SB 1446 Senate Bill - Bill Analysis

BILL ANALYSIS Ó

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|Hearing Date:May 7, 2012 |Bill No:SB |
| |1446 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Curren D. Price, Jr., Chair

Bill No: SB 1446Author:Negrete McLeod
As Amended:April 9, 2012 Fiscal: No

SUBJECT: Healing arts: naturopathic doctors.

SUMMARY: Authorizes a naturopathic doctor (ND) to independently
dispense, administer, order, prescribe or furnish specified
substances, consistent with specified routes of administration, as
well as epinephrine and natural synthetic hormones.

Existing law:

1)The Naturopathic Doctors Act provides for the licensure and
regulation of NDs by the Naturopathic Medicine Committee under the
Osteopathic Medical Board of California. (Business and Professions
Code (BPC) § 3640 et seq.)

2)Authorizes a ND to order and perform physical and laboratory
examinations for diagnostic purposes. (BPC § 3640(a))

3) Authorizes a ND to order diagnostic imaging studies consistent with
naturopathic training, as long as the studies are referred to an
appropriately licensed health care professional to conduct the study
and interpret the results. (BPC § 3640(b))

4)Authorizes a ND to perform various tasks, including dispensing,
administering, ordering, and prescribing specified substances, as
defined by the federal Food, Drug, and Cosmetic Act (FDCA)
including: (BPC § 3640(c))

a) Food, extracts of food, nutraceuticals, vitamins, amino acids,
minerals, enzymes, botanicals and their extracts, botanical
medicines, homeopathic medicines, all dietary supplements and

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nonprescription drugs a defined by the FDCA.

b) Hot or cold hydrotherapy; naturopathic physical medicine,
electromagnetic energy, colon hydrotherapy and therapeutic
exercise.

c) Therapeutic devices, barrier contraception and durable medical
equipment.

d) Health and education counseling.

e) Repair of incidental to superficial lacerations and abrasions
except suturing.

f) Removal of foreign bodies located in superficial tissues.
5)Authorizes a ND to use specified routes of administration, including
oral, nasal, auricular, ocular, rectal, vaginal, transdermal,
intradermal, subcutaneous, intravenous (IV) and intramuscular (IM).
(BPC § 3640(d))

6)Authorizes the Naturopathic Medicine Committee to establish
regulations regarding ocular or intravenous routes of administration
that are consistent with the education and training of a ND. (BPC §
3640(e))

7)Authorizes NDs to independently prescribe epinephrine to treat
anaphylaxis and natural and synthetic hormones. (BPC § 3640.7)

8)Authorizes NDs to furnish or order drugs including Schedule III to V
Controlled Substances under the supervision of a medical doctor.
(BPC § 3640.5)

9)Specifies that a drug, including a homeopathic drug, is not safe for
use except under the supervision of a practitioner licensed by law
to administer such drug, and may be dispensed only upon an oral or
written prescription of a practitioner licensed to administer such
drug.
(21 U.S.C. § 353)

10)Restricts NDs from performing any of the following functions: (BPC
§ 3642)

a) Prescribe, dispense or administer a controlled substance
except as authorized.

b) Administer therapeutic ionizing radiation or radioactive

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substances.

c) Practice or claim to practice any other system or method of
treatment for which licensure is required, unless otherwise
licensed to do so.

d) Administer general or spinal anesthesia.

e) Perform an abortion.

f) Perform any surgical procedure.

g) Perform acupuncture or traditional Chinese and Asian medicine,
unless also licensed in California as an acupuncturist.

This bill:

1)Clarifies that NDs are permitted furnish and administer
non-prescription substances that become prescription substances due
to route of administration, via IV or IM routes.

2)Permits NDs to independently dispense, administer, order, prescribe
and furnish epinephrine and natural and synthetic hormones.

FISCAL EFFECT: Unknown. This bill has been keyed "non-fiscal" by
Legislative Counsel.

COMMENTS:

1.Purpose. This bill is co-sponsored by the Naturopathic Medicine
Committe e and the California Naturopathic Doctors Association
(Co-Sponsors). According to the Author, this bill clarifies the
original intent of the Naturopathic Doctor's Act by specifying that
NDs may independently prescribe natural substances (such as
vitamins, minerals and amino acids) that only require a prescription
when they are administered via IV or IM routes. The Co-Sponsors
indicate that the bill does not alter the scope of practice for NDs
and would remove any confusion about the ability of a ND to serve
patients, e.g.: "A naturopathic doctor would be able to administer
an intramuscular vitamin B12 shot to an elderly patient with anemia
due to B12 deficiency."

2.Background. History of Naturopathic Medicine. In 1901, the American
School of Naturopathy was opened in Manhattan, NY. Its approach

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emphasized diet, exercise, physical medicine, herbs and homeopathy
as ways to improve and maintain health. By 1925, there were
approximately 2500 practitioners of naturopathic medicine and more
than 12 schools. As a result, many states enacted regulations
regarding the practice of naturopathic medicine.

Naturopathic medicine experienced a decline in popularity from the
post World War II era until the 1970s as most health care was
focused on the traditional medical model. In the 1970s, interest in
holistic and alternative health care increased leading to an
expansion of naturopathic medicine educational programs and state
licensure.

Naturopathic medicine includes the combination of a variety of
natural medicines and treatments. NDs practice integrative medicine
and are primary health care providers who are clinically trained in
both natural and conventional approaches to medicine. NDs also
write prescriptions for pharmaceuticals and refer patients to
conventional physicians and specialists as needed. NDs are also
permitted to administer substances via various routes of
administration.

a) Education. Currently, 16 states, the District of Columbia,
and the territories of Puerto Rico and the Virgin Islands license
NDs. All states that license NDs require graduation from a
course of study offered through a college approved by the
examining jurisdiction. NDs have limited opportunities to
complete hospital residencies, but perform at least 1500 hours of
clinical rotations at clinics and private doctors' offices during
their education program.

b) Licensure. In 2003, California became the 13th state to
recognize naturopathic medicine and license NDs. The
Naturopathic Medicine Committee which is under the Osteopathic
Medical Board of California licenses and regulates NDs. Over 500
ND licenses have been issued in California to date. To be
eligible for licensure in California, an applicant must have
graduated from one of six approved naturopathic medical schools
accredited by the Council on Naturopathic Medical education
(CNME). An applicant is also required to pass a standardized
licensing examination used in all states that license NDs, the
Naturopathic Physicians Licensing Examination (NPLEX). NDs take
board examinations after two and four years.

c) Scope of Practice. The scope of practice for NDs include
diagnosis and treatment of patients, the authority to order lab

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tests and prescribe most drugs subject to supervision of a
medical or osteopathic physician. Naturopathic Doctors may
perform minor procedures, such as treating lacerations and
removing moles and growths. In 11 states, NDs are also permitted
to administer substances via IV and IM routes of administration.

1.Nutraceuticals. This bill will clarify the language in the BPC §
3640 regarding a variety of substances that a ND may inject via IV
or IM routes. Included in the list of substances are
nutraceuticals. Dr. Stephen L. DeFelice, founder and chairman of
the Foundation of Innovation Medicine (FIM), coined the term
nutraceutical. Since the term was coined, its meaning has been
modified and is generally defined as a product isolated or purified
from foods, and generally sold in medicinal forms that reportedly
provides health and medical benefits, including the prevention and
treatment of disease. Such products may range from isolated
nutrients, dietary supplements, genetically engineered foods, herbal
products and processed foods such as cereals, soups, and beverages.
Nutraceutical foods are not subject to the same testing and
regulations as pharmaceutical drugs.

2.IV and IM routes of administration. There are various routes of
administration for substances including oral, nasal, auricular,
ocular, rectal, vaginal, transdermal, intradermal, subcutaneous, IV
and IM. An IV injection consists of the infusion of liquid
substances directly into a vein and is the fastest way to deliver
substances to the bloodstream. This route often includes a drip
chamber, such as an IV bag, which prevents air from entering the
blood stream and allows an estimation of flow rate. Intramuscular
injections are used for particular forms of medication that are
administered in small amounts and are injected directly into an
individual's muscle tissue and allow for quick uptake by the body
but with reasonably prolonged action.

a) Benefits. Depending on the substance and the patient, an IV
or IM injection may be preferable to other routes of
administration. Many substances have more immediate onset of
action when administered via IV or IM. For example, epinephrine,
a substance used to treat life-threatening allergic reactions
caused by insect bites, foods, medications and latex, may take
5-10 minutes to go into effect if administered orally. Oral
administration also requires the substance to pass through the
gastrointestinal tract and liver first. However, when
administered via IM or IV, the onset is more immediate and the
effects of the substance are intensified. Also, for patients who

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are unable to take medication orally, IV or IM may be an
alternative route of administration.

b) Risks. As with any medical procedure, there are risks with
utilizing IV and IM routes. If not trained properly, the
practitioner may cause nerve damage when administering substances
via IM. Site selection is also important because the effect of
the medication can be enhanced or diminished depending on the
site used. For example, medications which are more viscous and
larger in volume should be administered in the large muscles and
site selection should be based on the size of the muscle and the
client's body mass. In terms of IV administration, infection is
the biggest risk because the skin has been broken, giving
bacteria access to the body. In most cases, infection is
localized, appearing only at the IV site. However, bacteria can
spread throughout the bloodstream. Other risks include embolism,
caused by blood clots or air bubbles, but while potentially life
threatening, this occurs infrequently.

3. The Federal Food Drug and Cosmetic Act. The Act specifies that all
injectable solutions must be labeled as prescription only.

"A drug, including a homeopathic drug, intended for use by man
Ýsic] which, because of its toxicity or other potentiality for
harmful effect, or the method of its use, or the collateral
measures necessary to its use, is not safe for use except under the
supervision of a practitioner licensed by law to administer such
drug ,?, may be dispensed only upon an oral or written prescription
of a practitioner licensed to administer such drug as statutorily
specified." (21 U.S.C. § 353, emphasis added)

4.The Naturopathic Doctor's Act. The Act specifies the routes of
administration that a ND may utilize.

"A naturopathic doctor may utilize routes of administration that
include oral, nasal, auricular, ocular, rectal, vaginal,
transdermal, intradermal, subcutaneous, intravenous and
intramuscular." (BPC § 3640(d))

However, the allowance for NDs to utilize these routes of
administration for nutritional substances is not mentioned in the
independent formulary section of BPC § 3640.5. Section 3640.5 only
indicates that a ND may furnish and order drugs in accordance with

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standardized procedures or protocols developed by the ND and his or
her supervising physician and surgeon.

"Drugs furnished or ordered by a naturopathic doctor may include
Schedule III through Schedule V controlled substances under the
California Uniform Controlled Substances Act?of the Health and
Safety Code and shall be further limited to those drugs agreed upon
by the naturopathic doctor and physician and surgeon as specified in
the standardized procedure." (BPC § 3640.5(f))

5. NDs and Pharmacies. The inconsistency between the Naturopathic
Doctors Act and the federal Food Drug and Cosmetic Act, in regards
to prescription only substances, has led to confusion between
California NDs and pharmacists. Some pharmacies interpret the
Naturopathic Doctors Act as permitting a ND to order injectable
substances intended to be administered via IV and IM routes.
However, other pharmacies abide by the federal Food and Cosmetic
Act which specifies that substances become prescriptions once they
are injected and thus refuse to fill prescriptions for injectable
substances from NDs.

6.Arguments in Support. The Co-Sponsors and several NDs indicate that
the bill will clarify the original intent of the Naturopathic
Doctors Act by allowing NDs to independently administer substances
via IV and IM routes. They indicate: "because the laws pertaining
to the scope of practice are confusing" they prevent the
Naturopathic Medicine Committee from creating or enforcing
disciplinary guidelines and a clear scope of practice is needed.
They assert that making clarifications in current law will allow NDs
to best serve patients in the safest most effective manner possible.

7.Arguments in Opposition. The California Medical Association (CMA)
opposes the bill. They indicate: "While we recognize the role of
naturopathic doctors in the health care system, we remain concerned
about the consistency and depth of their education and training when
it comes to pharmaceuticals and related drugs. In order to
independently prescribe or administer any drug, physicians receive a
minimum of four years of medical school, followed by three to seven
years of residency. Residency programs are an essential part of
medical education, providing professional training under the
supervision of senior physician educators." The CMA also notes that

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they are concerned that this legislation will open the door for
"future expansions into pharmacology."

The Osteopathic Physicians & Surgeons of California (OPSC) oppose the
bill for several reasons. Specifically, they raise concern about
the safety of patients. They write "The administration of high
concentrations of natural products is not grounded in evidence based
medicine?and administering any substance in concentrated doses can
cause severe reactions including potentially fatal conditions."
They also indicate that NDs do not have sufficient training and/or
experience to recognize when a patient has experienced a
contraindication from excessive product administration or an
understanding of appropriate treatment for these cases. The group
also takes issue with the terminology within the bill and they state
"there is no official definition of nutraceuticals and therefore the
language could be broadly interpreted to include even more dangerous
substances than intended."

8.Related Legislation. AB 302 (Committee on Business and Professions,
Chapter 506, Statutes of 2005). This bill added NDs who prescribe
or order drugs to the list of persons authorized to furnish
dangerous drugs and write or issue prescriptions under the Pharmacy
Law and the Uniform Controlled Substances Act. It clarified that
medications provided by NDs may be provided through various routes
of administration. It clarified the circumstances under which a ND
may furnish or order drugs under the oversight of a supervising
physician and surgeon, and required the ND to function pursuant to
standardized procedures or protocols as authorized by provisions
relating to the furnishing or ordering of drugs or devices by nurse
practitioners, except as to Schedule II controlled substances.

SB 907 (Burton, Chapter 485, Statutes of 2003) established the
Naturopathic Doctor's Act and created the Bureau of Naturopathic
Medicine within the Department of Consumer Affairs. The Act set up
criteria for the licensure and regulation of NDs and established a
scope of practice for the profession.

9.Policy Issue. The Committee staff notes the concern raised by the
CMA regarding the limited hospital residency training experience
that naturopathic medicine students are afforded. The Committee
staff also notes that, according to the Co-Sponsors, naturopathic
medicine students receive 1500 hours of training in clinics and
private doctors' offices, and that many NDs currently administer
substances via IV and IM routes. The Committee staff would like to
highlight BPC § 3640(e) which authorizes the Naturopathic Medicine
Committee to establish regulations regarding the use of ocular and

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IV routes of administration for NDs. As such, Committee staff
suggests that, if this legislation is passed, the Naturopathic
Medicine Committee establish regulations regarding the training
needed to utilize specific routes of administration in order to
ensure patient safety.

SUPPORT AND OPPOSITION:

Support:

California Naturopathic Doctors Association (Co-sponsor)
Naturopathic Medicine Committee (Co-sponsor)
85 Naturopathic Doctors
56 individuals
Opposition:

California Medical Association
Osteopathic Physicians & Surgeons of California

Consultant:Le Ondra Clark