Patient Protection Act - American Legislative Exchange Council - American Legislative Exchange Council

Patient Protection Act

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Summary

The Patient Protection Act establishes conditions for prescribing certain prescription drugs that carry a high risk of severe adverse effects. The Act is intended to promote a higher standard of care in jurisdictions where constitutional or statutory limitations may preclude other legislative approaches to regulating telehealth prescribing practices. Under the Act, before prescribing a qualifying drug, a prescriber must: (1) conduct an in-person examination of the patient, (2) inform the patient that the drug causes severe adverse effects in more than five percent of users, and (3) schedule the patient for a follow-up appointment. For purposes of the Act, severe adverse effects are defined as death, organ failure, sepsis, or infections and hemorrhaging requiring hospitalization when such effects occur in more than five percent of the drug's users.

Draft

Patient Protection Act

Section 1. Purpose and scope.

This Act establishes conditions on the prescribing of prescription drugs causing severe adverse effects and may be cited as the Patient Protection Act.

Section 2. Definitions. For purposes of this Act, the following terms have the following meanings:

“Dangerous drug” means any drug that may be subject to a Risk Evaluation and Mitigation Strategy (REMS) required by the U.S. Food and Drug Administration under 21 U.S.C. § 355‑1.
“Prescriber” means a health care professional authorized to prescribe prescription drugs under [relevant state law].
“Severe adverse effect” means any of the following:
- (a) Death;
- (b) Infection requiring hospitalization;
- (c) Hemorrhaging requiring hospitalization;
- (d) Organ failure;
- (e) Sepsis.

Section 3. Prescribing Requirements.

(A) Before a prescriber may issue for a patient a prescription for a dangerous drug that causes one or more severe adverse effects in greater than five percent of the drug’s users, the prescriber shall do all of the following:
1. Conduct an in-person examination of the patient;
2. Inform the patient that the drug causes one or more severe adverse effects in greater than five percent of the drug’s users;
3. Schedule the patient for a follow-up appointment.

Section 4. Determination of Dangerous Drugs Causing Severe Adverse Effects.

(A) For purposes of this Act, the director of health is responsible for determining if a dangerous drug causes one or more severe adverse effects in greater than five percent of the drug’s users.
(B) In making such a determination, both of the following apply:
1. The director shall consult with the superintendent of insurance and executive directors of the state board of pharmacy and state medical board.
2. The director shall base the determination on the greater of insurance claims, patient reports of severe adverse effects to health care professionals, and any applicable data available from the United States Food and Drug Administration.
(C) The director of health shall prepare and update as needed a list containing each dangerous drug that the director determines causes one or more severe adverse effects in greater than five percent of the drug’s users.
(D) The director shall make the list, and each of its updates, available to the public on the internet web site maintained by the department of health.

Section 7. Effective date. This Act shall become effective [INSERT DATE].