BILL ANALYSIS Ó
SB 1446
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Date of Hearing: June 19, 2012
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Mary Hayashi, Chair
SB 1446 (Negrete McLeod) - As Amended: June 12, 2012
SENATE VOTE : 37-0
SUBJECT : Naturopathic doctors.
SUMMARY : Allows naturopathic doctors (NDs) to independently
prescribe any substances that require a prescription because
they are injectable solutions administered by intramuscular (IM)
or intravenous (IV) routes, and requires NDs to complete a
qualifying course in order to administer IV therapy.
Specifically, this bill :
1)Allows NDs to independently prescribe any substances that
require a prescription because they are injectable solutions
administered by IM or IV routes, including vitamins, minerals,
amino acids and glutathione, 2,3-Dimercapto-1-propanesulfonic
acid (DMPS), ethylenediaminetetraacetic acid (EDTA),
botanicals and their extracts, homeopathic medicines,
electrolytes, sugars, and diluents.
2)Requires an ND, in order to qualify to administer IV therapy
in his or her practice pursuant to existing law, to
demonstrate that he or she has a current California ND license
and has completed a qualifying course on IV therapy from a
course provider approved by the Naturopathic Medicine
Committee (NMC).
3)Requires the qualifying course to consist of a minimum of 25
classroom hours on IV administration through injection of
applicable naturopathic formulary substances, of which at
least 14 classroom hours shall be identified as practicum. At
a minimum, the qualifying course shall have covered all of the
following topics:
a) Evaluation of laboratory results, including, but not
limited to, the fluid status, cardiovascular status, and
kidney function of the patient;
b) The use of IV fluids, including, but not limited to,
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osmolarity calculations, diluents, and admixtures pertinent
to IV therapeutics;
c) Sterile techniques and admixing;
d) Vein and site selection, site preparation, and insertion
techniques;
e) Complications with therapies, nutrient and drug
interactions, errors and adverse reactions, reporting
errors to appropriate agencies, error prevention, and
follow-up with patient complications;
f) Emergency protocols, management, and referral;
g) Pharmacology, indications, preparation, and IV
administration of vitamins, minerals, amino acids and
glutathione, 2,3-Dimercapto-1-propanesulfonic acid (DMPS),
ethylenediaminetetraacetic acid (EDTA), botanicals and
their extracts, homeopathic medicines, electrolytes,
sugars, and diluents;
h) Practicum, including, but not limited to, the following:
i) Observation of at least 10 IV setups, including
administration and management;
ii) Successful completion of at least 10 IV setups,
including administration and management; and,
i) Successful completion of an examination with 70% or
greater correct answers to a minimum of 50 questions, where
10% or more of the questions have direct content to the
California formulary.
4)Defines, for the purposes of the qualifying course required by
this bill, one classroom hour as 50 minutes out of each
60-minute segment, which may include time devoted to
examinations. No credit shall be granted for distance
education, including, but not limited to, correspondence
courses, Internet courses, or video or remote television
offerings.
5)Allows the NMC to establish regulations regarding IV
administration that are consistent with the education and
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training of an ND.
6)Makes conforming and technical changes.
EXISTING LAW
1)Provides, under the Naturopathic Doctors Act (ND Act) for the
licensure and regulation of NDs by the NMC under the
Osteopathic Medical Board (OMB) of California.
2)Authorizes an 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 food, extracts of food, nutraceuticals,
vitamins, amino acids, minerals, enzymes, botanicals and their
extracts, botanical medicines, homeopathic medicines, all
dietary supplements and nonprescription drugs a defined by the
FDCA;
3)Authorizes NDs to use specified routes of administration,
including oral, nasal, auricular, ocular, rectal, vaginal,
transdermal, intradermal, subcutaneous, IV and IM.
4)Authorizes the NMC to establish regulations regarding ocular
or IV routes of administration that are consistent with the
education and training of an ND.
5)Authorizes NDs to independently prescribe epinephrine to treat
anaphylaxis, and natural and synthetic hormones.
6)Authorizes NDs to furnish or order drugs including Schedule
III to V controlled substances under the supervision of a
physician.
7)Specifies, under the FDCA, 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.
FISCAL EFFECT : Unknown
COMMENTS :
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Purpose of this bill . According to the author, "SB1446 will
clarify existing law for NDs pertaining to the prescribing and
administration of non-prescription substances that become
prescription substances solely depending on the route of
administration, i.e. vitamins through IV administration.
"Currently, the ND Act allows doctors to administer vitamins and
minerals orally and intravenously. However, there is
conflicting pharmaceutical law that states any substance
administered intravenously must be accompanied by a
prescription."
Background . 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.
In 2003, California became the 13th state to recognize
naturopathic medicine and license NDs. The NMC, which is under
the OMB, 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 graduate from one of six
approved naturopathic medical schools accredited by the Council
on Naturopathic Medical Education. An applicant is also
required to pass a standardized licensing examination used in
all states that license NDs, the Naturopathic Physicians
Licensing Examination. NDs take board examinations after two
and four years. 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.
The scope of practice for NDs include diagnosis and treatment of
patients and the authority to order lab tests and prescribe most
drugs, subject to supervision of a medical or osteopathic
physician. NDs 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.
The term nutraceutical generally means a product isolated or
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purified from foods, and generally sold in medicinal forms that
reportedly provide 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.
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.
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. 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. While potentially life-threatening, this
occurs infrequently.
The FDCA specifies which drugs must be labeled as prescription
only:
"A drug intended for use by man which (A) 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; or (B) is limited by an
approved application under section 505 to use under the
professional supervision of a practitioner licensed by law to
administer such drug; shall be dispensed only (i) upon a written
prescription of a practitioner licensed by law to administer
such drug, or (ii) upon an oral prescription of such
practitioner which is reduced promptly to writing and filed by
the pharmacist, or (iii) by refilling any such written or oral
prescription if such refilling is authorized by the prescriber
either in the original prescription or by oral order which is
reduced promptly to writing and filed by the pharmacist. The act
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of dispensing a drug contrary to the provisions of this
paragraph shall be deemed to be an act which results in the drug
being misbranded while held for sale."
According to the sponsor, the Legislative Counsel provided a
legal background on this issue citing case law and concluding,
"Whether a drug requires a prescription is often determined by
the (Food and Drug Administration) under the new drug
application process. Injectable vitamins, because of the method
of their use, and certain high dosages of vitamins, because of
their toxicity, may require a prescription under (the FDCA)."
The ND Act specifies the routes of administration that an ND may
utilize:
"An ND may utilize routes of administration that include oral,
nasal, auricular, ocular, rectal, vaginal, transdermal,
intradermal, subcutaneous, IV and IM."
However, the allowance for NDs to utilize these routes of
administration for nutritional substances is not mentioned in
the independent formulary section of the ND Act. It only
indicates that an ND may furnish and order drugs in accordance
with standardized procedures or protocols developed by the ND
and the 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 ND and physician and surgeon as specified in the
standardized procedure."
The inconsistency between the ND Act and the FDCA, in regards to
prescription-only substances, has led to confusion between
California NDs and pharmacists. Some pharmacies interpret the
ND Act as permitting an ND to order injectable substances
intended to be administered via IV and IM routes. However,
other pharmacies abide by the FDCA, which specifies that
substances become prescriptions once they are injected, and
refuse to fill prescriptions from NDs for injectable substances.
Support . The California Naturopathic Doctors Association
writes, "SB1446 would clarify the original intent of the ND Act
by specifying that naturopathic doctors may independently
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prescribe substances (such as vitamins, minerals and amino
acids) that would not ordinarily require a prescription except
that they become a 'drug' because of the route of administration
(IM or IV). SB1446 does not alter the scope of practice for
naturopathic doctors; it simply clarifies the original statute.
This would remove any confusion over the ability of a
naturopathic doctor to best serve patients in the safest most
effective manner possible?
"NDs are well trained in the use of nutritional IV therapy.
Naturopathic medical schools require 30 hours of live
instruction, of which at least 14 are hands-on. This is more
instruction than is provided in any conventional medical school.
NDs also perform IVs during clinical rotations in medical
school. Many MDs and (osteopathic physicians) who perform
nutritional IV therapy in their practices were taught by NDs.
Research studies have shown nutritional IV therapies to be safe
and effective for a variety of conditions."
Opposition . The Osteopathic Physicians and Surgeons of
California (OPSC) states, "OPSC is concerned that patients could
be placed in significant danger if this bill is approved in its
current form. Although it sounds rather innocuous to administer
natural products, any substance in concentrated doses can cause
severe reactions, including potentially fatal conditions.
Intravenous administration does not allow the body's natural
filters, such as the liver and kidneys, to perform their role in
protecting against harmful contraindications.
"OPSC is concerned 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."
Previous legislation .
SB 667 (Runner) of 2011 allows NDs to independently dispense,
furnish, administer and order epinephrine and natural and
synthetic hormones, and to independently dispense, furnish,
administer, order, and prescribe vitamins, minerals, and
nonprescription drugs, among other substances, using various
specified routes of administration. This bill was held in
Senate Business, Professions and Economic Development Committee.
AB 302 (Committee on Business and Professions), Chapter 506,
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Statutes of 2005, makes a number of changes to the authority of
NDs to furnish and prescribe dangerous drugs, clarifying that
medications provided by NDs may be provided through various
routes of administration, and the circumstances under which a ND
may furnish or order drugs under the oversight of a supervising
physician and surgeon; and, requires NDs to function pursuant to
standardized procedures or protocols, as specified.
SB 907 (Burton), Chapter 485, Statutes of 2003, establishes the
ND Act, creates the Bureau of Naturopathic Medicine within the
Department of Consumer Affairs, establishes criteria for the
licensure and regulation of NDs, and establishes a scope of
practice for the profession.
REGISTERED SUPPORT / OPPOSITION :
Support
California Naturopathic Doctors Association (sponsor)
Naturopathic Medicine Committee
Numerous individuals
Opposition
American Osteopathic Association
California Medical Association
California Podiatric Medical Association
Osteopathic Physicians and Surgeons of California
Analysis Prepared by : Angela Mapp / B.,P. & C.P. / (916)
319-3301