BILL ANALYSIS
SB 1390
Page 1
Date of Hearing: June 22, 2010
ASSEMBLY COMMITTEE ON HEALTH
William W. Monning, Chair
SB 1390 (Corbett) - As Amended: June 15, 2010
SENATE VOTE : Not relevant
SUBJECT : Prescription drug labels.
SUMMARY : Repeals the requirement of the Board of Pharmacy
(Board) to promulgate regulations that require a standardized,
patient-centered, prescription drug label on all prescription
medications dispensed to patients in California on or before
January 1, 2011 and instead requires the board to develop and
post specified language translations on its Web site, imposes
specified requirements on prescription drug labels, and requires
pharmacies to provide specified interpreter services to
patients. Specifically, this bill :
1)Makes legislative findings and declarations regarding the
prevalence of medication errors and attributes these errors to
language barriers.
2)Repeals the requirement of the Board to promulgate
regulations, on or before January 1, 2011, that require a
standardized, patient-centered, prescription drug label on all
prescription medications dispensed to patients in California.
3)Requires the Board to develop, collect, and publish the
following on its Internet Web site on or before January 1,
2012:
a) Translations for directions for use, as specified, in a
minimum of 14 languages, to include all of the non-English
languages identified by the Medi-Cal Managed Care Division
within the Department of Health Care Services (DHCS) for
translation in vital documents, as well as any other
primary languages for groups of 10,000 or more with
limited-English-proficient persons in California; and,
b) Examples of labels, as specified, to aid pharmacies in
label design and compliance.
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4)Requires all prescription drug labels on all prescription
drugs dispensed to patients in California to conform to the
following standardized, patient-centered format, on and after
January 1, 2012:
a) Specified information must be clustered into one area of
the label that comprises at least 50% of the label, printed
in at least a 12-point sans serif typeface, and listed in
specified order, and requires these items to be highlighted
in bold typeface, color, or use of a blank space, for added
emphasis;
b) Remaining elements required for the label, as specified,
shall be printed so as not to interfere with the legibility
or emphasis of the primary elements, as specified, and
authorizes the remaining elements to appear in any style,
font, and size typeface; and,
c) Specified phrases shall be used in appropriate language
of the patient, when applicable.
5)Exempts these requirements for prescriptions dispensed to a
patient in a specified health facility if the prescriptions
are administered by a licensed health care professional.
6)States that prescriptions dispensed to a patient in a health
facility that are not administered by a licensed health care
professional or that are provided to the patient upon
discharge from the facility are subject to the requirements of
this bill.
7)States that nothing in this bill alters or diminishes existing
statutory and regulatory informed consent, patients' rights,
or pharmaceutical labeling and storage requirements,
including, but not limited to specified laws and regulations.
8)Defines "limited-English proficient" or "LEP," as a person who
does not speak English as his or her primary language, and who
has a limited ability to read, write, speak, or understand
English and who can read, speak, or understand a language
other than English.
9)On or after January 1, 2012, requires each pharmacy to do the
following:
a) Provide during all hours of business, competent
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interpreter services to each LEP patient at no charge and
allows services to be provided in person by pharmacy staff,
in person by a third-party interpreter service, or by
telephone or video conference using a third-party
interpreter service; and,
b) Develop written policies and procedures, as specified,
to help an LEP patient orally understand the information on
his or her prescription drug label, including specified
directions for use.
10) Requires each pharmacy to provide LEP patients with any
other written information relevant to the prescription drug in
the language of each LEP patient on and after January 1, 2013.
11) Requires each pharmacy to develop written policies and
procedures to carry out specified provisions, on or before
January 1, 2013.
12) Requires the Board to promulgate any regulations necessary
to clarify the provisions of this bill.
EXISTING LAW :
1)Provides for the licensure and regulation of the practice of
pharmacy by the Board.
2)Requires the Board to do all of the following:
a) 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; and,
b) Hold public meetings statewide that are separate from
its normally scheduled hearings in order to seek
information from groups representing consumers, senior
citizens, pharmacists or the practice of pharmacy, other
health care professionals, and other interested parties.
c) Consider all of the following factors when developing
the requirements for prescription drug labels:
i) Medical literacy research that points to increased
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understandability of labels;
ii) Improved directions for use;
iii) Improved font types and sizes;
iv) Placement of information that is
patient-centered;
v) The needs of those patients with limited English
proficiency and the needs for seniors; and,
vi) Technology requirements necessary to implement
the standards.
d) Report to the Legislature by January 1, 2013, the status
of implementation of the prescription drug label
requirements adopted pursuant to this bill.
FISCAL EFFECT : This bill has not been analyzed by a fiscal
committee.
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, this bill
establishes patient-centered prescription labeling in
California, which will protect consumers from medication
errors. The author cites a report from the Institute of
Medicine of the National Academies that states that medication
errors are the most common medical errors, harming at least
1.5 million people each year. The author states that this
bill will minimize medication errors by ensuring that seniors
and individuals with LEP receive readable and adequate
information about their prescription drugs.
2)BACKGROUND . This bill is a follow-up measure to the author's
SB 472 (Corbett), Chapter 470, Statutes of 2007, the
California Patient Medication Safety Act, which requires 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 LEP patients. According to the author, the bill
was intended to make prescription drug labels easy to
understand by standardizing the information on them so as to
facilitate patient understanding of the information contained
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on these labels, thus reducing medication-related errors,
increasing prescription drug literacy, and improving the
health, safety, and well-being of consumers.
After holding several public meetings on the topic of
patient-centered labels on medication containers, the Board
approved the following regulations on June 10, 2010: Labels
on drug containers dispensed to patients in California must be
clustered into one area of the label that comprises at least
50% of the label, using at least 10-point font using sans
serif typeface, listing these items in the following order:
Name of the patient; name of the drug and strength of the
drug, directions for use; and, purpose or condition, if
entered onto the prescription by the prescriber. For added
emphasis, the label shall also highlight in bold or color, or
use blank space to set off the items listed. The regulations
also require pharmacies to print those specified elements in
12-point font if requested by the patient. The regulations
require pharmacies to provide LEP patients with oral
translation services at the time a prescription is filled,
requires the board to post standardized directions for use,
translated in at least five non-English languages, for use by
pharmacies, and requires the board to publish on its Web site
translation for specified directions for use into at least
five languages other than English, to assist California
Pharmacies. The Board will re-evaluate these regulations by
December 2013 to ensure optimal conformance.
3)SUPPORT . The Consumers Union (CU) supports this bill, which
it calls a common sense measure, essential to reducing
medication errors and fostering drug safety for California
patients. CU states that after extensive hearings and town
halls around the state, the National Association of Boards of
Pharmacy, and numerous consumer groups recognized that a
minimum 12-point type was crucial to patient safety. However,
according to supporters, the board instead voted to maintain a
10-point minimum. Regarding translation of drug labels, the
board settled on providing interpreter services "if
applicable." Supporters state that this bill will simply
require similar standards for patient-centered labels and
language interpretation that were originally proposed. CU
states that readable drug labels will reduce costly and
sometimes lethal medication errors.
4)OPPOSITION . The California Retailers Association and the
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National Association of Chain Drug Stores oppose this bill as
it undermines the legislative and regulatory processes and
imposes several new requirements on pharmacies that are costly
and currently not available in the market place. Regarding
the 12 point font requirement, opponents state that this
provision will impose significant costs on pharmacies and
unlike the recommendation of the Board, does not take into
account the difficulties of complying with such a requirement.
Additionally, opponents oppose to the translation
requirements in this bill, which they view as inappropriate
and may jeopardize patient safety.
5)DOUBLE REFERRAL . This bill has been double-referred. Should
this bill pass out of this committee, it will be referred to
the Assembly Committee on Business, Professions, and Consumer
Protection.
REGISTERED SUPPORT / OPPOSITION :
Support
Asian & Pacific Islander American Health Forum
California Alliance for Retired Americans
California Immigrant Policy Center
California Labor Federation
California Nurses Association/National Nurses Organizing
Committee
Consumers Union
National Health Law Program
Pan-Ethnic Health Network
Opposition
California Retailers Association
National Association of Chain Drug Stores
California Pharmacists Association
Safeway
Walgreens
Rite Aid
Analysis Prepared by : Martin Radosevich / HEALTH / (916)
319-2097
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