Nevada § 633.6945 - Individualized investigational treatment or investigational drug, biological product or device: Conditions under which osteopathic physician is authorized to prescribe or recommend; contents of form for consent; contents of informational form provided to patient; duty to notify Board of death or hospitalization of patient; biennial report to Legislature; action not grounds for disciplinary action

treatment or investigational drug, biological product or device to a patient if the

osteopathic physician has: (a) Diagnosed the patient with a life-threatening or severely debilitating disease

or condition; (b) Discussed with the patient all available methods of treating the life-threatening

or severely debilitating disease or condition that have been approved by the United

States Food and Drug Administration and the patient and the osteopathic physician

have determined that no such method of treatment is adequate to treat the life-threatening

or severely debilitating disease or condition of the patient; (c) For an individualized investigational treatment, conducted an analysis of the

patient's genomic sequence, human chromosomes, deoxyribonucleic acid, ribonucleic

acid, genes, gene products or metabolites or an immunity panel, as applicable to the

individualized investigational treatment; and (d) Obtained informed, written consent to the use of the individualized investigational

treatment or investigational drug, biological product or device, as applicable, from: (1) The patient; (2) If the patient is incompetent, the representative of the patient; or (3) If the patient is less than 18 years of age, a parent or legal guardian of the

patient. 2. An informed, written consent must be recorded on a form signed by the patient,

or the representative or parent or legal guardian of the patient, as applicable. The form must: (a) To the extent practicable, be in the preferred language of the patient, or the

representative or parent or legal guardian of the patient, as applicable. (b) Be in language that is at the reading level of an eighth grader or a pupil enrolled

in a lower grade. (c) Include or be accompanied by: (1) An overview of the provisions of this section and NRS 454.690 , including, without limitation, a detailed description of the provisions of subsection

1 and the terms defined in subsection 8; (2) A comprehensive explanation of all methods of treating the life-threatening or

severely debilitating disease or condition of the patient that are currently approved

by the United States Food and Drug Administration, including, without limitation,

information concerning such methods published by the United States Food and Drug Administration,

the National Institutes of Health or other federal agencies; (3) A statement that the patient, or the representative or parent or legal guardian

of the patient, as applicable, and the osteopathic physician agree that no such method

is likely to adequately treat the life-threatening or severely debilitating disease

or condition of the patient; (4) Clear identification of the specific individualized investigational treatment

or investigational drug, biological product or device proposed to treat the life-threatening

or severely debilitating disease or condition of the patient; (5) A detailed description of the consequences of using the individualized investigational

treatment or investigational drug, biological product or device, which must include,

without limitation: (I) A detailed description of the best and worst possible outcomes; (II) A realistic and detailed description of the most likely outcome, in the opinion

of the osteopathic physician; (III) A detailed description of relevant information that is not known about the individualized

investigational treatment or investigational drug, biological product or device;

and (IV) A statement of the possibility that using the individualized investigational

treatment or investigational drug, biological product or device may result in new,

unanticipated, different or worse symptoms or the death of the patient occurring sooner

than if the individualized investigational treatment or investigational drug, biological

product or device is not used and a detailed description of any known new, different

or worse symptoms the patient may suffer; (6) A statement of the rights of the patient, including, without limitation, the rights

to: (I) Make an informed decision concerning the use of the individualized investigational

treatment or investigational drug, biological product or device; and (II) Withdraw from or refuse treatment using the individualized investigational treatment

or investigational drug, biological product or device at any time; (7) Information concerning resources that may be useful to the patient, including,

without limitation, the contact information for agencies or organizations that may

be able to provide support to the patient; (8) A means by which the patient may contact the manufacturer of the individualized

investigational treatment or investigational drug, biological product or device with

any additional questions or concerns; (9) A statement that a health insurer of the patient may not be required to pay for

care or treatment of any condition resulting from the use of the individualized investigational

treatment or investigational drug, biological product or device unless such care or

treatment is specifically included in the policy of insurance covering the patient

and that future benefits under the policy of insurance covering the patient may be

affected by the patient's use of the individualized investigational treatment or investigational

drug, biological product or device; and (10) A statement that the patient, or the representative or parent or legal guardian

of the patient, as applicable, understands that the patient is liable for all costs

resulting from the use of the individualized investigational treatment or investigational

drug, biological product or device, including, without limitation, costs resulting

from care or treatment of any condition resulting from the use of the individualized

investigational treatment or investigational drug, biological product or device, and

that such liability will be passed on to the estate of the patient upon the death

of the patient. 3. An osteopathic physician who prescribes or recommends an individualized investigational

treatment or investigational drug, biological product or device to a patient shall

provide to the patient a form that: (a) To the extent practicable, is in the preferred language of the patient; and (b) Contains: (1) The name of the individualized investigational treatment or investigational drug,

biological product or device; (2) The instructions for use and, where applicable, the recommended dosage of the

individualized investigational treatment or investigational drug, biological product

or device; (3) Where applicable, the investigational new drug number assigned by the United States

Food and Drug Administration; (4) The telephone number for the hotline established pursuant to subsection 4 of NRS 454.690 ; (5) The contact information, telephone number, hours of operation and physical address

of an emergency room or urgent care facility that is easily accessible to the patient

if the patient experiences an adverse effect or symptom; and (6) Any other information concerning the individualized investigational treatment

or investigational drug, biological product or device that is relevant to the care

of the patient. 4. Not later than 72 hours after the death or hospitalization of a patient which results

from the use of an individualized investigational treatment or investigational drug,

biological product or device, the osteopathic physician who prescribed or recommended

the individualized investigational treatment or investigational drug, biological product

or device shall notify the Board. 5. On or before January 31 of each odd-numbered year, the Board shall submit to the

Director of the Legislative Counsel Bureau for transmittal to the next regular session

of the Legislature a summary of the information reported to the Board pursuant to

subsection 4 and subsection 4 of NRS 454.690 during the immediately preceding biennium. 6. An osteopathic physician is not subject to disciplinary action for prescribing

or recommending an individualized investigational treatment or investigational drug,

biological product or device when authorized to do so pursuant to subsection 1. 7. The Board may adopt regulations to ensure the safety and efficacy of individualized

investigational treatments and investigational drugs, biological products and devices

prescribed or recommended pursuant to this section. 8. As used in this section: (a) “ Individualized investigational treatment ” has the meaning ascribed to it in NRS 454.690 . (b) “ Investigational drug, biological product or device ” has the meaning ascribed to it in NRS 454.690 . (c) “ Life-threatening disease or condition ” has the meaning ascribed to it in NRS 454.690 . (d) “ Severely debilitating disease or condition ” has the meaning ascribed to it in NRS 454.690 .