BILL ANALYSIS �
SB 1446
Page 1
SENATE THIRD READING
SB 1446 (Negrete McLeod)
As Amended August 22, 2012
Majority vote
SENATE VOTE : 37-0
BUSINESS & PROFESSIONS 9-0
APPROPRIATIONS 17-0
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|Ayes:|Hayashi, Bill Berryhill, |Ayes:|Fuentes, Harkey, |
| |Allen, Butler, Eng, | |Blumenfield, Bradford, |
| |Hagman, Hill, Ma, Smyth | |Charles Calderon, Campos, |
| | | |Davis, Donnelly, Gatto, |
| | | |Hall, Hill, Lara, |
| | | |Mitchell, Nielsen, Norby, |
| | | |Solorio, Wagner |
|-----+--------------------------+-----+--------------------------|
| | | | |
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SUMMARY : Allows naturopathic doctors (NDs) to independently
prescribe and administer vitamins, minerals, amino acids,
glutathione, botanicals and their extracts, homeopathic
medicines, electrolytes, sugars, and diluents, as specified.
Specifically, this bill :
1)Allows NDs to independently prescribe and administer vitamins,
minerals, amino acids, glutathione, botanicals and their
extracts, homeopathic medicines, electrolytes, sugars, and
diluents that may be administered utilizing routes of
administration allowed under current law for NDs, only when
such substances are chemically identical to those for sale
without a prescription.
2)Requires an ND, in order to qualify to administer intravenous
(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
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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,
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,
glutathione, 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; and,
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
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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
training of an ND.
6)Makes conforming and technical changes.
FISCAL EFFECT : According to the Assembly Appropriations
Committee, minor, absorbable costs to the NMC of the Osteopathic
Medical Board of California to incorporate this bill's
provisions and requirements into regulations related to NDs'
administration of IV substances. These regulations are
currently being drafted; thus, this bill's provisions will not
add significant costs.
COMMENTS : 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."
The Federal Food, Drug, and Cosmetic Act (FDCA) specifies which
drugs must be labeled as prescription only. According to the
sponsor, the Legislative Counsel provided a legal background on
this issue citing case law and concluding, "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 allows NDs to utilize routes of administration that
include oral, nasal, auricular, ocular, rectal, vaginal,
transdermal, intradermal, subcutaneous, IV and intramuscular
(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
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with standardized procedures or protocols developed by the ND
and the supervising physician and surgeon.
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.
Analysis Prepared by : Angela Mapp / B.,P. & C.P. / (916)
319-3301
FN: 0005249