WSR 07-14-127

PROPOSED RULES

DEPARTMENT OF HEALTH


[ Filed July 3, 2007, 12:19 p.m. ]

Original Notice.

Preproposal statement of inquiry was filed as WSR 05-14-153, 05-14-152, and 05-14-155.

Title of Rule and Other Identifying Information: Naturopathic Physicians: WAC 246-836-210 Authority to use, prescribe, dispense and order, 246-836-211 Education and training requirements regarding controlled substances, and 246-836-220 Intramuscular, intravenous, subcutaneous, and intradermal injections.

Hearing Location(s): Holiday Inn, 1 South Grady Way, Renton, WA 98055, on August 17, 2007, at 11:00 a.m.

Date of Intended Adoption: August 17, 2007.

Submit Written Comments to: Susan Gragg, Program Manager, Department of Health, Naturopathy Program, P.O. Box 47866, Olympia, WA 98504-7866, web site http://www3.doh.wa.gov/policyreview/, fax (360) 236-2406, by August 3, 2007.

Assistance for Persons with Disabilities: Contact Susan Gragg by August 3, 2007, TTY (800) 833-6388 or 711.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The proposed rules implement chapter 158, Laws of 2005 (HB 1546), codified in part as RCW 18.36A.020 and 18.36A.040, which expands the scope of practice of naturopathic physicians to include legend drugs, controlled substances, codeine and testosterone products, and deletes other outdated language. The proposed rules also describe the requirements for authorization to administer, prescribe, or dispense codeine and testosterone products. Finally, the proposed rules identify the routes by which medical substances may be administered, as well as establishing the education and training requirements for including intramuscular, intravenous, subcutaneous, and intradermal injections into naturopathic practice.

Reasons Supporting Proposal: See above.

Statutory Authority for Adoption: RCW 18.36A.060.

Statute Being Implemented: RCW 18.36A.020, 18.36A.040, section 3, chapter 158, Laws of 2005.

Rule is not necessitated by federal law, federal or state court decision.

Name of Proponent: Department of health, naturopathy program, governmental.

Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: Susan Gragg, 310 Israel Road S.E., Tumwater, WA 98501, (360) 236-4941.

A small business economic impact statement has been prepared under chapter 19.85 RCW.

Small Business Economic Impact Statement

1. Briefly describe the proposed rule: The proposed rules:

Revise WAC 246-836-210 Authority to use, prescribe, dispense and order, to include legend drugs, the two authorized controlled substances, codeine and testosterone products, and deletes outdated language.
Creates WAC 246-836-211 Authorization regarding controlled substances, which describes the process by which naturopathic physicians are approved to add codeine and testosterone products into their practice.
Creates WAC 246-836-220 Intramuscular, intravenous, subcutaneous, and intradermal injections, which identifies how medical substances are administered and establishes the education and training requirements for naturopathic physicians who include intravenous therapy into their practice.
2. Is a small business economic impact statement (SBEIS) required for this rule? Yes.

3. Which industries are affected by this rule? The proposed rules impact naturopathic physicians who add codeine and testosterone products or intravenous therapy into their practice. To estimate costs to businesses, each licensee is assumed to be a business. Most practitioners have either one or no employees (this information was determined by a series of random telephone calls to licensed practitioners coupled with information obtained through internet searches).

SIC Industry Code and Title # of Businesses # of

Employees

8049 Offices and Clinics of Health Care Practitioners, Not Elsewhere Classified 837 867

4. What are the costs of complying with this rule for small businesses (those with fifty or fewer employees) and for the largest 10% of businesses affected? All businesses that must comply are considered small businesses. Costs incurred for those providers who add services to their practices are estimated as follows:

1. $0 Those choosing not to add controlled substances codeine and testosterone products to their practice.
2. $0 Those choosing not to add intravenous therapy to their practice.
3. Low

$65

High

$250

Those choosing to add codeine and testosterone products to their practice by completing additional training.
4. Low

$150

High

$500

Those choosing to add intravenous therapy to their practice.

To obtain or transfer registration from the Federal Drug Enforcement Agency (DEA) those practitioners adding codeine and testosterone products would pay a DEA registration fee, currently $551.

5. Does the rule impose a disproportionate impact on small businesses? No.

6. If the rule imposes a disproportionate impact on small businesses, what efforts were taken to reduce that impact (or why is it not "legal and feasible" to do so) by: The proposed rules do not impose a disproportionate impact on small businesses.

7. How are small businesses involved in the development of this rule? Department staff worked closely with the naturopathy advisory committee, the Washington Association of Naturopathic Physicians, and practitioners.

A copy of the statement may be obtained by contacting Susan Gragg, Department of Health, Naturopathy Program, P.O. Box 47866, Olympia, WA 98504-7866, phone (360) 236-4941, fax (360) 236-2406, e-mail susan.gragg@doh.wa.gov.

A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Susan Gragg, Department of Health, Naturopathy Program, P.O. Box 47866, Olympia, WA 98504-7866, phone (360) 236-4941, fax (360) 236-2406, e-mail susan.gragg@doh.wa.gov.

July 3, 2007

Mary C. Selecky

Secretary

OTS-9344.5


AMENDATORY SECTION(Amending Order 247, filed 2/25/92, effective 3/27/92)

WAC 246-836-210   Authority to use, prescribe, dispense and order.   ((Licensed naturopaths may use, prescribe, dispense, and order certain medicines of mineral, animal, and botanical origin including the following:)) (1) Naturopathic medical practice includes the prescription, administration, dispensing, and use of:

(a) Nutrition and food science, physical modalities, minor office procedures, homeopathy, hygiene, and immunizations/vaccinations;

(b) Nondrug contraceptive devices;

(c) Nonlegend medicines ((derived from animal organs, tissues, and oils, minerals, and plants administered orally and topically)) including vitamins, minerals, botanical medicines, homeopathic medicines, and hormones;

(d) Legend drugs as defined under RCW 69.41.010 with the exception of Botulinum Toxin (commonly known as, among other names, Botox, Vistabel, Dysport, or Neurobloc) and inert substances used for cosmetic purposes; and

(e) Codeine and testosterone products that are contained within Schedules III, IV, and V in RCW 69.50.010 (2)(d).

(2) In accordance with RCW 69.41.010(13), all prescriptions must be hand-printed, typewritten, or generated electronically.

(3) Prior to being allowed to administer, prescribe, dispense, or order controlled substances, a naturopathic physician must meet the requirements in WAC 246-836-211 and have obtained the appropriate registration issued by the Federal Drug Enforcement Administration.

(((2) Legend topical ointments, creams, and lotions containing antiseptics.

(3) Legend topical, local anesthetics applied to superficial structures for use during minor office procedures as appropriate. Topical local anesthetic means the local application of anesthetic which may be injected into the intradermal subcutaneous layers of the skin only to the extent necessary to care for superficial lacerations, abrasions and the removal of foreign bodies located in superficial structures not to include the eye.

(4) Legend vitamins, minerals, trace minerals, and whole gland thyroid.

(5) Nondrug contraceptive devices except intrauterine devices.

(6) All homeopathic preparations.

(7) Intramuscular injections limited to vitamin B-12 preparations and combinations when clinical or laboratory evaluation has indicated vitamin B-12 deficiency.

(8) Immunizing agents approved by the Bureau of Biologics, United States Food and Drug Administration and listed in the current Recommendations of the United States Public Health Services Immunizations Practices Advisory Committee (ACIP) or the Report of the Committee of Infectious Diseases published by the American Academy of Pediatrics.

(9) Legend substances as exemplified in traditional botanical and herbal pharmacopeia as identified by a list of substances to be developed by the secretary.)) (4) Naturopathic physicians may not treat malignancies and neoplastic diseases except in collaboration with a practitioner licensed under chapter 18.57 or 18.71 RCW.

[Statutory Authority: RCW 18.36A.060 [(1)](a). 92-06-020 (Order 247), 246-836-210, filed 2/25/92, effective 3/27/92.]


NEW SECTION
WAC 246-836-211   Authorization regarding controlled substances.   (1) Upon approval by the department, naturopathic physicians may obtain a current Federal Drug Enforcement Administration registration. The department may approve naturopathic physicians who have:

(a) Provided documentation of a current Federal Drug Enforcement Administration registration from another state; or

(b) Submitted an attestation of at least four hours of instruction. Instruction must be part of a graduate level course from a school approved under chapter 18.36A, 18.71, 18.57, or 18.79 RCW. Instruction must include the following:

(i) Principles of medication selection;

(ii) Patient selection and therapeutics education;

(iii) Problem identification and assessment;

(iv) Knowledge of interactions, if any;

(v) Evaluation of outcome;

(vi) Recognition and management of complications and untoward reactions; and

(vii) Education in pain management and drug seeking behaviors.

(2) The naturopathic physician must retain training documentation at least five years from attestation date.

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NEW SECTION
WAC 246-836-220   Intramuscular, intravenous, subcutaneous, and intradermal injections.   Naturopathic physicians may administer substances consistent with the practice of naturopathic medicine as indicated in WAC 246-836-210 through the means of intramuscular, intravenous, subcutaneous, and intradermal injections.

(1) Naturopathic physicians may use intravenous therapy when they have submitted an attestation of training. Training must be at least sixteen hours of instruction. At least eight hours must be part of a graduate level course from a school approved under chapter 18.36A, 18.71, 18.57, or 18.79 RCW. Instruction must include the following:

(a) Indications;

(b) Contraindications;

(c) Formularies;

(d) Emergency protocols;

(e) Osmolarity calculation;

(f) Aseptic technique; and

(g) Proper documentation.

(2) The naturopathic physician must retain training documentation at least five years from attestation date.

(3) Intravenous chelation therapy is limited to use for heavy metal toxicity.

(4) All naturopathic physicians who use injection therapy must have a plan to manage adverse events including sensitivity, allergy, overdose, or other unintended reactions.

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Washington State Code Reviser's Office