OHIO LEGISLATIVE SERVICE COMMISSION
Office of Research Legislative Budget
www.lsc.ohio.gov and Drafting Office
H.B. 73 Bill Analysis
135th General Assembly
Click here for H.B. 73’s Fiscal Note
Version: As Passed by the Senate
Primary Sponsors: Reps. Gross and Loychik
Effective date:
Elizabeth Molnar, Attorney
SUMMARY
▪ Generally authorizes a prescriber to prescribe an off-label drug and requires a pharmacist
practicing in a hospital or inpatient facility to dispense, and the hospital or inpatient
facility to allow the dispensing of, the off-label drug.
▪ Authorizes, under certain circumstances, the off-label drug to be brought into a hospital
or inpatient facility for administration to a patient.
▪ Establishes a process by which an outpatient Ohio-licensed physician prescriber may
obtain temporary hospital privileges to participate in the hospital patient’s care regarding
the administering and monitoring of the prescribed off-label drug.
▪ Grants the in-house pharmacist, physician, other licensed health care professional,
hospital, or inpatient facility qualified immunity from administrative and civil liability for
harm resulting from the use of the off-label drug prescribed by the outpatient physician
prescriber.
▪ Generally prohibits a licensing board from pursuing an administrative or disciplinary
action against a licensed health care professional, hospital, or inpatient facility for actions
taken under the bill.
▪ Prohibits a health-related licensing board and the Ohio Department of Health (ODH) from
infringing on medical free speech.
▪ Prohibits an administrative or disciplinary action against a licensed health care
professional, hospital, or inpatient facility for expressing a medical opinion about off-label
prescribing that does not align with those of a licensing board, a local board of health, or
ODH.
▪ Generally prohibits the denial of nutrition or fluids to a hospital or inpatient facility
patient.
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▪ Specifies that the World Health Organization has no jurisdiction in Ohio and prohibits a
political subdivision, public official, or state agency from enforcing or using any state
funding to implement or incentivize any guideline, mandate, recommendation, or rule it
issues, including one that prohibits issuing a prescription for, or dispensing, an off-label
drug.
▪ Names the act the Dave and Angie Patient and Health Provider Protection Act.
DETAILED ANALYSIS
Off-label drugs – prescribing
The bill authorizes a prescriber to issue for a human patient a prescription for an off-label
drug that is approved for human use – if the prescriber has obtained the patient’s informed
consent or the consent of the person holding the patient’s health care power of attorney.1
Definitions
The bill defines a prescriber to include a physician, advanced practice registered nurse,
physician assistant, optometrist, dentist, or veterinarian.2 It also defines an off-label drug to
mean a drug that is both of the following: (1) approved by the federal Food and Drug
Administration (FDA) to treat or prevent a disease, illness, or infection, but prescribed for or used
to treat or prevent another disease, illness, or infection and (2) legal for use in Ohio.3
Authority to prescribe off-label
In general, once the FDA approves a drug for a specific indication, it may be prescribed by
a health care provider for any indication, absent state law to the contrary, if the provider
determines it medically appropriate. This is often referred to as off-label use.4 The bill codifies
that authority.
Decision to accept an off-label drug
The bill states that the ultimate decision to accept an off-label drug prescribed by the
prescriber must be made by any of the following who has given informed consent – the patient,
minor patient’s parent or guardian, or person holding the patient’s health care power of
attorney.5
1 R.C. 3792.06(B).
2 R.C. 4729.01, not in the bill.
3 R.C. 3792.06(A).
4 U.S. Food and Drug Administration, Understanding Unapproved Use of Approved Drugs “Off Label”
(February 5, 2018), which is also available by conducting a keyword “off label” search on the FDA’s
website: fda.gov.
5 R.C. 3792.06(C).
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Off-label drugs − dispensing
The bill also requires a pharmacist practicing in a hospital or inpatient facility to dispense
an off-label drug, and the hospital or inpatient facility to allow its dispensing, except in the
following circumstances:
▪ The pharmacist, hospital, or inpatient facility has a moral, ethical, or religious belief or
conviction that conflicts with the off-label drug’s dispensing;
▪ The pharmacist has documented that the patient has a history of a life-threatening
allergic reaction to the off-label drug or there is a life-threatening contraindication;
▪ The pharmacist, hospital, or inpatient facility has an objective, good faith, and scientific
objection to the administration or dosage of the off-label drug for that patient or that
patient’s condition.6
The bill does not specifically address the dispensing of off-label drugs by pharmacists
practicing in other settings.
Public health emergency or period when health order in effect
The bill’s requirement that a hospital or inpatient facility pharmacist dispense an off-label
drug applies only during a public health emergency or period in which a local or state public
health order is in effect.7
Pharmacist discussion
The bill specifies that its provisions do not prevent the pharmacist from discussing a
prescription or expressing any dosage recommendations or other concerns with the prescriber
who issued the prescription.8
Prohibited off-label drugs
Under the bill, some off-label drugs cannot be prescribed, dispensed, or administered.9 It
prohibits a person from prescribing, dispensing, or administering an off-label drug if the person
knows, or has reasonable cause to know, that the off-label drug is any of the following:
▪ A controlled substance that is not intended for a medical purpose;
▪ A drug subject to a federal Food and Drug Administration (FDA) risk evaluation and
mitigation strategy;
6 R.C. 3792.06(C) and R.C. 4743.10, not in the bill.
7 R.C. 3792.06(C).
8 R.C. 3792.06(C).
9 R.C. 3792.06(G).
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▪ A cross-sex hormone or puberty-blocking drug to be used in violation of the law regarding
gender transition services for minors;10
▪ A drug to be used for euthanasia.
The bill does not specify a penalty for violating these provisions.
Off-label drugs − hospitals and inpatient facilities
Most of the bill’s provisions relate to the prescribing, dispensing, or use of an off-label
drug in a hospital or inpatient facility only, including those that address when the off-label drug
is not in stock or when the hospital, facility, in-house pharmacist, or treating prescriber has a
conflicting moral, ethical, or religious belief or conviction about it being prescribed, dispensed,
or used.11
For purposes of the bill, a hospital includes one owned or operated by the U.S.
Department of Veterans Affairs, while an inpatient facility means a freestanding inpatient
rehabilitation facility licensed by ODH or a skilled nursing facility.12
Good faith effort to locate off-label drug
Under the bill, when an in-house treating prescriber issues for a hospital or inpatient
facility patient a prescription for an off-label drug and the drug is neither in stock nor listed on
the hospital’s or facility’s formulary, the hospital or facility pharmacist must document in the
patient’s medical record that a good faith effort was made to find out if the drug is available from
another hospital, facility, or another United States distributor.13
Out-of-pocket costs – in-house off-label prescribing
If the off-label drug is available from another hospital, facility, or U.S. distributor, but the
off-label drug is not authorized under insurance or the patient does not want to wait for its
authorization, the bill requires the patient to be notified of estimated out-of-pocket costs and
the drug to be offered to the patient at an upfront, out-of-pocket cost to the patient. Under the
bill, the hospital or inpatient facility may require payment prior to ordering the off-label drug.14
Access to and administration of off-label drugs
If (1) the hospital or inpatient facility pharmacist is unable to obtain the off-label drug
prescribed by an in-house treating prescriber from another hospital, facility, or distributor or
(2) the hospital or facility or its pharmacist declines to fill the prescription for a moral, ethical, or
religious belief or conviction, and (3) the patient has access to the off-label drug through a
10 R.C. 3129.01 and 3129.02, not in the bill.
11 R.C. 3792.06(C).
12 R.C. 3792.06(A).
13 R.C. 3792.06(C).
14 R.C. 3792.06(C).
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pharmacy outside the hospital or facility or has the off-label drug available at home, the bill
provides for both of the following:
▪ The hospital or facility must permit the off-label drug to be brought in to be identified, or
determined by the hospital or facility pharmacist to be in its original packaging or labeled
from an outside retail pharmacy, approved by the prescriber for use, and not outside its
beyond use date,15 for the patient’s use and administration within the hospital or facility;
▪ When the hospital or inpatient facility or the patient’s in-house treating prescriber or
other in-house treating clinician is unwilling to administer the off-label drug to the patient
for a moral, ethical, or religious belief or conviction, another prescriber or prescriber’s
delegate may administer the drug.16
Temporary privileges − hospitals only
When a hospital patient’s condition is so serious that the patient cannot be safely
transported out of the hospital and the patient or person holding the patient’s health care power
of attorney wishes to try an off-label drug to treat the patient’s condition, but there is no in-
house prescriber willing to prescribe the drug, all of the following apply under the bill:
▪ The patient’s outpatient Ohio-licensed physician prescriber, after a prompt consultation
with the patient’s hospital care team and a review of all of the patient’s drugs, must be
allowed to immediately begin applying for temporary privileges, based on criteria within
the hospital medical staff bylaws used to determine the issuance of temporary privileges
to treat that patient only;
▪ The hospital bylaws must not be more restrictive for outpatient physicians than for other
physicians seeking temporary privileges;
▪ The physician applicant is not prevented by the bill from withdrawing the application
during the process and the hospital is not prevented by the bill from revoking temporary
privileges if at any point the physician’s license is found not to be in good standing;
▪ If the outpatient physician prescriber meets the bylaw requirements for temporary
privileges, the outpatient physician prescriber must 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 until the
patient is in a condition where the patient can be safely transported to a hospital or
inpatient facility that is willing to provide that off-label drug, or discharge home, or within
the maximum number of days temporary privileges are allowed within the hospital’s
bylaws, whichever comes first.17
In such a case, both of the following provisions apply:
15 R.C. 3792.06(A).
16 R.C. 3792.06(C) and 4743.10, not in the bill.
17 R.C. 3792.06(C).
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▪ The hospital or facility must permit the off-label drug to be brought in to be identified, as
described above in “Access to and administration of off-label drugs”;
▪ When the hospital or inpatient facility or the patient’s in-house treating prescriber or
other in-house treating clinician is unwilling to administer the off-label drug to the patient
for a moral, ethical, or religious belief or conviction, another prescriber or prescriber’s
delegate may administer the off-label drug.18
Outpatient physician – consultation with patient care team
The bill requires an outpatient physician with temporary privileges to make a good faith
effort to maintain ongoing consultation with the patient’s care team during the duration that the
privileges are in effect.
And in a case where there is a disagreement between the care team and the outpatient
physician on the continued use of the off-label drug, the decision to continue the use of the off-
label drug prescribed by the outpatient physician must be made by the patient, minor patient’s
parent or guardian, or person holding the patient’s health care power of attorney. The bill
provides that this decision is to be made after (1) having a discussion with the outpatient
physician and hospital care team on the risks and benefits of continuing the off-label drug and
(2) giving informed consent.
Out-of-pocket costs – outpatient off-label prescribing
If the off-label drug prescribed by the outpatient physician with temporary privileges is not
authorized under the patient’s insurance or the patient does not want to wait for its authorization,
the bill requires the patient to be offered the option to pay out-of-pocket, upfront before it is ordered.
It also requires the patient to be notified of estimated out-of-pocket costs prior to ordering.19
Immunity
The bill grants the in-house pharmacist, hospital, or inpatient facility and the in-house
physicians or other licensed health care professionals responsible for the patient’s care immunity
from administrative and civil liability for any harm that may arise from the patient’s use of the
off-label drug prescribed by an outpatient physician prescriber starting from the date of
dispensing.20
Disciplinary actions
The bill prohibits a health-related licensing board, the State Board of Pharmacy, and ODH
from considering any action taken by a prescriber, pharmacist, other licensed health care
professional, hospital, or inpatient facility under the bill to be unlawful, unethical, unauthorized,
or unprofessional conduct.21 It further prohibits such an entity from pursuing an administrative
18 R.C. 3792.06(C).
19 R.C. 3792.06(C).
20 R.C. 3792.06(C).
21 R.C. 3792.06(D).
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or disciplinary action against the prescriber, pharmacist, health care professional, hospital, or
inpatient facility, except in cases of recklessness or gross negligence.22
For purposes of the bill, gross negligence is defined to mean the intentional failure to
perform an apparent duty in reckless disregard of the consequences concerning the life or
property of another.23
Medical free speech and opinions
The bill prohibits a health-related licensing board, the State Board of Pharmacy, and ODH
from infringing on medical free speech or from threatening to pursue, or pursuing, an
administrative or disciplinary action against a prescriber, pharmacist, other licensed health
professional, hospital, or inpatient facility for publicly or privately expressing a medical opinion
about off-label prescribing that does not align with the opinions of the board, a local board of
health, or ODH.24
Denial of fluids or nutrition
The