BILL ANALYSIS
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|SENATE RULES COMMITTEE | SB 1390|
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THIRD READING
Bill No: SB 1390
Author: Corbett (D)
Amended: 4/26/10
Vote: 21
SENATE HEALTH COMMITTEE : 9-0, 4/14/10
AYES: Alquist, Strickland, Aanestad, Cedillo, Cox, Leno,
Negrete McLeod, Pavley, Romero
SENATE BUSINESS, PROF. & ECON. DEV. COMMITTEE : 7-0,
4/19/10
AYES: Negrete McLeod, Wyland, Aanestad, Correa, Oropeza,
Walters, Yee
NO VOTE RECORDED: Calderon, Florez
SENATE APPROPRIATIONS COMMITTEE : Senate Rule 28.8
SUBJECT : Prescription drug labels
SOURCE : California Association of Health Facilities
DIGEST : This bill allows the Board of Pharmacy to exempt
from regulations requiring a standardized, patient-centered
prescription drug label, those prescriptions dispensed to a
patient in a health facility, as defined.
ANALYSIS :
Existing law:
CONTINUED
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1. Provides for the licensure and regulation of the
practice of pharmacy by the Board of Pharmacy (Board).
2. Requires the Board to promulgate regulations that
require a standardized, patient-centered, prescription
drug label on all prescription medication dispensed to
patients in California. The Board has to promulgate
these regulations on or before January 1, 2011.
This bill:
1. Allows the Board to exempt from regulations requiring a
standardized, patient-centered prescription drug label,
those prescriptions dispensed to a patient in a health
facility, if the prescriptions are administered by a
licensed health care professional.
Under this bill, prescriptions dispensed to a patient in
a health facility that will not be administered by a
licensed health care professional, or prescriptions that
are provided to the patient upon discharge from the
facility, must still be subject to the prescription drug
labeling requirements in existing law and its associated
regulations.
2. States that the bill will not diminish existing
statutory and regulatory informed consent, patients'
rights, or pharmaceutical labeling and storage
requirements.
Comments
This bill is a follow-up measure to SB 472 (Corbett),
Chapter 470, Statutes of 2007, the California Patient
Medication Safety Act. SB 472 required the Board to adopt
regulations to create a patient-centered, standard format
for prescription drug labels that will take into account
the needs of California patients, including seniors and
limited-English proficient patients.
Background
The Board held a regulatory meeting on a proposed
regulation on January 20, 2010, and revised the
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requirements related to font size and the translation
requirements contained in the original regulation proposal.
Under the proposed regulation, labels on drug containers
dispensed to patients in California must meet specified
requirements to ensure they are patient-centered. Under
the proposed regulations, the following items must be
clustered into one area of the label that comprises at
least 50 percent of the label, using at least 10-point font
using sans serif typeface, listing these items in the
following order:
1. Name of the patient.
2. Name of the drug and strength of the drug ("name of the
drug" means either the manufacturer's trade name, or the
generic name and the name of the manufacturer).
3. Directions for use.
4. Purpose or condition, if entered onto the prescription
by the prescriber, or otherwise known to the pharmacy
and its inclusion on the label is requested by the
patient.
The proposed regulations also require pharmacies to have
policies and procedures in place to help patients with
limited or no English proficiency understand the
information on the label in the patient's language. The
pharmacy's policies and procedures must be specified in
writing, and must include, at minimum, the selected means
to identify the patient's language, and to provide
interpretive services in the patient's language.
Pharmacies must provide, at minimum, interpretive services
in the patient's language, if interpretive services in such
language are available, during all hours that the pharmacy
is open, either in person by pharmacy staff or by use of a
third-party interpretive service available by telephone at
or adjacent to the pharmacy counter.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: No
SUPPORT : (Verified 5/18/10)
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California Association of Health Facilities (source)
Aging Services of California
California Pharmacists Association
ARGUMENTS IN SUPPORT : The bill's sponsor, the California
Association of Health Facilities (CAHF), writes that SB 472
was intended to ensure that labels on prescription
containers were readable and understandable to the
consumers who obtained and used those medications. CAHF
argues that, while it was clear that SB 472 was intended to
provide specific labeling for consumer use, it did not
foresee that the new labeling would be required for
institutional settings, such as in long-term care
facilities. Prescriptions dispensed to patients for
self-administration have been distinguished historically
from prescriptions dispensed in institutional settings that
are administered by personnel of that facility. CAHF
states these prescriptions are, in practice, treated like
those for inpatients in hospitals, where staff are likewise
responsible for proper administration of the drugs.
CAHF states that skilled nursing facility inpatient
medications are administered pursuant to orders in the
patient's chart and are packaged in special systems as
requested by each facility (for example, unit dose and
blister packs). These medications are not in the
possession or control of the patient and are administered
to the patient by facility personnel. CAHF states the
Board has expressed concerns that under SB 472, it is not
clear that the Board can exempt prescriptions administered
in long-term care facilities. SB 1390 provides this clear
authority to the Board, thus allowing long-term care
facilities that have licensed health care personnel
administer medication to a patient to be exempt from the
labeling requirements required by SB 472.
CTW:mw 5/18/10 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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