BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | AB 1073|
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THIRD READING
Bill No: AB 1073
Author: Ting (D)
Amended: 7/8/15 in Senate
Vote: 21
SENATE BUS, PROF. & ECON. DEV. COMMITTEE: 7-0, 7/6/15
AYES: Hill, Bates, Berryhill, Block, Galgiani, Jackson,
Mendoza
NO VOTE RECORDED: Hernandez, Wieckowski
SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8
ASSEMBLY FLOOR: 76-0, 5/14/15 - See last page for vote
SUBJECT: Pharmacy: prescription drug labels
SOURCE: Board of Pharmacy
DIGEST: This bill requires a dispenser, upon the request of a
patient or patients representative, to provide translated
directions for use, authorizes a dispenser to use translations
made available by the Board of Pharmacy (Board), and requires a
dispenser to be responsible for the accuracy of the
English-language directions for use provided to a patient and
clarifies that veterinarians are not subject to these
provisions.
ANALYSIS:
Existing law:
1)Requires that each prescription dispensed by a pharmacist must
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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 or patients.
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 of the drug or drugs dispensed.
h) The quantity of the drug or drugs dispensed.
i) The expiration date of the effectiveness of the drug
dispensed.
j) The condition for which the drug was prescribed if
requested by the patient and the condition is indicated on
the prescription.
aa) The physical description of the dispensed medication,
including its color, shape, and any identification code
that appears on the tablets or capsules. (Business and
Professions Code (BPC) § 4076)
2)Requires the Board to promulgate regulations for a
standardized, patient-centered, prescription drug label on all
prescription medication dispensed in the state. (BPC § 4076.5
(a))
3)Requires the Board, when considering the requirements for
prescription labels, to consider:
a) Medical literacy research.
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b) Improved directions for use.
c) Improved font types and sizes.
d) Placement of information that is patient-centered.
e) The needs of patients with limited English proficiency.
f) The needs of senior citizens.
g) Technology requirements necessary to implement the
standards. (BPC § 4076.5 (c))
4)Establishes the Dymally-Alatorre Bilingual Services Act (Act)
which requires each state agency to conduct a survey, related
to its bilingual services, of each of its statewide offices
which render services to the public every two years to
determine specified information, and to report results and any
additional information requested to the California Department
of Human Resources (CalHR). Requires the survey to contain a
detailed description of complaints regarding language access
received by the agency. The Act also requires each agency
that serves a substantial number of non-English-speaking
people who comprise 5% or more of the people served to develop
an implementation plan, as specified, in every odd-numbered
year, and to submit the implementation plan to the department
for its review. Additionally, the Act requires CalHR, if it
determines that a state agency has not made reasonable
progress toward complying with the Act, to issue orders that
it deems appropriate to effectuate the purposes of the Act.
(Government Code (GC) § 7290 et seq.)
5)Stipulates that, by July 1, 2015, a state agency subject to
the Act must translate and make accessible on the homepage of
its Internet Web site, forms and processes for submitting
complaints of alleged violations of the Act. Also, requires
that the forms and processes be translated into all languages
spoken by a substantial number of non-English speaking people
served by the state agency. In addition, requires that
translated copies of the forms must be printed and made
available in the statewide office and any local office of the
state agency. (GC § 7299.3)
This bill:
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1)Requires a dispenser, upon the request of a patient or
patient's representative, to provide translated directions for
use printed on the prescription container, label, or on a
supplemental document.
2)Authorizes a dispenser to use translations made available by
the Board but does not require a dispenser to provide
translated directions for use beyond the language that the
Board has made available or beyond the directions that the
Board has made available in translated form.
3)Requires a dispenser to be responsible for the accuracy of the
English-language directions for use provided to a patient.
4)Clarifies that dispenser does not include a veterinarian, for
purposes of these requirements.
Background
State government agency efforts to serve California's limited
English proficient (LEP) population. The Dymally-Alatorre
Bilingual Services Act ensures that all residents, including
those who are LEP, have equal access to public services. The Act
requires every state and local agency to have a sufficient
number of qualified bilingual staff and translated written
materials so that the LEP population they serve are able to
effectively access and communicate with government. The Act
became law in 1973 with the legislative intent of ensuring
people are not precluded from accessing public services because
of language barriers. It requires agencies to provide the same
information that is available in English in other languages if
the agency services a "substantial number" of non-English
speakers.
Medication errors and legislative response. According to the
Journal of the American Medical Association, 46 percent of
adults cannot understand the information listed on their
prescription drug labels. Furthermore, the Institute of
Medicine of the National Academies indicates that medication
errors are among the most common medical errors, harming at
least 1.5 million people annually. Families USA reports that 90
percent of Medicare patients take medications for chronic
conditions with nearly half of them taking five or more
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medications a day. Given the large numbers of prescriptions
that may be prescribed, it is not easily discernable 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." 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.
Implementation of a standardized prescription drug label and
translation efforts by the Board of Pharmacy. 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 of 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's regulation, contained in
Title 16 California Code of Regulations Section 1707.5 -
"Requirements For Patient-Centered Prescription Container
Labels" outlines that 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: 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, 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 and 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.
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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.
The Board also promulgated a regulation to amend its Notice to
Consumers poster which has also been printed in six additional
languages: Chinese, Korean, Russian, Spanish, Tagalog, and
Vietnamese, and which is available upon request from the Board
or available for download from the Board's website. Pharmacies
are also authorized to request Board approval of another format
or display methodology. The Board also developed a "Point to
Your Language" poster, which is required to be posted in
pharmacies at or adjacent to the pharmacy counter so that
consumers can point to a language to receive interpreter
services. The "Point to Your Language" text is printed in 12
languages: Arabic, Cambodian, Farsi, Korean, Russian, Tagalog,
Armenian, Cantonese, Hmong, Mandarin, Spanish and Vietnamese. A
Board project supported by The California Endowment, in an
effort to support quality labels for those who do not read
English, relied on national patient literacy researchers to
develop and vet translations of the Board's standardized
directions for use as outlined in the patient-centered label
regulation. Those translations are available on the Board's
website.
The author and supporters of this bill believe that LEP
individuals who receive translated standardized directions for
use are more likely to take a single prescription medication
appropriately, dose more medications correctly in a multi-drug
regimen, and simplify medication use by consolidating when pills
should be taken but they are concerned that there is no existing
law that requires dispensers to provide patients with translated
directions for use and that although translations have been
posted in Chinese, Korean, Russian, Spanish, and Vietnamese,
they have not been widely adopted by pharmacies.
FISCAL EFFECT: Appropriation: No Fiscal
Com.:YesLocal: Yes
SUPPORT: (Verified8/18/15)
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Board of Pharmacy (source)
American Federation of State, County and Municipal Employees
Asian Americans Advancing Justice-Los Angeles
California Healthy Nail Salon Collaborative
California Immigrant Policy Center
California Pan-Ethnic Health Network
California Retailers Association
Greenlining Institute
Health Access California
Justice in Aging, Asian Health Services
Latino Coalition for a Health California
Rite Aid Pharmacy
Southeast Asia Resource Action Center
The City Project
Touro University of California
OPPOSITION: (Verified8/18/15)
None received
ARGUMENTS IN SUPPORT: Supporters cite studies that show that
a large percentage of patients misunderstand dosage instructions
on their labels and estimate that at least 1.5 million Americans
are sickened, injured, or killed each year because of medication
errors, which are only exacerbated for California's LEP
patients. Supporters believe that this lack of understanding
results in an increased risk of adverse drug reactions and
non-compliance with drug regimens and support this bill as a
means to reduce medical errors, increase patient compliance, and
meet the needs of LEP patients.
ASSEMBLY FLOOR: 76-0, 5/14/15
AYES: Achadjian, Alejo, Travis Allen, Baker, Bigelow, Bloom,
Bonilla, Bonta, Brough, Brown, Burke, Calderon, Campos, Chang,
Chau, Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dahle,
Daly, Dodd, Eggman, Frazier, Gallagher, Cristina Garcia,
Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray,
Grove, Hadley, Harper, Holden, Irwin, Jones, Jones-Sawyer,
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Kim, Lackey, Levine, Linder, Lopez, Low, Maienschein, Mathis,
Mayes, McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte,
O'Donnell, Olsen, Perea, Quirk, Ridley-Thomas, Rodriguez,
Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting,
Wagner, Waldron, Weber, Wilk, Williams, Wood, Atkins
NO VOTE RECORDED: Beth Gaines, Roger Hernández, Patterson,
Rendon
Prepared by:Sarah Mason / B., P. & E.D. / (916) 651-4104
8/19/15 20:42:56
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