locate it and offer to let the patient pay for it up front, out of pocket. If the hospital or facility cannot get the prescription, and the patient either has an outpatient pharmacy where they can get it, or they have it at home, then the hospital or inpatient facility must allow them to bring it to be identified by the in-house pharmacist as being the drug prescribed, properly labeled and not expired, so it can be given to the patient.
- If a patient is too sick to safely transfer out of a hospital and there is NO prescriber in the hospital or inpatient facility that is willing to prescribe a particular off label drug that the patient wants and that patient has an outpatient doctor willing to prescribe, then the hospital will have a prompt team meeting with that doctor to review all meds and treatments and start the application process for “temporary privileges” with oversight so the outpatient provider can participate in patient’s care regarding the specific off label drug being prescribed. The hospital or inpatient facility, as well as their pharmacist and the doctor in charge of the patients care, will be granted liability immunity for any harm from the specific drug that the patient and outpatient doctor are using as treatment during the remainder of the patients’ time in that facility. The temporary privileges will remain instated until the patient is able to safely transfer to a hospital facility where their outpatient physician is credentialed.
- Ensures a hospital or inpatient facility does not deny nutrition or fluids to a patient except for brief cases where patient is consenting to a procedure or test requiring nothing by mouth and in cases where it is part of their end-of-life health directive. This happened numerous times during COVID damaging the health of many patients.
- FREE SPEECH: Prohibits disciplinary action against ANY licensed health care professional for expressing a medical opinion that does not align with those of the licensing board, a local board of health, or the Ohio Department of Health.
- FEDERAL DRUG BAN PROTECTION: Prohibits a political subdivision, public official, or state agency from enforcing any rule or order issued by a federal agency that prohibits the use of an off-label drug.
As you can see this bill does a LOT of good with no real downside. It simply allows patients to work with their doctors without interference or risk to the hospitals in which they are treated. It is a great compromise that protects all parties, expands the rights of everyone, and ensures healthcare be focused on the patient and the doctor without interference from bureaucrats.
The next step is for this bill to go to the Ohio Senate and we are hoping that Senate Leader Matt Huffman will refer it to committee prior to recess (this should not be an issue in light of the fact that we know what committee it goes to and it is receiving HUGE bi-partisan support). Since this legislation has been thoroughly reviewed and was supported by so many Republicans AND even some Democrats this should be slam-dunk and HUGE win for the people of Ohio… like I said – on this issue of protecting patient rights – I think we have found something even Governor DeWine and I can come together on.
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