Ohio House Bill No. 12 – “Jeff, Dave, and Angie Patient Right to Try Act”
Subject: Analysis of House Bill No. 12, regarding prescribing, dispensing, and administering drugs, with a focus on off-label use and patient rights.
Purpose: To provide a concise overview of the key provisions and implications of Ohio House Bill No. 12.
Summary:
Ohio House Bill No. 12, the “Jeff, Dave, and Angie Patient Right to Try Act,” aims to expand patient access to drugs, including those used “off-label” (using an FDA-approved drug for a different condition than its approved purpose). The bill focuses on ensuring that prescribers can prescribe, pharmacists can dispense, and healthcare facilities can administer drugs, including for off-label uses, provided certain conditions are met, primarily informed consent. It also addresses potential conflicts between healthcare providers’ beliefs and patient requests, and aims to protect healthcare professionals’ free speech while setting limitations for liability and regulatory oversight. However, the act explicitly excludes controlled substances, drugs with REMS, cross-sex hormones or puberty blockers used in violation of existing law, abortifacients for known pregnant patients, and drugs intended for euthanasia.
Key Themes and Provisions:
- Off-Label Use and Informed Consent: The bill permits prescribers to issue prescriptions for any drug, including for off-label use, provided they obtain informed consent from the patient or their representative. “Informed consent means communication between the patient or the patient’s personal representative and the prescriber that results in the patient or the patient’s personal representative authorizing, or agreeing to accept, a specific drug.”
- The prescriber must provide the patient with:
- The patient’s diagnosis (if known).
- Information about the drug consistent with on-label use.
- Information about the risks and benefits of off-label uses, including the option of forgoing treatment.
- Any known financial conflicts of interest.
- Pharmacist and Facility Dispensing Requirements: Pharmacists and healthcare facilities are generally required to dispense and allow the dispensing of drugs prescribed as described above unless:
- They have a “moral, ethical, or religious belief or conviction that conflicts with the drug’s dispensing” (referencing section 4743.10 of the Revised Code).
- The patient has a history of a life-threatening allergic reaction or there is a life-threatening contraindication or drug interaction.
- If a pharmacist/facility has an objective, good-faith, and scientific objection to the drug’s administration or dosage, they must explain and discuss the objection with the prescriber. If they dispense after this discussion, they are immune from civil liability, professional discipline, and regulatory sanctions for harm arising from the dispensing, provided they document the objection within 24 hours.
- Hospital/Inpatient Facility Specifics:
- If an in-house prescriber prescribes a drug not in stock or on the formulary, the pharmacist must make a good faith effort to find the drug from other sources.
- If the drug is unavailable or the facility declines to dispense due to moral/ethical objections (as above), and the patient can obtain the drug outside the facility, the facility must allow the drug to be brought in for identification and administration if it meets certain criteria (prescribed for the patient, original packaging or pharmacy labeling, approved by the prescriber, and not expired).
- If the in-house prescriber is unavailable to administer the drug, the prescriber may designate a delegate, meeting the facility’s accreditation standards, to administer the drug.
- When there is a disagreement about continuing a drug (including off-label), the patient or their representative makes the final decision after discussing risks and benefits with the in-house prescriber and other medical staff.
- Facilities cannot obstruct or delay transfer or discharge if a patient wants to try a drug that no in-house prescriber will prescribe.
- Out-of-Pocket Costs: In an outpatient setting, if the drug isn’t covered by insurance or the patient doesn’t want to wait for prior authorization, the prescriber/pharmacist must inform the patient of the option to pay out-of-pocket and provide an estimated cost. The pharmacist must offer the drug at an upfront, out-of-pocket cost. This also applies to hospitals finding drugs per (C)(3)(a).
- Protection from Regulatory Action: Health-related licensing boards and other state agencies cannot consider prescribing, dispensing, or administering a drug with informed consent, including off-label use, as unlawful, unethical, unauthorized, or unprofessional conduct unless it was done with recklessness or gross negligence. The prescriber remains liable in civil court if harm comes to the patient.
- Important Exception: This protection does not apply to gross negligence or recklessness. “The prescriber is not immune from civil liability if harm comes to the patient.”
- Free Speech Protection: The bill explicitly protects healthcare professionals’ free speech regarding opinions on the safety, risks, benefits, or efficacy of drugs, preventing regulatory action based solely on differing opinions. “A health-related licensing board, the department of health, or other state agency responsible for the licensure or regulation of health care professionals shall neither infringe on free speech nor pursue or threaten to pursue professional discipline or fines or other regulatory sanctions against a prescriber, pharmacist, or other licensed health care professional for publicly or privately expressing an opinion regarding the safety, risks, benefits, or efficacy of a drug or other medical intervention because that opinion does not align with the opinions of the board, department, other state agency, a board of health of a city or general health district, or other health authority.” This protection does not limit liability for medical acts that cause actual harm.
- Exclusions: The bill does not apply to or supersede existing law regarding:
- Controlled substances (including opioids).
- Drugs subject to FDA Risk Evaluation and Mitigation Strategies (REMS).
- Cross-sex hormones or puberty-blocking drugs used in violation of section 3129.02 of the Revised Code.
- Abortifacients when prescribed to known pregnant patients.
- Drugs known to be used for euthanasia.
Potential Implications:
- Increased Access to Off-Label Treatments: The bill could potentially expand patient access to drugs used off-label, particularly for conditions where conventional treatments are ineffective or unavailable.
- Patient Empowerment: By emphasizing informed consent and patient autonomy, the bill aims to empower patients to make decisions about their treatment options.
- Conflicts of Conscience: The bill attempts to balance patient rights with the moral and ethical beliefs of healthcare providers, but potential conflicts may still arise.
- Legal Challenges: The bill could face legal challenges, particularly regarding its scope and the clarity of its provisions.
- Impact on Healthcare Costs: The provisions regarding out-of-pocket costs could impact patients’ financial burden.
Next Steps:
- Monitor the bill’s progress through the legislative process.
- Analyze potential amendments and their impact.
- Assess potential legal and ethical challenges.
- Consider the implications for healthcare providers, patients, and the healthcare system as a whole.