DPC News | Author: Zachary K. West, DO | Article Link: Click Here
It is common in medicine to utilize prescription therapies in an “off-label” manner. The future of such a practice is now being debated before the Ohio General Assembly.
Ohio House Bill 73 (HB 73), also known as the “Dave and Angie Patient and Health Provider Protection Act,” was introduced in March 2023 by Ohio State Representatives Jennifer Gross and Mike Loychik.1 In her sponsor testimony before the Ohio House Health Provider Services Committee, Representative Gross, a nurse practitioner, stated, “it is estimated that between 40 and 60 percent of all prescriptions in the United States are for off-label uses.”2 HB 73 includes provisions that protect access to “off-label” use when a patient is hospitalized or at an inpatient facility. HB 73 also outlines a process for “objective, good faith, and scientific objection to the administration or dosage of the drug for the patient.”1
HB 73 intends to codify the authority of a physician to prescribe any FDA approved medication that is deemed to be medically necessary for a patient and to do so without retaliation from health or state licensing agencies. Representative Gross stated, “Healthcare providers undergo extensive education to obtain licensure and this licensure indicates their ability to give sound medical advice. No health provider should fear retribution for stating their medical opinion, either privately or publicly.”2
Several provisions in HB 73 specify the dispensing and administering of an off-label drug in a hospital or inpatient facility, including when such a drug is not in stock or the hospital, facility, pharmacist, or treating prescriber has a conflicting moral, ethical, or religious belief or conviction. In circumstances where the drug is not in stock, provisions in HB 73 outline that a “good faith effort” must be taken to locate a supply of the medication from another hospital, facility or distributor. If no supply is located and the patient has access to the drug through an outside pharmacy or at home, then the hospital or facility must allow the drug to be brought in for the patient’s use and administration. In circumstances where no in-house prescriber is willing to prescribe the drug, HB 73 outlines a process for the patient’s outpatient physician to be granted temporary privileges and “immediately be allowed to participate in the patient’s care in the narrowed scope of practice regarding the administering and monitoring of the prescribed off-label drug within the hospital or facility.”1
Medicine is considered to be both an art and a science. It is the art of the practice of medicine that oftentimes is deployed to meet the unique needs of an individual patient. Those unique needs might present in the use of therapy considered “off-label”. A patient may have failed the current standard of therapy or the standard might simply be inappropriate for that particular patient. Other times, there may be no current standard therapy to address the present needs of the patient. It is in such circumstances that a physician utilizes his or her training and medical judgment to develop and propose a course of treatment. Such practice is often a daily occurrence for a physician regardless of whether he or she is working in an outpatient clinic, hospital, or emergency or urgent care setting.
The title of HB 73 comes from a Wooster, Ohio couple that became ill and expressed a desire to attempt treatment that was not available while hospitalized. After repeated denial of his request, Dave consented to the standard hospital protocol and unfortunately soon passed. Angie refused the standard hospital protocol and was told that the medication was not available. Representative Loychik explained in his sponsor testimony, “Angie made the informed decision not to consent to [the] hospital protocol and as a result, was denied fluids and nutrition by the staff because they claimed it was ‘not safe’ for her to receive nutrition unless she was ventilated. Angie and her children continued to beg staff for IV and nutrition fluids and were denied. Ultimately, Angie’s children watched their mother succumb to the effects of dehydration rather than from the illness itself.”3 HB 73 also prohibits a patient in a hospital or inpatient facility from being denied sufficient means of fluids or nutrition, unless that wish is clearly stated in the patient’s end of life health directive or the denial is necessary for a medical procedure whereby such a denial must be for the shortest amount of time medically possible and with the informed consent of the patient or person holding the patient’s health care power of attorney.1
It should come as no surprise that the Ohio Hospital Association and some of members of Ohio’s largest corporate health systems have expressed opposition to HB 73. The Ohio Hospital Association requested that the scope of HB 73 be modified “to only the outpatient and retail pharmacy setting.”4 As a reminder, lobbying by traditional hospital trade organizations resulted in a provision within the Affordable Care Act that effectively banned the expansion of existing physician-owned hospitals and prevented any new physician-owned hospitals from opening.5 The position expressed by the Ohio Hospital Association is one ofconvenience considering the guaranteed control and influence now wielded by hospitals and corporate health systems over the practice of inpatient medicine.
With the rising number of physicians employed by hospitals or corporate health systems we continue to witness actions by such organizations that ultimately undermine and impede upon the patient-physician relationship. Does medical liberty exist when a physician’s opinions or decisions are made in a climate of coercion, threats or fear of retaliation? Does medical liberty exist where interference from entities (i.e. pharmacies, hospitals or other facilities) disrupt the delivery of a mutually agreed upon course of treatment made by a patient and his or her physician?
HB 73 passed the Ohio House Health Care Provider Services Committee by a vote of 8 to 4 and the Ohio House of Representatives by a vote of 75 to 17 and is now before the Ohio Senate Health Committee.
References:
1. https://search-prod.lis.state.oh.us/api/v2/general_assembly_135/legislation/hb73/03_PSC/pdf/
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