BILL ANALYSIS �
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|SENATE RULES COMMITTEE | SB 205|
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VETO
Bill No: SB 205
Author: Corbett (D)
Amended: 9/6/13
Vote: 21
SENATE BUSINESS, PROF. & ECON. DEVELOP. COMM : 6-0, 4/22/13
AYES: Price, Block, Corbett, Hernandez, Hill, Padilla
NO VOTE RECORDED: Emmerson, Galgiani, Wyland, Yee
SENATE APPROPRIATIONS COMMITTEE : 5-0, 5/13/13
AYES: De Le�n, Hill, Lara, Padilla, Steinberg
NO VOTE RECORDED: Walters, Gaines
SENATE FLOOR : 23-9, 5/16/13
AYES: Beall, Block, Calderon, Corbett, Correa, De Le�n,
DeSaulnier, Evans, Hancock, Hernandez, Hill, Hueso, Jackson,
Lara, Leno, Lieu, Liu, Padilla, Pavley, Roth, Steinberg, Wolk,
Wright
NOES: Anderson, Emmerson, Fuller, Gaines, Huff, Knight,
Nielsen, Wyland, Yee
NO VOTE RECORDED: Berryhill, Cannella, Galgiani, Monning,
Price, Walters, Vacancy, Vacancy
ASSEMBLY FLOOR : 47-27, 9/10/13 - See last page for vote
SENATE FLOOR : 24-12, 9/11/13
AYES: Beall, Block, Calderon, Corbett, Correa, De Le�n,
DeSaulnier, Evans, Galgiani, Hancock, Hernandez, Hill, Hueso,
Jackson, Lara, Leno, Monning, Padilla, Pavley, Roth,
Steinberg, Torres, Wolk, Wright
NOES: Anderson, Berryhill, Emmerson, Fuller, Gaines, Huff,
Knight, Nielsen, Vidak, Walters, Wyland, Yee
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NO VOTE RECORDED: Cannella, Lieu, Liu, Vacancy
SUBJECT : Prescription drugs: labeling
SOURCE : Author
DIGEST : This bill requires certain portions of the required
information on prescription labels, including the name of the
patient(s), to be printed in at least 12-point sans serif
typeface.
ANALYSIS :
Existing law:
1.Requires that each prescription dispensed by a pharmacist must
be in a container complying with state and federal law and
correctly labeled as specified, including (a) unless otherwise
ordered by the prescriber, the manufacturer's trade name of
the drug or the generic name and the name of the manufacturer,
as specified; (b) the directions for the use of the drug; (c)
the name of the patient(s); (d) the name of the prescriber, as
specified; (e) the date of issue; (f) the name and address of
the pharmacy, and prescription number or other means of
identifying the prescription; (g) the strength and quantity of
the drug(s) dispensed; (h) the expiration date of the
effectiveness of the drug dispensed; (i) the condition for
which the drug was prescribed if requested by the patient and
the condition is indicated on the prescription; and (j) the
physical description of the dispensed medication, including
its color, shape, and any identification code that appears on
the tablets or capsules.
2.Requires the Board of Pharmacy (Board) to promulgate
regulations on or before January 1, 2011, for a standardized,
patient-centered, prescription drug label on all prescription
medication dispensed in the state.
3.Requires the Board to hold public meetings statewide in order
to seek information on a standardized label from groups
representing consumers, seniors, pharmacists, the practice of
pharmacy, other health care professionals, and other
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interested parties.
4.Requires the Board, when considering the requirements for
prescription labels, to consider medical literacy research,
improved directions for use, improved font types and sizes,
placement of information that is patient-centered, the needs
of patients with limited English proficiency, the needs of
senior citizens, and technology requirements necessary to
implement the standards.
This bill:
1.Prohibits, beginning January 1, 2016, a pharmacist from
dispensing any prescription except in a container that meets
the requirements of state and federal law and is correctly
labeled with certain information required under existing law,
including the name of the patient(s) and printed in at least
12-point typeface.
2.Adds language to avoid chaptering conflicts with SB 493
(Hernandez).
Background
Medication errors and legislative response . According to the
Journal of the American Medical Association, 46% of adults
cannot understand the information listed on their prescription
drug labels. Furthermore, the Institute of Medicine of the
National Academies, medication errors are among the most common
medical errors, harming at least 1.5 million people annually and
senior citizens are especially vulnerable. Families USA reports
that 90% of Medicare patients take medications for chronic
conditions with nearly half of them taking five or more
medications a day. Given the large numbers of prescriptions
that may be prescribed, it is not easily discernible what the
purpose for each of these medications is. This increases the
chances that a patient may take the wrong medication increasing
the likelihood of serious injury or death.
SCR 49 (Speier, Resolution Chapter 123, Statutes of 2005)
established the Medication Errors Panel (Panel) which published
a report in March 2007 entitled "Prescription for Improving
Patient Safety: Addressing Medication Errors." The report
listed six general goals to reduce medication errors. Under
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each goal were recommendations (12 in all) and methods to
accomplish each recommendation. The Panel report states that
"the information that consumers need to know about their
medication is often complex and may include unfamiliar language
or concepts. Expecting a consumer to retain all the pertinent
knowledge from a brief verbal encounter may not be reasonable in
many instances." The Panel acknowledged that there are a
variety of factors which may increase an individual's risk for
experiencing a medication error. These include (1) low health
literacy; (2) limited English proficiency; (3) cultural
incongruence with healthcare providers; (4) physical, cognitive
and/or other impairments that make understanding and/or
complying with medication instructions difficult; (5) age at
either end of the age spectrum (the variability of a
medication's response, metabolism and dose increases in children
and seniors); (6) multiple medications; (7) multiple
prescribers; (8) non-prescription medication use (including
herbals, dietary supplements, alcohol, and tobacco); and (9)
medication procurement from more than one pharmacy including
mail-order. The Panel stated that these factors must be taken
into consideration in the development of any consumer education
efforts.
One bill was pursued in response to the Panel report - SB 472
(Corbett, Chapter 470, Statutes of 2007), the California Patient
Medication Safety Act, which sought to deal with the lack of
uniformity in prescription drug labels throughout the state and
the resulting confusion and medication errors that may arise.
Much of the conversation during the SB 472 debate focused on the
fact that individual pharmacies design and format their own
labels, resulting in a lack of standards across all pharmacies
which adversely affects medication users who are elderly, suffer
from poor vision, have difficulty reading and understanding
instructions on labels or have limited English proficiency.
The bill required the Board to promulgate regulations on or
before January 1, 2011 that require a standardized,
patient-centered, prescription drug label on all prescription
medicine dispensed to patients. Additionally, the Board was
required to report to the Legislature by January 1, 2010, on its
progress in implementing these regulations.
Font size . According to information provided by the author's
office, seniors are having difficulty reading the small print on
their prescription labels and, for those who take multiple
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medications, their inability to read the label puts them in
serious danger. Among adults 65 years of age or older, 40% take
five to nine medications and 18% take 10 or more medications.
Medications that are taken incorrectly or mixed with other
medications can cause adverse drug events that can lead to
injury and death.
The New England Journal of Medicine estimates that between 2007
and 2009, there were more than 260,000 emergency room visits for
adverse drug events in U.S. adults 65 years of age or older. Of
those, almost 100,000 required emergency hospitalizations, and
nearly two-thirds of those hospitalizations were due to
unintentional overdoses.
According to a study on The Variability and Quality of
Medication Container Labels published in the Archives of
Internal Medicine, September 10, 2007, the prescription
container label may play an important role in the appropriate
administration of prescription medication. The study identified
characteristics of container labels that improve readability and
understanding, including larger font, boldfacing and use of
white space to emphasize important details.
The United States Pharmacopeial Convention (USP), a scientific
nonprofit organization that sets standards for the identity,
strength, quality, and purity of medicines, recommends the use
of large font size to improve prescription label readability.
USP states that type smaller than size 10-point Times New Roman
should not be used on prescription labels, and suggests 12-point
Times New Roman or 11-point Arial.
Implementation of a standardized prescription drug label by the
Board . California is the first state to require redesigned
prescription container labels to emphasize information most
important to consumers - offering an element of safety and
consistency since prescription labels are the key source
patients' reference for information when taking medications in
their homes. Part of this current requirement also ensures that
oral interpreter services are available to limited English
speaking patients in pharmacies, to insure such patients have
access to information about how to take their medications.
The Board was charged promulgating regulations that require a
standardized, patient-centered prescription drug container label
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for all prescription drugs dispensed to patients in California.
The Board reported on its efforts in a January 2010 report to
the Legislature. The Board established the "SB 472 Medication
Label Subcommittee" in January 2008 to conduct public forums and
to work with organizations and individuals to develop
recommendations to implement the provisions of the law to
establish a patient-centered prescription drug label. In May
2008, the Board 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:
Print should be larger or darker = 30.1%
Nothing needs to be changed on the label = 24.6%
Include purpose of drug = 12%
The Board concluded that most consumers participating in the
survey requested larger and 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
multiple medications and family members. Many consumers
responded that they want to know 'what the drug is for' and
suggested that 'purpose of drug' be printed directly on
prescription labels.
The Board approved a regulation per the requirements set forth
in SB 472 after engaging in a lengthy process. The Board
conducted outreach, hearings and information gathering sessions
throughout 2008, to collect data from the public on prescription
labels and standards for those labels. The Board considered
testimony and information provided from the public, the
pharmaceutical industry, pharmacy professionals and literacy
subject matter experts on medical literacy research, improved
directions for use, improved font types and sizes, the placement
of information that is patient-centered, the needs of patients
with limited English proficiency, the needs of senior citizens,
and technology requirements necessary to implement the standards
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developed. Board members were also provided with research
articles on designing patient-centered labels. In 2009, the
Board discussed the requirements of the regulation at regularly
scheduled meetings.
Throughout early 2010, the Board held regulation hearings to
adopt the proposed regulation, a new section at Title 16
California Code of Regulations Section 1707.5 - "Requirements
For Patient-Centered Prescription Container Labels." The
regulation outlines that the following items 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: (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; and (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 regulation also requires 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: Yes
According to the Assembly Appropriations Committee, there are
minor and absorbable costs.
SUPPORT : (Verified 9/10/13)
California Alliance for Retired Americans
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California Commission on Aging
California Pan-Ethnic Health Network
California State Retirees, Chapter 1
Paramedics Plus
Pharmacists Planning Services, Inc.
Visi�n y Compromiso
OPPOSITION : (Verified 9/10/13)
California Board of Pharmacy
California Department of Consumer Affairs
California Department of Finance
California Grocers Association
California Pharmacists Association
National Association of Chain Drug Stores
ARGUMENTS IN SUPPORT : According to the author, "seniors are
having difficulty reading the small print on their prescription
labels and, for those who take multiple medications, their
inability to read the label puts them in serious danger." The
author's office states that among adults 65 years of age or
older, 40% take five to nine medications and 18% take ten or
more medications and that taking these incorrectly or mixed with
other medications can cause adverse drug events that can lead to
injury and death. The author's office also notes that The New
England Journal of Medicine estimates that between 2007 and
2009, there were more than 260,000 emergency room visits for
adverse drug events in U.S. adults 65 years of age or older. Of
those, almost 100,000 required emergency hospitalizations, and
nearly two-thirds of those hospitalizations were due to
unintentional overdoses.
ARGUMENTS IN OPPOSITION : The California Pharmacists
Association (CPhA) cites the reasonable balance that was struck
during the Board's exhaustive, collaborative rulemaking process
to implement a standardized label and lack of data indicating
that the existing regulations are insufficient to protect
patients. CPhA cites a Board report provided at a follow-up
Public Education and Communication Committee meeting which
detailed consumer complaints about the fact that non-key items
on the label, like number of remaining refills, were too crowded
on the label making them difficult to read. CPhA also notes
that labels are naturally limited in terms of space to provide
information and there is already required information that must
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occupy 50% of the label.
The California Grocers Association (CGA) states that the
typeface settings required by this bill are unworkable in a real
world setting. Existing law requires no fewer than 11 discrete
pieces of information to be placed on a prescription drug label.
In some situations, where a patient's use instructions are
non-standard, more detailed information must be included on the
label. According to CGA, requiring size 12-sans serif typeface
will force pharmacists to dispense some medications in very
large containers to accommodate a label large enough to include
all the required information.
GOVERNOR'S VETO MESSAGE:
"I am returning Senate Bill 205 without my signature.
The bill would require certain parts of a prescription drug's
label to be printed in at least 12-point typeface.
The Board of Pharmacy is required to provide an update of its
2010 labeling guidelines to the Legislature next month. I
prefer to wait for their findings before mandating such a
change."
ASSEMBLY FLOOR : 47-27, 9/10/13
AYES: Alejo, Ammiano, Atkins, Bloom, Bocanegra, Bonilla, Bonta,
Bradford, Brown, Campos, Chau, Chesbro, Cooley, Dickinson,
Eggman, Fong, Fox, Frazier, Garcia, Gomez, Gonzalez, Gordon,
Hall, Roger Hern�ndez, Holden, Jones-Sawyer, Levine,
Lowenthal, Medina, Mitchell, Mullin, Muratsuchi, Nazarian,
Pan, V. Manuel P�rez, Quirk, Quirk-Silva, Rendon, Salas,
Skinner, Stone, Ting, Weber, Wieckowski, Williams, Yamada,
John A. P�rez
NOES: Achadjian, Allen, Bigelow, Ch�vez, Conway, Dahle,
Donnelly, Beth Gaines, Gatto, Gorell, Gray, Grove, Hagman,
Harkey, Jones, Linder, Logue, Maienschein, Mansoor, Melendez,
Morrell, Nestande, Olsen, Patterson, Wagner, Waldron, Wilk
NO VOTE RECORDED: Buchanan, Ian Calderon, Daly, Perea, Vacancy,
Vacancy
MW:ndek 1/6/14 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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