BILL ANALYSIS
SB 1390
Page 1
Date of Hearing: June 29, 2010
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Mary Hayashi, Chair
SB 1390 (Corbett) - As Amended: June 15, 2010
SENATE VOTE : 32-0
SUBJECT : Prescription drug labels.
SUMMARY : Repeals the requirement that the Board of Pharmacy
(BOP) promulgate regulations requiring a standardized,
patient-centered, prescription drug label on all prescription
medications dispensed to patients in California on or before
January 1, 2011, and establishes requirements for standardized,
patient centered prescription drug labels. Specifically, this
bill :
1)Deletes the requirement for BOP to promulgate regulations
requiring standardized, patient centered prescription drug
labels by January 1, 2011.
2)Requires BOP to promulgate any regulations necessary to
clarify the provisions of this bill.
3)Requires BOP to develop, collect, and publish on its Internet
Web site, by January 1, 2012:
a) Translations for directions for prescription medicine
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 State Department of Health
Care Services for translation in vital documents, as well
as any other primary languages for groups of 10,000 or more
with limited-English-proficient (LEP) persons in
California, to facilitate the use of those directions for
use by pharmacies in California; and,
b) Examples of labels conforming to the requirements
described in this bill to aid pharmacies in label design
and compliance.
4)Requires all prescription drug labels on all prescription
drugs dispensed to patients in California to conform to the
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following standardized, patient-centered format by January 1,
2012:
a) Each of the following elements shall be clustered into
one area of the label that comprises at least 50% of the
label. Each item shall be printed in at least a 12-point
sans serif typeface and highlighted in a bold typeface or
color, or use a blank space to set off, and listed in the
following order:
i) Patient's name;
ii) Drug's name and strength;
iii) Directions for use; and,
iv) Purpose or condition, if entered on the prescription
by the prescriber or otherwise known to the pharmacy.
b) The remaining elements required for the label, as well
as any other items of information appearing on the label or
the container, shall be printed so as not to interfere with
the legibility or emphasis of the primary elements
specified. These remaining elements may appear in any
style, font, and size typeface;
c) When applicable, directions for use shall utilize one of
the phrases indicated on BOP's Web site, and, when
appropriate, shall be in the language of the patient; and,
d) These requirements shall not apply to prescriptions
dispensed to a patient in a health facility, as specified,
if the prescriptions are administered by a licensed health
care professional. However, prescriptions dispensed to a
patient in a health facility that will not be 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.
5)States that nothing in this bill shall alter or diminish
existing statutory and regulatory informed consent, patients'
rights, or pharmaceutical labeling and storage requirements.
6)Requires a pharmacy to provide, by January 1, 2012, during all
hours when the pharmacy is open, competent interpreter
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services to each LEP patient in order to help an LEP
understand the information on his or her prescription drug
label. The interpreter services may 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. A pharmacy shall develop
written policies and procedures to carry out this requirement
by January 1, 2013.
7)Requires pharmacies, by January 1, 2012, to develop written
policies and procedures to help an LEP patient orally
understand the information on his or her prescription drug
label, including the directions for use, as specified. The
policies and procedures shall include, at a minimum, the means
to:
a) Identify and record the patient's oral and written
language;
b) Provide language assistance services, including
interpreter services and translation services;
c) Train pharmacy staff on the policies and procedures;
d) Provide clear and prominent notice to LEP patients about
the availability of free language assistance services; and,
e) Monitor and update the relevant policies and procedures.
8)Requires pharmacies to provide an LEP patient with any other
written information relevant to the prescription drug in the
language of the LEP patient by January 1, 2013.
9)Defines the following terms for purposes of this bill:
a) "LEP" means a person who does not speak English as his
or her primary language, who has a limited ability to read,
write, speak, or understand English, and who can read,
speak, or understand a language other than English;
b) "Name of the drug" means the generic name of the drug
and, if applicable, the manufacturer's trade name; and,
c) "Appropriate dosage form" means the prescribed form of
the prescription medication and includes a pill, caplet,
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capsule, or tablet.
10)Makes legislative findings and declarations.
EXISTING LAW :
1)Provides for the licensure and regulation of the practice of
pharmacy by BOP.
2)Requires BOP 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
by January 1, 2011;
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
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 LEP patients and seniors; and,
vi) Technology requirements necessary to implement
the standards; and,
d) Report to the Legislature by January 1, 2013, the status
of implementation of the prescription drug label
requirements adopted pursuant to these requirements.
FISCAL EFFECT : Unknown
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COMMENTS :
Purpose of this bill . According to the author's office, "The
purpose of patient-centered prescription labeling is to protect
consumers from the serious consequences of medical errors when
they don't have the ability to read or understand prescription
drug labels. Seniors and consumers with LEP are especially
vulnerable to this problem."
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. SB 472 required BOP to adopt
regulations creating a patient-centered, standard format for
prescription drug labels that take into account the needs of
California patients, including seniors and LEP patients.
According to the author, the bill was intended to standardize
prescription drug labels to facilitate patient understanding,
thus reducing medication-related errors, increasing prescription
drug literacy, and improving the health, safety, and well-being
of consumers. To achieve this end, BOP was tasked with holding
public meetings statewide to seek information from groups
representing consumers, senior citizens, pharmacists, other
health care professionals, and other interested parties, and to
consider their needs when adopting regulations.
In May 2008, BOP developed an open-ended prescription label
survey for distribution at public outreach events. A total of
606 consumers completed the surveys.
When asked what to change on the prescription label, the top
responses were:
1)Print should be larger or darker = 30.1%
2)Nothing needs to be changed on the label =24.6%
3)Include purpose of drug = 12%
BOP concluded that most consumers requested larger/bolder type
font on prescription labels to increase readability. Many
participants suggested that if a generic drug is provided, the
prescription label should state the name of the generic drug
name AND the brand-name it is generic for. They also noted that
color printing and highlighting on labels brings attention to
important information. Some participants suggested that the
labels themselves be color-coded to help differentiate between
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multiple medications and family members. Many consumers want to
know 'what the drug is for' and suggested that 'purpose of drug'
be printed directly on prescription labels.
Font size emerged as critical issue during the meetings between
industry and consumer advocates, with industry preferring a
10-point standard, and consumer groups requesting 12-point font.
The public sent more than 1,000 pages of letters to BOP urging
the adoption of a larger text requirement on drug labels.
BOP approved regulations that detailed the following on June 10,
2010:
1)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:
a) Name of the patient;
b) Name of the drug;
c) Strength of the drug;
d) Directions for use; and,
e) Purpose or condition, if entered onto the prescription
by the prescriber.
2)For added emphasis, the label shall also highlight in bold or
color, or use blank space to set off the items listed.
3)Pharmacies must:
a) Print specified elements in 12-point font if requested
by the patient; and,
b) Provide LEP patients with oral translation services at
the time a prescription is filled.
4)BOP must:
a) Post standardized directions for use, translated in at
least five non-English languages, for use by pharmacies;
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b) Publish on its Web site translation for specified
directions for use into at least five languages other than
English.
The author argues that the final regulations did not reflect
BOP's findings from the public hearings, and thus BOP's
regulation package does not achieve the goal of its enabling
legislation. Opponents argue that they, in good faith,
negotiated the final regulation package with BOP and the
regulations reflect the input of all stakeholders. Further,
they state, because the purpose of SB 472 has been effectuated
through this complete, legal, and public, process, this
legislation is unnecessary.
Arguments in support . The California Alliance for Retired
Americans write, "[This bill] establishes meaningful
patient-centered prescription labeling in California.
Patient-centered prescription labeling protects consumers from
the serious consequences of medical errors when they don't have
the ability to read or understand prescription drug labels.
Seniors, who represent over 48% of the prescription drug users
in California, and [LEP consumers] are especially vulnerable to
this problem.
"We look forward to the day when seniors and [LEP consumers] are
provided these simple protections that will save lives and save
our state money by avoiding costly trips to the doctor or
emergency room to remedy a medical error."
Arguments in opposition . The California Retailers Association
and the National Association of Chain Drug Stores write, "We
oppose this measure for two principle reasons: first, it
undermines the integrity of both the legislative and regulatory
processes; and second, this measure seeks to impose a number of
new requirements that are extremely costly or currently not
available in the marketplace, jeopardize pharmacists and
pharmacies' licenses and pose significant safety risks to
consumers.
"SB 472 required BOP to consider improved directions for use,
improved font sizes and types, placement of information that is
patient-centered, needs of LEP patients, needs of seniors and
the technology requirements needed to implement the standards
when developing the regulations. At no time did SB 472 mandate
the BOP adopt a minimum font size for prescription labels.
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Additionally, numerous provisions mandating the provision of
either oral translation services or written translated labels
were stricken from the bill because of numerous concerns about
patient safety and pharmacist/pharmacy liability. Pharmacy
stakeholders worked with Senator Corbett on SB 472 and
ultimately supported the measure that sent the issue to the
Board of Pharmacy, the appropriate regulatory board, for the
development of regulations."
Previous legislation . SB 472 (Corbett), Chapter 470, Statutes
of 2007, required BOP to adopt regulations to establish a
patient-centered, standard format for prescription drug labels
that will take into account the needs of California patients,
including seniors and LEP patients.
REGISTERED SUPPORT / OPPOSITION :
Support
California Pan-Ethnic Health Network (sponsor)
California Alliance for Retired Americans
Consumer's Union
Opposition
The California Retailers Association
The Civil Justice Association
Medco Health Solutions, Inc.
National Association of Chain Drug Stores
Analysis Prepared by : Sarah Weaver / B.,P. & C.P. / (916)
319-3301