Scope of Naturopathic Practice

The following text was adopted in the first meeting of our joint organizations on February 5, 2010:

In accordance with the laws governing naturopathic medicine in Arizona, specifically the following:

32-1581. Dispensing of natural substances, drugs and devices; conditions; civil penalty; dispensing minerals; definitions
A. A doctor of naturopathic medicine may dispense a natural substance, drug or device to a patient for a condition being diagnosed or treated by the doctor if:
1. The doctor is certified to dispense by the board and the certificate has not been suspended or revoked by the board.

We agree to conform the administration (as defined below) of the substances we use to the above guidelines for dispensing (as defined below). Such substances include but are not limited to the following:

Organic and bio-inorganic, sterile, liquid substances delivered by IV, IM, SQ and other routes of delivery as necessary for optimal treatment as determined by the physician in consultation with the patient, and/or

Non-sterile solid, liquid and/or aerosolized substances delivered PO, topically or by nebulizer to the lungs and other routes of delivery as necessary for optimal treatments as determined by the physician in consultation with the patient.

Each of our patients with whom we use any therapy, experimental or FDA-approved, will be given a Statement of Informed Consent to sign, the form and purpose of which is described below. The Informed Consent will conform to the Naturopathic Rule as follows:

R4-18-802. Informed Consent and Duty to Follow Protocols

A. A physician, medical student engaged in an approved clinical training program, preceptee, or intern who conducts research involving an experimental procedure, medication, or device, shall ensure that all research subjects give informed consent to participate.

B. A physician, medical student engaged in an approved clinical training program, preceptee, or intern, that conducts research on humans involving an experimental procedure, medication, or device shall have a protocol for that research approved by an Institutional Review Board.

Patients will be informed that the therapies used may be experimental and investigational according to the FDA; however, we use them with the knowledge that most of our therapies have been in use for decades or much longer, and that there is a body of medical literature that discusses their use. Utmost consideration will be given by each of the members to each patient with regard to their understanding of the nature of the treatments to be used and the complete absence of coercion, preserving the patient’s free will to engage in any of our treatments or not. The members agreed to only offer therapies to patients that are likely to improve their condition or remove the cause of their condition without causing further harm.

DEFINITIONS

 We declare the following definitions, in the absence of definition by any legal authority with jurisdiction over naturopathic medicine:

“Administer” means the direct application of a prescription-only drug, homeopathic medication, natural substance, or non-prescription drug, whether by injection, inhalation, ingestion or any other means, to the body of a patient or research subject by a naturopathic physician, a naturopathic physician’s nurse or assistant, or by the patient or research subject at a naturopathic physician’s direction.

“Natural substance” means herbal phytotherapeutic or oxygen, carbon, or nitrogen-based therapeutic agent, vitamin, mineral, and food factor concentrate isolated from animal, vegetable or mineral sources for nutritional augmentation.

From R4-18-101 of the Rules of the Naturopathic Medical Board of Arizona, the following definitions will be used in our discussions and deliberations:

“Informed consent” means a document, signed by a patient or the patient’s legal guardian, that verifies that the patient or legal guardian understands the type of treatment the patient is to receive, and whether the clinician is a physician, preceptee, or an intern who is treating the patient. If an experimental or investigational protocol is to be followed, the informed consent form shall clearly state that the patient understands the procedures to be carried out, the risks and benefits of the procedure, medication or device to be used, that the patient can withdraw at any time, that the patient is voluntarily complying, and that the protocol meets the requirements of the institutional review board that approves the protocol.

“Institutional review board” means a group of persons that reviews investigational or experimental protocols and approves its use on animals or humans within an institution for the purposes of protecting the subjects of the investigational or experimental protocol from undue harm and assures that the research and its review is carried out according to guidelines of the United States Department of Health and Human Services, Office of Human Research Protection.

Arizona Law defines the following terms:

32-1581. Dispensing of natural substances, drugs and devices; conditions; civil penalty; dispensing minerals; definitions

1. “Device” means an appliance, apparatus or instrument administered or dispensed to a patient by a doctor of naturopathic medicine.

2. “Dispense” means the delivery by a doctor of naturopathic medicine of a natural substance, drug or device to a patient and only for a condition being diagnosed or treated by that doctor, except for free samples packaged for individual use by licensed manufacturers or repackagers, and includes the prescribing, administering, packaging, labeling and security necessary to prepare and safeguard the natural substance, drug or device for delivery to the treating doctor’s own patient.

The new definition of substances that are acceptable for intravenous use reads as follows:

 15. “Drug” has the same meaning prescribed in section 32-1901 but does not include:

(a) Intravenous administration of legend drugs, except for:

(i) Vitamins, chelation therapy and drugs used in emergency resuscitation and stabilization.

(ii) Minerals.

(iii) Nutrients. For the purposes of this item, “nutrient” means a substance that provides nourishment for growth or metabolism and that is manufactured and supplied for intravenous use by a manufacturer registered with the United States food and drug administration or compounded by a pharmacy licensed by the state board of pharmacy.

(b) Controlled substances listed as schedule I or II controlled substances as defined in the federal controlled substances act of 1970 (21 United States Code section 802), except morphine and any homeopathic preparations that are also controlled substances.

(c) Cancer chemotherapeutics classified as legend drugs.

(d) Antipsychotics.