Rhode Island § 27-55-1 - Off-Label Uses of Prescription Drugs

§ 27-55-1. Definitions.

For the purpose of this chapter, the following words and terms have the following meanings:

(1) “Drug” or “drugs” means any substance prescribed by a licensed healthcare provider acting within the scope of the provider’s license that is intended for use in the diagnosis, mitigation, treatment, or prevention of disease that is taken by mouth; injected into a muscle, the skin, a blood vessel, or cavity of the body; applied to the skin; or otherwise assimilated by the body. The term includes only those substances that are approved by the FDA for at least one indication.

(2) “FDA” means the federal Food and Drug Administration.

(3) “Health insurer” means all persons, firms, corporations, or other organizations offering and assuring health services on a prepaid or primarily expense-incurred basis including, but not limited to, policies of accident or sickness insurance, as defined in chapter 18 of this title, nonprofit hospital or medical service plans, whether organized under chapter 19 or 20 of this title or under any public law or by special act of the general assembly, health maintenance organizations, and any other entity that insures or reimburses for diagnostic, therapeutic, or preventive services to a determined population on the basis of a periodic premium.

(4) “Medical literature” means published scientific studies published in at least two (2) articles from major peer-reviewed medical journals that present data supporting the proposed off-label use, or uses, as generally safe and effective unless there is clear and convincing contradictory evidence presented in a major peer-reviewed medical journal.

(5) “Peer-reviewed medical journals” means a published study in a journal or other publication in which original manuscripts have been critically reviewed for scientific accuracy, validity, and reliability by unbiased independent experts, and that has been determined by the International Committee of Medical Journal Editors to have met its Uniform Requirements for Manuscripts Submitted to Biomedical Journals. It does not include publications or supplements to publications that are sponsored to a significant extent by a pharmaceutical manufacturing company or any health insurer, healthcare center, hospital service corporation, medical service corporation, or fraternal benefit society that delivers, issues for delivery, renews, amends, or continues a health insurance policy in this state.

(6) “Standard reference compendia” means: (i) The United States Pharmacopoeia drug information, (ii) The American Medical Association drug evaluations, or (iii) The American Hospital Formulary Service drug information.